Status:
COMPLETED
Targeting Obesity to Optimize Health in Cardiac Rehab (TOPCARE)
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Obesity
Weight Loss
Eligibility:
All Genders
40+ years
Phase:
NA
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 imp...
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 imp...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 10 2020
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT03423238
Start Date
March 21 2018
End Date
April 10 2020
Last Update
November 23 2021
Active Locations (1)
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1
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157