ObesityTOPCARENCT03423238
Targeting Obesity to Optimize Health in Cardiac Rehab (TOPCARE)
A study testing Exercise, Health Education and Exercise Compliance in people with Obesity and Weight Loss, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Obesity, Weight Loss, CHD - Coronary Heart Disease
- What is being tested?
- Exercise, Health Education and Exercise Compliance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2018to 10 Apr 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
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.
Read the 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.
- Conditions
- Obesity, Weight Loss, CHD - Coronary Heart Disease
- Being tested
- Exercise, Health Education, Exercise Compliance, Calorie-Restricted Diet, Behavioral Modification
- Keywords
- Cardiac, Rehab, Diet, Exercise, Obese
- Medical subject headings
- Obesity, Weight Loss, Coronary Artery Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
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
Health EducationBehavioural
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.
Exercise ComplianceOther
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.
Calorie-Restricted DietDietary 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.
Behavioral ModificationBehavioural
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.
Weight-Loss ComplianceOther
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.
Dietary CounselingOther
Participants have one meeting with the Rehab dietitian upon starting.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Exercise; Behavioral: Health Education; Other: Exercise Compliance; Dietary Supplement: Calorie-Restricted Diet; Behavioral: Behavioral Modification; Other: Weight-Loss Compliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - Number of Enrolled Participants
Total number of participants who met all inclusion/exclusion criteria and were enrolled in the study
Measured: 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)
Measured: 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
Measured: 6 months
Secondary outcomes (28)
Body Weight
Body weight measured in kg
Measured: Baseline
Body Weight
Body weight measured in kg
Measured: 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.
Measured: 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.
Measured: Months 3 and 6
Grip Strength
Grip strength was measured twice in each hand using an isometric hydraulic hand dynamometer.
Measured: Baseline
Grip Strength
Grip strength was measured twice in each hand using an isometric hydraulic hand dynamometer.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Months 3 and 6
Hemoglobin A1c
Hemoglobin A1c was measured in whole blood using a turbidimetric inhibition immunoassay.
Measured: Baseline
Hemoglobin A1c
Hemoglobin A1c was measured in whole blood using a turbidimetric inhibition immunoassay.
Measured: Months 3 and 6
Fasting Insulin
Insulin was determined by a chemiluminescent immunoassay.
Measured: Baseline
Fasting Insulin
Insulin was determined by a chemiluminescent immunoassay.
Measured: Months 3 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study start21 Mar 2018
- Primary completion10 Apr 2020
- Study completion10 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Tina Brinkley, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03423238
- Sponsor's protocol ID
- IRB00046110
- Other IDs
- 1R56HL134989-01A1
- Acronym
- TOPCARE
- Status last verified
- Sep 2021
- First submitted
- 26 Jan 2018
- Last updated
- 23 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Obesity to Optimize Health in Cardiac Rehab (TOPCARE)
- ClinicalTrials.gov ID
- NCT03423238
- Acronym / sponsor ID
- TOPCARE / IRB00046110
- Conditions
- Obesity, Weight Loss, CHD - Coronary Heart Disease
- Keywords
- Cardiac, Rehab, Diet, Exercise, Obese
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 21 Mar 2018 (actual)
- Primary completion
- 10 Apr 2020 (actual)
- Study completion
- 10 Apr 2020 (actual)
- First posted
- 6 Feb 2018 (actual)
- Results
- Posted 23 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rehab Only | Active comparator | Other: Exercise, Behavioral: Health Education, Other: Exercise Compliance, Other: Dietary CounselingPatients 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. |
| Rehab+Weight Loss (WL) | Experimental | Other: Exercise, Behavioral: Health Education, Other: Exercise Compliance, Dietary Supplement: Calorie-Restricted Diet, Behavioral: Behavioral Modification, Other: Weight-Loss CompliancePatients 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseEach 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 | Other | Rehab Only, Rehab+Weight Loss (WL) |
| Health EducationGroup 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. | Behavioural | Rehab Only, Rehab+Weight Loss (WL) |
| Exercise ComplianceMultiple 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 | Rehab Only, Rehab+Weight Loss (WL) |
| Calorie-Restricted DietDiet 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. | Dietary supplement | Rehab+Weight Loss (WL) |
| Behavioral ModificationDuring 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. | Behavioural | Rehab+Weight Loss (WL) |
| Weight-Loss ComplianceParticipants 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. | Other | Rehab+Weight Loss (WL) |
| Dietary CounselingParticipants have one meeting with the Rehab dietitian upon starting. | Other | Rehab Only |
Primary outcome
Feasibility - Number of Enrolled Participants
Time frame: 18 months
Total number of participants who met all inclusion/exclusion criteria and were enrolled in the study
Compliance - Percentage of Sessions Attended
Time frame: 6 months
The percentage of exercise/counseling sessions attended (calculated as the number of sessions attended divided by the number of sessions prescribed multiplied by 100)
Retention - Percentage of Participants Who Returned for Follow-up Testing
Time frame: 6 months
The number of participants who returned for the 6-month follow-up visit divided by the total number of randomized participants multiplied by 100
28 secondary outcomes
Body Weight
Time frame: Baseline
Body Weight
Time frame: Months 3 and 6
6 Minute Walk (6MW) Test
Time frame: Baseline
6 Minute Walk (6MW) Test
Time frame: Months 3 and 6
Grip Strength
Time frame: Baseline
Grip Strength
Time frame: Months 3 and 6
Mobility - MAT-sf
Time frame: Baseline
Mobility - MAT-sf
Time frame: Months 3 and 6
Expanded Short Physical Performance Battery (eSPPB)
Time frame: Baseline
Expanded Short Physical Performance Battery (eSPPB)
Time frame: Months 3 and 6
Health-related Quality of Life SF-36 - Mental Component Summary (MCS) Score
Time frame: Baseline
Health-related Quality of Life SF-36 - Mental Component Summary (MCS) Score
Time frame: Months 3 and 6
Health-related Quality of Life SF-36 - Physical Component Summary (PCS) Score
Time frame: Baseline
Health-related Quality of Life SF-36 - Physical Component Summary (PCS) Score
Time frame: Months 3 and 6
Arterial Stiffness
Time frame: Baseline
Arterial Stiffness
Time frame: Months 3 and 6
Brachial Blood Pressure - Systolic
Time frame: Baseline
Brachial Blood Pressure - Systolic
Time frame: Months 3 and 6
Brachial Blood Pressure - Diastolic
Time frame: Baseline
Brachial Blood Pressure - Diastolic
Time frame: Months 3 and 6
Aortic Blood Pressure - Systolic
Time frame: Baseline
Aortic Blood Pressure - Systolic
Time frame: Months 3 and 6
Aortic Blood Pressure - Diastolic
Time frame: Baseline
Aortic Blood Pressure - Diastolic
Time frame: Months 3 and 6
Hemoglobin A1c
Time frame: Baseline
Hemoglobin A1c
Time frame: Months 3 and 6
Fasting Insulin
Time frame: Baseline
Fasting Insulin
Time frame: Months 3 and 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tina Brinkley, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise, Health Education and Exercise Compliance in people with Obesity and Weight Loss, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility - Number of Enrolled Participants (time frame: 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2021.