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NCT07644143Not yet recruiting

Effect of A Theory-based Multicomponent eHealth Intervention Program

Effect Of A Theory-Based Multicomponent Ehealth Intervention On Weight Self - Stigma, Bodyweight And Quality Of Life Among Overweight And Obese Adults: A Pilot Randomized Controlled Trial

Source: ClinicalTrials.gov · Last updated 12 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
60 (estimated)
First submitted
6 Jun 2026
Start date
1 Jul 2026
Primary completion date
29 Nov 2026
Lead sponsor
Taipei Medical University
Diseases
Obesity
NCT number
NCT07644143

What you commit to

  • Study type: Interventional
  • Planned participants: 60
  • From 1 Jul 2026 to the primary completion date, 29 Nov 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Current use of weight-loss medication

Other illness

  • 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
  • Cognitive impairment, including a diagnosis of dementia
  • Psychiatric condition, including major depression or generalized anxiety disorder
  • History of bariatric surgery

Other

  • 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
  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to 55 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Phan Dinh Phung Ward Health center
Coordinator of this site? Confirm its status
Phan Dinh Phung WardVietnamUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.