Clinical trial NCT03423238: Targeting Obesity to Optimize Health in Cardiac Rehab (TOPCARE)
Official title: Targeting Obesity to Optimize Health in Cardiac Rehab (TOPCARE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Weight Loss
CHD - Coronary Heart Disease
Keywords: Cardiac
Rehab
Diet
Exercise
Obese
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2018-02-06
Enrollment: 38
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility - Number of Enrolled Participants
timeFrame: 18 months
measure: Compliance - Percentage of Sessions Attended
timeFrame: 6 months
measure: Retention - Percentage of Participants Who Returned for Follow-up Testing
timeFrame: 6 months
Secondary outcomes:
measure: Body Weight
timeFrame: Baseline
measure: Body Weight
timeFrame: Months 3 and 6
measure: 6 Minute Walk (6MW) Test
timeFrame: Baseline
measure: 6 Minute Walk (6MW) Test
timeFrame: Months 3 and 6
measure: Grip Strength
timeFrame: Baseline
measure: Grip Strength
timeFrame: Months 3 and 6
measure: Mobility - MAT-sf
timeFrame: Baseline
measure: Mobility - MAT-sf
timeFrame: Months 3 and 6
measure: Expanded Short Physical Performance Battery (eSPPB)
timeFrame: Baseline
measure: Expanded Short Physical Performance Battery (eSPPB)
timeFrame: Months 3 and 6
measure: Health-related Quality of Life SF-36 - Mental Component Summary (MCS) Score
timeFrame: Baseline
measure: Health-related Quality of Life SF-36 - Mental Component Summary (MCS) Score
timeFrame: Months 3 and 6
measure: Health-related Quality of Life SF-36 - Physical Component Summary (PCS) Score
timeFrame: Baseline
measure: Health-related Quality of Life SF-36 - Physical Component Summary (PCS) Score
timeFrame: Months 3 and 6
measure: Arterial Stiffness
timeFrame: Baseline
measure: Arterial Stiffness
timeFrame: Months 3 and 6
measure: Brachial Blood Pressure - Systolic
timeFrame: Baseline
measure: Brachial Blood Pressure - Systolic
timeFrame: Months 3 and 6
measure: Brachial Blood Pressure - Diastolic
timeFrame: Baseline
measure: Brachial Blood Pressure - Diastolic
timeFrame: Months 3 and 6
measure: Aortic Blood Pressure - Systolic
timeFrame: Baseline
measure: Aortic Blood Pressure - Systolic
timeFrame: Months 3 and 6
measure: Aortic Blood Pressure - Diastolic
timeFrame: Baseline
measure: Aortic Blood Pressure - Diastolic
timeFrame: Months 3 and 6
measure: Hemoglobin A1c
timeFrame: Baseline
measure: Hemoglobin A1c
timeFrame: Months 3 and 6
measure: Fasting Insulin
timeFrame: Baseline
measure: Fasting Insulin
timeFrame: Months 3 and 6
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Tina Brinkley, PhD
role: PRINCIPAL_INVESTIGATOR
References: