68
Participants
Start Date
October 1, 2020
Primary Completion Date
August 31, 2022
Study Completion Date
October 31, 2022
Intensive Lifestyle Intervention
"The intensive lifestyle intervention program employs a structured, multi-component approach under professional supervision to achieve and sustain 15% weight reduction from baseline. This 12-month intervention features:~1. A weight loss phase (months 1-5) incorporating:~ Individualized calorie restriction using partial meal replacement (carbohydrate energy supply ratio is 20\~25%, and the daily calorie intake is 22.5\*70% kcal/kg/d); exercise recommends at least 150 min of moderate intensity and 2 to 3 resistance training per week; with monthly follow-ups;~2. A maintenance phase (months 6-12) focusing on:~ Healthy balanced diet, total daily calorie intake is 20-25 kcal/kg/d; exercise recommends at least 150 minutes of moderate intensity and 2-3 resistance training per week; with follow-ups every 2 months;~3. Digital health integration:~Mobile application-based monitoring of metabolic parameters; real-time feedback and adherence tracking."
Conventional Treatment
"The conventional treatment arm receive standardized metabolic syndrome management through monthly group education sessions and peer support, with a target of 7% weight reduction from baseline. The program incorporates:~1. A weight loss phase (months 1-5) incorporating:~ Structured lifestyle education; limit the total energy diet (total daily calorie intake is 22.5\*85% kcal/kg/d), with carbohydrates, fat, proteins accounting for 45-55%, 20-30%, and 20-30%, respectively, for the daily energy intake.; physical activity(150 min medium intensity exercise and 2 to 3 resistance training); with monthly follow-ups;~2. A maintenance phase (months 6-12) focusing on:~ Healthy balanced diet, total daily calorie intake is 20\~25 kcal/kg/d; physical activity(150 min medium intensity exercise and 2 to 3 resistance training);with follow-ups every 2 months;~3. Digital health integration:~Mobile application-based monitoring of metabolic parameters; real-time feedback and adherence tracking."
The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou
Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER