Targeting Obesity to Optimize Health in Cardiac Rehab (TOPCARE)

NCT03423238 | Completed Results DMC

• 2 other identifiers: IRB000461101R56HL134989-01A1
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Weight Loss; CHD - Coronary Heart Disease

Keywords

Cardiac; Rehab; Diet; Exercise; Obese

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (28)

• Body Weight

  Baseline

• Body Weight

  Months 3 and 6

• 6 Minute Walk (6MW) Test

  Baseline

• 6 Minute Walk (6MW) Test

  Months 3 and 6

• Grip Strength

  Baseline

Study Arms (2)

Rehab Only

ACTIVE COMPARATOR

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; Behavioral: Health Education; Other: Exercise Compliance; Other: Dietary Counseling

Rehab+Weight Loss (WL)

EXPERIMENTAL

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; Behavioral: Health Education; Other: Exercise Compliance; Dietary Supplement: Calorie-Restricted Diet; Behavioral: Behavioral Modification; Other: Weight-Loss Compliance

Interventions

Exercise OTHER

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

Rehab Only; Rehab+Weight Loss (WL)

Health Education BEHAVIORAL

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.

Rehab Only; Rehab+Weight Loss (WL)

Exercise Compliance OTHER

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.

Rehab Only; Rehab+Weight Loss (WL)

Calorie-Restricted Diet DIETARY_SUPPLEMENT

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.

Rehab+Weight Loss (WL)

Behavioral Modification BEHAVIORAL

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.

Rehab+Weight Loss (WL)

Weight-Loss Compliance OTHER

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.

Rehab+Weight Loss (WL)

Dietary Counseling OTHER

Participants have one meeting with the Rehab dietitian upon starting.

Rehab Only

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Obesity; Weight Loss; Coronary Artery Disease; Motor Activity

Interventions

Exercise; Caloric Restriction; Behavior Therapy; Nutrition Assessment

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Psychotherapy; Behavioral Disciplines and Activities; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Results Point of Contact

• Title: Tina Brinkley
• Organization: Wake Forest School of Medicine

tbrinkle@wakehealth.edu

336-713-8534

Study Officials

• Tina Brinkley, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2018
• First Posted: February 6, 2018
• Study Start: March 21, 2018
• Primary Completion: April 10, 2020
• Study Completion: April 10, 2020
• Last Updated: November 23, 2021
• Results First Posted: November 23, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)