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 range
9 Years – 14 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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;