About this trial
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.
Eligibility criteria
Qualifiers
Aged 18 to 55 years
Body mass index (BMI) ≥23 kg/m²
Weight self-stigma, defined as a Weight Self-Stigma Questionnaire (WSSQ) score >36
Owns or has regular access to a smartphone
Disqualifiers
Type 1 or type 2 diabetes
Uncontrolled hypertension, defined as blood pressure ≥160/100 mmHg
Cardiovascular event, such as stroke or myocardial infarction, within the past year
Weight loss of ≥5% of initial body weight in the past 3 months or ≥10% in the past 2 years
Trial design
Treatments tested in this trial
- Mobile app weight self-stigma program
Treatment groups
Locations
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