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
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.
Basic eligibility
Full registry criteria
Treatments and study arms
EMA-based weight management intervention
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
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
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.