Clinical trial

An Innovative Care Model Integrating Mobile Health Support to Promote Weight Management in Adults With Overweight or Obesity

Invitation only · Not applicable · 1 countries · Registry ID NCT06996431

Invitation onlyNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionOverweight or Obesity, Physical Activities, Healthy Diet, Weight Change, Body Fat, Muscle Mass

Full registry criteria

Inclusion Criteria: 1. Hong Kong residents aged ≥18 years; 2. able to read and communicate in Chinese; 3. own a smartphone with internet access; 4. have good mobility alone without gait aid; 5. body mass index ≥ 23.0; 6. 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 Exclusion Criteria: 1. 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; 2. currently receiving treatment for any cancer (active cancer patients) or cancer survivor of any GI cancers (e.g. colorectal cancer, stomach cancer); 3. lactating, pregnant or planning for pregnancy in the coming 6 months; 4. have current diagnosis of psychiatric disorder; 5. have previous diagnosis of eating disorder; 6. have diagnoses of gastrointestinal conditions (e.g. Irritable Bowel Syndrome, Ulcerative Colitis, Crohn's Disease, Coeliac Disease); 7. currently receiving intensive diet or exercise treatment; 8. 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).

Treatments and study arms

EMA-based weight management intervention

Behavioral

Participants will complete four 7-day EMA sessions, reporting their diet for 3 days and physical activity for 4 days by completing five brief daily mobile app surveys (under 2 minutes each), using a 5-digit case number for privacy. The app automatically retrieves Fitbit data-such as step count, moderate-to-vigorous physical activity (MVPA), sedentary behavior, and heart rate- and sends timely reminders if surveys are missed. Within one week after the first EMA session, participants will attend a nurse- led counseling session using the 5A Model (Assess, Advise, Agree, Assist, Arrange), providing tailored feedback based on EMA and Fitbit data, and addressing barriers to change. This is followed by risk-based coaching from a dietitian and fitness instructor, with individualized diet and exercise plans. Between sessions, participants receive ongoing support, including instant reminder messaging and weekly motivational messages to encourage healthy behaviors.

Minimal Intervention

Behavioral

Participants will not receive risk-stratified services but will be provided with informational leaflets offering general advice on maintaining a healthy diet, regular exercise, smoking cessation, and alcohol cessation.

Primary outcomes

Change in weight6-month from baseline

Defined as the change in weight of participants over a specified period, this measurement compares the weight change between the intervention and control groups. Participants' weights will be recorded in kilograms at baseline and at a 6-month follow-up using a calibrated digital scale.

Study locations

3 locations were listed when this page was built. The first 40 are shown.

Aberdeen Kaifong Welfare Association🇭🇰 Hong Kong, Hong Kong
Haven of Hope Christian Service🇭🇰 Hong Kong, Hong Kong
Hong Kong Sheng Kung Hui Welfare Council🇭🇰 Hong Kong, Hong Kong