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Digital health promotion programs tailored to the individual are a potential cost-effective and scalable solution to enable self-management and provide support to people with excess body weight. However, solutions that are widely accessible, personalized, and theory- and evidence-based are still limited.
This study aimed to develop a digital behavior change program,
We applied an Intervention Mapping protocol to design the program. This systematic approach to develop theory- and evidence-based health promotion programs consisted of 6 steps: development of a logic model of the problem, a model of change, intervention design and intervention production, the implementation plan, and the evaluation plan. The decisions made during the Intervention Mapping process were guided by theory, existing evidence, and our own research—including 4 focus groups (n=40), expert consultations (n=12), and interviews (n=11). The stakeholders included researchers, public representatives (including individuals with overweight and obesity), and experts from a variety of relevant backgrounds (including nutrition, physical activity, and the health care sector).
Following a structured process, we developed a tailored intervention that has the potential to reduce excess body weight and support behavior changes in people with overweight and obesity. The
The use of an Intervention Mapping protocol enabled the systematic development of the
RR2-10.1136/bmjopen-2020-040183
Worldwide, overweight and obesity are a major public health concern showing continuous increase over the past 4 decades [
Intervention tailoring involves adapting the intervention based on specific characteristics of the recipient [
An alternative way to tailor the intervention is through
To the best of our knowledge, to date, only 1 study has explored the predictors and outcomes associated with weight loss maintenance in individuals using EMA and N-of-1 designs [
To develop personalized interventions, within-person studies exploring weight loss trajectories and changes in cognition and outcomes are needed [
Intervention mapping protocols [
Intervention mapping protocols have been successfully applied to design several health promotion programs, including interventions to decrease sedentary behavior [
In this manuscript, we describe the systematic development of the
This was an Intervention Mapping study; all study materials, standard operating procedures, and design decisions were documented, and the intervention content was published in the Open Science Framework repository [
The Intervention Mapping procedure included 6 steps that comprised several tasks integrating theory and evidence [
In step 1, we established the planning group (ie, study authors) and conducted a needs assessment to create a logic model of the health problem (
In step 2, we created a logic model of change (
Step 3 consisted of generating theory-based program themes, components, scopes, and sequences. The planning group chose theories that were relevant to the program and decided to include 5 theoretical themes from a recent theory review of behavior change maintenance as underpinning the program [
The aim of step 4 was to develop and refine the program structure and organization, preparation of program materials—including drafting theory- and evidence-based messages (emails, text messages, and book)—and program protocols. During this stage, we pretested and refined the materials through focus groups, expert ratings, and interviews.
We conducted 4 focus groups (framed as user engagement workshops, of which 3/4 (75%) were conducted face-to-face and 1/4 (25%) were held on the web because of the COVID-19 pandemic) between November 2019 and May 2020. The focus group participants were recruited through Facebook (event advertisements posted on health-related pages) and through websites listing local events. They were also advertised through newsletters (of the university and of local health-related organizations) and posters placed in community venues and the university. Representatives of the general population (n=40), including some people with overweight (10/40, 25%; 8/10, 80% women and 2/10, 20% men) and obesity (6/40, 15%; 4/6, 67% women and 2/6, 33% men), took part in the focus groups to discuss the project’s rationale, aim, proposed format, and materials. The focus group participants’ mean age was 31.55 (SD 13.15, range 19-65) years, and 22% (9/40) men and 78% (31/40) women took part, with most having a high school education (21/40, 52%) and some having higher education (11/40, 28% Bachelor of Arts or Bachelor of Science and 8/40, 20% Master of Arts or Master of Science. Their average BMI was 24.09 (SD 6.26, range 16.94-34.09; 1/40, 2% of the participants specified their height but not their weight).
The focus group participants assessed and rated the sample intervention materials to assess their clarity (on a scale of 1=unclear to 10=clear), attractiveness (on a scale of 1=unattractive to 10=attractive), and informativeness (on a scale of 1=uninformative to 10=informative). They rated some of the emails (25/96, 25%) and text messages (340/757, 44.9%). Materials were discussed within the group, and the pros and cons were elaborated on. The focus groups were audio recorded, transcribed (by PI), and verified (by IPP), and the transcripts were analyzed verbatim using the framework method [
The full set of intervention materials, including 109 emails and 759 text messages, was pretested with psychology, physical activity, and nutrition experts (n=12). The experts were recruited through the researchers’ network as well as through web-based message boards and Facebook groups for professionals with relevant expertise. The experts were Polish, based in Poland, and they reviewed materials written in Polish. The experts had a mean age of 30.42 (SD 10.9, range 24-64) years and were 8% (1/12) men and 92% (11/12) women; 33% (4/12) had an MSc in Nutrition, 33% (4/12) had an MSc in Psychology, 25% (3/12) had an MSc in Public Health, and 8% (1/12) had a PhD in Health Sciences (including physical activity background). All text messages were assessed by at least two experts who rated the content using the same measures as the ones used during the focus groups to assess content attractiveness and informativeness and, in addition, emotional reactions (
The experts were asked to assign each text message to relevant theoretical domains, with clear definitions of each domain provided (eg, habits, stress, and obstacles). The experts were asked to indicate their first, second, and third choice for the domain that the message aligned with. The experts did not have to have any background in behavioral science to assign messages to theoretical domains as clear definitions were provided and examples were given. They also provided additional open-ended comments if they had any feedback or reflections regarding specific text messages or emails. The experts completed this task in a Microsoft Excel form in their own time. The theoretical domains and definitions of the theoretical constructs were based on a comprehensive theory review [
We also asked 11 representatives of the general population (n=6, 55% men and n=5, 45% women; mean age 39.27, SD 16.32, range 18-72 years) to evaluate the intervention book or e-book (our program participants had a choice between a physical book and an e-book). Interviewed participants were recruited through the researchers’ networks. Each person read through the whole book and, by means of unstructured interviews (conducted by IPP), provided feedback on content, comprehensibility, user-friendliness of the design, and inclusiveness. The key points from each interview were summarized and noted by the interviewer, and the book was revised in line with the suggestions given.
The materials (emails, text messages, and book) were iteratively revised by 4 members of the project team (IPP, PI, DK, and AJ) and continuously adapted based on insights from the focus groups, interviews, and study experts. During the intervention content development stage (June 2020-August 2020), the core team (IPP, PI, DK, and AJ) met 11 times; each meeting took 2 to 3 hours, approximately 30 hours in total. The
In step 5, we defined the intervention adaptation, implementation, and sustainability plan developing matrices defining change objectives to promote
In the final step, we planned how to best evaluate the program effects, costs, and processes. A specific evaluation plan was developed by the core planning group, and the trial protocol was published [
Ethics approval was granted by the Faculty of Psychology, SWPS University of Social Sciences and Humanities, Poland (approval 03/P/12/2019).
In this study, we used the Intervention Mapping approach following the aforementioned steps (
In step 2, the program’s objectives were specified—namely, to develop a program that could support self-guided personalized weight loss, including behavior changes in physical activity, nutrition, and prompting psychological changes (in motivation, habits, self-regulation, resources, and context). The list of combined performance objectives and relevant changeable determinants included the following: individuals who complete the program will need to complete 2 key phases to lose weight and maintain weight loss. First, we need to learn about their individual predictors of weight loss and weight loss maintenance (therefore, we will encourage program users to self-monitor their determinants—theory-based constructs including motivation, habits, self-regulation, resources, and context). Subsequently, we will intervene on the strongest predictors of behavioral outcomes, providing relevant intervention content. For each determinant, we mapped the corresponding theoretical explanations and techniques [
In step 3, techniques fitting the problem and objectives were chosen. On the basis of theory and evidence, we divided our intervention into 5 conceptual domains (maintained motivation, habit, self-regulation, resources, and environmental influences) and, within these domains, suitable BCTs were identified [
In step 4, we conducted focus groups to refine the intervention content. A total of 40 participants took part in the focus groups, and the key themes discussed were analyzed and divided into 2 groups of themes: intervention content and form of program delivery. The first theme had three main subthemes: (1) the participant being an active agent in the change process, (2) inclusivity of the information provided, and (3) problem-solving. The second theme also had three main subthemes: (1) ensuring that the content was informative, (2) unambiguity of the provided information, and (3) including direct actionable messages. In
The focus group participants’ mean scores for the proposed text message content were relatively high on a scale of 1 to 10 (mean 8.38; clarity mean 9.27, SD 1.32; attractiveness mean 8.48, SD 1.24; informativeness mean 8.6, SD 1.33); higher scores reflected positive results, and lower scores reflected negative results for each category. These findings were corroborated in the focus group discussions (
Experts rated the quality of the text messages as moderately high (mean 7.21; positive emotions mean 6.95, SD 1.41; attractiveness mean 7.23, SD 1.38; informativeness mean 7.47, SD 1.61). All text messages rated below an average of 4.5 across all categories were excluded or adjusted, and text messages that did not fit specific themes were reallocated or adjusted. In total, we excluded 3.7% (28/759) of text messages and 0.9% (1/109) of emails that were considered inappropriate or scored low overall.
In step 5, we identified potential program users as adults with overweight and obesity living in Poland. Initial program users were individuals living in Wroclaw and nearby areas as the initial test of the program (via RCT) required face-to-face assessments to objectively measure weight. Implementers of the program initially included the researchers involved in the program development and research assistants. Future program implementers and maintainers (if the program is proven effective) could include representatives from the government, health care representatives recommending the program, and community representatives. One of the routes to intervention implementation that we are assessing now is wide implementation through the program partner Lifestyle Medicine [
In step 6, we generated a plan for cost, effect, and process evaluations. Currently, the program is being evaluated through an RCT assessing between-group effects (intervention vs control), and it is also being evaluated within people looking at the trajectories of change investigated through EMA using an N-of-1 design and inferential tailoring [
Lessons learnt for the
Theme and theme description | Lessons learned | Example quotes | |||
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Study participants need to be treated as equal partners in the behavior change and behavior maintenance process. Understanding of personal needs and preferences is key to providing useful intervention content. Each message needs to contain elements of flexibility (the participant may want to take the suggestion on or not; they do not need to follow the suggestions fully). |
Condescending, stereotypical, and negative messages were unacceptable: “Not everyone who carries extra kilograms sits nonstop in front of the TV and eats crisps. We can’t speak to them [intervention users] as if they did not have a clue that a week without the TV or a week without crisps is possible. The worse thing we could do is to look down on them.” [Participant 14, woman, aged 24 years, BMI 29] Intervention aims should be personalized and defined with the study participants: “I would simply ask what are the intentions of this person, what exactly motivates them? Why are they taking part in your program? Probably they want to lose weight but you need to understand other factors too...” [Participant 7, woman, aged 30 years, BMI 20] To many participants, the provided information was not new and often complemented what they already knew and what they had already experienced: “From my own experience I can say that the feeling of hunger is just so personal. I had to relearn to understand when I’m hungry, when I’m full and when I’ve totally overeaten. Since childhood I was ‘trained’ to eat like a horse, to just feel more than full. I had to relearn to eat till I’m almost full, so I feel slightly unsatisfied. Some people still need to learn it and work on it.” [Participant 9, man, aged 47 years, BMI 20] People’s levels of motivation and motivation sources vary, and interventions need to account for that: “Social support is very important but if other people don’t want to support me, they should at least not criticise my choices. I look for support or at least lack of criticism of what I do. Maybe other people find it helpful to be criticised, for me, I find it really demotivating.” [Participant 9, man, aged 47 years, BMI 20] All messages suggesting that physical activity needs to be chosen in line with personal preferences were rated positively: “I really get on board with this, I really like that you suggest that physical activity doesn’t need to be forced, and that I can just pick whatever I like, as long as I am active.” [Participant 39, man, aged 39 years, BMI 25] Most messages need to give the participant some options and choices. The participants prefer to choose what fits their lifestyle and preferences: “I love this message—I like that you say that there is not one type of food that makes someone feel better—one person may like nuts, other one may prefer fish, I just really like how you pointed out that this is all personal.” [Participant 38, man, aged 65 years, BMI 30] |
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The person’s identity needs to be considered when defining intervention content. The information provided needs to be inclusive, especially when discussing social support. |
Participants who did not have close family or lived far away from their family felt excluded when reading the messages pointing toward fun social family activities: “Someone who I don’t actually even know, writes to me and says hug a family member, and I’m alone, I do not have any close family, I would get so p***** off, and sorry to phrase it like that, but I would just not continue with this.” [Participant 32, woman, aged 44 years, BMI 28] |
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People usually knew what the negative consequences were, and they did not need to be reminded. They needed constructive suggestions for how to best problem solve. Messages based on fear and negative emotions were considered unhelpful. |
Participants appreciated messages that emphasized their psychological resources and constructive ways of using self-motivation: “The message I really, really like is this one: ‘Think about the day when you decided to join Choosing Health program! What motivated you to join? Note down thoughts that you had then.’ I really liked this message coz people often undertake challenges and then half way through they forget why they actually doing it. The motivation is gone, and sometimes it’s enough to just remind someone why are they doing it. Remembering your past success, can really reinforce your motivation and help you look more positively towards the future.” [Participant 24, woman, aged 24 years, BMI 26] The messages that described unpleasant situations, evoked negative emotions, and reminded the participants of some negative past events but did not include any actionable solutions that needed to be avoided: “Imagine, I’m in a good mood, having a really good day, everything going well and then I’m getting one of your messages, this one, it says ‘consider what’s causing stress in your life and think about how you could tackle it and change it’—So now what? I’m doing my exercise, drinking water, I eat healthily and now what? I’m stressing thinking oh dear God...my husband, all the debt I have...” [Participant 29, woman, aged 34 years, BMI 28] The participants rated positively the messages that encouraged them to self-monitor and pointed them toward the strategies that they could implement immediately to improve: “I really like these messages that said that I should write down certain things, note what motivates me, and note what my goals are. That was great, a systematic way of doing things, if I write it down, I will remember it. If I read your text and I’m on the go, I may remember it but I may not...” [Participant 30, woman, aged 37 years, BMI 21] |
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Just the fact that participants receive messages may be motivating, but this motivation is not long-lived if the content is not informative. To maintain participants’ engagement, they need to receive evidence-based, state-of-the-art, engaging, and original content. People do not want to be overloaded with the information. |
It is important that the participants learn something new that they did not know before: “I really liked it because the information provided was interesting and some of it was surprising for me, especially when you elaborated on different causes of stress. It was clear, it made me feel good, I simply learnt new information.” [Participant 36, woman, aged 25 years, BMI 17] People want to read evidence-based information: “Some of the messages were just too simple. I don’t want to sound big-headed but for me that was just way too simple. I would add (to the emails) at least few lines describing some background evidence, at least something showing that it’s actually based on scientific evidence.” [Participant 26, man, aged 24 years, BMI 20] The intervention should encourage them to learn more: “Maybe you could encourage people to be more conscious and to learn more: ‘Check if what you think is healthy, is actually healthy and good for you?’ [...] A while ago I went to the shops, I had some time and I saw minced meat. I usually don’t buy that type of meat, and then I read what’s on the label, and I couldn’t believe it! [...] Maybe you could consider that people need to seek to educate themselves a bit more.” [Participant 21, woman, aged 34 years, BMI 34] The intervention should include valuable messages without sounding superficial: “I just have a general suggestion—for me messages that include phrases ‘healthy food,’ ‘balanced diet,’ ‘balance’ sound a bit superficial, as people don’t really know what that means.” [Participant 26, man, aged 24 years, BMI 20] Explaining psychological and physiological mechanisms related to weight loss was always welcome, especially if communicated in a clear way (but only in emails as SMS text messages were perceived as too short to clearly communicate the meaning and dependencies): “I was positively surprised to read the email ‘What stress actually is?’ [...] This message had a lot of important, easy to digest info, stress is so common these days so I was glad to read more on this topic.” [Participant 36, woman, aged 25 years, BMI 17] Psychological evidence was expected, and the participants wanted to learn more about the mechanisms of action and behavior change techniques: “So where are all the psychological aspect here? You say monitor eating to not overdo it, but how am I meant to do that?!” [Participant 32, woman, aged 44 years, BMI 28] |
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When the message includes multiple topics, it is more difficult to understand, reflect on, and implement. |
The participants did not perceive it helpful when healthy eating, physical activity, education, and social support were all mentioned in one message: “For me it is problematic that you talk about healthy eating and physical activity. Someone may be concentrating hard on eating healthily but not really on improving physical activity. [...] I would probably just emphasize one or the other as tackling both at the same time is hard.” [Participant 7, woman, aged 30 years, BMI 20] |
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Study participants preferred direct, clear, and actionable messages. |
Participants did not appreciate “mental shortcuts,” and every change of topic in the message had to be clearly announced to them: “This message about feeling grateful—I completely don’t get what’s the relationship between feeling grateful and losing weight or improving health.” [Participant 38, man, aged 65 years, BMI 30] Idioms and messages including humor were negatively received. Losing weight and maintaining weight loss are often perceived as sensitive topics, and the use of humor is often considered inappropriate: “...again you are using an idiom here—and I’m fairly sure that not everyone is able to understand it in this context.” [Participant 40, man, aged 65 years, BMI 32] |
aInterview data were analyzed with the aim of improving intervention content and form (ie, look and feel, intensity, and sequence) so that the main themes were predefined before the analysis process. The subthemes emerged from the discussions and data analysis.
The overall aim of this Intervention Mapping study was to inform the
In relation to the intervention content, the main results were that program participants need to be actively involved in the change process, which aligns with theory [
This study has several strengths. The key strength is the use of the thorough and rigorous Intervention Mapping protocol that served as a tool and provided us with vocabulary to comprehensively map out and plan the proposed intervention [
The study limitations include lack of involvement of some key stakeholders in the planning group. Namely, representative policy-makers from the local or national government and IT did not participate in the planning group. To ensure scalability and long-term maintenance of the proposed program, it would need to be integrated with existing intervention programs or policies operating within the health care system or local communities [
The proposed intervention has specific components that combine different technology aspects—data harvesting via EMA, automated text messaging, automated emails, and book; therefore, this intervention could further benefit from the active involvement of technology developers, data scientists, and computer programmers. The researchers working on the project designed the technology interface using existing components (eg, automated messaging systems). However, to further enhance the scalability of the intervention, the engagement of computer scientists would allow us to implement more sophisticated data analytics and intervention setup methods. Future interventions need to include automated machine learning algorithms that would allow for the analysis of data in real time and automated setup of the intervention to improve efficiencies and reduce the resources needed [
In Poland, the prevalence of overweight and obesity is higher in men than in women (46.8% vs 32.2% for overweight, respectively, and 20.1% vs 18.1% for obesity, respectively); however, the sample recruited for the focus groups comprised predominantly women (31/40, 78%) and a predominantly normal weight BMI category (24/40, 60%). In the ideal scenario, most of the focus group participants would have been men, and most or all participants would have been overweight and obese. Specific challenges, including social stigma and stereotypes associated with dieting and weight loss programs, played a role in recruiting a more representative sample of the user population. However, we have explored whether there are any differences among the opinions and feedback given by men and women and also by people who fall into BMI categories below and above 25, and we have not found any pronounced differences.
The key take-home messages from our
We developed a comprehensive weight loss and maintenance intervention targeting important behavioral and contextual determinants. The development of the intervention followed comprehensive steps of the Intervention Mapping process and was grounded in theory and relevant literature. Future evaluation studies will investigate the program effectiveness, cost-effectiveness, and process and further analyze the relevance and utility of the specific program components. The findings from this study may be particularly useful for other intervention developers who are also planning to design and implement personalized digital health weight loss interventions targeting behavioral nutrition, physical activity, and health behavior change.
The 6 steps of Intervention Mapping undertaken during the Choosing Health program development combining methodologies and results.
A logic model of the health problem.
The logic model of change.
behavior change technique
ecological momentary assessment
randomized controlled trial
The
The data sets generated and analyzed during this study are available in the Open Science Framework repository [
DK, EQ, MSH, and FN conceived the project and obtained project funding. All authors (IPP, PI, DK, AL, MSH, EQ, SP, PV, SR, AJ, and FN) have made conceptual contributions to the project design and procedures. PV is a trial statistician who designed a data analysis plan together with FN and DK. SR is a trial health economist who designed an economic evaluation plan. SP and AJ provided practitioner insights. PI and IPP managed the day-to-day activities of the trial and executed the study. DK is the project lead. IPP, PI, and DK drafted the manuscript. All authors read, edited, and approved the final version.
None declared.