The Assessment of Supportive Accountability in Adults Seeking Obesity Treatment: Psychometric Validation Study

Background Technology-mediated obesity treatments are commonly affected by poor long-term adherence. Supportive Accountability Theory suggests that the provision of social support and oversight toward goals may help to maintain adherence in technology-mediated treatments. However, no tool exists to measure the construct of supportive accountability. Objective This study aimed to develop and psychometrically validate a supportive accountability measure (SAM) by examining its performance in technology-mediated obesity treatment. Methods Secondary data analyses were conducted in 2 obesity treatment studies to validate the SAM (20 items). Study 1 examined reliability, criterion validity, and construct validity using an exploratory factor analysis in individuals seeking obesity treatment. Study 2 examined the construct validity of SAM in technology-mediated interventions involving different self-monitoring tools and varying amounts of phone-based interventionist support. Participants received traditional self-monitoring tools (standard, in-home self-monitoring scale [SC group]), newer, technology-based self-monitoring tools (TECH group), or these newer technology tools plus additional phone-based support (TECH+PHONE group). Given that the TECH+PHONE group involves more interventionist support, we hypothesized that this group would have greater supportive accountability than the other 2 arms. Results In Study 1 (n=353), the SAM showed strong reliability (Cronbach α=.92). A factor analysis revealed a 3-factor solution (representing Support for Healthy Eating Habits, Support for Exercise Habits, and Perceptions of Accountability) that explained 69% of the variance. Convergent validity was established using items from the motivation for weight loss scale, specifically the social regulation subscale (r=0.33; P<.001) and social pressure for weight loss subscale (r=0.23; P<.001). In Study 2 (n=80), the TECH+PHONE group reported significantly higher SAM scores at 6 months compared with the SC and TECH groups (r2=0.45; P<.001). Higher SAM scores were associated with higher adherence to weight management behaviors, including higher scores on subscales representing healthy dietary choices, the use of self-monitoring strategies, and positive psychological coping with weight management challenges. The association between total SAM scores and percent weight change was in the expected direction but not statistically significant (r=−0.26; P=.06). Conclusions The SAM has strong reliability and validity across the 2 studies. Future studies may consider using the SAM in technology-mediated weight loss treatment to better understand whether support and accountability are adequately represented and how supportive accountability impacts treatment adherence and outcomes. Trial Registration ClinicalTrials.gov NCT01999244; https://clinicaltrials.gov/ct2/show/NCT01999244

INTRODUCTION 2a-i) Problem and the type of system/solution "Internet is a powerful and popular source for health information among parents" "Mobile health (mHealth) and eHealth interventions are gaining popularity, as such interventions have the potential to reach a large target group, can easily be adapted to new groups, are available 24/7, and can be cost-effective" 2a-ii) Scientific background, rationale: What is known about the (type of) system We report results for prosess evaluations of similar interventions e.g. the Early Food for Future Health study and the Growing Healhty Program.In adition to describe the potential and interest of developing and evaluating the usage and satisfaction of this type of interventions.

Does your paper address CONSORT subitem 2b?
"The objectives of this study were to conduct a process evaluation of this eHealth intervention by examining the usage and perceived satisfaction of the intervention website among parents of toddlers and to explore whether this differed according to educational level and number of children in the household."We have stated that the parents were recruited through Facebook, and signed in on a website.Online questionnaires were used for assessment.4a-iii) Information giving during recruitment "A total of 404 parents of 12-month-old children were recruited through a Facebook advertisement, who then responded to a baseline questionnaire and were randomized into an intervention group and a control group".4b) CONSORT: Settings and locations where the data were collected Norway (Facebook) 4b-i) Report if outcomes were (self-)assessed through online questionnaires The mode of delivery of the intervetion was not stated in the section, however there was a link to the protocol paper listed.4b-ii) Report how institutional affiliations are displayed All procedures were reviewed and approved by the NSD (Norwegian centre for research data), and informed consent from the parents was obtained when they signed in online for participation in the study.5) CONSORT: Describe the interventions for each group with sufficient details to allow replication, including how and when they were actually administered 5-i) Mention names, credential, affiliations of the developers, sponsors, and owners "The authors thank the participants.This study is funded by the University of Agder."

5-ii) Describe the history/development process
This paper is a process evaluation and such details are presented in the protocol paper of for the intervention (https://doi.org/10.1186/dois12889-019-6915-x).5-iii) Revisions and updating NA 5-iv) Quality assurance methods NA 5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used "The intervention group had 6 months of access to the Food4toddlers website which comprised 4 main elements: (1) lessons (n=22) on how to provide healthy food and create a healthy eating environment for the toddler, (2) recipes, (3) a discussion forum, and (4) basic information about food and beverages (called Good to know)".

5-vi) Digital preservation
NA. (The content will be developed on another digital platform in the future)

5-vii) Access
"Participants in the intervention group were given access to the Food4toddlers website for 6 months".More details are presented in the protocol paper of for the intervention (https://doi.org/10.1186/dois12889-019-6915-x).

5-viii) Mode of delivery, features/functionalities/components of the intervention and comparator, and the theoretical framework
These issues are presented in the protocol paper of for the intervention (https://doi.org/10.1186/dois12889-019-6915-x).

5-ix) Describe use parameters
The duration of the intervention is listed (6 months) in the Intervention development section along with the content.5-

5-x) Clarify the level of human involvement
The duration of the intervention is listed (6 months) and no tailoring except for push notivifactions were awailible.5-xi) Report any prompts/reminders used "Initially, the web page was limited to information relevant for the child's age at baseline and gradually expanded in 20 steps as the child got older."5-xii) Describe any co-interventions (incl.training/support) NA 6a) CONSORT: Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed Stated in the Data and Measurements and statistics section.6a-i) Online questionnaires: describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed All questions used are validated and reliability tested.Stated in the "Measures and outcomes" section.6a-ii) Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored THis is the main results of this article.Se the results section.6a-iii) Describe whether, how, and when qualitative feedback from participants was obtained NA 6b) CONSORT: Any changes to trial outcomes after the trial commenced, with reasons Norway (Facebook) 7a) CONSORT: How sample size was determined 7a-i) Describe whether and how expected attrition was taken into account when calculating the sample size This issues was stated in the protocol paper of the study.7b) CONSORT: When applicable, explanation of any interim analyses and stopping guidelines Stated in the Data and Measurements and statistics section.8a) CONSORT: Method used to generate the random allocation sequence This issues was stated in the protocol paper of the study.https://doi.org/10.1186/s12889-019-6915-x8b) CONSORT: Type of randomisation; details of any restriction (such as blocking and block size) "The parents had to be literate in Norwegian.Of the 404 recruited parents, 298 (73.8%) filled in more than half of the baseline questionnaire which was the minimum requirement to be randomized into either the control or intervention group (n=148)."9) CONSORT: 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 This issues were stated in the protocol paper of the study.https://doi.org/10.1186/s12889-019-6915-x10) CONSORT: Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions This issues were stated in the protocol paper of the study.https://doi.org/10.1186/s12889-019-6915-x11a) CONSORT: Blinding -If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how 11a-i) Specify who was blinded, and who wasn't NA 11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" NA 11b) CONSORT: If relevant, description of the similarity of interventions NA 12a) CONSORT: Statistical methods used to compare groups for primary and secondary outcomes "Means with standard deviations for continuous variables and frequencies and percentages for categorical variables were reported.The chi-square tests were used to test potential differences in the perceived value of the intervention between the 2 education groups and according to the number of children in the household.Independent sample t tests were used to test potential group differences for continuous variables."12a-i) Imputation techniques to deal with attrition / missing values Listed in the result section.12b) CONSORT: Methods for additional analyses, such as subgroup analyses and adjusted analyses We listed subgroup analyses.RESULTS 13a) CONSORT: For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome NA (We use only data from the intervetion group, but the numbers are listed in the method section).13b) CONSORT: For each group, losses and exclusions after randomisation, together with reasons "In the intervention group, 93/148 (62.8%) participants answered at least parts of the questionnaire at follow-up 1.However, only 83/148 (56.1%) participants answered the last questions in the questionnaire that concerned the website use".

13b-i) Attrition diagram Se table 2 14a) CONSORT: Dates defining the periods of recruitment and follow-up
This is listed in the study design section.14a-i) Indicate if critical "secular events" fell into the study period NA 14b) CONSORT: Why the trial ended or was stopped (early) NA

Se table 1 15-i) Report demographics associated with digital divide issues
Se table 1 16a) CONSORT: For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups 16-i) Report multiple "denominators" and provide definitions The the restult swection.

16-ii) Primary analysis should be intent-to-treat
Se table 2: "One participant got access to the intervention but decided to quit.Two did not get access to the intervention mistakenly.These 3 are included in the reported numbers."17a) CONSORT: For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) "Statistical significance was set to the P≤.05 level".17a-i) Presentation of process outcomes such as metrics of use and intensity of use METHODS3a) CONSORT: Description of trial design (such as parallel, factorial) including allocation ratio "Food4toddlers is a randomized controlled trial, aiming to promote healthy dietary habits among toddlers" 3b) CONSORT: Important changes to methods after trial commencement (such as eligibility criteria), with reasons NA 3b-i) Bug fixes, Downtimes, Content Changes NA 4a) CONSORT: Eligibility criteria for participants "Eligible individuals were parents of children born between June 2016 and May 2017.The parents had to be literate in Norwegian" 4a-i) Computer / Internet literacy "Eligible individuals were parents of children born between June 2016 and May 2017.The parents had to be literate in Norwegian" No other eligibility criteria was applied.4a-ii) Open vs. closed, web-based vs. face-to-face assessments: See the result section.17b) CONSORT: For binary outcomes, presentation of both absolute and relative effect sizes is recommended NA 18) CONSORT: Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory NA 18-i) Subgroup analysis of comparing only users NA 19) CONSORT: All important harms or unintended effects in each group NA 19-i) Include privacy breaches, technical problems Not listed in this paper.See the protocol paper.https://doi.org/10.1186/s12889-019-6915-x19-ii) Include qualitative feedback from participants or observations from staff/researchers NA DISCUSSION 20) CONSORT: Trial limitations, addressing sources of potential bias, imprecision, multiplicity of analyses 20-i) Typical limitations in ehealth trials Se the strengths and limitaion section.21) CONSORT: Generalisability (external validity, applicability) of the trial findings 21-i) Generalizability to other populations We higlight the biased sample of this intervention (highly educated mothers).21-ii) Discuss if there were elements in the RCT that would be different in a routine application setting NA 22) CONSORT: Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence 22-i) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use) "More than 86.5% (128/148) of parents in the intervention group visited the website and most of them found the website useful, especially the modules and the recipes.The website content, texts, and interface were highly valued by most parents, which may have influenced parental engagement on the website.Besides, most parents in the intervention group found the content applicable to their child's age."22-ii) Highlight unanswered new questions, suggest future research IN the conclusion section: "Developing eHealth interventions and may inform future interventions to take particular care in matching intervention content to different educational and socioeconomic groups' needs."Other information 23) CONSORT: Registration number and name of trial registry "The study was approved by the Norwegian Centre for Research Data on June 08, 2016 (reference number 48643)."24) CONSORT: Where the full trial protocol can be accessed, if available https://doi.org/10.1186/s12889-019-6915-x25) CONSORT: Sources of funding and other support (such as supply of drugs), role of funders "This study is funded by the University of Agder.The financial contributor was not involved in designing the study, collection, analyses, and interpretation of data or in writing the manuscript."X26-i) Comment on ethics committee approval "The study was approved by the Norwegian Centre for Research Data on June 08, 2016 (reference number 48643)" x26-ii) Outline informed consent procedures Informed consent from parents was obtained when they signed in online for participation.X26-iii) Safety and security procedures This issues were stated in the protocol paper of the study.https://doi.org/10.1186/s12889-019-6915-xX27-i) State the relation of the study team towards the system being evaluated This study is funded by the University of Agder.The financial contributor was not involved in designing the study, collection, analyses, and interpretation of data or in writing the manuscript.