Healthy Eating Aerobic and Resistance Training in Youth (HEARTY) Trial

NCT00195858 | Completed Phase 2

• 1 other identifier: MCT-71979
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity

Keywords

Youth; Exercise; Physical Activity; Aerobic; Resistance; Overweight; obese; Canada; Sigal

Outcome Measures

Primary Outcomes (1)

• change in percent body fat (MRI scan)

  end of study

Secondary Outcomes (17)

• Resting energy expenditure (indirect calorimetry).

  end of study

• Lean body mass

  end of study

• abdominal visceral and subcutaneous fat

  end of study

• waist and hip circumference

  end of study

• Apolipoprotein A1

  end of study

Study Arms (4)

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

Interventions

aerobic and resistance exercise BEHAVIORAL

aerobic and resistance exercise

Also known as: non applicable

Diet and Aerobic Exercise; Diet and Combined Aerobic and Resistance Exercise; Diet and Resistane Exercise; Diet-only control group

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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:
• Fasting glucose ≥6.0 fasting,
• 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

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Canadian Diabetes Association: collaborator

Study Sites (1)

Ottawa Hospital Research Institute

Ottawa, Ontario, K1Y 4E9, Canada

Location

Related Publications (13)

• 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.

  PMID: 37034563 DERIVED

• Goldfield 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.

  PMID: 34867148 DERIVED

• Goldfield 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.

  PMID: 33829867 DERIVED

• Walsh 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.

  PMID: 30363954 DERIVED

• Goldfield 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.

  PMID: 29679660 DERIVED

• Cameron 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.

  PMID: 27545672 DERIVED

• Goldfield 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.

  PMID: 26322787 DERIVED

• Alberga 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.

  PMID: 26202452 DERIVED

• Goldfield 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.

  PMID: 26096064 DERIVED

• Sigal 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.

  PMID: 25243536 DERIVED

• Goldfield 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.

  PMID: 23498300 DERIVED

• Alberga 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.

  PMID: 22548962 DERIVED

• Goldfield 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.

  PMID: 22069461 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Obesity; Motor Activity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Ronald J Sigal, MD MPH FRCPC

  Ottawa Hospital Research Institute, University of Ottawa and the Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: April 1, 2005
• Primary Completion: November 1, 2010
• Study Completion: June 1, 2011
• Last Updated: April 22, 2015

Record last verified: 2015-04

Locations

CA (1)