NCT06996431Enrolling by invitation
An Innovative Care Model Integrating Mobile Health Support to Promote Weight Management in Adults With Overweight or Obesity
Development and Effectiveness of an Innovative Care Model Integrating Mobile Health Support to Promote Weight Management in Adults With Overweight or Obesity: A Stepped-wedge Cluster Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 11 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The objective of this clinical trial is to evaluate whether an innovative care model integrating mobile health (mHealth) support improves weight management in adults with overweight or obesity. The primary research questions are: (1) Does the intervention promote weight change at the 6-month follow-up? (2) Does the intervention enhance physical activity and encourage a healthy diet at the 3- and 6-month follow-ups? To address these questions, researchers will compare the intervention group with a control group to measure changes in weight, physical activity, and dietary habits. At baseline, all participants will complete a survey assessing demographics, body weight, height, central obesity, lifestyle, weight loss history, and expectations. The intervention group will receive a weight management program based on Ecological Momentary Assessment (EMA), incorporating risk-stratified health services, with follow- ups at 3 and 6 months. The control group will receive minimal intervention in the form of general health advice, with follow-ups at the same intervals.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 876 (estimated)
- First submitted
- 17 Apr 2025
- Start date
- 10 Feb 2025
- Primary completion date
- 16 Dec 2026
- Lead sponsor
- The University of Hong Kong
- Diseases
- Obesity
- NCT number
- NCT06996431
What you commit to
- Study type: Interventional
- Planned participants: 876
- From 10 Feb 2025 to the primary completion date, 16 Dec 2026
- 3 sites 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
- currently receiving treatment for any cancer (active cancer patients) or cancer survivor of any GI cancers (e.g. colorectal cancer, stomach cancer);
- have previous diagnosis of eating disorder;
- currently receiving intensive diet or exercise treatment;
Other illness
- Have a terminal illness (e.g., advanced cancer, dementia, pulmonary, neurological, motor-neuron, and advanced cardiovascular disease) or with a life expectancy of less than 6 months;
- have current diagnosis of psychiatric disorder;
- have diagnoses of gastrointestinal conditions (e.g. Irritable Bowel Syndrome, Ulcerative Colitis, Crohn's Disease, Coeliac Disease);
Age
- have clinical obesity (e.g. confirmation of excess body fat plus limitations of day-to-day activities or signs or symptoms of obesity-related organ dysfunction). Examples of obesity-related organ dysfunction include NAFLD with hepatic fibrosis, the cluster of hyperglycaemia, high triglyceride levels, and low HDL cholesterol levels. Examples of limitations of day-to-day activities include significant age-adjusted limitations of mobility and/or other basic ADL (e.g. bathing, dressing, toileting, continence, eating).
Other
- lactating, pregnant or planning for pregnancy in the coming 6 months;
Who the study is looking for
- Hong Kong residents aged ≥18 years;
- able to read and communicate in Chinese;
- own a smartphone with internet access;
- have good mobility alone without gait aid;
- body mass index ≥ 23.0;
- and no contraindication for physical activity as evidenced by: If aged \< 70: do not meet any criteria in PAR-Q, or sign declaration of having medical clearance if meet any criteria in PAR-Q; If aged ≥ 70: sign the declaration about conducting physical activity frequently or having medical clearance
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hong Kong Sheng Kung Hui Welfare Council Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
| Aberdeen Kaifong Welfare Association Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
| Haven of Hope Christian Service Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.