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Targeting Obesity to Optimize Health in Cardiac Rehab (TOPCARE) (TOPCARE)

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ClinicalTrials.gov Identifier: NCT03423238
Recruitment Status : Recruiting
First Posted : February 6, 2018
Last Update Posted : August 31, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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.

Condition or disease Intervention/treatment Phase
Obesity Weight Loss CHD - Coronary Heart Disease Other: Exercise Behavioral: Health Education Other: Exercise Compliance Dietary Supplement: Calorie-Restricted Diet Behavioral: Behavioral Modification Other: Weight-Loss Compliance Other: Dietary Counseling Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: All assessments will take place by study staff blinded to the participant's treatment assignment. To ensure that staff remain blinded, participants will be asked not to discuss their intervention with the assessor
Primary Purpose: Supportive Care
Official Title: Targeting Obesity to Optimize Health in Cardiac Rehab (TOPCARE)
Actual Study Start Date : March 21, 2018
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Rehab Only
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
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

Behavioral: Health Education
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.

Other: Exercise Compliance
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.

Other: Dietary Counseling
Participants have one meeting with the Rehab dietitian upon starting.

Experimental: Rehab+Weight Loss (WL)
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
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

Behavioral: Health Education
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.

Other: Exercise Compliance
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.

Dietary Supplement: Calorie-Restricted Diet
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.

Behavioral: Behavioral Modification
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. At the end of the 6-month weight loss intervention, the RD will meet with participants to devise a weight maintenance strategy, including sample meal plans.

Other: Weight-Loss Compliance
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.




Primary Outcome Measures :
  1. Study Feasibilty [ Time Frame: 6 months ]
    Feasibility will be assessed in terms of the ability to 1) recruit study participants (i.e., total number randomized divided by total number eligible); 2) retain participants in the study for the full 6 months (i.e., the proportion of randomized participants who return for follow-up testing).

  2. Compliance [ Time Frame: 6 months ]
    Feasibility will be assessed in terms of the ability to obtain adequate compliance to the prescribed intervention (i.e., total number of exercise/counseling sessions attended divided by total number of sessions prescribed).


Secondary Outcome Measures :
  1. Change in Body weight [ Time Frame: baseline, 3, and 6 month ]
    Body weight in measured in kgs

  2. Change in 6 minute walk (6MW) test [ Time Frame: baseline, 3, and 6 month ]
    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 will be 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 will be measured by the total distance covered in feet.

  3. Change in Expanded Short Physical Performance Battery (eSPPB) [ Time Frame: baseline, 3, and 6 month ]
    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.

  4. Change in Grip strength [ Time Frame: baseline, 3, and 6 month ]
    Grip strength will be measured twice in each hand using an isometric hydraulic hand dynamometer.

  5. Change in Mobility [ Time Frame: baseline, 3, and 6 month ]
    Mobility will be 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.

  6. Change in Health-related quality of life [ Time Frame: baseline, 3, and 6 month ]
    Health-related quality of life will be assessed using the Medical Outcomes Study Short Form 36 (SF-36), a self-report measure with well-documented psychometric properties across a wide range of populations. 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 will be used to derive a physical component summary (PCS) score and a mental component summary (MCS) score, with higher scores indicating more favorable quality of life.

  7. Change in Arterial stiffness- pulse wave velocity (PWV) [ Time Frame: baseline, 3, and 6 month ]
    Arterial stiffness will be assessed as carotid-femoral pulse wave velocity (PWV). Carotid-femoral PWV will be 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.

  8. Change in Blood pressure [ Time Frame: baseline, 3, and 6 month ]
    Blood pressure will be measured with the participant in a seated or supine position after resting quietly for 5-10 minutes. Brachial and central (aortic) blood pressure will be measured using a conventional mercury sphygmomanometer and the SphygmoCor XCEL system, respectively.

  9. Change in Hemoglobin A1c [ Time Frame: baseline, 3, and 6 month ]
    Hemoglobin A1c will be measured in whole blood using a turbidimetric inhibition immunoassay.

  10. Change in Insulin [ Time Frame: baseline, 3, and 6 month ]
    Insulin will be determined by a chemiluminescent immunoassay.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03423238


Contacts
Contact: Tina Brinkley, PhD 336-713-8534 tbrinkle@wakehealth.edu
Contact: Kimberly Kennedy 336-713-8567 kkennedy@wakehealth.edu

Locations
United States, North Carolina
Wake Forest Baptist Medical Center Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Tina Brinkley, Ph.D.    336-713-8534    tbrinkle@wakehealth.edu   
Contact: Kimberly Kennedy    336-713-8567    kkennedy@wakehealth.edu   
Sub-Investigator: Denise Houston, PhD         
Sub-Investigator: Fang-Chi Hsu, PhD         
Sub-Investigator: Barbara Nicklas, PhD         
Sub-Investigator: Dalane Kitzman, MD         
Sponsors and Collaborators
Wake Forest University Health Sciences
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Tina Brinkley, PhD Wake Forest University Health Sciences

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03423238     History of Changes
Other Study ID Numbers: IRB00046110
1R56HL134989-01A1 ( U.S. NIH Grant/Contract )
First Posted: February 6, 2018    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wake Forest University Health Sciences:
Cardiac
Rehab
Diet
Exercise
Obese

Additional relevant MeSH terms:
Obesity
Heart Diseases
Weight Loss
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Cardiovascular Diseases
Body Weight Changes
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases