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

April 20, 2015 updated by: Ottawa Hospital Research Institute

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Interventional

Enrollment (Actual)

304

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4E9
        • Ottawa Hospital Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Diet and Aerobic Exercise
aerobic and resistance exercise
Other Names:
  • non applicable
ACTIVE_COMPARATOR: Diet and Resistane Exercise
aerobic and resistance exercise
Other Names:
  • non applicable
ACTIVE_COMPARATOR: Diet and Combined Aerobic and Resistance Exercise
aerobic and resistance exercise
Other Names:
  • non applicable
OTHER: Diet-only control group
aerobic and resistance exercise
Other Names:
  • non applicable

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change in percent body fat (MRI scan)
Time Frame: end of study
end of study

Secondary Outcome Measures

Outcome Measure
Time Frame
Resting energy expenditure (indirect calorimetry).
Time Frame: end of study
end of study
Lean body mass
Time Frame: end of study
end of study
abdominal visceral and subcutaneous fat
Time Frame: end of study
end of study
waist and hip circumference
Time Frame: end of study
end of study
Apolipoprotein A1
Time Frame: end of study
end of study
plasma insulin
Time Frame: end of study
end of study
HOMA insulin resistance
Time Frame: end of study
end of study
apoprotein B
Time Frame: end of study
end of study
C-reactive protein
Time Frame: end of study
end of study
HDL-C
Time Frame: end of study
end of study
LDL-C
Time Frame: end of study
end of study
triglycerides
Time Frame: end of study
end of study
total/HDL cholesterol ratio
Time Frame: end of study
end of study
fasting and 2-hour postload glucose
Time Frame: end of study
end of study
HbA1c
Time Frame: end of study
end of study
BP
Time Frame: end of study
end of study
Health related quality of life
Time Frame: end of study
end of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ronald J Sigal, MD MPH FRCPC, Ottawa Hospital Research Institute, University of Ottawa and the Ottawa Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (ACTUAL)

November 1, 2010

Study Completion (ACTUAL)

June 1, 2011

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (ESTIMATE)

September 20, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

April 22, 2015

Last Update Submitted That Met QC Criteria

April 20, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • MCT-71979

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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