Targeting Obesity to Optimize Health in Cardiac Rehab (TOPCARE)



Status:Recruiting
Conditions:Obesity Weight Loss, Peripheral Vascular Disease, Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases, Endocrinology
Healthy:No
Age Range:40 - Any
Updated:9/2/2018
Start Date:March 21, 2018
End Date:August 31, 2019
Contact:Tina Brinkley, PhD
Email:tbrinkle@wakehealth.edu
Phone:336-713-8534

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Although coronary heart disease (CHD) treatment guidelines recognize obesity as a major
modifiable risk factor,2 nearly half of all CHD patients are obese and the current standard
of care fails to implement evidence-based obesity treatment for this high-risk population.
Multiple lines of evidence suggest that weight loss improves outcomes in CHD patients. The
primary goal of this study is to determine the feasibility of adding a 6-month behavioral
weight loss intervention to exercise-based cardiac rehabilitation.

Although coronary heart disease (CHD) treatment guidelines recognize obesity as a major
modifiable risk factor,2 nearly half of all CHD patients are obese and the current standard
of care fails to implement evidence-based obesity treatment for this high-risk population.
The efficacy of exercise-based cardiac rehabilitation for improving exercise capacity and CHD
risk factors is markedly blunted in CHD patients with obesity. Current programs largely focus
on nutrient intake and produce minimal weight loss, on average. Our data show that despite
appropriate exercise prescription and adherence, only 22% of CHD patients with obesity lose
even the minimum recommended body weight over a 3-month program. These findings indicate that
targeting reductions in caloric intake is needed to optimize outcomes in these patients and
suggest that current programs are too short to produce adequate weight loss and ensure the
necessary behavioral adaptations for long-term maintenance. Randomization to diet-induced
weight loss in combination with aerobic exercise improves exercise capacity, quality of life,
and CHD risk factors more than exercise alone and reduces long-term mortality in overweight
and obese adults. The primary goal of this study is to determine the feasibility of adding a
6-month behavioral weight loss intervention to exercise-based cardiac rehabilitation.

Inclusion Criteria:

- documented CHD defined as hospitalization for MI/heart attack coronary artery bypass
grafting (CABG) or percutaneous coronary intervention (i.e., angioplasty, stent)

- age = 40 and older

- overweight or obese based on an elevated BMI (≥25 kg/m2)

Exclusion Criteria:

- body weight >450 lbs

- congestive heart failure (ejection fraction <35%)

- advanced kidney disease (on dialysis, or dialysis anticipated within 6 months)

- cognitive impairment (Montreal Cognitive Assessment [MoCA] score <22)

- major depression (Patient Health Questionnaire [PHQ-9] ≥20)

- severe pulmonary disease (i.e., oxygen-dependent)

- significant impairment from a prior stroke or other neurologic disease or injury

- high risk for non-adherence (i.e., unwilling or unable to comply with study
requirements)

- current participation in physical therapy or another weight loss study

- current or recent use of weight loss medications (e.g., orlistat)

- prior weight loss procedure

- drug/substance abuse or excessive alcohol (> 14 drinks per week) within the past 6
months

- pregnant or pre-menopausal women

- peanut allergy

- milk allergy/lactose intolerance
We found this trial at
1
site
Winston-Salem, North Carolina 27157
Phone: 336-713-8534
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from
Winston-Salem, NC
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