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

ISRCTN	ISRCTN29738990
DOI	https://doi.org/10.1186/ISRCTN29738990
ClinicalTrials.gov number	NCT00195858
Secondary identifying numbers	MCT-71979

Submission date: 22/06/2007
Registration date: 22/06/2007
Last edited: 20/02/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Ron Sigal
Scientific

7th floor, North Tower
Foothills Medical Center
1403 29 Street NW
Calgary
Alberta
T2N 2T9
Canada

Phone	+1 (0)403 944 2783
Email	rsigal@ucalgary.ca

Ms Penny Phillips
Public

-
-
-
Canada

Phone	+1 (0)613 738 8400 ext. 81959
Email	pphillips@ohri.ca

Study information

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
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
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
Study acronym	HEARTY
Study objectives	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(s)	1. Research Ethics Board of the Ottawa Hospital, December 2004 2. CHEO Research Ethics Board, 01/03/2005
Health condition(s) or problem(s) studied	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
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 study start date	01/05/2005
Completion date	31/08/2011

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	14 Years
Upper age limit	18 Years
Sex	Both
Target number of participants	292
Key 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
Key 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
Date of first enrolment	01/05/2005
Date of final enrolment	31/08/2011

Locations

Countries of recruitment

Canada

Study participating centre

Foothills Medical Center

Alberta
T2N 2T9
Canada

Sponsor information

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

Att: Ms. Carolyn Adams-Smith, Director
Finance & Grants
725 Parkdale Avenue
Ottawa
Ontario
K1Y 4E9
Canada

Phone	+1 (0)613 798 5555 ext. 13176
Email	cadamssmith@ohri.ca
Website	http://www.ohri.ca/
"ROR"	https://ror.org/03c62dg59

Funders

Funder type

Research organisation

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-71979)
Government organisation / National government

Alternative name(s): Instituts de Recherche en Santé du Canada, Canadian Institutes of Health Research (CIHR), CIHR_IRSC, Canadian Institutes of Health Research | Ottawa ON, CIHR, IRSC
Location: Canada

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	30/09/2018	20/02/2019	Yes	No

Editorial Notes

20/02/2019: Publication reference added.
25/02/2009: This record was updated to include an amendment to the end date; the initial overall trial end date was 31/08/2009.