A Multifaceted Intervention to Reduce Obesity Among Preschool Children: Study Protocol for a Randomized Controlled Trial in Suzhou City

Soochow University

Status: Active, not recruiting

Conditions: Intervention; Obesity & Overweight; Children

Treatments: Behavioral: Activities towards schools (providing a supportive school environment); Behavioral: Activities towards parents (providing a supportive family environment); Behavioral: Activities towards community (providing a supportive community environment); Behavioral: Student-focused activities; Behavioral: Policy

Study type: Interventional

Funder types: Other

Identifiers

NCT07361211

86362525

Details and patient eligibility

About

This study aimed to develop a comprehensive, multi-faceted intervention program for weight control and systematically evaluated its effectiveness on indicators of adiposity.

Full description

The rising prevalence of obesity among preschool children has become a critical public health concern in Suzhou of China. Nevertheless, evidence-based, personalized, and multi-component intervention strategies tailored to overweight and obese children remain inadequately established in current practice.

This is a cluster randomized controlled trial conducted among children in Suzhou City, Jiangsu Province. Children from junior and middle classes (aged 3 to 6) were recruited from six kindergartens. Three kindergartens were assigned to the intervention group and three to the control group. The one-year intervention includes health education, dietary guidance, and increased physical activity. The program takes a multi-level approach, engaging children, families, schools, communities, and society. Parental education and ongoing tracking of knowledge, attitudes, and practices are key components of the family-based intervention. Assessments will be conducted at 6 months, 12 months and subsequent follow-up periods after the baseline. The primary outcome will be the difference in body mass index (BMI) and body fat percentage between the two groups of children at the end of the intervention.

This program will test the effectiveness of comprehensive multi-faceted interventions on children. The results of this study will provide scientific evidence for formulating effective intervention strategies for childhood overweight and obesity, and are also expected to offer crucial practical references for the formulation and improvement of treatment guidelines for childhood obesity in China.

Enrollment: 1,486 patients

Sex: All

Ages: 3 to 6 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Children were eligible for inclusion if they were between 3 and 6 years old and their guardians had been informed and provided consent to participate in the study.

Exclusion criteria

• Exclusion criteria included: a history of heart disease, hypertension, diabetes mellitus, asthma, viral hepatitis, or nephritis; obesity due to endocrine disease or medication; abnormal physical development or deformities; inability to participate in school sports; or recent weight loss due to vomiting or medication use within the past three months.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,486 participants in 2 patient groups

the intervention group

Experimental group

Description:

Based on the Social Ecological Model (SEM) and Social Cognitive Theory (SCT), this multi-component, school-based, and family-involved program adopts a "community-school-family-medical" integrated prevention model.The program implements targeted interventions at individual, family, school, community, and societal levels to address childhood obesity and influence preschool children's knowledge, attitudes, and behaviors. Interventions will also be carried out during holidays. Trained professionals will distribute health materials to children and organize a three-week check-in activity. During this period, children's daily habits-including diet (regular meals, adequate water intake, no sugary beverages), exercise (outdoor activities, sedentary time, screen time), and sleep patterns-will be recorded. The aim is to help children gradually develop healthy habits.

Treatment:

Behavioral: Policy

Behavioral: Student-focused activities

Behavioral: Activities towards community (providing a supportive community environment)

Behavioral: Activities towards parents (providing a supportive family environment)

Behavioral: Activities towards schools (providing a supportive school environment)

Control

No Intervention group