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

Obesity Clinical Trial

— FITT-online  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06254508
• Other study ID #: FITT-online-[2023]-251
• Status: Recruiting
• Phase: N/A
• Start date: February 22, 2024
• Est. completion date: September 30, 2026

Study information

• Verified date: February 2024
• Source: Children's Hospital of Fudan University
• Contact: Feihong Luo
• Phone: +862164931226
• Email: luofh[@]fudan.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 30, 2026
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 14 Years

Eligibility

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;

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Online program that includes exercise guided by the FITT-VP principle and dietary advice
Week 1: Children received 2 sessions of exercise initiation and 1 session of small group exercise training (45 minutes) with 4~6 peers. 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). 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.
• 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.

Locations

Country	Name	City	State
China	Children's Hospital of Fudan University	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University	Shanghai Simlab Health Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI	Reduction in body mass index (the body mass [kg] divided by the square of the body height [m])	16, 32, 52, 104 weeks
Secondary	Dietary habits	Change in dietary habits assessed by food frequency questionaire (2015 CHNS)	16, 32, 52, 104 weeks
Secondary	AE	Adverse events during active intervention by questionaire and healthcare records according to local regulations (PMID: 34327433)	16, 32, 52, 104 weeks
Secondary	Uric acid	Reduction in serum uric acid levels	16, 32 weeks
Secondary	Tch	Reduction in serum total cholesterol	16, 32 weeks
Secondary	LDL-c	Reduction in serum low density lipoprotein cholesterol	16, 32 weeks
Secondary	HbA1c	Reduction in glycated hemoglobin	16, 32 weeks
Secondary	HOMA-IR	Reduction in this surrogate marker of beta-cell function and insulin resistance (IR) from basal (fasting) glucose and concentrations.	16, 32 weeks