ISRCTN - ISRCTN29738990: The Healthy Eating, Aerobic and Resistance Training in Youth (HEARTY) trial

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ron Sigal

ORCID ID

Contact details

7th floor
North Tower
Foothills Medical Center
1403 29 Street NW
Calgary
Alberta
T2N 2T9
Canada
+1 403 944 2783
rsigal@ucalgary.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00195858

Protocol/serial number

MCT-71979

Study information

Scientific title

A single centre, four arm, randomised parallel trial of healthy eating, aerobic exercise and resistance training to reduce percent body fat in overweight or obese adolescents

Acronym

HEARTY

Study hypothesis

1. Reduction in percent body fat will be larger in diet and aerobic exercise and diet and 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
2. 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 10-months follow-up
3. Groups that include resistance training will produce greater psychosocial changes and better adherence than aerobic training alone at post-treatment and follow-up

As of 25/02/2009 this record was updated to include an amendment to the end date; the initial anticipated end date was 31/08/2009.

Ethics approval

1. Research Ethics Board of the Ottawa Hospital approved in December 2004
2. CHEO Research Ethics Board approved on the 1st March 2005

Study design

Single centre four arm randomised parallel trial with outcome assessor and study investigator blinding

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Sedentary post-pubertal overweight or obese youth aged 14 - 18 years

Intervention

After a four-week supervised low-intensity exercise run-in period to test compliance, 292 adolescents with BMI greater than or equal to 85th percentile for age and gender will be randomised in equal numbers to one of four arms:
1. Diet and aerobic exercise
2. Diet and resistance exercise
3. Diet and combined aerobic and resistance exercise
4. Diet-only control

The intervention will last 16 weeks, with a follow-up assessment at six-months post-treatment (11-months post-randomisation).

Contact for public queries:
Penny A Phillips, BSc., MA
Tel: +1 613 738 8400 ext. 81959
Email: pphillips@ohri.ca

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measure

Amended 24/02/2009:
Percent body fat measured using Magnetic Resonance Imaging (MRI) at six months (end of intervention).

Initial information at time of registration:
Percent body fat measured using Magnetic Resonance Imaging (MRI) at six months post treatment measured at six months post treatment/12 months post randomisation.

Secondary outcome measures

1. Resting energy expenditure (indirect calorimetry)
2. Lean body mass (DEXA)
3. Waist circumference
4. Important non-traditional CHD risk factors:
4.1. LDL particle diameter
4.2. Plasma insulin
4.3. Apoprotein B
4.4. C-reactive protein
5. Traditional metabolic CHD risk factors:
5.1. HDL-C
5.2. LDL-C
5.3. Triglycerides
5.4. Total/HDL cholesterol ratio
5.5. Blood pressure
5.6. HbA1c
5.7. Fasting and two-hour glucose
6. Effects on psychosocial adjustment will also be examined, including health related:
6.1. Quality of life (Pediatric Quality of Life Inventory™ [PedsQL™] - adolescent version)
6.2. Body image (Body Esteem Scale)
6.3. Mood (Profile of Mood States)
6.4. Self-esteem (Rosenberg self-Esteem Scale)

Overall trial start date

01/05/2005

Overall trial end date

31/08/2011

Reason abandoned (if study stopped)

Eligibility

Participant 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 two diabetes

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

292

Participant 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

Recruitment start date

01/05/2005

Recruitment end date

31/08/2011

Locations

Countries of recruitment

Canada

Trial participating centre

7th floor, North Tower
Alberta
T2N 2T9
Canada

Sponsor information

Organisation

Ottawa Hospital Research Institute (OHRI) (Canada) - formerly Ottawa Health Research Institute

Sponsor type

Research organisation

Website

http://www.ohri.ca/

Funders

Funder type