Clinical Trial

Effect of A Theory-based Multicomponent eHealth Intervention Program

Not Yet Recruiting
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Summary
This study is a two-arm pilot randomized controlled trial designed to evaluate the feasibility and preliminary effects of an Acceptance and Commitment Therapy (ACT) theory-based mobile application integrated with a smartphone pedometer plus health education on weight self-stigma and lifestyle behaviors among overweight or obese adults. A total of 60 participants will be recruited and randomized 1:1 to the intervention (ACT-based app + pedometer + health education) or control condition. Outcomes will be assessed at baseline (T0), immediately after intervention (T1), and at 1 month after intervention (T2) and 3 months after intervention (T3) following intervention initiation. The primary outcomes are body weight (weight loss) and weight self-stigma measured; secondary outcomes include eating behavior, physical activity level, and quality of life. Analyses will include per-protocol evaluation using linear mixed-effects models to test group, time, and group-by-time effects on primary and secondary outcomes, with intention-to-treat analyses conducted as sensitivity analyses using multiple imputation for missing weight and weight self-stigma data. Findings will inform the design of a future definitive trial and contribute evidence on eHealth approaches to reducing weight-related stigma and supporting healthier lifestyles.
Trial Details
NCT Number NCT07644143
Lead Sponsor Taipei Medical University
Conditions Overweight , Obesity
Enrollment 60 participants
Start Date 2026-07-01
Primary Completion 2026-11-29 (estimated)
Study Completion 2026-12-15 (estimated)
Updated on ClinicalTrials.gov 2026-06-12