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 (0)403 944 2783
rsigal@ucalgary.ca
Type
Public
Additional contact
Ms Penny Phillips
ORCID ID
Contact details
-
-
-
Canada
+1 (0)613 738 8400 ext. 81959
pphillips@ohri.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
Ethics approval
1. Research Ethics Board of the Ottawa Hospital, December 2004
2. CHEO Research Ethics Board, 01/03/2005
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 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).
Intervention type
Behavioural
Phase
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 2 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
Foothills Medical Center
Alberta
T2N 2T9
Canada
Sponsor information
Organisation
Ottawa Hospital Research Institute (OHRI) (Canada) - formerly Ottawa Health Research Institute
Sponsor details
Att: Ms. Carolyn Adams-Smith
Director
Finance & Grants
725 Parkdale Avenue
Ottawa
Ontario
K1Y 4E9
Canada
+1 (0)613 798 5555 ext. 13176
cadamssmith@ohri.ca
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-71979)
Alternative name(s)
Instituts de Recherche en Santé du Canada, CIHR, IRSC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Canada
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30363954 [added 20/02/2019]