Intensive Lifestyle Intervention for Remission of Metabolic Syndrome

NACompletedINTERVENTIONAL
Enrollment

68

Participants

Timeline

Start Date

October 1, 2020

Primary Completion Date

August 31, 2022

Study Completion Date

October 31, 2022

Conditions
Metabolic Syndrome
Interventions
BEHAVIORAL

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."

BEHAVIORAL

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."

Trial Locations (1)

310009

The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou

All Listed Sponsors
lead

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

NCT04116905 - Intensive Lifestyle Intervention for Remission of Metabolic Syndrome | Biotech Hunter | Biotech Hunter