Accepted for/Published in: JMIR Research Protocols
Date Submitted: May 2, 2023
Open Peer Review Period: Apr 18, 2023 - Jun 13, 2023
Date Accepted: Dec 8, 2023
(closed for review but you can still tweet)
A Web-based Intervention to Act for Weight Loss in Type 2 Diabetes Adults with Obesity (Chance2Act): Protocol for a Non-Randomized Controlled Trial
ABSTRACT
Background:
In type 2 diabetes (T2D) adults, weight loss can improve hemoglobin A1c, blood pressure, triglycerides, quality of life, and reduce the frequency of medications needed. Unfortunately, there is a large proportion of T2D adults who are not ready to change for weight loss. Over decades, web-based health technologies are increasingly used as a delivery mode for health promotion and prevention for obesity. However, evidence of their effectiveness for initializing and maintaining healthy behavior, particularly among T2D adults, is still scarce.
Objective:
This study aims to develop, validate, and determine the effectiveness of a web-based intervention called “Chance2Act” among T2D adults with obesity to act for weight loss.
Methods:
A web-based intervention will be developed based on the Transtheoretical Model targeting T2D adults with obesity who are not ready to change for weight loss. Phase 1 will involve the development and validation of the web-based health intervention module. In phase 2, a quasi-experimental study will be conducted in two government health clinics selected by the investigator. This is an unblinded study with a parallel assignment (i.e. intervention vs. control (usual care) with an allocation ratio of 1:1). 124 study participants will be recruited, of which 62 participants will receive the Chance2Act intervention in addition to the usual care. The primary outcome is the changes of the stages of change to lose weight. The secondary outcomes include changes in self-efficacy, decisional balance, family support for weight loss, BMI, waist circumference, and body fat composition.
Results:
This study is funded by the Ministry of Higher Education Malaysia since July 2022. We hypothesize that the Chance2Act intervention will elicit significant behavioral changes for weight loss among the participants (i.e. readiness to change, self-efficacy, and decisional balance), cause meaningful improvement in family support for weight loss, and significantly reduce the BMI as well as the body fat composition among the participants. Until May 2023, the Chance2Act intervention module was still in the phase 1. The intervention protocol is being reviewed by the panel experts for the first round. The face validation is expected to be started in June 2023. The data collection for the phase 2 is expected to start in August 2023, after the final version of the Chance2Act intervention has been published in the website. The results on the effectiveness of the Chance2Act intervention is expected to be published by March 2024.
Conclusions:
The Chance2Act intervention is expected to yield new knowledge on the effects of a theory-based digital intervention targeting behavior change from an individual perspective. It is hoped that the evidence obtained from this study will enhance the delivery of obesity care among T2D adults in primary care settings. Clinical Trial: U.S. Clinical Trial Register NCT05736536; https://beta.clinicaltrials.gov/study/NCT05736536
Citation
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Copyright
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