NCT06254508

Online Exercise Program and Dietary Advice (FITT-online) for Children and Adolescents With Obesity

The Effectiveness of an Online FITT-VP Principle Based Exercise Program and Dietary Guidance in the Management of Childhood and Adolescent Obesity.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Children's Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 9 Years – 14 Years
• Healthy volunteers: Not accepted

Summary

This controlled clinical trial aims to compare the effects of an online program that includes exercise guided by the FITT-VP principle and dietary advice, conducted by fitness coaches, in children and adolescents with obesity with a control group that will be enrolled in conventional in-clinic nutrition and exercise advice. All participants will be monitored for 8 months during the active intervention, and followed by 16 months of observation. The study will evaluate the following parameters between groups: BMI, anthropometry, blood biochemistry panel (ALT/AST, lipids, uric acid, HOMA-IR, HbA1c), food frequency questionaire, household survey, satisfaction survey, and adverse events.

Conditions

• Obesity

Interventions

Type	Name	Description
BEHAVIORAL	Online program that includes exercise guided by the FITT-VP principle and dietary advice	1. Week 1: Children received 2 sessions of exercise initiation and 1 session of small group exercise training (45 minutes) with 4\~6 peers. 2. Weeks 2 to 16: 3 small group exercise sessions per week (45 minutes, 4-6 peers) of moderate-to-vigorous physical activity (MVPA). Effective exercise time was assessed by the time subjects reached the heart rate corresponding to the exercise intensity (64-95% of maximal heart rate), as measured by the instantaneous heart rate recorded during each exercise session. The type of exercise was a combination of aerobic, resistance, and flexibility exercises (time ratio 2.5:1:1). 3. Dietary guidance was provided concurrently during the 16-week intervention period: by establishing a WeChat group for caregivers and uploading daily pictures of the day's food to the group, the group's health coaches provided daily targeted dietary guidance.
BEHAVIORAL	Conventional in-clinic nutrition and exercise advice and self-control	Physicians provide instructions on exercise and nutrition (total daily calorie intake) for the patients to conduct self-control for 16 weeks.

Timeline

• Start date: 2024-02-22
• Primary completion: 2024-12-28
• Completion: 2024-12-28
• First posted: 2024-02-12
• Last updated: 2026-03-19

Locations

1 site across 1 country: China