N/A
N=38
Targeting Obesity to Optimize Health in Cardiac Rehab (TOPCARE)
Obesity · Weight Loss · CHD - Coronary Heart Disease
Bottom Line
View on ClinicalTrials.gov: NCT03423238 ↗Enrolled (actual)
38
Serious AEs
5.3%
Results posted
Nov 2021
Primary outcome: Primary: Feasibility - Number of Enrolled Participants — 38 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Exercise (Other); Health Education (Behavioral); Exercise Compliance (Other); Calorie-Restricted Diet (Dietary_supplement); Behavioral Modification (Behavioral); Weight-Loss Compliance (Other); Dietary Counseling (Other)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility - Number of Enrolled Participants |
38 | — |
| PRIMARY Compliance - Percentage of Sessions Attended |
45.2; 68.6; NA; 98.2 | — |
| PRIMARY Retention - Percentage of Participants Who Returned for Follow-up Testing |
17; 19 | — |
| SECONDARY Body Weight |
104.852; 101.658; 104.811; 99.122 | 0.017 sig |
| SECONDARY Body Weight |
104.852; 101.658; 104.811; 99.122 | 0.017 sig |
| SECONDARY 6 Minute Walk (6MW) Test |
452.962; 446.916; 448.506; 462.986 | 0.684 |
| SECONDARY 6 Minute Walk (6MW) Test |
452.962; 446.916; 448.506; 462.986 | 0.684 |
| SECONDARY Grip Strength |
33.711; 33.652; 34.534; 35.837 | 0.973 |
| SECONDARY Grip Strength |
33.711; 33.652; 34.534; 35.837 | 0.973 |
| SECONDARY Mobility - MAT-sf |
64.839; 65.212; 64.613; 65.069 | 0.854 |
| SECONDARY Mobility - MAT-sf |
64.839; 65.212; 64.613; 65.069 | 0.854 |
| SECONDARY Expanded Short Physical Performance Battery (eSPPB) |
2.252; 1.992; 2.121; 2.135 | 0.008 sig |
| SECONDARY Expanded Short Physical Performance Battery (eSPPB) |
2.252; 1.992; 2.121; 2.135 | 0.008 sig |
| SECONDARY Health-related Quality of Life SF-36 - Mental Component Summary (MCS) Score |
54.778; 53.698; 53.885; 55.463 | 0.692 |
| SECONDARY Health-related Quality of Life SF-36 - Mental Component Summary (MCS) Score |
54.778; 53.698; 53.885; 55.463 | 0.692 |
| SECONDARY Health-related Quality of Life SF-36 - Physical Component Summary (PCS) Score |
42.458; 41.595; 41.949; 42.569 | 0.721 |
| SECONDARY Health-related Quality of Life SF-36 - Physical Component Summary (PCS) Score |
42.458; 41.595; 41.949; 42.569 | 0.721 |
| SECONDARY Arterial Stiffness |
8.760; 8.061; 9.611; 8.487 | 0.488 |
| SECONDARY Arterial Stiffness |
8.760; 8.061; 9.611; 8.487 | 0.488 |
| SECONDARY Brachial Blood Pressure - Systolic |
124.089; 126.987; 124.272; 129.860 | 0.549 |
| SECONDARY Brachial Blood Pressure - Systolic |
124.089; 126.987; 124.272; 129.860 | 0.549 |
| SECONDARY Brachial Blood Pressure - Diastolic |
70.024; 69.247; 72.738; 69.989 | 0.792 |
| SECONDARY Brachial Blood Pressure - Diastolic |
70.024; 69.247; 72.738; 69.989 | 0.792 |
| SECONDARY Aortic Blood Pressure - Systolic |
130.234; 129.328; 127.204; 126.692 | 0.854 |
| SECONDARY Aortic Blood Pressure - Systolic |
130.234; 129.328; 127.204; 126.692 | 0.854 |
| SECONDARY Aortic Blood Pressure - Diastolic |
78.322; 78.965; 76.221; 78.783 | 0.824 |
| SECONDARY Aortic Blood Pressure - Diastolic |
78.322; 78.965; 76.221; 78.783 | 0.824 |
| SECONDARY Hemoglobin A1c |
6.046; 6.239; 6.033; 6.190 | 0.338 |
| SECONDARY Hemoglobin A1c |
6.046; 6.239; 6.033; 6.190 | 0.338 |
| SECONDARY Fasting Insulin |
20.161; 20.197; 17.558; 19.623 | 0.992 |
| SECONDARY Fasting Insulin |
20.161; 20.197; 17.558; 19.623 | 0.992 |
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.
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 14 drinks per week) within the past 6 months
- pregnant or pre-menopausal women
- peanut allergy
- milk allergy/lactose intolerance
Data sourced from ClinicalTrials.gov (NCT03423238). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.