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

Launched by CHILDREN'S HOSPITAL OF FUDAN UNIVERSITY · Feb 3, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at an online exercise program combined with dietary advice to help children and adolescents who are struggling with obesity. The program is designed by fitness coaches and follows guidelines that emphasize different types of exercise and nutrition. The trial will compare how well this online program works compared to traditional in-person advice that participants might get at a clinic. The study will last for 8 months while participants follow the program, and then they will be observed for an additional 16 months to see how they continue to do.

To be eligible for this trial, children and adolescents must have a body mass index (BMI) that falls within a specific range indicating obesity, and they shouldn’t be involved in any other weight management programs currently or in the last 3 months. Participants will be monitored for various health measures and can expect to receive support for their exercise and dietary habits. It's important to know that some children may not be eligible if they have certain medical conditions or are taking medications that affect weight. Overall, this study aims to find out if online support can be an effective way to help young people manage their weight.

Gender

ALL

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;