NCT01500356: Heart Health

Effect of Exercise and Weight Loss on Cardiovascular Health

Completed NA Last updated 25 July 2017

What this trial tests

NA trial testing Behavioral weight loss intervention in Cardiovascular Disease in 383 participants. Completed in 30 June 2016.

Timeline

13 December 2011

Primary endpoint
30 June 2016

30 June 2016

Quick facts

Lead sponsor	University of Pittsburgh
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	383
Start date	13 December 2011
Primary completion	30 June 2016
Estimated completion	30 June 2016
Sites	1 location across United States

Drugs / interventions tested

• Behavioral weight loss intervention
• Diet Plus Moderate Exercise
• Diet Plus High Exercise

Conditions studied

• Cardiovascular Disease — all drugs for Cardiovascular Disease →
• Obesity — all drugs for Obesity →

Sponsor

University of Pittsburgh

Who can join

Adults 18 to 55, any sex, with Cardiovascular Disease or Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary aim of this study is to examine the effect of the consensus public health recommended level of physical activity \[moderate physical activity (MOD-PA) = 150 min/wk\] versus a higher dose of physical activity \[high physical activity (HIGH-PA) = 250 min/wk\] in the context of a comprehensive behavioral weight loss program that a includes a reduction in energy intake measures of cardiovascular function using cardiac MRI and biomarkers of vascular disease risk. Each of these exercise doses will be compared independently to a Diet Only group intervention on the proposed primary and secondary outcomes, with MOD-PA also compared to HIGH-PA. This study involves the recruitment of 390 overweight and obese adults who will be randomly assigned to one of the above conditions (Diet Only, MOD-PA, HIGH-PA) for a period of 12 months. The primary outcome is LVM measured by cardiac MRI. Secondary outcomes include additional cardiac MRI measures (aortic pulse wave velocity, end diastolic volume, aortic distensibility), inflammatory markers (CRP and TNFα) and selected adipocytokines (adiponectin) as biomarkers of risk related to vascular outcomes, body weight, body composition, and cardiorespiratory fitness, and traditional CVD risk factors (lipids, glucose, insulin, blood pressure). Additional secondary analyses will allow for examination of the effects of physical activity independent of weight change on the primary and secondary outcomes.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Effects of a 12-Month Weight Loss Intervention on Cognitive Outcomes in Adults with Overweight and Obesity.
   Peven JC, Jakicic JM, Rogers RJ, Lesnovskaya A, et al · · 2020 · cited 25× · PMID 33003548 · DOI 10.3390/nu12102988
2. Impact of weight loss with diet or diet plus physical activity on cardiac magnetic resonance imaging and cardiovascular disease risk factors: Heart Health Study randomized trial.
   Jakicic JM, Rogers RJ, Lang W, Gibbs BB, et al · · 2022 · cited 17× · PMID 35470972 · DOI 10.1002/oby.23412
3. Association of fitness and body fatness with left ventricular mass: The Heart Health Study.
   Rogers RJ, Schelbert EB, Lang W, Fridman Y, et al · · 2020 · cited 13× · PMID 32128239 · DOI 10.1002/osp4.380
4. Obesity, Psychological Distress, and Resting State Connectivity of the Hippocampus and Amygdala Among Women With Early-Stage Breast Cancer.
   Donofry SD, Lesnovskaya A, Drake JA, Ripperger HS, et al · · 2022 · cited 10× · PMID 35431843 · DOI 10.3389/fnhum.2022.848028
5. Change in circulating klotho in response to weight loss, with and without exercise, in adults with overweight or obesity.
   Collins KA, Ambrosio F, Rogers RJ, Lang W, et al · · 2023 · cited 8× · PMID 37457921 · DOI 10.3389/fragi.2023.1213228
6. Accumulated physical activity and the association with obesity, fitness, and cardiometabolic risk factors in healthy adults.
   Jackson RE, Lang W, Rogers RJ, Schelbert EB, et al · · 2024 · cited 5× · PMID 37789600 · DOI 10.1002/oby.23890
7. Reduced brain activity during a working memory task in middle-aged apolipoprotein E ε4 carriers with overweight/obesity.
   Drake JA, Jakicic JM, Rogers RJ, Aghjayan SL, et al · · 2022 · cited 5× · PMID 36504632 · DOI 10.3389/fnhum.2022.1001229
8. Effect of behavioral weight-loss program on biomarkers of cardiometabolic disease risk: Heart Health Study randomized trial.
   Collins KA, Kraus WE, Rogers RJ, Hauser ER, et al · · 2023 · cited 3× · PMID 36621902 · DOI 10.1002/oby.23618