Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Healthy Eating Aerobic and Resistance Training in Youth (HEARTY) Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00195858
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : April 22, 2015
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Canadian Diabetes Association
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: aerobic and resistance exercise Phase 2 Phase 3

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 304 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Healthy Eating, Aerobic and Resistance Training in Youth (HEARTY) Trial
Study Start Date : April 2005
Actual Primary Completion Date : November 2010
Actual Study Completion Date : June 2011
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Diet and Aerobic Exercise Behavioral: aerobic and resistance exercise
aerobic and resistance exercise
Other Name: non applicable
Active Comparator: Diet and Resistane Exercise Behavioral: aerobic and resistance exercise
aerobic and resistance exercise
Other Name: non applicable
Active Comparator: Diet and Combined Aerobic and Resistance Exercise Behavioral: aerobic and resistance exercise
aerobic and resistance exercise
Other Name: non applicable
Diet-only control group Behavioral: aerobic and resistance exercise
aerobic and resistance exercise
Other Name: non applicable


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. change in percent body fat (MRI scan) [ Time Frame: end of study ]

Secondary Outcome Measures :
  1. Resting energy expenditure (indirect calorimetry). [ Time Frame: end of study ]
  2. Lean body mass [ Time Frame: end of study ]
  3. abdominal visceral and subcutaneous fat [ Time Frame: end of study ]
  4. waist and hip circumference [ Time Frame: end of study ]
  5. Apolipoprotein A1 [ Time Frame: end of study ]
  6. plasma insulin [ Time Frame: end of study ]
  7. HOMA insulin resistance [ Time Frame: end of study ]
  8. apoprotein B [ Time Frame: end of study ]
  9. C-reactive protein [ Time Frame: end of study ]
  10. HDL-C [ Time Frame: end of study ]
  11. LDL-C [ Time Frame: end of study ]
  12. triglycerides [ Time Frame: end of study ]
  13. total/HDL cholesterol ratio [ Time Frame: end of study ]
  14. fasting and 2-hour postload glucose [ Time Frame: end of study ]
  15. HbA1c [ Time Frame: end of study ]
  16. BP [ Time Frame: end of study ]
  17. Health related quality of life [ Time Frame: end of study ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   14 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female;
  • aged 14-18 years,
  • Tanner stage IV or above,
  • waist circumference ≥75th percentile for age/gender
  • body mass index ≥95th percentile for age, and gender
  • AND/OR ≥85th percentile for age/gender with any of:
  • Fasting glucose ≥6.0 fasting,
  • 2-hour plasma glucose 7.8-11 mmol/L after 75 G oral glucose,
  • fasting triglycerides > 1.7 mmol/L,
  • fasting plasma insulin >105 pmol/L,
  • HDL-C<0.9 mmol/L, LDL-C>3.0 mmol/L,
  • total cholesterol/HDL-C >90th percentile,
  • or first-degree relative with type 2 diabetes

Exclusion Criteria:

  • Participation during the previous 4 months in a regular program of exercise or aerobic sports greater than 2 times per week for at least 20 minutes per session.
  • Diabetes mellitus.
  • Body weight over 159 kg, and/or BMI>45 kg/m2, exceeding capacity of DEXA and CT machines.
  • Use of any performance-enhancing medication.
  • Use of any medication or herbal supplement that is likely to affect body composition, lipids or glucose metabolism.
  • Significant weight change (increase of ≥10%, or decrease≥5% of body weight during the two months before enrollment).
  • Uncontrolled hypertension: BP >150 mm Hg systolic or >95 mm Hg diastolic BP in sitting position.
  • Activity restrictions due to disease: unstable cardiac or pulmonary disease, significant arthritis.
  • Other illness judged by the patient or study physician to make participation in this study inadvisable.
  • Unwillingness/lack of availability to attend exercise and/or nutrition sessions at scheduled times and locations.
  • Significant cognitive deficit resulting in inability to understand or comply with instructions.
  • Pregnancy at the start of the study, or intention to become pregnant in the next year.
  • Inability to communicate in English or French.
  • Unwillingness of subject and/or parent/guardian to sign informed consent.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00195858


Locations
Layout table for location information
Canada, Ontario
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1Y 4E9
Sponsors and Collaborators
Ottawa Hospital Research Institute
Canadian Institutes of Health Research (CIHR)
Canadian Diabetes Association
Investigators
Layout table for investigator information
Principal Investigator: Ronald J Sigal, MD MPH FRCPC Ottawa Hospital Research Institute, University of Ottawa and the Ottawa Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00195858    
Other Study ID Numbers: MCT-71979
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: April 22, 2015
Last Verified: April 2015
Keywords provided by Ottawa Hospital Research Institute:
Youth
Exercise
Physical Activity
Aerobic
Resistance
 Overweight
obese
Canada
Sigal