Effect of A Theory-based Multicomponent eHealth Intervention Program

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorTaipei Medical University

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

60 Participants
are divided into 2 treatment groups

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Phan Dinh Phung Ward Health center Status unavailable 250000, Phan Dinh Phung Ward, Thai NguyenVietnamVietnam

Sponsors and collaborators