Development and Validation of a Web-based Intervention to Act for Weight Loss for Adults with Type 2 Diabetes and Obesity (Chance2Act): an Intervention Mapping Approach (Preprint)

<sec> <title>BACKGROUND</title> Weight loss can improve metabolic parameters and potentially lead to remission in adults with type 2 diabetes (T2D). However, a large proportion of T2D patients are overweight or obese, with 59% to 79% unready for weight loss. There is a scarcity of stage-matched approaches for this population. </sec> <sec> <title>OBJECTIVE</title> This study aimed to develop and validate a behavioural intervention module targeting T2D adults with obesity who are unready-to-act for weight loss, following the Intervention Mapping (IM) framework. </sec> <sec> <title>METHODS</title> The intervention development was guided by the Intervention Mapping (IM) framework. Step 1 involved the creation of a Logic Model of the Problem to summarize the findings from the needs assessment. Step 2 focused on developing Matrices of Change Objectives, which outlined the preliminary content for the intervention. This content was refined in Step 3, into the final themes, scopes, and activities of the intervention. In Step 4, the content was validated using both Content Validity Index and Face Validity Index to determine the content’s relevance clarity, simplicity and unambiguity of the intervention. Finally, the usability testing of the intervention website was done to ensure it met the recommended standards of website usability. </sec> <sec> <title>RESULTS</title> In Step 1, the Logic Model identified barriers such as poor knowledge, low self-efficacy, and lack of social support. Twenty change objectives were formulated as the preliminary content during Step 2. These content was finalised into four modules with twenty activities in Step 3. In Step 4, the content was produced as the Chance2Act Intervention Manual, with I-CVI, S-CVI/Average, I-FVI, and S-FVI/Average all exceeding 0.9, indicating excellent validity. Usability testing yielded a system usability score of 69.5, surpassing the recommended threshold for website usability. </sec> <sec> <title>CONCLUSIONS</title> The Chance2Act Intervention was developed and validated, providing a tailored approach for behaviour change in T2D adults who are unready-to-act for weight loss. Future research is needed to evaluate its effectiveness and explore its integration into primary care to enhance weight management strategies for this high-risk group. </sec> <sec> <title>CLINICALTRIAL</title> U.S. Clinical Trial Register NCT05736536; https://beta.clinicaltrials.gov/study/NCT05736536 </sec> <sec> <title>INTERNATIONAL REGISTERED REPORT</title> RR2-10.2196/48313 </sec>