Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00195858
Status:
COMPLETED
Last Update Posted:
2015-04-22
First Post:
2005-09-12
Brief Title:
Healthy Eating Aerobic and Resistance Training in Youth HEARTY Trial
Sponsor:
Ottawa Hospital Research Institute
Organization:
Ottawa Hospital Research Institute
Study Overview
Official Title:
Healthy Eating Aerobic and Resistance Training in Youth HEARTY Trial
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the effects of resistance training aerobic training and combined aerobic and resistance training on percent body fat measured using Magnetic Resonance Imaging MRI in sedentary post-pubertal overweight or obese youth aged 14-18 years
Detailed Description:
Background Obesity and inactivity independently increase risks of chronic disease in adolescence and all-cause mortality in adulthood In clinical trials changes in exercise and diet can reduce adiposity and risk of diabetes and other chronic diseases in obese adults and youth In many school systems physical education is mandatory in elementary school but not high school and physical activity often declines during adolescence Because physical activity habits track from adolescence to adulthood adolescence may represent a critical period for establishing a physically active lifestyle to prevent diseases associated with inactivity in adulthood Obesity can make adherence to aerobic activity challenging but would present less of an obstacle to resistance training Resistance exercise has shown favorable effects on lean body mass metabolic rate insulin resistance and quality of life in adults but almost no research has examined effects of resistance training in obese adolescents Our own survey in a sample of obese primarily sedentary youth found greater overall interest in resistance exercise than aerobic exercise
Objectives The primary objective of this study is to evaluate the effects of resistance training aerobic training and combined aerobic and resistance training on percent body fat measured using Magnetic Resonance Imaging MRI in sedentary post-pubertal overweight or obese youth aged 14-18 years
Study Design Randomized controlled trial conducted at a single site After a 4-week supervised low-intensity exercise run-in period to test compliance 292 adolescents with BMI 85th percentile for age and gender will be randomized in equal numbers to one of 4 arms Diet aerobic exercise diet resistance exercise diet combined aerobic and resistance exercise or diet-only control The intervention will last 22 weeks with a follow-up assessment at 6-months post-treatment 11-months post-randomization
Hypotheses Reduction in percent body fat will be larger in diet aerobic exercise and diet resistance exercise than diet-only controls at post-treatment and the combined aerobic and resistance training will be superior to either aerobic or resistance training alone in reducing percent body fat at post-treatment The combined resistance and aerobic group will show greater improvements in percent body fat body composition and physiological and psychosocial function at post-treatment and 12-months follow-up Groups that include resistance training will produce greater psychosocial changes and better adherence than aerobic training alone at post-treatment and follow-up
Significance The global burden of obesity in youth is increasing and more effective intervention is needed This study may identify that resistance training is an important component in the treatment of overweight adolescents As such findings may influence clinical decision making in the management of juvenile obesity as well as inform public health exercise guidelines and school-based physical education curricula in attempt to reduce the economic medical and psychosocial burden of obesity in youth
Objectives The primary objective of this study is to evaluate the effects of resistance training aerobic training and combined aerobic and resistance training on percent body fat measured using Magnetic Resonance Imaging MRI in sedentary post-pubertal overweight or obese youth aged 14-18 years
Study Design Randomized controlled trial conducted at a single site After a 4-week supervised low-intensity exercise run-in period to test compliance 292 adolescents with BMI 85th percentile for age and gender will be randomized in equal numbers to one of 4 arms Diet aerobic exercise diet resistance exercise diet combined aerobic and resistance exercise or diet-only control The intervention will last 22 weeks with a follow-up assessment at 6-months post-treatment 11-months post-randomization
Hypotheses Reduction in percent body fat will be larger in diet aerobic exercise and diet resistance exercise than diet-only controls at post-treatment and the combined aerobic and resistance training will be superior to either aerobic or resistance training alone in reducing percent body fat at post-treatment The combined resistance and aerobic group will show greater improvements in percent body fat body composition and physiological and psychosocial function at post-treatment and 12-months follow-up Groups that include resistance training will produce greater psychosocial changes and better adherence than aerobic training alone at post-treatment and follow-up
Significance The global burden of obesity in youth is increasing and more effective intervention is needed This study may identify that resistance training is an important component in the treatment of overweight adolescents As such findings may influence clinical decision making in the management of juvenile obesity as well as inform public health exercise guidelines and school-based physical education curricula in attempt to reduce the economic medical and psychosocial burden of obesity in youth
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None