Online exercise and dietary program for children with obesity

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

This study tests whether an online exercise and diet program led by coaches can help children and teens with obesity lose weight and improve their health compared to regular in-person advice.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 9 Years to 14 Years
• Sex: All
• Sponsor: Children's Hospital of Fudan University (Academic / other)
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT06254508 on ClinicalTrials.gov

What this trial studies

This clinical trial compares the effects of an online exercise program and dietary advice, guided by fitness coaches, against conventional in-clinic nutrition and exercise advice for children and adolescents with obesity. Participants will be monitored for 8 months during the intervention, followed by 16 months of observation. The study will evaluate various health parameters, including BMI, blood biochemistry, and participant satisfaction. The aim is to determine the effectiveness of the online program in managing obesity in this population.

Who should consider this trial

Good fit: Ideal candidates are children and adolescents with simple obesity, defined as a BMI between +2SD and +3SD of the reference range.

Not a fit: Patients with obesity caused by medical conditions or those currently taking medications that affect body weight may not benefit from this study.

Why it matters

Potential benefit: If successful, this program could provide an effective and accessible method for managing obesity in children and adolescents.

How similar studies have performed: Other studies have shown success with online interventions for obesity management, indicating potential for this approach.

Eligibility criteria

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;

Where this trial is running

Shanghai, Shanghai

• Children's Hospital of Fudan University — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Feihong Luo

Conditions Obesity