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Type 2 diabetes is a major challenge for Canadian public health authorities, and regular physical activity is a key factor in the management of this disease. Given that less than half of people with type 2 diabetes in Canada are sufficiently active to meet the Canadian Diabetes Association's guidelines, effective programs targeting the adoption of regular physical activity are in demand for this population. Many researchers have argued that Web-based interventions targeting physical activity are a promising avenue for insufficiently active populations; however, it remains unclear if this type of intervention is effective among people with type 2 diabetes.
This research project aims to evaluate the effectiveness of two Web-based interventions targeting the adoption of regular aerobic physical activity among insufficiently active adult Canadian Francophones with type 2 diabetes.
A 3-arm, parallel randomized controlled trial with 2 experimental groups and 1 control group was conducted in the province of Quebec, Canada. A total of 234 participants were randomized at a 1:1:1 ratio to receive an 8-week, fully automated, computer-tailored, Web-based intervention (experimental group 1); an 8-week peer support (ie, Facebook group) Web-based intervention (experimental group 2); or no intervention (control group) during the study period.
The primary outcome of this study is self-reported physical activity level (total min/week of moderate-intensity aerobic physical activity). Secondary outcomes are attitude, social influence, self-efficacy, type of motivation, and intention. All outcomes are assessed at baseline and 3 and 9 months after baseline with a self-reported questionnaire filled directly on the study websites.
By evaluating and comparing the effectiveness of 2 Web-based interventions characterized by different behavior change perspectives, findings of this study will contribute to advances in the field of physical activity promotion in adult populations with type 2 diabetes.
International Standard Randomized Controlled Trial Number (ISRCTN): ISRCTN15747108; http://www.isrctn.com/ISRCTN15747108 (Archived by WebCite at http://www.webcitation.org/6eJTi0m3r)
In 2009, 2.4 million Canadians were living with type 2 diabetes (T2D), and this number is expected to grow to 3.7 million by 2019 [
To date, a significant number of scientific reviews have studied the effectiveness of Web-based interventions designed for PA adoption and/or maintenance, with evidence showing that they can be effective across various populations and settings [
The first intervention consists of a fully automated, computer-tailored, Web-based intervention developed from the perspective of offering tracking and personalized feedback. In eHealth research, the technology underlying the tracking and personalized feedback component of interventions is known as “computer tailoring,” which can be defined as the generation of personalized feedback by a computer program based on prior individual assessment(s) [
The second intervention consists of a peer support, Web-based intervention that was developed from the perspective of offering Web-based opportunities for peer support. Within a health care context, peer support is defined as “the provision of emotional, appraisal, and informational assistance by a created social network member who possesses experiential knowledge of specific behavior or stressor and similar characteristics as the target population, to address a health-related issue of a potentially or actually stressed focal person” [
A substantial body of evidence stresses the importance of using a theoretical framework to inform the development of behavior change interventions [
In addition, to explore a current trend in Web-based interventions with health behavior change purposes [
The primary aim of this study is to evaluate the independent effectiveness of two Web-based interventions in promoting regular moderate-intensity aerobic PA among insufficiently active adult Canadian Francophones with T2D. In line with this aim, it is hypothesized that the Web-based computer-tailored intervention (H1) and the Web-based peer support intervention (H2) will be more effective at increasing moderate-intensity aerobic PA levels compared to a control group at 3 and 9 months after baseline. Another aim of this study is to compare the relative effectiveness of the two Web-based interventions at increasing moderate-intensity aerobic PA levels. Hence, the third hypothesis is that participants in both intervention groups will show a different level of moderate-intensity aerobic PA at 3 and 9 months after baseline. This hypothesis is formulated bilaterally, because no study to date has compared these two methods.
The study design is a parallel, randomized controlled trial (RCT) with the following 3 study arms: (1) an experimental group receiving an 8-week, fully automated, computer-tailored, Web-based intervention; (2) an experimental group receiving an 8-week, peer support, Web-based intervention; and (3) a control group that does not receive any intervention during the study period. A baseline measurement (T0) and two follow-up measurements at three (T1) and nine (T2) months after baseline are included. All three arms follow the same study timeline and are invited to complete the assessments during the same period. The protocol was developed in accordance with the CONSORT-EHEALTH checklist [
The target population for this research project is Canadian men and women with self-reported T2D residing in the province of Quebec. Other inclusion criteria to be eligible for the research project are not meeting the Canadian Diabetes Association guidelines on moderate-intensity aerobic PA [
As for the recruitment process, the research project was implemented in partnership with Diabète Québec, a recognized association for people with T2D in the province of Québec, Canada. Following a joint agreement between both parties, Diabète Québec sent 2 invitation emails over a 2-week period (from 2014 September 15 to 28) to all Canadian Francophones with T2D meeting the age criteria and who subscribed to the association’s newsletter.
Two websites were created for this study: one to host activities related to the computer-tailored intervention, and the other to host activities for the peer support intervention and those of the control group. Randomization with a 1:1:1 allocation ratio was performed in three steps. First, all Diabète Québec newsletter recipients with T2D who were between 18 and 65 years of age received invitation emails to participate in the study, resulting in 6425 potential participants. Next, 35% of these 6425 potential participants were randomly sampled by Diabète Québec via a computer algorithm to receive emails with a URL link redirecting them to the first website (computer tailoring group). Meanwhile, the remaining 65% of potential participants received emails giving them access to a URL redirecting them to the second website. Finally, potential participants who had been redirected to the second website were then allocated randomly by the web solution company responsible for the website development to either the peer support intervention group or the control group via a computer algorithm. The randomization procedures mentioned above were conducted independently of the research team. This is an open-label RCT, meaning that participants and investigators know who has received which intervention.
Calculation of the sample size was achieved with GPower 3.0.10, and instructions for selecting different criteria were taken from Erdfelder et al [
The Web-based computer-tailored intervention and the Web-based peer support intervention followed a rigorous theory-based and evidence-based development process involving a literature review, focus groups with T2D patients, a usability testing phase, and multidisciplinary expertise. As outlined in the background section, both interventions are based on the I-Change Model, in which concepts borrowed from SDT and the MI approach are integrated as part of the theoretical framework (
The theoretical framework of both interventions integrating the I-Change Model, Self-Determination Theory (SDT), and Motivational Interviewing (MI).
A key component of the computer-tailored intervention is that it uses recent techniques borrowed from computer-tailoring research to provide messages in a personalized fashion to its participants [
A key component of the peer support intervention is that it provides opportunities for participants to support each other by using a Web-based discussion group. More precisely, the online peer support component can be viewed as a semi-guided private Facebook group moderated by a clinical nurse. At their convenience, participants had the opportunity to visit either the intervention website or to interact with other participants via the Facebook group during an 8-week intervention period. Participants randomized into the peer support intervention were exposed to the same content as participants in the computer-tailored intervention regarding PA-related cognitions. However, the peer support intervention was targeted, meaning that the same content was provided to all participants, regardless of their individual characteristics beyond being adults with T2D. For the first 4 weeks, participants received 2 web articles per week that provided information on PA-related topics (eg, risk perception, PA guidelines, attitude), which were made available directly on the website and posted simultaneously in the Facebook group. For weeks 5, 6, and 7, participants received 1 web article per week that provided information on other PA-related topics (eg, self-efficacy, intention, and action planning). No article was offered during the last week, allowing the nurse-moderator to discuss participants’ appreciation for the intervention through the Facebook group. Similar to the computer-tailored intervention, the order in which each web article was made available was established to correspond to the theoretical framework of the study. All topics in each web article are presented in
The clinical nurse moderated the group using a method we developed that integrates SDT concepts and MI techniques, aiming to encourage participants to focus their discussions on PA-related topics and develop their own reasons for practicing more moderate-intensity aerobic PAs [
Despite their distinct core content, both interventions possessed the following similar features: (1) the appearance of the website home page, (2) a tool for self-monitoring of PA behavior, (3) tools for goal setting and action planning, (4) tabs providing safety tips on how to practice PA properly, and (5) access to technical support via email. The designs of the websites were different except for the home page (see
Overview of components found in each intervention group and the control group
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Study groups | ||
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Computer-tailored |
Peer support |
Control group |
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Personalizationa | xb |
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Content matchinga | xb |
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Feedbacka | xb |
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Peer support opportunities |
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xb |
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Intention | x | x |
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Attitude (pros and cons) | x | x |
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Social influence | x | x |
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Self-efficacy | x | x |
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Risk perception | x | x |
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Type of motivation | x | x |
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Action planning |
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x | x |
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Goal setting |
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x | x |
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Self-monitoring of PA |
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x | x |
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Periodic email promptsc |
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x | x | x |
aContemporary computer-tailoring terminology summarized by Harrington and Noar [
bDistinctive components of each intervention
cEmails were sent only to stimulate participants to reuse the interventions or to complete posttest evaluations.
Participants in this group did not participate in any intervention for the duration of the study. Following the last follow-up questionnaire, participants from this group were offered the fully automated, computer-tailored, Web-based intervention.
Emails were used to invite participants to complete baseline, 3-month, and 9-month follow-up questionnaires on the intervention websites. Participants were invited to complete their baseline questionnaire during the enrolment period between 2014 September 15 to 2014 September 18. Participants were invited to complete their 3-month and 9-month follow-up questionnaires during the period between 2014 December 16 and 2015 January 4 and during the period between 2015 June 5 and 2015 July 4, respectively. As it is well known that Internet interventions generally suffer from a high attrition rate [
PA level was evaluated with an adapted version of the Godin Leisure Time Exercise Questionnaire (GLTEQ) [
PA-related cognitions were also assessed to identify the mediating processes through which behavior change occurred in participants according to the answers they provided during the baseline, 3-month, and 9-month follow-up assessments on the study’s websites. The items used for the assessment of attitude, social influence, self-efficacy/perceived behavioral control, and intention were developed according to the guidelines from Ajzen's Theory of Planned Behavior [
Description of psychosocial variables and psychometric values.
Variable | Items | Scale |
Internal |
Test-retest |
Intention |
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.84 | .45 |
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I intend to be regularly active in the next month. | Unlikely (+1)/likely (+7) |
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My plans are to practice physical activities regularly in the next month. | Disagree (+1)/agree (+7) |
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I estimate that my chances of practicing physical activities regularly over the next month are... | Weak (+1)/good (+7) |
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Attitude |
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.58 | .49 |
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I think that practicing physical activities regularly in the next month would be… | Bad (+1)/good (+7) |
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Useless (+1)/useful (+7) | ||||
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Unenjoyable (+1)/enjoyable (+7) |
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Unpleasant (+1)/pleasant (+7) |
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Self-efficacy |
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.83 | .57 |
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I feel capable of practicing physical activities regularly in the next month. | Disagree (+1)/agree (+7) |
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For me, practicing physical activities regularly in the next month would be… | Difficult (+1)/easy (+7) |
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How much control do you feel you have over your ability to practice physical activities regularly? | No control (+1)/control (+7) |
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Social influence (subjective norm) |
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.87b | .77 |
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People who are important to me would support me if I were to practice physical activities regularly in the next month. | Disagree (+1)/agree (+7) |
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People who are important to me think I should practice physical activities regularly in the next month. | Disagree (+1)/agree (+7) |
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Social influence (descriptive norm) d |
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— | — |
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How many people who are part of your daily life (children, spouse/partner, physician, friends, colleagues, etc) are physically active on a regular basis? | Nobody (+1); a minority (+2); half (+3); a majority (+4); everybody (+5) |
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aInternal consistency reported as Cronbach alpha coefficient for variables of 3 items or more.
bInternal consistency reported as Spearman’s correlation coefficient for variables of 2 items.
cIntraclass correlation coefficient.
dNo data provided for descriptive norm, given the change of scale following the test-retest.
Descriptive statistics will be used to summarize the baseline characteristics of the participants for sociodemographic variables (ie, origin, occupation, gender, age, and education), anthropometric variables (ie, height, weight, and body mass index), psychosocial variables (ie, attitude, social influence, self-efficacy, type of motivation, and intention), and PA level. In line with the hypotheses, linear mixed model analyses for repeated measures will be used to examine the effectiveness of the computer-tailored intervention (H1) and peer support intervention (H2) relative to the control group and also to compare both interventions to each other (H3). A linear mixed-model approach is very well suited for modelling data containing repeated measures from several participants [
Ethics approval was obtained from the Ethics Committee of Research with Humans from the Université du Québec à Trois-Rivières on 2014 September 12 (CER–13–194–08.03.04). All participants in the study gave their informed consent online via the study websites during the registration process.
The project was funded in 2011 and enrolment was completed in September 2014. Data analysis is currently under way and the first results are expected to be submitted for publication in 2016.
The purpose of this study is to assess the effectiveness of two Web-based interventions, each of which was developed based on different behavior change perspectives, to promote regular moderate-intensity aerobic PA among adults living with T2D. Several meta-analyses of traditional T2D self-management education programs have demonstrated the effectiveness of certain lifestyle programs [
The proposed study has several strengths. First, a rigorous theory-based and evidence-based intervention development process was employed. Notably, considerable efforts were devoted to base the intervention offering online peer support on an evidence-based theoretical framework, which is less frequent for this type of intervention [
However, this study is not without limitations. First, given its open-label design (ie, not blinded), although quite common in Web-based interventions delivered under free-living conditions [
To the best of our knowledge, this trial represents one of the first studies seeking to compare a Web-based computer tailoring intervention and a Web-based peer support intervention that are both PA-focused and designed for patients with T2D. Results of this study have the potential to inform future developers about the effectiveness of PA-focused, Web-based interventions for patients with T2D, including which of the two behavior change perspectives employed should be prioritized. If positive results are observed, developers could also use information provided in this manuscript to gain insights about which additional components to include in their Web-based interventions.
Motivational Interviewing (MI) and Self-Determination Theory (SDT) concepts application to both interventions.
Trial overview: timeline and intervention components.
Moderator's questions: peer support intervention.
Layout of websites.
Behavior change techniques for both interventions.
Diabète en Forme
motivational interviewing
physical activity
self-determination theory
type 2 diabetes
This study was made possible through a grant awarded to FB by the Fonds de Recherche en Santé du Québec (FRQS-22855) and the Diabète Québec organization. We would also like to thank all the main external collaborators on the intervention development, including Gilles Tanguay from AlphaZero Inc, Véronique Raby, Sébastien Talbot, Mark Lardinois from Overnite Software Europe, John William Kayser from PsyMontreal Inc, Sylvie Croteau from RA Malatest & Associates Ltd, Marie-Pierre Gagnon from Laval University, Omnimedia Inc and Point Bleu Productions. Finally, we would like to thank Hein de Vries from Maastricht University and two of his graduate students (Daniela Schulz and Michel Walthouwer) for their relevant contribution to the development of the fully automated, computer-tailored intervention.
FB and MM are equal contributors and co-first authors of this paper. Both were primarily in charge of drafting the manuscript. FB was the original author of the study design, which was complemented with input from MM and JC. MM was primarily in charge of developing the fully automated, computer-tailored intervention with relevant contributions from FB. FB was primarily in charge of developing the peer support intervention with relevant contributions from MM.
None declared.