The Effectiveness of an Online FITT-VP Principle Based Exercise Program and Dietary Guidance in the Management of Childhood and Adolescent Obesity.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- BMI
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 9 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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;
研究组 & 干预措施
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.
干预措施: Online program that includes exercise guided by the FITT-VP principle and dietary advice (Behavioral)
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.
干预措施: Conventional in-clinic nutrition and exercise advice and self-control (Behavioral)
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.
干预措施: Online program that includes exercise guided by the FITT-VP principle and dietary advice (Behavioral)
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.
干预措施: Conventional in-clinic nutrition and exercise advice and self-control (Behavioral)
结局指标
主要结局
BMI
时间窗: 16, 32, 52, 104 weeks
Reduction in body mass index (the body mass \[kg\] divided by the square of the body height \[m\])
次要结局
- 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)
研究者
Feihong Luo
Chief, Department of Endocrinology and Inherited Metabolic Diseases
Children's Hospital of Fudan University