Effectiveness of Digital Guided Self-help Mindfulness Training During Pregnancy on Maternal Psychological Distress and Infant Neuropsychological Development: Randomized Controlled Trial

Background Maternal psychological distress during pregnancy is associated with unfavorable outcomes in infants. Mindfulness-based interventions (MBIs) can effectively alleviate psychological distress, but there are often barriers to the access of face-to-face interventions. Objective This study aimed to investigate the effectiveness of a digital guided self-help (GSH) MBI (GSH-MBI) in reducing maternal psychological distress and improving infant neuropsychological performance. Methods This was a randomized controlled trial. We recruited 160 women who were 12 to 20 weeks pregnant and exhibited psychological distress. We randomized them into a digital GSH-MBI group and a control group (usual perinatal care). The digital GSH-MBI consisted of a 6-week intervention through a WeChat mini program, with a daily reminder sent to the participants by a research assistant via WeChat. The primary outcomes consisted of maternal psychological distress, including depression, anxiety, and pregnancy-related anxiety symptoms, which were assessed at 6 time points from baseline to 6 months post partum (only pregnancy-related anxiety symptoms were assessed 3 times during pregnancy). The secondary outcomes were infant neuropsychological outcomes, including temperament and developmental behaviors, which were assessed at 6 weeks and 6 months post partum. Results Compared with the control group, the digital GSH-MBI group showed a significant reduction in depression, anxiety, and pregnancy-related anxiety symptoms. In addition, the scores of the digital GSH-MBI group were lower than those of the control group for the 3 types of infant temperament at 6 weeks post partum, including quality of mood, distractibility, and adaptability. Conclusions Digital GSH-MBIs are effective in alleviating psychological distress among pregnant women and protecting infant outcomes. Trial Registration Chinese Clinical Trial Register ChiCTR2000040717; https://www.chictr.org.cn/showproj.aspx?proj=65376

CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form The CONSORT-EHEALTH checklist is intended for authors of randomized trials evaluating web-based and Internet-based applications/interventions, including mobile interventions, electronic games (incl multiplayer games), social media, certain telehealth applications, and other interactive and/or networked electronic applications. Some of the items (e.g. all subitems under item 5 -description of the intervention) may also be applicable for other study designs.
The goal of the CONSORT EHEALTH checklist and guideline is to be a) a guide for reporting for authors of RCTs, b) to form a basis for appraisal of an ehealth trial (in terms of validity) CONSORT-EHEALTH items/subitems are MANDATORY reporting items for studies published in the Journal of Medical Internet Research and other journals / scienti c societies endorsing the checklist.
As the CONSORT-EHEALTH checklist is still considered in a formative stage, we would ask that you also RATE ON A SCALE OF 1-5 how important/useful you feel each item is FOR THE PURPOSE OF THE CHECKLIST and reporting guideline (optional).
Mandatory reporting items are marked with a red *. In the textboxes, either copy & paste the relevant sections from your manuscript into this form -please include any quotes from your manuscript in QUOTATION MARKS, or answer directly by providing additional information not in the manuscript, or elaborating on why the item was not relevant for this study.
Is this a full powered effectiveness trial or a pilot/feasibility trial? * Manuscript tracking number * If this is a JMIR submission, please provide the manuscript tracking number under "other" (The ms tracking number can be found in the submission acknowledgement email, or when you login as author in JMIR. If the paper is already published in JMIR, then the ms tracking number is the four-digit number at the end of the DOI, to be found at the bottom of each published article in JMIR) TITLE AND ABSTRACT 1a) TITLE: Identification as a randomized trial in the title yes 其他: subitem not at all important 1 2 3 4 5 essential 1a) Does your paper address CONSORT item 1a? * I.e does the title contain the phrase "Randomized Controlled Trial"? (if not, explain the reason under "other") 1a-i) Identify the mode of delivery in the title Identify the mode of delivery. Preferably use "web-based" and/or "mobile" and/or "electronic game" in the title. Avoid ambiguous terms like "online", "virtual", "interactive". Use "Internet-based" only if Intervention includes non-web-based Internet components (e.g. email), use "computer-based" or "electronic" only if o ine products are used. Use "virtual" only in the context of "virtual reality" (3-D worlds). Use "online" only in the context of "online support groups". Complement or substitute product names with broader terms for the class of products (such as "mobile" or "smart phone" instead of "iphone"), especially if the application runs on different platforms.

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Does your paper address subitem 1a-i? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, it is "a digital self-help mindfulness training" 1a-ii) Non-web-based components or important co-interventions in title Mention non-web-based components or important co-interventions in title, if any (e.g., "with telephone support").

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Does your paper address subitem 1a-ii?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study No, we provided only perinatal care for participants in both intervention and control group, which are not an important component for this trail.
1a-iii) Primary condition or target group in the title Mention primary condition or target group in the title, if any (e.g., "for children with Type I Diabetes") Example: A Web-based and Mobile Intervention with Telephone Support for Children with Type I Diabetes: Randomized Controlled Trial 清除所选内容 Does your paper address subitem 1a-iii? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study 1b) ABSTRACT: Structured summary of trial design, methods, results, and conclusions NPT extension: Description of experimental treatment, comparator, care providers, centers, and blinding status.
subitem not at all important 1 2 3 4 5 essential 1b-i) Key features/functionalities/components of the intervention and comparator in the METHODS section of the ABSTRACT Mention key features/functionalities/components of the intervention and comparator in the abstract. If possible, also mention theories and principles used for designing the site. Keep in mind the needs of systematic reviewers and indexers by including important synonyms. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) 清除所选内容 Does your paper address subitem 1b-i? * Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes. The key intervention is " a six-week intervention through a WeChat mini program, with a daily reminder sent to participants by a research assistant via WeChat".
subitem not at all important 1 2 3 4 5 essential 1b-ii) Level of human involvement in the METHODS section of the ABSTRACT Clarify the level of human involvement in the abstract, e.g., use phrases like "fully automated" vs. "therapist/nurse/care provider/physician-assisted" (mention number and expertise of providers involved, if any). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) 清除所选内容 Does your paper address subitem 1b-ii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes. The intervention is " a six-week intervention through a WeChat mini program, with a daily reminder sent to participants by a research assistant via WeChat".
subitem not at all important 1 2 3 4 5 essential 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT Mention how participants were recruited (online vs. o ine), e.g., from an open access website or from a clinic or a closed online user group (closed usergroup trial), and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment). Clearly say if outcomes were self-assessed through questionnaires (as common in web-based trials). Note: In traditional o ine trials, an open trial (open-label trial) is a type of clinical trial in which both the researchers and participants know which treatment is being administered. To avoid confusion, use "blinded" or "unblinded" to indicated the level of blinding instead of "open", as "open" in web-based trials usually refers to "open access" (i.e. participants can self-enrol). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) 清除所选内容 Does your paper address subitem 1b-iii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Participant were recruited offline. We gathered information on all maternal and infant neuropsychological outcomes using printed questionnaires and computer/smartphoneassisted self-administered surveys. The manuscript has been submitted. Thus, we won't be able to upload a new manuscript. We would like to update the abstract if we get the opportunity to revise it after peer review. essential 1b-iv) RESULTS section in abstract must contain use data Report number of participants enrolled/assessed in each group, the use/uptake of the intervention (e.g., attrition/adherence metrics, use over time, number of logins etc.), in addition to primary/secondary outcomes. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) 清除所选内容 Does your paper address subitem 1b-iv?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "We recruited 160 women who were at 12-20 weeks of pregnancy and exhibited psychological distress. " Among 160 participants, 135 completed the assessment at 6 months postpartum: 11 participants dropped out from the intervention group, and 14 from the control group (dropout rate: 15.6 %). A total of 65 participants completed the intervention (intervention completion rate: 81.25 %). The manuscript has been submitted. Thus, we won't be able to upload a new manuscript. We would like to update the abstract if we get the opportunity to revise it after peer review. Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study No, the manuscript has been submitted. Thus, we won't be able to upload a new manuscript. We would like to update the abstract if we get the opportunity to revise it after peer review.

2a-i) Problem and the type of system/solution
Describe the problem and the type of system/solution that is object of the study: intended as stand-alone intervention vs. incorporated in broader health care program? Intended for a particular patient population? Goals of the intervention, e.g., being more cost-effective to other interventions, replace or complement other solutions? (Note: Details about the intervention are provided in "Methods" under 5) Does your paper address subitem 2a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes.
The main problems in this area are: 1) "Previous studies have preliminarily identified the potential of MBIs during pregnancy [6,7], although most of these studies were non-randomized controlled pilot trials, or had high dropout rates and poor compliance. More robust evidence in future research is necessary [8]. In addition, pregnant women frequently encounter practical and psychosocial barriers to accessing face-to-face psychological interventions, especially in low-and middle-income countries (LMICs) [9]. These barriers include a lack of professional staff who can facilitate psychological interventions, cost concerns, and stigma related to mental disorders [10,11]. " 2) "The application of digital GSH-MBIs in pregnancy is still in its infancy. Two preliminary randomized controlled trials (RCTs) involving pregnant women have used digital MBIs; one was a pilot study [17], and the other had a very low completion rate [18]. " 3) "Although the impact of psychological distress during pregnancy on infant neurodevelopment outcomes was discovered years ago, there has been little progress made in addressing this problem [23]. Limited studies have investigated the effects of maternal face-to-face psychological interventions on child development. Among the three RCTs that investigated the ripple effect of cognitive-behavioral therapy during pregnancy on child outcomes, two [23,24] had small sample sizes (N = 29 and N = 25) and the third one [25] found no beneficial effects on maternal psychological distress and child outcomes. In addition, the "Thinking Healthy Program" [26], which was a perinatal psychological intervention, showed a very limited effect on child neurodevelopment. However, the intervention program mainly focused on the postpartum period. Therefore, it is unclear whether psychological interventions can affect infant outcomes by ameliorating maternal psychological distress during pregnancy, and more well-designed RCTs are needed." The target population of this study is pregnant women with depressive or anxiety symptoms. Goal of the intervention is " to investigate the effectiveness of a digital guided self-help (GSF)-MBI in reducing maternal psychological distress and improving infant neuropsychological performance." Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes.
What we have know about mindfulness intervention during pregnancy: "Mindfulness-based interventions (MBIs) teach participants to recognize habitual patterns of response, to be more mindful in their daily lives, and to make changes in how they relate to their thoughts, feelings, bodily sensations, and external environments [5]. Previous studies have preliminarily identified the potential of MBIs during pregnancy [6,7], although most of these studies were non-randomized controlled pilot trials, or had high dropout rates and poor compliance. More robust evidence in future research is necessary. " What we have know about the effects of maternal face-to-face psychological interventions on child development: "Among the three RCTs that investigated the ripple effect of cognitivebehavioral therapy during pregnancy on child outcomes, two [23,24] had small sample sizes (N = 29 and N = 25) and the third one [25] found no beneficial effects on maternal psychological distress and child outcomes. In addition, the "Thinking Healthy Program" [26], which was a perinatal psychological intervention, showed a very limited effect on child neurodevelopment. However, the intervention program mainly focused on the postpartum period." Motivation for the study: "In recent years, we have developed three generations of a digital GSH-MBI targeting psychological distress during pregnancy. The first generation [19] involved WeChat as the intervention medium. With a small sample size and a high dropout rate, we did not find effectiveness in reducing depression and anxiety in pregnant women. To increase the retention rate, the second-generation [9] applied a smartphone app as the intervention medium. However, there were still a high dropout rate and a low completion rate, which may explain the small effect size detected only immediately after the intervention." "Therefore, it is unclear whether psychological interventions can affect infant outcomes by ameliorating maternal psychological distress during pregnancy, and more well-designed RCTs are needed." METHODS 3a) Description of trial design (such as parallel, factorial) including allocation ratio 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons Does your paper address CONSORT subitem 2b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes. "Our first aim was to examine the effect of the digital GSH-MBI based on a WeChat mini program on reducing psychological distress (i.e., depression, anxiety, and pregnancy-related anxiety symptoms) among pregnant women, with a relatively large sample size and approximately one-year follow-up. Our second aim was to explore the ripple effect of our digital GSH-MBI on infant neuropsychological outcomes. If the ripple effect existed, we would further analyze whether the ripple effect was correlated with reduced depression, anxiety, or pregnancy-related anxiety symptoms in pregnant women." Does your paper address CONSORT subitem 3a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes. "This study was a two-arm, parallel RCT. Eligible participants who agreed to participate were randomized 1:1 to one of two groups: the digital GSH-MBI group (i.e., usual perinatal care and mindfulness intervention) or the control group (i.e., usual perinatal care) according to the random numbers in the envelopes."

3b-i) Bug fixes, Downtimes, Content Changes
Bug xes, Downtimes, Content Changes: ehealth systems are often dynamic systems. A description of changes to methods therefore also includes important changes made on the intervention or comparator during the trial (e.g., major bug xes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have in uenced study design such as staff changes, system failures/downtimes, etc. [2].

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Does your paper address subitem 3b-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study no change related to intervention content was made. subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 4a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes. "The inclusion criteria were as follows: age of 18 and older; single pregnancy; 12 to 20 weeks of gestation; Edinburgh Postnatal Depression Scale (EPDS) scores ≥9 or Generalized Anxiety Disorder 7-item (GAD-7) scale scores ≥5; fluency in reading and writing Chinese; no participation in a psychological intervention; and able to access the WeChat mini program. We excluded participants if they had suicidal ideations (EPDS item 10 scores ≥1), serious mental disorders (e.g., schizophrenia, bipolar disorder), or physical illnesses (e.g., cancer, cardiovascular or cerebrovascular diseases), drug abuse or dependence, or prior experiences in mindfulness exercises."

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clari ed.

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Does your paper address subitem 4a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes. Participants need to be " able to access the WeChat mini program." 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. o ine), e.g., from an open access website or from a clinic, and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email con rmation, phone calls) were used to detect/prevent these.

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Does your paper address subitem 4a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes. "We gathered information on all maternal and infant neuropsychological outcomes using printed questionnaires and computer/smartphone-assisted self-administered surveys." 4a-iii) Information giving during recruitment Information given during recruitment. Specify how participants were briefed for recruitment and in the informed consent procedures (e.g., publish the informed consent documentation as appendix, see also item X26), as this information may have an effect on user self-selection, user expectation and may also bias results. Does your paper address subitem 4a-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study 您的回答 Does your paper address CONSORT subitem 4b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes. "The participants were pregnant women who received routine obstetric exams at the outpatient centers of two comprehensive tertiary hospitals in Shandong Province from December 2020 to April 2021." 4b-i) Report if outcomes were (self-)assessed through online questionnaires Clearly report if outcomes were (self-)assessed through online questionnaires (as common in web-based trials) or otherwise. subitem not at all important 1 2 3 4 5 essential 5) The interventions for each group with sufficient details to allow replication, including how and when they were actually administered Does your paper address subitem 4b-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "We gathered information on all maternal and infant neuropsychological outcomes using printed questionnaires and computer/smartphone-assisted self-administered surveys. " 4b-ii) Report how institutional affiliations are displayed Report how institutional a liations are displayed to potential participants [on ehealth media], as a liations with prestigious hospitals or universities may affect volunteer rates, use, and reactions with regards to an intervention.(Not a required item -describe only if this may bias results) 清除所选内容 Does your paper address subitem 4b-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study essential 5-i) Mention names, credential, affiliations of the developers, sponsors, and owners Mention names, credential, a liations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Con ict of interest" section or mentioned elsewhere in the manuscript).

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Does your paper address subitem 5-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study 您的回答 5-ii) Describe the history/development process Describe the history/development process of the application and previous formative evaluations (e.g., focus groups, usability testing), as these will have an impact on adoption/use rates and help with interpreting results. subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study 您的回答

5-iii) Revisions and updating
Revisions and updating. Clearly mention the date and/or version number of the application/intervention (and comparator, if applicable) evaluated, or describe whether the intervention underwent major changes during the evaluation process, or whether the development and/or content was "frozen" during the trial. Describe dynamic components such as news feeds or changing content which may have an impact on the replicability of the intervention (for unexpected events see item 3b).

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Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.

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Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study 您的回答 5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screencapture video, and/or providing owcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scienti c reporting. subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-v?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study 您的回答

5-vi) Digital preservation
Digital preservation: Provide the URL of the application, but as the intervention is likely to change or disappear over the course of the years; also make sure the intervention is archived (Internet Archive, webcitation.org, and/or publishing the source code or screenshots/videos alongside the article). As pages behind login screens cannot be archived, consider creating demo pages which are accessible without login.

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Does your paper address subitem 5-vi?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study

5-vii) Access
Access: Describe how participants accessed the application, in what setting/context, if they had to pay (or were paid) or not, whether they had to be a member of speci c group. If known, describe how participants obtained "access to the platform and Internet" [1]. To ensure access for editors/reviewers/readers, consider to provide a "backdoor" login account or demo mode for reviewers/readers to explore the application (also important for archiving purposes, see vi).

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Does your paper address subitem 5-vii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Participants who were allocated to digital GSH-MBI received WeChat mini program and invitation code to of mini program. The mini program is free and they do not need to be a member of specific group. Logs of practice on formal practice were recorded in the backend. The manuscript has been submitted. Thus, we won't be able to upload a new manuscript. We would like to added the information if we get the opportunity to revise it after peer review.

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Does your paper address subitem 5-viii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes. " The intervention program included 6 modules and each module lasted for 1 week, which were delivered on a WeChat mini program developed by the research team. Each module consisted of thematic lessons and homework (formal and informal practice). On the first day of each week, participants viewed animated videos that gave thematic lessons of each module. Each video was 10-20 minutes long, including a variety of cartoon images and mindfulness practice demonstrations recorded by our research team. We hoped this would increase participants' interest in the course content and improve their compliance. For the remaining 6 days of each week, participants were asked to do homework, including formal and informal practice. The formal practice involved daily audio-based practice such as mindful breathing and body scans. Participants were also encouraged to engage in informal practice daily, such as mindfulness in everyday life or 3-minute breathing space exercises. Participants in the intervention group were sent standardized practice reminders every day by the research assistant via WeChat. The content of the reminder was, "Ding ~ remember to attend class! Today is week X, day X." Supplementary Table 2 illustrates the program outline. Figure 1 shows a screenshot of the mini program. " subitem not at all important 1 2 3 4 5 essential 5-ix) Describe use parameters Describe use parameters (e.g., intended "doses" and optimal timing for use). Clarify what instructions or recommendations were given to the user, e.g., regarding timing, frequency, heaviness of use, if any, or was the intervention used ad libitum.
Does your paper address subitem 5-ix?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes. " The intervention program included 6 modules and each module lasted for 1 week, which were delivered on a WeChat mini program developed by the research team. Each module consisted of thematic lessons and homework (formal and informal practice). On the first day of each week, participants viewed animated videos that gave thematic lessons of each module. Each video was 10-20 minutes long, including a variety of cartoon images and mindfulness practice demonstrations recorded by our research team. We hoped this would increase participants' interest in the course content and improve their compliance. For the remaining 6 days of each week, participants were asked to do homework, including formal and informal practice. The formal practice involved daily audio-based practice such as mindful breathing and body scans. Participants were also encouraged to engage in informal practice daily, such as mindfulness in everyday life or 3-minute breathing space exercises. Participants in the intervention group were sent standardized practice reminders every day by the research assistant via WeChat. The content of the reminder was, "Ding ~ remember to attend class! Today is week X, day X." Supplementary Table 2 illustrates the program outline. Figure 1 shows a screenshot of the mini program. "

5-x) Clarify the level of human involvement
Clarify the level of human involvement (care providers or health professionals, also technical assistance) in the e-intervention or as co-intervention (detail number and expertise of professionals involved, if any, as well as "type of assistance offered, the timing and frequency of the support, how it is initiated, and the medium by which the assistance is delivered". It may be necessary to distinguish between the level of human involvement required for the trial, and the level of human involvement required for a routine application outside of a RCT setting (discuss under item 21 -generalizability).

Does your paper address subitem 5-x?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes. "Participants in the intervention group were sent standardized practice reminders every day by the research assistant via WeChat." 5-xi) Report any prompts/reminders used Report any prompts/reminders used: Clarify if there were prompts (letters, emails, phone calls, SMS) to use the application, what triggered them, frequency etc. It may be necessary to distinguish between the level of prompts/reminders required for the trial, and the level of prompts/reminders for a routine application outside of a RCT setting (discuss under item 21 -generalizability). subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 6a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes. "The primary outcome was maternal psychological distress, including symptoms of depression, anxiety, and pregnancy-related anxiety. We assessed depression and anxiety using the EPDS [28] and , respectively, at baseline (12 to 20 weeks of gestation, T1), immediately after the intervention (about 20 to 28 weeks of gestation, T2), before birth (36 to 37 weeks of gestation, T3), and at 6 weeks (T4), 3 months (T5), and 6 months postpartum (T6). Symptoms of pregnancy-related anxiety refer to symptoms specific to pregnancy, including concerns about the health of the baby and oneself, as well as concerns about childbirth [30]. We assessed symptoms of pregnancy-related anxiety at T1, T2, and T3, using the pregnancy-related anxiety scale [30]. Secondary outcomes were infant neuropsychological outcomes, including temperament and developmental behaviors. We assessed infant temperament at six weeks postpartum using the Early Infancy Temperament Questionnaire (EITQ) [31,32], which is suitable for infants aged 1 to 4 months. It consists of 76 items and 9 dimensions, including activity level, rhythmicity, approach, intensity of reaction, quality of mood, attention span, distractibility, intensity of reaction, and adaptability. Higher scores reflect more activities, worse rhythm, easier withdrawal, a more negative mood, less persistence, less distraction, lower intensity of reaction, and slower adaptation. We assessed infant temperament at six months postpartum using the Very Short Form of the Infant Behavior Questionnaire-Revised (IBQ-R) [33], which is suitable for infants aged more than 3 months. It consists of 3 dimensions, including surgency, negative affect, and effortful control. We measured infant developmental behaviors at six weeks and six months postpartum using the Age and Stages Questionnaires-Third Edition (ASQ-3) [34]. The ASQ-3 assesses the development of five functional areas in infants: communication, gross motor skills, fine motor skills, problemsolving, and individual-social aspects, with higher scores indicating better developmental behaviors. Both infant temperament and developmental behaviors were rated by the mothers. " 6a-i) Online questionnaires: describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed subitem not at all important 1 2 3 4 5 essential 7b) When applicable, explanation of any interim analyses and stopping guidelines 7a-i) Describe whether and how expected attrition was taken into account when calculating the sample size Describe whether and how expected attrition was taken into account when calculating the sample size.

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Does your paper address subitem 7a-i?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes. "We used G* Power software to calculate the sample size. As reported in previous studies, the mindfulness intervention among pregnant women revealed a medium effect size for anxiety and depression [6], and the effect sizes of the self-help intervention for depression and anxiety were small to medium [27]. Based on a medium intervention effect (Cohen's d = 0.50), an estimated total sample size of 128 was needed to achieve 80% power and a two-sided P < 0.05. Considering a 20 % attrition rate, a total of 160 participants were included in the study." Does your paper address CONSORT subitem 7b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study No interim analyses was made in the formal trail. 8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group 8b) Type of randomisation; details of any restriction (such as blocking and block size) 9) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned Does your paper address CONSORT subitem 8a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes. " Random sequences were generated via a computerized random number generator. Random numbers were placed in opaque envelopes and were assigned to participants according to the sequence of participant enrollment." Does your paper address CONSORT subitem 8b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This trial used a simple randomization approach. The manuscript has been submitted. Thus, we won't be able to upload a new manuscript. We would like to added the information if we get the opportunity to revise it after peer review.
10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 11a) If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment Does your paper address CONSORT subitem 9? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes. " Random sequences were generated via a computerized random number generator. Random numbers were placed in opaque envelopes and were assigned to participants according to the sequence of participant enrollment." Does your paper address CONSORT subitem 10? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Sequence generation and randomization of participants were made by a research assistant who was not involved in the intervention delivery, data collection, or data analysis. Participants were enrolled in the study by a staff not involved in the randomization process. We would like to added the information if we get the opportunity to revise it after peer review.
subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 11a-i) Specify who was blinded, and who wasn't Specify who was blinded, and who wasn't. Usually, in web-based trials it is not possible to blind the participants [1, 3] (this should be clearly acknowledged), but it may be possible to blind outcome assessors, those doing data analysis or those administering cointerventions (if any).

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Does your paper address subitem 11a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes. "Data collectors were blind to the treatment allocation." 11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator". 清除所选内容 11b) If relevant, description of the similarity of interventions (this item is usually not relevant for ehealth trials as it refers to similarity of a placebo or sham intervention to a active medication/intervention) 12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, details of whether and how the clustering by care providers or centers was addressed Does your paper address subitem 11a-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study 您的回答 Does your paper address CONSORT subitem 11b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study No. The interventions of intervention and control group are different. subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 12a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes. "We employed the generalized estimated equation (GEE) with an unstructured working correlation matrix to explore the effect of the digital GSH-MBI group on maternal psychological distress, including symptoms of depression, anxiety, and pregnancy-related anxiety. The GEE does not require imputing missing values, which are especially advantageous in longitudinal studies with missing data, as all data available are used and no cases are deleted. We followed the intention-to-treat analysis and performed a sensitivity analysis using a mixed-effects modeling approach (see Supplementary Table 1) that assumed data was missing at random (MAR).
We employed linear regression to scrutinize the intervention's effects on infant neuropsychological outcomes, controlling for infant sex, maternal age, maternal education, and average monthly household income. This part of the analysis was a complete case analysis. Due to multiple comparisons, we employed false discovery rate (FDR) with the Benjamini-Hochberg correction to adjust the P-values." 12a-i) Imputation techniques to deal with attrition / missing values Imputation techniques to deal with attrition / missing values: Not all participants will use the intervention/comparator as intended and attrition is typically high in ehealth trials. Specify how participants who did not use the application or dropped out from the trial were treated in the statistical analysis (a complete case analysis is strongly discouraged, and simple imputation techniques such as LOCF may also be problematic [4]). Does your paper address subitem 12a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes. "The GEE does not require imputing missing values, which are especially advantageous in longitudinal studies with missing data, as all data available are used and no cases are deleted." Does your paper address CONSORT subitem 12b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes. "We followed the intention-to-treat analysis and performed a sensitivity analysis using a mixed-effects modeling approach (see Supplementary Table 1) that assumed data was missing at random (MAR). We performed further exploratory analyses using Amos 26.0 to examine the intervention's effects on infant neuropsychological outcomes by mitigating maternal psychological distress. The model of mediation was established with an independent variable (X, treatment allocation), a mediating variable (M, maternal psychological distress at T2 or T3), and a dependent variable (Y, infant outcomes). We performed a partial correlation analysis to investigate the relationship between maternal psychological distress at T2 or T3 and infant outcomes, adjusting for psychological distress at T1. We only included maternal psychological distress variables that were significantly correlated with infant outcomes in the mediation analysis. The mediating effect analysis was exploratory; we did not conduct a p-value adjustment."

RESULTS
13a) For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome NPT: The number of care providers or centers performing the intervention in each group and the number of patients treated by each care provider in each center Does your paper address subitem X26-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study 您的回答

X26-iii) Safety and security procedures
Safety and security procedures, incl. privacy considerations, and any steps taken to reduce the likelihood or detection of harm (e.g., education and training, availability of a hotline) 清除所选内容 Does your paper address subitem X26-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Does your paper address CONSORT subitem 13a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes. "We approached and screened 608 pregnant women at 12 to 20 weeks of gestation for eligibility, and we obtained a final sample of 160 (Fig. 2) " Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT flow diagram) * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes. This is shown in flow chart.

13b-i) Attrition diagram
Strongly recommended: An attrition diagram (e.g., proportion of participants still logging in or using the intervention/comparator in each group plotted over time, similar to a survival curve) or other gures or tables demonstrating usage/dose/engagement. Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the gure number if applicable (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes. "Among 160 participants, 135 completed the assessment at 6 months postpartum: 11 participants dropped out from the intervention group, and 14 from the control group (dropout rate: 15.6 %)." Does your paper address CONSORT subitem 14a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes. "This study was a two-arm, parallel RCT. The participants were pregnant women who received routine obstetric exams at the outpatient centers of two comprehensive tertiary hospitals in Shandong Province from December 2020 to April 2021." 14a-i) Indicate if critical "secular events" fell into the study period Indicate if critical "secular events" fell into the study period, e.g., signi cant changes in Internet resources available or "changes in computer hardware or Internet delivery resources" 清除所选内容 14b) Why the trial ended or was stopped (early) 15) A table showing baseline demographic and clinical characteristics for each group NPT: When applicable, a description of care providers (case volume, quali cation, expertise, etc.) and centers (volume) in each group Does your paper address subitem 14a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study 您的回答 Does your paper address CONSORT subitem 14b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study No. The trial did not stop halfway. It ended as long as the sample size reached 160.
Does your paper address CONSORT subitem 15? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes. The baseline demographic and clinical characteristics were shown in Table1. 16-i) Report multiple "denominators" and provide definitions Report multiple "denominators" and provide de nitions: Report N's (and effect sizes) "across a range of study participation [and use] thresholds" [1], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants "used" the intervention/comparator at speci c pre-de ned time points of interest (in absolute and relative numbers per group). Always clearly de ne "use" of the intervention. subitem not at all important 1 2 3 4 5 essential 17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) Does your paper address subitem 16-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes. "We approached and screened 608 pregnant women at 12 to 20 weeks of gestation for eligibility, and we obtained a final sample of 160 (Fig. 2). Among 160 participants, 135 completed the assessment at 6 months postpartum: 11 participants dropped out from the intervention group, and 14 from the control group (dropout rate: 15.6 %)."

16-ii) Primary analysis should be intent-to-treat
Primary analysis should be intent-to-treat, secondary analyses could include comparing only "users", with the appropriate caveats that this is no longer a randomized sample (see 18-i).

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Does your paper address subitem 16-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes. "We followed the intention-to-treat analysis and performed a sensitivity analysis using a mixed-effects modeling approach (see Supplementary subitem not at all important 1 2 3 4 5 essential 17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended Does your paper address CONSORT subitem 17a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes. Table 2 and Table 3. 17a-i) Presentation of process outcomes such as metrics of use and intensity of use In addition to primary/secondary (clinical) outcomes, the presentation of process outcomes such as metrics of use and intensity of use (dose, exposure) and their operational de nitions is critical. This does not only refer to metrics of attrition (13-b) (often a binary variable), but also to more continuous exposure metrics such as "average session length". These must be accompanied by a technical description how a metric like a "session" is de ned (e.g., timeout after idle time) [1] (report under item 6a).

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Does your paper address subitem 17a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study 您的回答 18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 17b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The outcomes in this study were all continuous variables.
Does your paper address CONSORT subitem 18? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes. Results related to sensitivity analysis and exploratory analysis were conducted.

18-i) Subgroup analysis of comparing only users
A subgroup analysis of comparing only users is not uncommon in ehealth trials, but if done, it must be stressed that this is a self-selected sample and no longer an unbiased sample from a randomized trial (see 16-iii 22-i) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use).

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Does your paper address subitem 22-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes. "To our knowledge, this is the first RCT study examining the effectiveness of a digital GSH-MBI based on a WeChat mini program in alleviating maternal psychological distress and promoting infant neuropsychological outcomes. Overall, the results imply that pregnant women who received the digital GSH-MBI displayed less psychological distress (depression, anxiety, and pregnancy-related anxiety symptoms) compared to women in the control group at all post-intervention time points. In addition, the digital GSH-MBI had a ripple effect on infant neuropsychological outcomes, and the ripple effect on infants' quality of mood at six weeks was mediated via mitigating pregnancy-related anxiety symptoms."

22-ii) Highlight unanswered new questions, suggest future research
Highlight unanswered new questions, suggest future research. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes. "Future intervention studies are needed to examine whether maternal parenting and mother-infant bonding serve as a mediating pathway for the effect of mindfulness on infant regulatory development."

20-i) Typical limitations in ehealth trials
Typical limitations in ehealth trials: Participants in ehealth trials are rarely blinded. Ehealth trials often look at a multiplicity of outcomes, increasing risk for a Type I error. Discuss biases due to non-use of the intervention/usability issues, biases through informed consent procedures, unexpected events.

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Does your paper address subitem 20-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes. "First, there might be reporting bias because infants' neurodevelopmental outcomes were reported by their mothers. Women in the intervention group may have become more emotionally literate and thus more likely to notice specific reactions in their infants. Second, most participants reported a high socioeconomic status, limiting the generalizability of the findings to the disadvantaged pregnant population." 21) Generalisability (external validity, applicability) of the trial findings NPT: External validity of the trial ndings according to the intervention, comparators, patients, and care providers or centers involved in the trial subitem not at all important 1 2 3 4 5 essential 21-i) Generalizability to other populations Generalizability to other populations: In particular, discuss generalizability to a general Internet population, outside of a RCT setting, and general patient population, including applicability of the study results for other organizations 清除所选内容 Does your paper address subitem 21-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes. 1)"We implemented the study in China, as WeChat is most popular in the Chinese population; however, our intervention package can be used in other apps. It is important to note that using existing widely used apps to deliver brief psychological interventions is more promising than developing new apps as the intervention delivery platform. " 2) "Second, most participants reported a high socioeconomic status, limiting the generalizability of the findings to the disadvantaged pregnant population." Discuss if there were elements in the RCT that would be different in a routine application setting (e.g., prompts/reminders, more human involvement, training sessions or other cointerventions) and what impact the omission of these elements could have on use, adoption, or outcomes if the intervention is applied outside of a RCT setting.

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Does your paper address subitem 21-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study 您的回答 Does your paper address CONSORT subitem 23? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes. "The study was registered in the Chinese Clinical Trial Register (identifier: ChiCTR2000040717). " 24) Where the full trial protocol can be accessed, if available 25) Sources of funding and other support (such as supply of drugs), role of funders X27) Conflicts of Interest (not a CONSORT item) subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 24? * Cite a Multimedia Appendix, other reference, or copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study No. The protocol of this study was not published.
Does your paper address CONSORT subitem 25? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This study was funded by the Surface Project of National Natural Science Foundation of China (Grant Number: 32071084).

X27-i) State the relation of the study team towards the system being evaluated
In addition to the usual declaration of interests ( nancial or otherwise), also state the relation of the study team towards the system being evaluated, i.e., state if the authors/evaluators are distinct from or identical with the developers/sponsors of the intervention. About the CONSORT EHEALTH checklist yes, major changes yes, minor changes no Does your paper address subitem X27-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study 您的回答 As a result of using this checklist, did you make changes in your manuscript? * STOP -Save this form as PDF before you click submit To generate a record that you lled in this form, we recommend to generate a PDF of this page (on a Mac, simply select "print" and then select "print as PDF") before you submit it.
When you submit your (revised) paper to JMIR, please upload the PDF as supplementary le.
Don't worry if some text in the textboxes is cut off, as we still have the complete information in our database. Thank you! Final step: Click submit ! Click submit so we have your answers in our database! As a result of using this checklist, do you think your manuscript has improved? * Would you like to become involved in the CONSORT EHEALTH group? This would involve for example becoming involved in participating in a workshop and writing an "Explanation and Elaboration" document 清除所选内容 Any other comments or questions on CONSORT EHEALTH 您的回答