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

NCT06254508 | Terminated

• 1 other identifier: FITT-online-[2023]-251
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Dietary habits

  16, 32, 52, 104 weeks

• AE

  16, 32, 52, 104 weeks

• Uric acid

  16, 32 weeks

• Tch

  16, 32 weeks

• LDL-c

  16, 32 weeks

Study Arms (2)

FITT to CON

ACTIVE COMPARATOR

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; Behavioral: Conventional in-clinic nutrition and exercise advice and self-control

CON to FITT

ACTIVE COMPARATOR

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; Behavioral: Conventional in-clinic nutrition and exercise advice and self-control

Interventions

Conventional in-clinic nutrition and exercise advice and self-control BEHAVIORAL

Physicians provide instructions on exercise and nutrition (total daily calorie intake) for the patients to conduct self-control for 16 weeks.

CON to FITT; FITT to CON

Online program that includes exercise guided by the FITT-VP principle and dietary advice BEHAVIORAL

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.

CON to FITT; FITT to CON

Eligibility Criteria

• Age: 9 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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;
• Not participating in other weight management programs currently or in the 3 months prior to the study;
• Accepts to participate and signs informed consent.

You may not qualify if:

• Currently taking or planning to take medications or interventions that affect body weight during the study period (32 weeks)
• Obesity caused by other medical conditions. For example, hypothalamic-pituitary disease, hypothyroidism, growth hormone deficiency, Cushing's syndrome, obesity-related syndromes.
• Comorbidity with other chronic diseases. E.g. psychiatric diseases, respiratory diseases, gastrointestinal diseases, rheumatic diseases, hepatic and renal insufficiency, chronic infectious diseases;
• 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.
• 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;

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead
• Shanghai Simlab Health Technology: collaborator

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

MeSH Terms

Conditions

Obesity

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Department of Endocrinology and Inherited Metabolic Diseases

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: February 12, 2024
• Study Start: February 22, 2024
• Primary Completion: December 28, 2024
• Study Completion: December 28, 2024
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)