Effect of A Theory-based Multicomponent eHealth Intervention Program

Starting soon · Not applicable

Conditions studied: Overweight , Obesity

In brief

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.

Key facts

Study ID

NCT07644143

Run by

Taipei Medical University

People needed

60

Starts

2026-07-01

Expected to finish

2026-12-15

Last updated by the study team

2026-06-12

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Resides in Phan Dinh Phung municipality, Thai Nguyen Province, Vietnam
• Able to read and write in Vietnamese

You may not qualify if…

• 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
• Participation in a weight-loss program within the past 3 months
• Cognitive impairment, including a diagnosis of dementia
• Psychiatric condition, including major depression or generalized anxiety disorder
• Current use of weight-loss medication
• History of bariatric surgery
• Unable to perform physical activity
• Engages in ≥150 minutes of structured physical activity per week or >75 minutes of high-intensity exercise per week
• Pregnant or planning pregnancy within the next 6 months

Where it is running

• Phan Dinh Phung Ward Health center — Phan Dinh Phung Ward, Thai Nguyen, Vietnam

Full record on ClinicalTrials.gov

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