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

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

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.

Study Overview

• Status: Terminated
• Conditions: Obesity
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 201102
      • Children's Hospital of Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: FITT to CON; 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.	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.; 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.
Active Comparator: CON to FITT; 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.	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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University
• Collaborators: Shanghai Simlab Health Technology

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2024
• Primary Completion (Actual): December 28, 2024
• Study Completion (Actual): December 28, 2024

Study Registration Dates

• First Submitted: January 26, 2024
• First Submitted That Met QC Criteria: February 3, 2024
• First Posted (Actual): February 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Epidemiologic Measurements; Nutrition Assessment
• Other Study ID Numbers: FITT-online-[2023]-251

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No