Intensive Lifestyle Intervention for Remission of Metabolic Syndrome

NCT ID: NCT04116905

Last Updated: 2025-12-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2022-10-31

Brief 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.

Detailed Description

Background:

Metabolic syndrome is a global public health concern, with prevalence rates ranging from 10% to 84% across different populations. It is strongly associated with multiple chronic non-communicable diseases, including type 2 diabetes, cardiovascular diseases, non-alcoholic fatty liver disease, polycystic ovary syndrome, and certain cancers. Notably, obesity plays a central role in the development of metabolic syndrome, and substantial evidence supports the benefits of significant weight loss in improving its components. Currently, there is a lack of research on lifestyle interventions aimed at weight loss to alleviate metabolic syndrome in affected populations.

Study Design:

This study is a single-center, prospective, randomized controlled trial. Metabolic syndrome (MetS) subjects aged 18-60 years were enrolled and randomly assigned to either an intensive lifestyle intervention group (a low-carbohydrate diet combined with physical exercise, target weight loss of 15%) or a conventional lifestyle intervention group ( energy-restricted diet combined with physical exercise, target weight loss of 7%). Participants underwent a 5-month weight-loss intervention (with monthly follow-ups) followed by a 7-month weight-maintenance phase (with follow-ups every 2 months). During the follow-up period, anthropometric and laboratory parameters were regularly monitored.

Conditions

Metabolic Syndrome

Keywords

Metablolic syndrome; remission; life style; weight loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intensive Lifestyle Intervention

Participants randomized to the intensive lifestyle intervention arm will receive a structured, multi-component program consisting of both individualized counseling and group-based sessions. This intervention is specifically designed to facilitate achievement of a clinically significant 15% weight reduction and support long-term weight maintenance."

Group Type: EXPERIMENTAL

Intensive Lifestyle Intervention

Intervention Type: BEHAVIORAL

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.

Conventional Treatment

Participants in the conventional treatment arm receive structured group-based education sessions focusing on metabolic syndrome management principles and peer support, with the therapeutic goal of achieving a modest 7% weight reduction

Group Type: ACTIVE_COMPARATOR

Conventional Treatment

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• BMI of 27-45 kg/m2
• Metabolic syndrome: meet at least 3 of the following 5 criteria: waist circumference ≥85 cm (male) or 80 cm (female); TG ≥1.7 mmol/L or with lipid-lowering treatment; HDL<1.04 mmol/L(male) /1.3 mmol/L (female)；SBP ≥ 130 mmHg and / or DBP ≥ 85 mmHg and / or with diagnosed hypertension and anti-hypertensive treatment; fasting glucose ≥ 5.6 mmol/L and / or with diagnosed type 2 diabetes and hypoglycemic treatment. (If with type 2 diabetes, the process of the disease should not exceed 6 years, with the level of C-P ≥3/4 of the lower limit of limit; if with hypertension, BP ≤ 180/110 mmHg without anti-hypertensive agent, or BP ≤160/100 mmHg with 1-2 kinds of anti-hypertensive agents, or BP ≤140/90 mmHg with 3-4 kinds of anti-hypertensive agents; if with hyper-triglyceridemia, TG ≤ 11.2 mmol/L without lipid-lowering agent, or TG ≤ 5.6 mmol/L with lipid-lowering agent.)
• Han Chinese
• Willingness to participate

Exclusion Criteria

• Participants with metabolic syndrome caused by other secondary factors (genetic diseases related to obesity and hyperlipidemia, Cushing's syndrome, drug-induced obesity and etc.);
• Participants whose body weight fluctuated by more than 5 kg in the last 6 months; who trying to lose weight in the last 3 months; who had used anti-obesity drugs, oral contraceptive, or glucocorticoids in the last 3 months;
• Participants with Type 1 diabetes or gestational diabetes or other types of diabetes;
• Participants with BP ≥ 180/110 mmHg, or malignant hypertension;
• Participants with previous severe gastrointestinal diseases;
• Participants with significant dysfunction of heart, liver, kidney and systemic organs (NYHA Class III or IV; ALT and / or AST ≥ 4 times the normal upper limit; GFR < 60 ml/min) or with malignant tumor;
• Participants with drug abuse or alcohol addiction; with serious mental and neurological disorders;
• Pregnant or lactating women; those who have planned to give birth within the past 1 year;
• Participants with special dietary requirements, or with soy products, milk and other daily food allergies;
• Participants in other clinical trials.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pengfei Shan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital, School of Medicine, Zhejiang University

Yuezhong Ren, MD

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital, School of Medicine, Zhejiang University

Locations

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

LIMS

Identifier Type: -

Identifier Source: org_study_id