Status:
COMPLETED
Healthy Eating Aerobic and Resistance Training in Youth (HEARTY) Trial
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Canadian Diabetes Association
Conditions:
Obesity
Eligibility:
All Genders
14-18 years
Phase:
PHASE2
PHASE3
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 Imagi...
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 adip...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
304 Patients enrolled
Trial Details
Trial ID
NCT00195858
Start Date
April 1 2005
End Date
June 1 2011
Last Update
April 22 2015
Active Locations (1)
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1
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1Y 4E9