The Effectiveness of an Online FITT-VP Principle Based Exercise Program and Dietary Guidance in the Management of Childhood and Adolescent Obesity.
Overview
- Phase
- Not Applicable
- Intervention
- Online program that includes exercise guided by the FITT-VP principle and dietary advice
- Conditions
- Obesity
- Sponsor
- Children's Hospital of Fudan University
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- BMI
- Status
- Terminated
- Last Updated
- last month
Overview
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.
Investigators
Feihong Luo
Chief, Department of Endocrinology and Inherited Metabolic Diseases
Children's Hospital of Fudan University
Eligibility Criteria
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;
Arms & Interventions
FITT to CON
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.
Intervention: Online program that includes exercise guided by the FITT-VP principle and dietary advice
FITT to CON
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.
Intervention: Conventional in-clinic nutrition and exercise advice and self-control
CON to FITT
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.
Intervention: Online program that includes exercise guided by the FITT-VP principle and dietary advice
CON to FITT
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.
Intervention: Conventional in-clinic nutrition and exercise advice and self-control
Outcomes
Primary Outcomes
BMI
Time Frame: 16, 32, 52, 104 weeks
Reduction in body mass index (the body mass \[kg\] divided by the square of the body height \[m\])
Secondary Outcomes
- Dietary habits(16, 32, 52, 104 weeks)
- AE(16, 32, 52, 104 weeks)
- Tch(16, 32 weeks)
- LDL-c(16, 32 weeks)
- Uric acid(16, 32 weeks)
- HbA1c(16, 32 weeks)
- HOMA-IR(16, 32 weeks)