Condition category
Nutritional, Metabolic, Endocrine
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Ron Sigal


Contact details

7th floor
North Tower
Foothills Medical Center
1403 29 Street NW
T2N 2T9
+1 (0)403 944 2783



Additional contact

Ms Penny Phillips


Contact details

+1 (0)613 738 8400 ext. 81959

Additional identifiers

EudraCT number number


Protocol/serial number


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



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


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

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


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


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



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


Overall trial end date


Reason abandoned (if study stopped)


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 (,
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


Age group




Target number of participants


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


Recruitment end date



Countries of recruitment


Trial participating centre

Foothills Medical Center
T2N 2T9

Sponsor information


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

Sponsor details

Att: Ms. Carolyn Adams-Smith
Finance & Grants
725 Parkdale Avenue
K1Y 4E9
+1 (0)613 798 5555 ext. 13176

Sponsor type

Research organisation



Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - (ref: MCT-71979)

Alternative name(s)

Instituts de Recherche en Santé du Canada, CIHR

Funding Body Type

government organisation

Funding Body Subtype

National government



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: [added 20/02/2019]

Publication citations

Additional files

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.