The Healthy Eating, Aerobic and Resistance Training in Youth (HEARTY) trial

Not Applicable

Completed

• Conditions: Sedentary post-pubertal overweight or obese youth aged 14 - 18 years; Nutritional, Metabolic, Endocrine; Obesity

• Registration Number: ISRCTN29738990
• Lead Sponsor: Ottawa Hospital Research Institute (OHRI) (Canada) - formerly Ottawa Health Research Institute

Brief Summary

2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30363954 [added 20/02/2019]

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-06-22
• Study Completion: 2011-08-31
• Last Update Posted: 18 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 292

Inclusion Criteria

1. Male or female
2. Aged 14 to 18 years
3. Tanner stage IV or above
4. Body mass index (BMI) greater than or equal to 95th percentile for age, and gender (http://www.cdc.gov/growthcharts),
AND/OR
greater than or equal to 85th percentile for age/gender with any of:
4.1. Fasting glucose greater than or equal to 6.0 fasting
4.2. Two-hour plasma glucose 7.8 - 11 mmol/L after 75 G oral glucose (impaired glucose tolerance)
4.3. Fasting triglycerides greater than 1.7 mmol/L
4.4. Fasting plasma insulin greater than 105 pmol/L
4.5. High density lipoprotein-cholesterol (HDL-C) less than 0.9 mmol/L
4.6. Low density lipoprotein-cholesterol (LDL-C) greater than 3.0 mmol/L
4.7. Total cholesterol/HDL-C greater than 90th percentile
4.8. First-degree relative with type 2 diabetes

Exclusion Criteria

1. Participation during the previous four months in a regular program of exercise or aerobic sports greater than or equal to two times per week for at least 20 minutes per session
2. Diabetes mellitus
3. Body weight over 159 kg, and/or BMI greater than 45 kg/m^2, exceeding capacity of dual energy X-ray absorptiometry (DEXA) and computed tomography (CT) machines
4. Use of any performance-enhancing medication
5. Use of any medication or herbal supplement that is likely to affect body composition, lipids or glucose metabolism
6. Significant weight change (increase of greater than or equal to 10%, or decrease greater than or equal to 5% of body weight during the two months before enrolment)
7. Uncontrolled hypertension: blood pressure (BP) greater than 150 mmHg systolic or greater than 95 mmHg diastolic BP in sitting position
8. Activity restrictions due to disease: unstable cardiac or pulmonary disease, significant arthritis
9. Other illness judged by the patient or study physician to make participation in this study inadvisable
10. Unwillingness/lack of availability to attend exercise and/or nutrition sessions at scheduled times and locations
11. Significant cognitive deficit resulting in inability to understand or comply with instructions
12. Pregnancy at the start of the study, or intention to become pregnant in the next year
13. Inability to communicate in English or French
14. Unwillingness of subject and/or parent/guardian to sign informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Amended 24/02/2009:<br> Percent body fat measured using Magnetic Resonance Imaging (MRI) at six months (end of intervention).<br><br> Initial information at time of registration:<br> Percent body fat measured using Magnetic Resonance Imaging (MRI) at six months post treatment measured at six months post treatment/12 months post randomisation.<br>