Online Exercise Program and Dietary Advice (FITT-online) for Children and Adolescents With Obesity (NCT06254508) | Clinical Trial Compass
TerminatedNot Applicable
Online Exercise Program and Dietary Advice (FITT-online) for Children and Adolescents With Obesity
Stopped: Poor patient compliance and Withdrawal of support from the exercise training institution
China33 participantsStarted 2024-02-22
Plain-language 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.
Who can participate
Age range9 Years – 14 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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;