A Multifaceted Intervention to Reduce Obesity Among Preschool Children: Study Protocol for a Randomized Controlled Trial in Suzhou City
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 1,486
- Locations
- 1
- Primary Endpoint
- Healthy weight development
Study Overview
Brief Summary
This study aimed to develop a comprehensive, multi-faceted intervention program for weight control and systematically evaluated its effectiveness on indicators of adiposity.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 3 Years to 6 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Healthy weight development
Time Frame: through study completion, an average of 1 year
Child BMI, child BMI z-score, child body fat percentage Child BMI: Use the automatic height and weight measuring device to measure height and weight. The subject should wear light clothing and stand barefoot, facing away from the pillar and standing on the base plate of the height gauge with the trunk naturally straight and the head upright, looking straight ahead. Height is measured in centimeters, with a test error not exceeding 0.5 centimeters. Weight is measured in kilograms, with a test error not exceeding 0.1 kilograms. BMI will be calculated as weight (kg) divided by height squared (m²). Child BMI z-score: Use the WHO child growth standards, taking into account the child's gender and age. Child body fat percentage: Use the InBody 570 body composition analyzer to measure the body fat percentage of children. Use InBody wet wipes to wipe hands and feet, which helps to increase the conductivity of the current. Stand on the InBody to measure the body fat percentage.Unit: %
Secondary Outcomes
- Healthy weight development(through study completion, an average of 1 year)
- Child cardiovascular(through study completion, an average of 1 year)
- Child well-being(through study completion, an average of 1 year)
- Child eating habits(through study completion, an average of 1 year)
- Child physical activity(through study completion, an average of 1 year)
- Child sleep(through study completion, an average of 1 year)
- Family food and meals(through study completion, an average of 1 year)
- Family physical activity(through study completion, an average of 1 year)
- Family healthy knowledge(through study completion, an average of 1 year)
Investigators
Jieyun Yin
Ph.D
Soochow University