Targeting Obesity to Optimize Health in Cardiac Rehab (TOPCARE)

Study Overview
=================
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.

Official Title
-----------------
Targeting Obesity to Optimize Health in Cardiac Rehab (TOPCARE)

Conditions
-----------------
Obesity, Weight Loss, CHD - Coronary Heart Disease

Intervention / Treatment
-----------------
* Other: Exercise
* Behavioral: Health Education
* Other: Exercise Compliance
* Dietary Supplement: Calorie-Restricted Diet
* Behavioral: Behavioral Modification
* Other: Weight-Loss Compliance
* Other: Dietary Counseling


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rehab Only<br>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. | Other: Exercise<br>* Each exercise session lasts for 60 to 90 minutes and consists of 5-10 minutes of warm-up and cool-down activity; up to 30 minutes of aerobic exercise using a variety of modalities (e.g., walking laps on a track, cycle ergometry, treadmills, stair climbers); and 15-20 minutes of upper and lower body resistance exercises using Thera-Bands. An exercise physiologist creates an individualized plan<br>Behavioral: Health Education<br>* Group education classes conducted by an exercise physiologist and/or dietitian are designed to provide support and general information on healthy lifestyle behaviors. Topics include risk factor control, diabetes, hypertension, lipids, medications, aerobic exercise, strength training and flexibility, weight control, reading food nutrition labels, eating out, holiday eating, intimacy, stress, relaxation, cardiac symptoms, and cardiac interventions.<br>Other: Exercise Compliance<br>* Multiple behavioral management strategies to create a positive exercise environment and promote adherence and retention will be utilized. These include promptly contacting participants who miss a session, scheduling makeup sessions, and offering individual counseling sessions to discuss strategies to promote attendance and limit obstacles to participation.<br>Other: Dietary Counseling<br>* Participants have one meeting with the Rehab dietitian upon starting.<br>|
| Experimental: Rehab+Weight Loss (WL)<br>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. | Other: Exercise<br>* Each exercise session lasts for 60 to 90 minutes and consists of 5-10 minutes of warm-up and cool-down activity; up to 30 minutes of aerobic exercise using a variety of modalities (e.g., walking laps on a track, cycle ergometry, treadmills, stair climbers); and 15-20 minutes of upper and lower body resistance exercises using Thera-Bands. An exercise physiologist creates an individualized plan<br>Behavioral: Health Education<br>* Group education classes conducted by an exercise physiologist and/or dietitian are designed to provide support and general information on healthy lifestyle behaviors. Topics include risk factor control, diabetes, hypertension, lipids, medications, aerobic exercise, strength training and flexibility, weight control, reading food nutrition labels, eating out, holiday eating, intimacy, stress, relaxation, cardiac symptoms, and cardiac interventions.<br>Other: Exercise Compliance<br>* Multiple behavioral management strategies to create a positive exercise environment and promote adherence and retention will be utilized. These include promptly contacting participants who miss a session, scheduling makeup sessions, and offering individual counseling sessions to discuss strategies to promote attendance and limit obstacles to participation.<br>Dietary Supplement: Calorie-Restricted Diet<br>* Diet plans will provide a caloric deficit of 500 kcals per day. The lowest calorie level permitted will be 1,100 kcals for women and 1,200 kcals for men. The calorie distribution goal will be 15-20% from protein, <30% from fat, and 45-60% from carbohydrates. Participants will consume 2 meal replacements per day (Premier Protein shakes and bars); provided by the study)), along with one meal composed of traditional foods (500-750 kcals, low in fat, high in vegetables), and 1-3 snacks as needed (e.g., cereal bar, fruit, or vegetable, providing 100-150 kcals each). For the meal, patients will follow a weekly menu plan and recipes provided by the study. The food plan will be tailored to individual preferences and energy needs.<br>Behavioral: Behavioral Modification<br>* During months 1-3, participants will attend weekly individual behavioral counseling sessions with the study registered dietitian (RD); individual sessions will be held twice per month during months 4-6. The sessions will focus on self-monitoring, portion control, mindful eating, coping with negative thoughts, eating at regular times, and stress management. The RD will review individual progress, solve problems, answer questions, and set weight loss goals.<br>Other: Weight-Loss Compliance<br>* Participants will be asked to record their food and beverage intake in daily logs which will be reviewed weekly by the RD to verify compliance to the diet. Body weight will be measured weekly to ensure that participants are losing weight at an appropriate rate. If a participant is not meeting weight loss goals, energy intake will be modified accordingly to produce the desired rate of weight loss.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility - Number of Enrolled Participants | Total number of participants who met all inclusion/exclusion criteria and were enrolled in the study | 18 months | 
| Compliance - Percentage of Sessions Attended | The percentage of exercise/counseling sessions attended (calculated as the number of sessions attended divided by the number of sessions prescribed multiplied by 100) | 6 months | 
| Retention - Percentage of Participants Who Returned for Follow-up Testing | The number of participants who returned for the 6-month follow-up visit divided by the total number of randomized participants multiplied by 100 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Weight | Body weight measured in kg | Baseline | 
| Body Weight | Body weight measured in kg | Months 3 and 6 | 
| 6 Minute Walk (6MW) Test | The 6MW test is a valid and reproducible measure of submaximal exercise capacity that reflects the level at which most activities of daily living are performed, predicts clinical events in cardiac patients, and is therefore a clinically meaningful outcome in cardiac rehabilitation studies. Participants were asked to walk at their own maximal pace on an established course, covering as much ground as they can during the allotted time, without running. Performance was measured by the total distance covered in meters. | Baseline | 
| 6 Minute Walk (6MW) Test | The 6MW test is a valid and reproducible measure of submaximal exercise capacity that reflects the level at which most activities of daily living are performed, predicts clinical events in cardiac patients, and is therefore a clinically meaningful outcome in cardiac rehabilitation studies. Participants were asked to walk at their own maximal pace on an established course, covering as much ground as they can during the allotted time, without running. Performance was measured by the total distance covered in meters. | Months 3 and 6 | 
| Grip Strength | Grip strength was measured twice in each hand using an isometric hydraulic hand dynamometer. | Baseline | 
| Grip Strength | Grip strength was measured twice in each hand using an isometric hydraulic hand dynamometer. | Months 3 and 6 | 
| Mobility - MAT-sf | Mobility was assessed using the MAT-sf, a 10-item computer-based, self-administered assessment that uses animated video clips of 10 different tasks to illustrate various mobility-related challenges that cover a broad range of functioning. Participants provide an assessment of their ability to perform each task on the computer by clicking the appropriate response (yes/no, number of minutes, number of times). Scores range from 30 to 80, with higher scores indicative of better mobility. | Baseline | 
| Mobility - MAT-sf | Mobility was assessed using the MAT-sf, a 10-item computer-based, self-administered assessment that uses animated video clips of 10 different tasks to illustrate various mobility-related challenges that cover a broad range of functioning. Participants provide an assessment of their ability to perform each task on the computer by clicking the appropriate response (yes/no, number of minutes, number of times). Scores range from 30 to 80, with higher scores indicative of better mobility. | Months 3 and 6 | 
| Expanded Short Physical Performance Battery (eSPPB) | The expanded Short Physical Performance Battery (eSPPB) is a modified version of a widely used assessment of lower extremity physical function that consists of 3 standing balance tasks held for 10 seconds each (side-by-side, tandem and semi-tandem), two 4-m walk tests to assess usual gait speed, and 5 repeated chair stands. To minimize ceiling effects and maximize overall dispersion of test scores, the eSPPB increases the holding time of the semi- and full-tandem stands to 30 seconds and adds a single leg stand and a narrow walk test of balance (walking at usual pace within lines of tape spaced 20 cm apart). eSPPB scores are continuous and range from 0 to 4, with higher scores indicative of better performance. | Baseline | 
| Expanded Short Physical Performance Battery (eSPPB) | The expanded Short Physical Performance Battery (eSPPB) is a modified version of a widely used assessment of lower extremity physical function that consists of 3 standing balance tasks held for 10 seconds each (side-by-side, tandem and semi-tandem), two 4-m walk tests to assess usual gait speed, and 5 repeated chair stands. To minimize ceiling effects and maximize overall dispersion of test scores, the eSPPB increases the holding time of the semi- and full-tandem stands to 30 seconds and adds a single leg stand and a narrow walk test of balance (walking at usual pace within lines of tape spaced 20 cm apart). eSPPB scores are continuous and range from 0 to 4, with higher scores indicative of better performance. | Months 3 and 6 | 
| Health-related Quality of Life SF-36 - Mental Component Summary (MCS) Score | Health-related quality of life was assessed using the Medical Outcomes Study Short Form 36 (SF-36), a 36-item self-report measure with well-documented psychometric properties across a wide range of populations. All items are scored on a 0 to 100 range such that a high score defines a more favorable quality of life. The SF-36 generates eight subscale scores (general health perceptions; physical functioning; role limitations due to physical problems; bodily pain; mental health; role limitations due to emotional problems; vitality; and social functioning) which are generated by averaging items in the same subscale. The mental component summary (MCS) score is derived using a factor analysis technique that includes positive weights for the vitality, social functioning, role-emotional, and mental health scales and negative weights for the physical functioning, role-physical, bodily pain and general health scales. | Baseline | 
| Health-related Quality of Life SF-36 - Mental Component Summary (MCS) Score | Health-related quality of life was assessed using the Medical Outcomes Study Short Form 36 (SF-36), a 36-item self-report measure with well-documented psychometric properties across a wide range of populations. All items are scored on a 0 to 100 range such that a high score defines a more favorable quality of life. The SF-36 generates eight subscale scores (general health perceptions; physical functioning; role limitations due to physical problems; bodily pain; mental health; role limitations due to emotional problems; vitality; and social functioning) which are generated by averaging items in the same subscale. The mental component summary (MCS) score is derived using a factor analysis technique that includes positive weights for the vitality, social functioning, role-emotional, and mental health scales and negative weights for the physical functioning, role-physical, bodily pain and general health scales. | Months 3 and 6 | 
| Health-related Quality of Life SF-36 - Physical Component Summary (PCS) Score | Health-related quality of life was assessed using the Medical Outcomes Study Short Form 36 (SF-36), a 36-item self-report measure with well-documented psychometric properties across a wide range of populations. All items are scored on a 0 to 100 range such that a high score defines a more favorable quality of life. The SF-36 generates eight subscale scores (general health perceptions; physical functioning; role limitations due to physical problems; bodily pain; mental health; role limitations due to emotional problems; vitality; and social functioning) which are generated by averaging items in the same subscale. The physical component summary (PCS) score is derived using a factor analysis technique that includes positive weights for the physical functioning, role-physical, bodily pain, general health and vitality scales and negative weights for the social functioning, role-emotional and mental health scales. | Baseline | 
| Health-related Quality of Life SF-36 - Physical Component Summary (PCS) Score | Health-related quality of life was assessed using the Medical Outcomes Study Short Form 36 (SF-36), a 36-item self-report measure with well-documented psychometric properties across a wide range of populations. All items are scored on a 0 to 100 range such that a high score defines a more favorable quality of life. The SF-36 generates eight subscale scores (general health perceptions; physical functioning; role limitations due to physical problems; bodily pain; mental health; role limitations due to emotional problems; vitality; and social functioning) which are generated by averaging items in the same subscale. The physical component summary (PCS) score is derived using a factor analysis technique that includes positive weights for the physical functioning, role-physical, bodily pain, general health and vitality scales and negative weights for the social functioning, role-emotional and mental health scales. | Months 3 and 6 | 
| Arterial Stiffness | Arterial stiffness was assessed as carotid-femoral pulse wave velocity (PWV). Carotid-femoral PWV was measured in the supine position using the SphygmoCor XCEL system. PWV is calculated by dividing the distance between the carotid and femoral arteries by the pulse transit time. | Baseline | 
| Arterial Stiffness | Arterial stiffness was assessed as carotid-femoral pulse wave velocity (PWV). Carotid-femoral PWV was measured in the supine position using the SphygmoCor XCEL system. PWV is calculated by dividing the distance between the carotid and femoral arteries by the pulse transit time. | Months 3 and 6 | 
| Brachial Blood Pressure - Systolic | Brachial blood pressure was measured using a conventional mercury sphygmomanometer with the participant in a seated position after resting quietly for 5-10 minutes. | Baseline | 
| Brachial Blood Pressure - Systolic | Brachial blood pressure was measured using a conventional mercury sphygmomanometer with the participant in a seated position after resting quietly for 5-10 minutes. | Months 3 and 6 | 
| Brachial Blood Pressure - Diastolic | Brachial blood pressure was measured using a conventional mercury sphygmomanometer with the participant in a seated position after resting quietly for 5-10 minutes. | Baseline | 
| Brachial Blood Pressure - Diastolic | Brachial blood pressure was measured using a conventional mercury sphygmomanometer with the participant in a seated position after resting quietly for 5-10 minutes. | Months 3 and 6 | 
| Aortic Blood Pressure - Systolic | Aortic blood pressure was measured using the SphygmoCor XCEL system with the participant in the supine position after resting quietly for 5-10 minutes. | Baseline | 
| Aortic Blood Pressure - Systolic | Aortic blood pressure was measured using the SphygmoCor XCEL system with the participant in a supine position after resting quietly for 5-10 minutes. | Months 3 and 6 | 
| Aortic Blood Pressure - Diastolic | Aortic blood pressure was measured using the SphygmoCor XCEL system with the participant in a supine position after resting quietly for 5-10 minutes. | Baseline | 
| Aortic Blood Pressure - Diastolic | Aortic blood pressure was measured using the SphygmoCor XCEL system with the participant in a supine position after resting quietly for 5-10 minutes. | Months 3 and 6 | 
| Hemoglobin A1c | Hemoglobin A1c was measured in whole blood using a turbidimetric inhibition immunoassay. | Baseline | 
| Hemoglobin A1c | Hemoglobin A1c was measured in whole blood using a turbidimetric inhibition immunoassay. | Months 3 and 6 | 
| Fasting Insulin | Insulin was determined by a chemiluminescent immunoassay. | Baseline | 
| Fasting Insulin | Insulin was determined by a chemiluminescent immunoassay. | Months 3 and 6 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac, Rehab, Diet, Exercise, Obese