Targeting Obesity to Optimize Health in Cardiac Rehab (TOPCARE)

Wake Forest University (WFU)

Status: Completed

Conditions: CHD - Coronary Heart Disease; Weight Loss; Obesity

Treatments: Other: Dietary Counseling; Other: Exercise Compliance; Other: Exercise; Other: Weight-Loss Compliance; Dietary Supplement: Calorie-Restricted Diet; Behavioral: Behavioral Modification; Behavioral: Health Education

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03423238

IRB00046110

1R56HL134989-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 38 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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38 participants in 2 patient groups

Rehab Only

Active Comparator group

Description:

Patients will be randomized to Rehab only using a randomization scheme with blocking stratified by sex and obesity severity (BMI\<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation, which includes meeting with dietitian, exercise, health education, and exercise compliance.

Treatment:

Other: Exercise Compliance

Other: Exercise

Behavioral: Health Education

Other: Dietary Counseling

Rehab+Weight Loss (WL)

Experimental group

Description:

Patients will be randomized to Rehab+WL using a randomization scheme with blocking stratified by sex and obesity severity (BMI\<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation in addition to a weight-loss intervention, which includes meeting with dietitian, exercise, health education, and exercise compliance, calorie-restricted diet, behavioral modification, and weight-loss compliance.

Treatment:

Other: Weight-Loss Compliance

Dietary Supplement: Calorie-Restricted Diet

Behavioral: Behavioral Modification

Other: Exercise Compliance

Other: Exercise

Behavioral: Health Education