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

Not Applicable

Recruiting

• Conditions: Obesity
• Interventions: Behavioral: Online program that includes exercise guided by the FITT-VP principle and dietary advice; Behavioral: Conventional in-clinic nutrition and exercise advice and self-control

• Registration Number: NCT06254508
• Lead Sponsor: Children's Hospital of Fudan University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-26
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-03
• Study First Posted: 2024-02-12
• Study Start: 2024-02-22
• Last Update Submitted: 2024-02-22
• Last Update Posted: 2024-02-23
• Primary Completion: 2025-03-31
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Simple obesity: Body mass index (BMI) between +2SD and +3SD of the reference range: based on the "Standard Deviation Curve of BMI for Children 0-18 Years of Age in China", which was developed by the Physical Development Survey of Children in Nine Provinces/Cities in 2005;
2. Not participating in other weight management programs currently or in the 3 months prior to the study;
3. Accepts to participate and signs informed consent.

Exclusion Criteria

1. Currently taking or planning to take medications or interventions that affect body weight during the study period (32 weeks)
2. Obesity caused by other medical conditions. For example, hypothalamic-pituitary disease, hypothyroidism, growth hormone deficiency, Cushing's syndrome, obesity-related syndromes.
3. Comorbidity with other chronic diseases. E.g. psychiatric diseases, respiratory diseases, gastrointestinal diseases, rheumatic diseases, hepatic and renal insufficiency, chronic infectious diseases;
4. Presence of abnormal laboratory values at the time of screening indicating a clinically significant underlying disease or condition that may prevent the subject from participating in the study; or presence of abnormalities in the following laboratory tests: alanine aminotransferase (ALT) greater than 5 times the upper limit of normal, serum creatinine (Scr) greater than 1.5 times the upper limit of normal.
5. Contraindications to physical exercise or exercise-related risks. For example, history of asthma, history of hypoglycemia/diabetes, history of heart disease, history of cardiovascular disease, fracture/surgery/planned surgery within the last 1 year, psychomotor retardation, motor system defects/disabilities, previous history of exercise intolerance;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
FITT to CON	Online program that includes exercise guided by the FITT-VP principle and dietary advice	Online program that includes exercise guided by the FITT-VP principle and dietary advice for 16 weeks, followed by conventional in-clinic nutrition and exercise advice and self-control for 16 weeks.
CON to FITT	Online program that includes exercise guided by the FITT-VP principle and dietary advice	Conventional in-clinic nutrition and exercise advice and self-control for 16 weeks, followed by online program that includes exercise guided by the FITT-VP principle and dietary advice for 16 weeks.
FITT to CON	Conventional in-clinic nutrition and exercise advice and self-control	Online program that includes exercise guided by the FITT-VP principle and dietary advice for 16 weeks, followed by conventional in-clinic nutrition and exercise advice and self-control for 16 weeks.
CON to FITT	Conventional in-clinic nutrition and exercise advice and self-control	Conventional in-clinic nutrition and exercise advice and self-control for 16 weeks, followed by online program that includes exercise guided by the FITT-VP principle and dietary advice for 16 weeks.

Primary Outcome Measures

Name	Time	Method
BMI	16, 32, 52, 104 weeks	Reduction in body mass index (the body mass \[kg\] divided by the square of the body height \[m\])

Secondary Outcome Measures

Name	Time	Method
LDL-c	16, 32 weeks	Reduction in serum low density lipoprotein cholesterol
Dietary habits	16, 32, 52, 104 weeks	Change in dietary habits assessed by food frequency questionaire (2015 CHNS)
AE	16, 32, 52, 104 weeks	Adverse events during active intervention by questionaire and healthcare records according to local regulations (PMID: 34327433)
Tch	16, 32 weeks	Reduction in serum total cholesterol
Uric acid	16, 32 weeks	Reduction in serum uric acid levels
HbA1c	16, 32 weeks	Reduction in glycated hemoglobin
HOMA-IR	16, 32 weeks	Reduction in this surrogate marker of beta-cell function and insulin resistance (IR) from basal (fasting) glucose and concentrations.

Trial Locations

Locations (1)

Children's Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China