ObesityPhase 2/3NCT00195858
Healthy Eating Aerobic and Resistance Training in Youth (HEARTY) Trial
A Phase 2/3 study testing aerobic and resistance exercise in people with Obesity, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- aerobic and resistance exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2005to Jun 2011
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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:
Show all 13Show fewer
- 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
Who cannot join
- 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).
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity
- Being tested
- aerobic and resistance exercise
- Keywords
- Youth, Exercise, Physical Activity, Aerobic, Resistance, Overweight, obese, Canada, Sigal
- Medical subject headings
- Obesity, Motor Activity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic and resistance exerciseBehavioural
Also called non applicable
aerobic and resistance exercise
| Study group | Role | What they receive |
|---|---|---|
| Diet and Aerobic Exercise | Active comparator | Not described Receives: Behavioral: aerobic and resistance exercise |
| Diet and Resistane Exercise | Active comparator | Not described Receives: Behavioral: aerobic and resistance exercise |
| Diet and Combined Aerobic and Resistance Exercise | Active comparator | Not described Receives: Behavioral: aerobic and resistance exercise |
| Diet-only control group | Other | Not described Receives: Behavioral: aerobic and resistance exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in percent body fat (MRI scan)
Measured: end of study
Secondary outcomes (17)
Resting energy expenditure (indirect calorimetry).
Measured: end of study
Lean body mass
Measured: end of study
abdominal visceral and subcutaneous fat
Measured: end of study
waist and hip circumference
Measured: end of study
Apolipoprotein A1
Measured: end of study
plasma insulin
Measured: end of study
HOMA insulin resistance
Measured: end of study
apoprotein B
Measured: end of study
C-reactive protein
Measured: end of study
HDL-C
Measured: end of study
LDL-C
Measured: end of study
triglycerides
Measured: end of study
total/HDL cholesterol ratio
Measured: end of study
fasting and 2-hour postload glucose
Measured: end of study
HbA1c
Measured: end of study
BP
Measured: end of study
Health related quality of life
Measured: end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startApr 2005
- Primary completionNov 2010
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Canadian Diabetes Association
- Responsible party
- Sponsor
- Investigators
- Ronald J Sigal, MD MPH FRCPC, Principal investigator, Ottawa Hospital Research Institute, University of Ottawa and the Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00195858
- Sponsor's protocol ID
- MCT-71979
- Status last verified
- Apr 2015
- First submitted
- 12 Sep 2005
- Last updated
- 22 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Alberga AS, Edache IY, Sigal RJ, von Ranson KM, Russell-Mayhew S, Kenny GP, Doucette S, Prud'homme D, Hadjiyannakis S, Cameron JD, Goldfield GS. Effects of the HEARTY exercise randomized controlled trial on eating behaviors in adolescents with obesity. Obes Sci Pract. 2022 Sep 6;9(2):158-171. doi: 10.1002/osp4.620. eCollection 2023 Apr.
PubMed 37034563Goldfield GS, Walsh J, Sigal RJ, Kenny GP, Hadjiyannakis S, De Lisio M, Ngu M, Prud'homme D, Alberga AS, Doucette S, Goldfield DB, Cameron JD. Associations of the BDNF Val66Met Polymorphism With Body Composition, Cardiometabolic Risk Factors, and Energy Intake in Youth With Obesity: Findings From the HEARTY Study. Front Neurosci. 2021 Nov 12;15:715330. doi: 10.3389/fnins.2021.715330. eCollection 2021.
PubMed 34867148Goldfield GS, Cameron JD, Sigal RJ, Kenny GP, Holcik M, Prud'homme D, Guerin E, Alberga AS, D'Angiulli A, Tremblay MS, Mougharbel F, Walsh J. Screen time is independently associated with serum brain-derived neurotrophic factor (BDNF) in youth with obesity. Appl Physiol Nutr Metab. 2021 Sep;46(9):1083-1090. doi: 10.1139/apnm-2020-0756. Epub 2021 Apr 8.
PubMed 33829867Walsh JJ, D'Angiulli A, Cameron JD, Sigal RJ, Kenny GP, Holcik M, Doucette S, Alberga AS, Prud'homme D, Hadjiyannakis S, Gunnell K, Goldfield GS. Changes in the Brain-Derived Neurotrophic Factor Are Associated with Improvements in Diabetes Risk Factors after Exercise Training in Adolescents with Obesity: The HEARTY Randomized Controlled Trial. Neural Plast. 2018 Sep 30;2018:7169583. doi: 10.1155/2018/7169583. eCollection 2018.
PubMed 30363954Goldfield GS, Kenny GP, Prud'homme D, Holcik M, Alberga AS, Fahnestock M, Cameron JD, Doucette S, Hadjiyannakis S, Tulloch H, Tremblay MS, Walsh J, Guerin E, Gunnell KE, D'Angiulli A, Sigal RJ. Effects of aerobic training, resistance training, or both on brain-derived neurotrophic factor in adolescents with obesity: The hearty randomized controlled trial. Physiol Behav. 2018 Jul 1;191:138-145. doi: 10.1016/j.physbeh.2018.04.026. Epub 2018 Apr 19.
PubMed 29679660Cameron JD, Maras D, Sigal RJ, Kenny GP, Borghese MM, Chaput JP, Alberga AS, Goldfield GS. The mediating role of energy intake on the relationship between screen time behaviour and body mass index in adolescents with obesity: The HEARTY study. Appetite. 2016 Dec 1;107:437-444. doi: 10.1016/j.appet.2016.08.101. Epub 2016 Aug 18.
PubMed 27545672Goldfield GS, Kenny GP, Alberga AS, Prud'homme D, Hadjiyannakis S, Gougeon R, Phillips P, Tulloch H, Malcolm J, Doucette S, Wells GA, Ma J, Cameron JD, Sigal RJ. Effects of aerobic training, resistance training, or both on psychological health in adolescents with obesity: The HEARTY randomized controlled trial. J Consult Clin Psychol. 2015 Dec;83(6):1123-35. doi: 10.1037/ccp0000038. Epub 2015 Aug 31.
PubMed 26322787Alberga AS, Prud'homme D, Kenny GP, Goldfield GS, Hadjiyannakis S, Gougeon R, Phillips P, Malcolm J, Wells G, Doucette S, Ma J, Sigal RJ. Effects of aerobic and resistance training on abdominal fat, apolipoproteins and high-sensitivity C-reactive protein in adolescents with obesity: the HEARTY randomized clinical trial. Int J Obes (Lond). 2015 Oct;39(10):1494-500. doi: 10.1038/ijo.2015.133. Epub 2015 Jul 23.
PubMed 26202452Goldfield GS, Cameron JD, Murray M, Maras D, Wilson AL, Phillips P, Kenny GP, Hadjiyannakis S, Alberga AS, Tulloch H, Doucette S, Sigal RJ. Screen time is independently associated with health-related quality of life in overweight and obese adolescents. Acta Paediatr. 2015 Oct;104(10):e448-54. doi: 10.1111/apa.13073. Epub 2015 Jul 14.
PubMed 26096064Sigal RJ, Alberga AS, Goldfield GS, Prud'homme D, Hadjiyannakis S, Gougeon R, Phillips P, Tulloch H, Malcolm J, Doucette S, Wells GA, Ma J, Kenny GP. Effects of aerobic training, resistance training, or both on percentage body fat and cardiometabolic risk markers in obese adolescents: the healthy eating aerobic and resistance training in youth randomized clinical trial. JAMA Pediatr. 2014 Nov;168(11):1006-14. doi: 10.1001/jamapediatrics.2014.1392.
PubMed 25243536Goldfield GS, Saunders TJ, Kenny GP, Hadjiyannakis S, Phillips P, Alberga AS, Tremblay MS, Sigal RJ. Screen viewing and diabetes risk factors in overweight and obese adolescents. Am J Prev Med. 2013 Apr;44(4 Suppl 4):S364-70. doi: 10.1016/j.amepre.2012.11.040.
PubMed 23498300Alberga AS, Goldfield GS, Kenny GP, Hadjiyannakis S, Phillips P, Prud'homme D, Tulloch H, Gougeon R, Wells GA, Sigal RJ. Healthy Eating, Aerobic and Resistance Training in Youth (HEARTY): study rationale, design and methods. Contemp Clin Trials. 2012 Jul;33(4):839-47. doi: 10.1016/j.cct.2012.04.004. Epub 2012 Apr 21.
PubMed 22548962Goldfield GS, Kenny GP, Hadjiyannakis S, Phillips P, Alberga AS, Saunders TJ, Tremblay MS, Malcolm J, Prud'homme D, Gougeon R, Sigal RJ. Video game playing is independently associated with blood pressure and lipids in overweight and obese adolescents. PLoS One. 2011;6(11):e26643. doi: 10.1371/journal.pone.0026643. Epub 2011 Nov 1.
PubMed 22069461
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Eating, Aerobic and Resistance Training in Youth (HEARTY) Trial
- ClinicalTrials.gov ID
- NCT00195858
- Acronym / sponsor ID
- MCT-71979
- Conditions
- Obesity
- Keywords
- Youth, Exercise, Physical Activity, Aerobic, Resistance, Overweight, obese, Canada
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Canadian Diabetes Association
- Study start
- Apr 2005
- Primary completion
- Nov 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Diet and Aerobic Exercise | Active comparator | Behavioral: aerobic and resistance exercise |
| Diet and Resistane Exercise | Active comparator | Behavioral: aerobic and resistance exercise |
| Diet and Combined Aerobic and Resistance Exercise | Active comparator | Behavioral: aerobic and resistance exercise |
| Diet-only control group | Other | Behavioral: aerobic and resistance exercise |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aerobic and resistance exerciseAlso: non applicableaerobic and resistance exercise | Behavioural | Diet and Aerobic Exercise, Diet and Combined Aerobic and Resistance Exercise, Diet and Resistane Exercise, Diet-only control group |
Primary outcome
change in percent body fat (MRI scan)
Time frame: end of study
17 secondary outcomes
Resting energy expenditure (indirect calorimetry).
Time frame: end of study
Lean body mass
Time frame: end of study
abdominal visceral and subcutaneous fat
Time frame: end of study
waist and hip circumference
Time frame: end of study
Apolipoprotein A1
Time frame: end of study
plasma insulin
Time frame: end of study
HOMA insulin resistance
Time frame: end of study
apoprotein B
Time frame: end of study
C-reactive protein
Time frame: end of study
HDL-C
Time frame: end of study
LDL-C
Time frame: end of study
triglycerides
Time frame: end of study
total/HDL cholesterol ratio
Time frame: end of study
fasting and 2-hour postload glucose
Time frame: end of study
HbA1c
Time frame: end of study
BP
Time frame: end of study
Health related quality of life
Time frame: end of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2015.
- Derived from this study: PubMed 37034563Alberga AS, Edache IY, Sigal RJ, von Ranson KM, Russell-Mayhew S, Kenny GP, Doucette S, Prud'homme D, Hadjiyannakis S, Cameron JD, Goldfield GS. Effects of the HEARTY exercise randomized controlled trial on eating behaviors in adolescents with obesity. Obes Sci Pract. 2022 Sep 6;9(2):158-171. doi: 10.1002/osp4.620. eCollection 2023 Apr.
- Derived from this study: PubMed 34867148Goldfield GS, Walsh J, Sigal RJ, Kenny GP, Hadjiyannakis S, De Lisio M, Ngu M, Prud'homme D, Alberga AS, Doucette S, Goldfield DB, Cameron JD. Associations of the BDNF Val66Met Polymorphism With Body Composition, Cardiometabolic Risk Factors, and Energy Intake in Youth With Obesity: Findings From the HEARTY Study. Front Neurosci. 2021 Nov 12;15:715330. doi: 10.3389/fnins.2021.715330. eCollection 2021.
- Derived from this study: PubMed 33829867Goldfield GS, Cameron JD, Sigal RJ, Kenny GP, Holcik M, Prud'homme D, Guerin E, Alberga AS, D'Angiulli A, Tremblay MS, Mougharbel F, Walsh J. Screen time is independently associated with serum brain-derived neurotrophic factor (BDNF) in youth with obesity. Appl Physiol Nutr Metab. 2021 Sep;46(9):1083-1090. doi: 10.1139/apnm-2020-0756. Epub 2021 Apr 8.
- Derived from this study: PubMed 30363954Walsh JJ, D'Angiulli A, Cameron JD, Sigal RJ, Kenny GP, Holcik M, Doucette S, Alberga AS, Prud'homme D, Hadjiyannakis S, Gunnell K, Goldfield GS. Changes in the Brain-Derived Neurotrophic Factor Are Associated with Improvements in Diabetes Risk Factors after Exercise Training in Adolescents with Obesity: The HEARTY Randomized Controlled Trial. Neural Plast. 2018 Sep 30;2018:7169583. doi: 10.1155/2018/7169583. eCollection 2018.
- Derived from this study: PubMed 29679660Goldfield GS, Kenny GP, Prud'homme D, Holcik M, Alberga AS, Fahnestock M, Cameron JD, Doucette S, Hadjiyannakis S, Tulloch H, Tremblay MS, Walsh J, Guerin E, Gunnell KE, D'Angiulli A, Sigal RJ. Effects of aerobic training, resistance training, or both on brain-derived neurotrophic factor in adolescents with obesity: The hearty randomized controlled trial. Physiol Behav. 2018 Jul 1;191:138-145. doi: 10.1016/j.physbeh.2018.04.026. Epub 2018 Apr 19.
- Derived from this study: PubMed 27545672Cameron JD, Maras D, Sigal RJ, Kenny GP, Borghese MM, Chaput JP, Alberga AS, Goldfield GS. The mediating role of energy intake on the relationship between screen time behaviour and body mass index in adolescents with obesity: The HEARTY study. Appetite. 2016 Dec 1;107:437-444. doi: 10.1016/j.appet.2016.08.101. Epub 2016 Aug 18.
- Derived from this study: PubMed 26322787Goldfield GS, Kenny GP, Alberga AS, Prud'homme D, Hadjiyannakis S, Gougeon R, Phillips P, Tulloch H, Malcolm J, Doucette S, Wells GA, Ma J, Cameron JD, Sigal RJ. Effects of aerobic training, resistance training, or both on psychological health in adolescents with obesity: The HEARTY randomized controlled trial. J Consult Clin Psychol. 2015 Dec;83(6):1123-35. doi: 10.1037/ccp0000038. Epub 2015 Aug 31.
- Derived from this study: PubMed 26202452Alberga AS, Prud'homme D, Kenny GP, Goldfield GS, Hadjiyannakis S, Gougeon R, Phillips P, Malcolm J, Wells G, Doucette S, Ma J, Sigal RJ. Effects of aerobic and resistance training on abdominal fat, apolipoproteins and high-sensitivity C-reactive protein in adolescents with obesity: the HEARTY randomized clinical trial. Int J Obes (Lond). 2015 Oct;39(10):1494-500. doi: 10.1038/ijo.2015.133. Epub 2015 Jul 23.
- Derived from this study: PubMed 26096064Goldfield GS, Cameron JD, Murray M, Maras D, Wilson AL, Phillips P, Kenny GP, Hadjiyannakis S, Alberga AS, Tulloch H, Doucette S, Sigal RJ. Screen time is independently associated with health-related quality of life in overweight and obese adolescents. Acta Paediatr. 2015 Oct;104(10):e448-54. doi: 10.1111/apa.13073. Epub 2015 Jul 14.
- Derived from this study: PubMed 25243536Sigal RJ, Alberga AS, Goldfield GS, Prud'homme D, Hadjiyannakis S, Gougeon R, Phillips P, Tulloch H, Malcolm J, Doucette S, Wells GA, Ma J, Kenny GP. Effects of aerobic training, resistance training, or both on percentage body fat and cardiometabolic risk markers in obese adolescents: the healthy eating aerobic and resistance training in youth randomized clinical trial. JAMA Pediatr. 2014 Nov;168(11):1006-14. doi: 10.1001/jamapediatrics.2014.1392.
- Derived from this study: PubMed 23498300Goldfield GS, Saunders TJ, Kenny GP, Hadjiyannakis S, Phillips P, Alberga AS, Tremblay MS, Sigal RJ. Screen viewing and diabetes risk factors in overweight and obese adolescents. Am J Prev Med. 2013 Apr;44(4 Suppl 4):S364-70. doi: 10.1016/j.amepre.2012.11.040.
- Derived from this study: PubMed 22548962Alberga AS, Goldfield GS, Kenny GP, Hadjiyannakis S, Phillips P, Prud'homme D, Tulloch H, Gougeon R, Wells GA, Sigal RJ. Healthy Eating, Aerobic and Resistance Training in Youth (HEARTY): study rationale, design and methods. Contemp Clin Trials. 2012 Jul;33(4):839-47. doi: 10.1016/j.cct.2012.04.004. Epub 2012 Apr 21.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald J Sigal, MD MPH FRCPC principal investigator
Ottawa Hospital Research Institute, University of Ottawa and the Ottawa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing aerobic and resistance exercise in people with Obesity, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in percent body fat (MRI scan) (time frame: end of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00195858, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2015.