Intensive Lifestyle Intervention for Remission of Metabolic Syndrome

Summary

This is a randomized, prospective clinical trial investigating metabolic syndrome in overweight or obese Chinese individuals. The study aims to evaluate the efficacy of a structured intensive lifestyle intervention program in achieving significant weight reduction (targeting 15% weight loss) and promoting metabolic syndrome remission. Additionally, the research will explore the potential mechanisms underlying these therapeutic effects. Furthermore, this study enables phased presentation of the findings.

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: A Healthy, balanced diet, total daily calorie intake is 20-25 kcal/kg/d; exercise recommendations 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University

  lead OTHER

Principal Investigators

• Pengfei Shan, MD, PhD · Second Affiliated Hospital, School of Medicine, Zhejiang University

• Yuezhong Ren, MD · Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-10-01

Primary Completion

2022-08-31

Completion

2022-10-31

Countries

• China

Study Locations