Obesity, Weight Loss, CHD - Coronary Heart Disease
Conditions
Keywords
Cardiac, Rehab, Diet, Exercise, Obese
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.
Interventions
OTHERExercise
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
BEHAVIORALHealth 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.
OTHERExercise 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_SUPPLEMENTCalorie-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.
BEHAVIORALBehavioral 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.
OTHERWeight-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.
OTHERDietary Counseling
Participants have one meeting with the Rehab dietitian upon starting.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
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
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility - Number of Enrolled Participants | 18 months | Total number of participants who met all inclusion/exclusion criteria and were enrolled in the study |
| Compliance - Percentage of Sessions Attended | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mobility - MAT-sf | Baseline | 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. |
| Expanded Short Physical Performance Battery (eSPPB) | Baseline | 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. |
| Health-related Quality of Life SF-36 - Mental Component Summary (MCS) Score | Baseline | 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. |
| Health-related Quality of Life SF-36 - Physical Component Summary (PCS) Score | Baseline | 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. |
| Arterial Stiffness | Baseline | 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. |
| Body Weight | Baseline | Body weight measured in kg |
| Brachial Blood Pressure - Diastolic | Baseline | Brachial blood pressure was measured using a conventional mercury sphygmomanometer with the participant in a seated position after resting quietly for 5-10 minutes. |
| Aortic Blood Pressure - Systolic | Baseline | Aortic blood pressure was measured using the SphygmoCor XCEL system with the participant in the supine position after resting quietly for 5-10 minutes. |
| Aortic Blood Pressure - Diastolic | Baseline | Aortic blood pressure was measured using the SphygmoCor XCEL system with the participant in a supine position after resting quietly for 5-10 minutes. |
| Hemoglobin A1c | Baseline | Hemoglobin A1c was measured in whole blood using a turbidimetric inhibition immunoassay. |
| Fasting Insulin | Baseline | Insulin was determined by a chemiluminescent immunoassay. |
| Brachial Blood Pressure - Systolic | Baseline | Brachial blood pressure was measured using a conventional mercury sphygmomanometer with the participant in a seated position after resting quietly for 5-10 minutes. |
| 6 Minute Walk (6MW) Test | Baseline | 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. |
| Grip Strength | Baseline | Grip strength was measured twice in each hand using an isometric hydraulic hand dynamometer. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 19 |
| 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. | 19 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Rehab+Weight Loss (WL) | Rehab Only | Total |
|---|---|---|---|
| Age, Continuous | 63.5 years STANDARD_DEVIATION 7.7 | 65.9 years STANDARD_DEVIATION 7.9 | 64.5 years STANDARD_DEVIATION 7.9 |
| Race/Ethnicity, Customized Black | 1 Participants | 3 Participants | 4 Participants |
| Race/Ethnicity, Customized Hispanic | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 18 Participants | 14 Participants | 32 Participants |
| Region of Enrollment United States | 19 participants | 19 participants | 38 participants |
| Sex: Female, Male Female | 3 Participants | 6 Participants | 9 Participants |
| Sex: Female, Male Male | 16 Participants | 13 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 19 |
| other Total, other adverse events | 10 / 19 | 10 / 19 |
| serious Total, serious adverse events | 2 / 19 | 0 / 19 |
Outcome results
Primary
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)
Time frame: 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Compliance - Percentage of Sessions Attended | Exercise compliance | 45.2 percentage of sessions attended | Standard Deviation 27.5 |
| All Participants | Compliance - Percentage of Sessions Attended | Dietary compliance | NA percentage of sessions attended | — |
| Rehab+Weight Loss (WL) | Compliance - Percentage of Sessions Attended | Exercise compliance | 68.6 percentage of sessions attended | Standard Deviation 16.6 |
| Rehab+Weight Loss (WL) | Compliance - Percentage of Sessions Attended | Dietary compliance | 98.2 percentage of sessions attended | Standard Deviation 1.9 |
Primary
Feasibility - Number of Enrolled Participants
Total number of participants who met all inclusion/exclusion criteria and were enrolled in the study
Time frame: 18 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants | Feasibility - Number of Enrolled Participants | 38 Participants |
Primary
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
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants | Retention - Percentage of Participants Who Returned for Follow-up Testing | 17 Participants |
| Rehab+Weight Loss (WL) | Retention - Percentage of Participants Who Returned for Follow-up Testing | 19 Participants |
Secondary
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | 6 Minute Walk (6MW) Test | 441.37 meters | Standard Deviation 81.86 |
| Rehab+Weight Loss (WL) | 6 Minute Walk (6MW) Test | 429.47 meters | Standard Deviation 79.95 |
Comparison: Baselinep-value: 0.653t-test, 2 sided
Secondary
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.
Time frame: Months 3 and 6
Population: All available follow-up data were included. Rehab Only: 2 subjects dropped out prior to follow-up testing; 3 did not complete Month 3 testing due to a broken foot (n=1), could not be reached (n=1), and safety/health concerns (n=1); 5 did not complete Month 6 testing due to a COVID related pause on in-person research. Rehab+WL: 1 subject did not complete Month 3 testing due to safety/health concerns; 1 did not complete Month 6 testing due to a COVID related pause on in-person research.
| Arm | Measure | Group | Value (GEOMETRIC_LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | 6 Minute Walk (6MW) Test | Month 3 | 452.962 meters | Standard Error 10.935 |
| All Participants | 6 Minute Walk (6MW) Test | Month 6 | 448.506 meters | Standard Error 14.479 |
| Rehab+Weight Loss (WL) | 6 Minute Walk (6MW) Test | Month 3 | 446.916 meters | Standard Error 9.867 |
| Rehab+Weight Loss (WL) | 6 Minute Walk (6MW) Test | Month 6 | 462.986 meters | Standard Error 12.668 |
Comparison: Month 3p-value: 0.684ANCOVA
Comparison: Month 6p-value: 0.458ANCOVA
Secondary
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.
Time frame: Baseline
Population: 1 participant (Rehab Only) did not complete baseline testing due to safety/health concerns.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Aortic Blood Pressure - Diastolic | 83.72 mmHg | Standard Deviation 15.23 |
| Rehab+Weight Loss (WL) | Aortic Blood Pressure - Diastolic | 81.11 mmHg | Standard Deviation 12.36 |
Comparison: Baselinep-value: 0.569t-test, 2 sided
Secondary
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.
Time frame: Months 3 and 6
Population: All available follow-up data were included. Rehab Only: 2 subjects dropped out prior to follow-up testing; 2 did not complete Month 3 testing due to a broken foot (n=1) and could not be reached (n=1); 5 did not complete Month 6 testing due to a COVID related pause on in-person research. Rehab+WL: 1 subject did not complete Month 6 testing due to a COVID related pause on in-person research.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Aortic Blood Pressure - Diastolic | Month 3 | 78.322 mmHg | Standard Error 2.127 |
| All Participants | Aortic Blood Pressure - Diastolic | Month 6 | 76.221 mmHg | Standard Error 2.307 |
| Rehab+Weight Loss (WL) | Aortic Blood Pressure - Diastolic | Month 3 | 78.965 mmHg | Standard Error 1.905 |
| Rehab+Weight Loss (WL) | Aortic Blood Pressure - Diastolic | Month 6 | 78.783 mmHg | Standard Error 1.924 |
Comparison: Month 3p-value: 0.824ANCOVA
Comparison: Month 6p-value: 0.401ANCOVA
Secondary
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.
Time frame: Baseline
Population: 1 participant (Rehab Only) did not complete baseline testing due to safety/health concerns.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Aortic Blood Pressure - Systolic | 132.89 mmHg | Standard Deviation 19.33 |
| Rehab+Weight Loss (WL) | Aortic Blood Pressure - Systolic | 130.47 mmHg | Standard Deviation 16.57 |
Comparison: Baselinep-value: 0.685t-test, 2 sided
Secondary
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.
Time frame: Months 3 and 6
Population: All available follow-up data were included. Rehab Only: 2 subjects dropped out prior to follow-up testing; 2 did not complete Month 3 testing due to a broken foot (n=1) and could not be reached (n=1); 5 did not complete Month 6 testing due to a COVID related pause on in-person research. Rehab+WL: 1 subject did not complete Month 6 testing due to a COVID related pause on in-person research.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Aortic Blood Pressure - Systolic | Month 3 | 130.234 mmHg | Standard Error 3.65 |
| All Participants | Aortic Blood Pressure - Systolic | Month 6 | 127.204 mmHg | Standard Error 3.203 |
| Rehab+Weight Loss (WL) | Aortic Blood Pressure - Systolic | Month 3 | 129.328 mmHg | Standard Error 3.255 |
| Rehab+Weight Loss (WL) | Aortic Blood Pressure - Systolic | Month 6 | 126.692 mmHg | Standard Error 2.647 |
Comparison: Month 3p-value: 0.854ANCOVA
Comparison: Month 6p-value: 0.903ANCOVA
Secondary
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.
Time frame: Baseline
Population: 15 participants (n=8, Rehab Only; n=7, Rehab+WL) did not complete baseline PWV testing due to technical difficulties (i.e., equipment malfunction, could not acquire signal); 1 participant (Rehab Only) refused.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Arterial Stiffness | 8.67 m/s | Standard Deviation 2.53 |
| Rehab+Weight Loss (WL) | Arterial Stiffness | 8.40 m/s | Standard Deviation 2.73 |
Comparison: Baselinep-value: 0.815t-test, 2 sided
Secondary
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.
Time frame: Months 3 and 6
Population: All available follow-up data were included. Rehab Only: 2 subjects dropped out prior to follow-up testing; 8 did not complete Month 3 testing due to a broken foot (n=1), could not be reached (n=1), and technical issues (n=6); 11 did not complete Month 6 testing due to a COVID related pause (n=5) and technical issues (n=6). Rehab+WL: 2 subjects did not complete Month 3 testing due to technical issues; 4 did not complete Month 6 testing due to a COVID related pause (n=1) and technical issues (n=3)
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Arterial Stiffness | Month 3 | 8.760 m/s | Standard Error 0.768 |
| All Participants | Arterial Stiffness | Month 6 | 9.611 m/s | Standard Error 0.719 |
| Rehab+Weight Loss (WL) | Arterial Stiffness | Month 3 | 8.061 m/s | Standard Error 0.616 |
| Rehab+Weight Loss (WL) | Arterial Stiffness | Month 6 | 8.487 m/s | Standard Error 0.567 |
Comparison: Month 3p-value: 0.488ANCOVA
Comparison: Month 6p-value: 0.237ANCOVA
Secondary
Body Weight
Body weight measured in kg
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Body Weight | 108.76 kg | Standard Deviation 19.32 |
| Rehab+Weight Loss (WL) | Body Weight | 102.85 kg | Standard Deviation 22.27 |
Comparison: Baselinep-value: 0.388t-test, 2 sided
Secondary
Body Weight
Body weight measured in kg
Time frame: Months 3 and 6
Population: All available follow-up data were included. Rehab Only: 2 subjects dropped out prior to follow-up testing; 2 did not complete Month 3 testing due to a broken foot (n=1) and could not be reached (n=1); 5 did not complete Month 6 testing due to a COVID related pause on in-person research. Rehab+WL: 1 subject did not complete Month 6 testing due to a COVID related pause on in-person research.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Body Weight | Month 3 | 104.852 kg | Standard Error 0.93 |
| All Participants | Body Weight | Month 6 | 104.811 kg | Standard Error 1.29 |
| Rehab+Weight Loss (WL) | Body Weight | Month 3 | 101.658 kg | Standard Error 0.854 |
| Rehab+Weight Loss (WL) | Body Weight | Month 6 | 99.122 kg | Standard Error 1.14 |
Comparison: Month 3p-value: 0.017ANCOVA
Comparison: Month 6p-value: 0.002ANCOVA
Secondary
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.
Time frame: Months 3 and 6
Population: All available follow-up data were included. Rehab Only: 2 subjects dropped out prior to follow-up testing; 2 did not complete Month 3 testing due to a broken foot (n=1) and could not be reached (n=1); 5 did not complete Month 6 testing due to a COVID related pause on in-person research. Rehab+WL: 1 subject did not complete Month 6 testing due to a COVID related pause on in-person research.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Brachial Blood Pressure - Diastolic | Month 3 | 70.024 mmHg | Standard Error 2.166 |
| All Participants | Brachial Blood Pressure - Diastolic | Month 6 | 72.738 mmHg | Standard Error 2.546 |
| Rehab+Weight Loss (WL) | Brachial Blood Pressure - Diastolic | Month 3 | 69.247 mmHg | Standard Error 1.962 |
| Rehab+Weight Loss (WL) | Brachial Blood Pressure - Diastolic | Month 6 | 69.989 mmHg | Standard Error 2.168 |
Comparison: Month 3p-value: 0.792ANCOVA
Comparison: Month 6p-value: 0.417ANCOVA
Secondary
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Brachial Blood Pressure - Diastolic | 76.26 mmHg | Standard Deviation 14.02 |
| Rehab+Weight Loss (WL) | Brachial Blood Pressure - Diastolic | 75.89 mmHg | Standard Deviation 13.26 |
Comparison: Baselinep-value: 0.934t-test, 2 sided
Secondary
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.
Time frame: Months 3 and 6
Population: All available follow-up data were included. Rehab Only: 2 subjects dropped out prior to follow-up testing; 2 did not complete Month 3 testing due to a broken foot (n=1) and could not be reached (n=1); 5 did not complete Month 6 testing due to a COVID related pause on in-person research. Rehab+WL: 1 subject did not complete Month 6 testing due to a COVID related pause on in-person research.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Brachial Blood Pressure - Systolic | Month 6 | 124.272 mmHg | Standard Error 4.11 |
| All Participants | Brachial Blood Pressure - Systolic | Month 3 | 124.089 mmHg | Standard Error 3.564 |
| Rehab+Weight Loss (WL) | Brachial Blood Pressure - Systolic | Month 6 | 129.860 mmHg | Standard Error 3.399 |
| Rehab+Weight Loss (WL) | Brachial Blood Pressure - Systolic | Month 3 | 126.987 mmHg | Standard Error 3.178 |
Comparison: Month 3p-value: 0.549ANCOVA
Comparison: Month 6p-value: 0.303ANCOVA
Secondary
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Brachial Blood Pressure - Systolic | 132.84 mmHg | Standard Deviation 21.14 |
| Rehab+Weight Loss (WL) | Brachial Blood Pressure - Systolic | 128.63 mmHg | Standard Deviation 17.3 |
p-value: 0.506t-test, 2 sided
Secondary
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Expanded Short Physical Performance Battery (eSPPB) | 1.99 score on a scale | Standard Deviation 0.42 |
| Rehab+Weight Loss (WL) | Expanded Short Physical Performance Battery (eSPPB) | 2.08 score on a scale | Standard Deviation 0.55 |
Comparison: Baselinep-value: 0.563t-test, 2 sided
Secondary
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.
Time frame: Months 3 and 6
Population: All available follow-up data were included. Rehab Only: 2 subjects dropped out prior to follow-up testing; 2 did not complete Month 3 testing due to a broken foot (n=1) and could not be reached (n=1); 5 did not complete Month 6 testing due to a COVID related pause on in-person research. Rehab+WL: 1 subject did not complete Month 6 testing due to a COVID related pause on in-person research.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Expanded Short Physical Performance Battery (eSPPB) | Month 3 | 2.252 score on a scale | Standard Error 0.069 |
| All Participants | Expanded Short Physical Performance Battery (eSPPB) | Month 6 | 2.121 score on a scale | Standard Error 0.11 |
| Rehab+Weight Loss (WL) | Expanded Short Physical Performance Battery (eSPPB) | Month 3 | 1.992 score on a scale | Standard Error 0.061 |
| Rehab+Weight Loss (WL) | Expanded Short Physical Performance Battery (eSPPB) | Month 6 | 2.135 score on a scale | Standard Error 0.091 |
Comparison: Month 3p-value: 0.008ANCOVA
Comparison: Month 6p-value: 0.922ANCOVA
Secondary
Fasting Insulin
Insulin was determined by a chemiluminescent immunoassay.
Time frame: Months 3 and 6
Population: All available follow-up data were included. Rehab Only: 2 subjects dropped out prior to follow-up testing; 2 did not complete Month 3 testing due to a broken foot (n=1) and could not be reached (n=1); 5 did not complete Month 6 testing due to a COVID related pause on in-person research. Rehab+WL: 1 subject did not complete Month 6 testing due to a COVID related pause on in-person research.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Fasting Insulin | Month 3 | 20.161 mg/dl | Standard Error 2.626 |
| All Participants | Fasting Insulin | Month 6 | 17.558 mg/dl | Standard Error 3.276 |
| Rehab+Weight Loss (WL) | Fasting Insulin | Month 3 | 20.197 mg/dl | Standard Error 2.414 |
| Rehab+Weight Loss (WL) | Fasting Insulin | Month 6 | 19.623 mg/dl | Standard Error 2.878 |
Comparison: Month 3p-value: 0.992ANCOVA
Comparison: Month 6p-value: 0.639ANCOVA
Secondary
Fasting Insulin
Insulin was determined by a chemiluminescent immunoassay.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Fasting Insulin | 22.67 mg/dl | Standard Deviation 14.24 |
| Rehab+Weight Loss (WL) | Fasting Insulin | 20.08 mg/dl | Standard Deviation 10.89 |
Comparison: Baselinep-value: 0.533t-test, 2 sided
Secondary
Grip Strength
Grip strength was measured twice in each hand using an isometric hydraulic hand dynamometer.
Time frame: Baseline
Population: 2 participants (Rehab+WL) did not complete baseline testing due to safety/health concerns (n=2, Rehab+WL).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Grip Strength | 34.21 kg | Standard Deviation 8.74 |
| Rehab+Weight Loss (WL) | Grip Strength | 35.94 kg | Standard Deviation 8.4 |
Comparison: Baselinep-value: 0.55t-test, 2 sided
Secondary
Grip Strength
Grip strength was measured twice in each hand using an isometric hydraulic hand dynamometer.
Time frame: Months 3 and 6
Population: All available follow-up data were included. Rehab Only: 2 subjects dropped out prior to follow-up testing; 2 did not complete Month 3 testing due to a broken foot (n=1) and could not be reached (n=1); 5 did not complete Month 6 testing due to a COVID related pause on in-person research. Rehab+WL: 2 subjects did not complete Month 3 testing due to safety/health concerns; 3 did not complete Month 6 testing due to a COVID related pause on in-person research (n=1) or safety/health concerns (n=2).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Grip Strength | Month 6 | 34.534 kg | Standard Error 1.218 |
| All Participants | Grip Strength | Month 3 | 33.711 kg | Standard Error 1.242 |
| Rehab+Weight Loss (WL) | Grip Strength | Month 3 | 33.652 kg | Standard Error 1.182 |
| Rehab+Weight Loss (WL) | Grip Strength | Month 6 | 35.837 kg | Standard Error 1.082 |
Comparison: Month 3p-value: 0.973ANCOVA
Comparison: Month 6p-value: 0.432ANCOVA
Secondary
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.
Time frame: Months 3 and 6
Population: All available follow-up data were included. Rehab Only: 2 subjects dropped out prior to follow-up testing; 2 did not complete Month 3 testing due to a broken foot (n=1) and could not be reached (n=1).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Health-related Quality of Life SF-36 - Mental Component Summary (MCS) Score | Month 3 | 54.778 score on a scale | Standard Error 2.003 |
| All Participants | Health-related Quality of Life SF-36 - Mental Component Summary (MCS) Score | Month 6 | 53.885 score on a scale | Standard Error 2.107 |
| Rehab+Weight Loss (WL) | Health-related Quality of Life SF-36 - Mental Component Summary (MCS) Score | Month 3 | 53.698 score on a scale | Standard Error 1.82 |
| Rehab+Weight Loss (WL) | Health-related Quality of Life SF-36 - Mental Component Summary (MCS) Score | Month 6 | 55.463 score on a scale | Standard Error 1.995 |
Comparison: Month 3p-value: 0.692ANCOVA
Comparison: Month 6p-value: 0.59ANCOVA
Secondary
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Health-related Quality of Life SF-36 - Mental Component Summary (MCS) Score | 54.92 score on a scale | Standard Deviation 8.52 |
| Rehab+Weight Loss (WL) | Health-related Quality of Life SF-36 - Mental Component Summary (MCS) Score | 53.50 score on a scale | Standard Deviation 11.45 |
Comparison: Baselinep-value: 0.667t-test, 2 sided
Secondary
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.
Time frame: Months 3 and 6
Population: All available follow-up data were included. Rehab Only: 2 subjects dropped out prior to follow-up testing; 2 did not complete Month 3 testing due to a broken foot (n=1) and could not be reached (n=1).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Health-related Quality of Life SF-36 - Physical Component Summary (PCS) Score | Month 6 | 41.949 score on a scale | Standard Error 2.374 |
| All Participants | Health-related Quality of Life SF-36 - Physical Component Summary (PCS) Score | Month 3 | 42.458 score on a scale | Standard Error 1.771 |
| Rehab+Weight Loss (WL) | Health-related Quality of Life SF-36 - Physical Component Summary (PCS) Score | Month 3 | 41.595 score on a scale | Standard Error 1.615 |
| Rehab+Weight Loss (WL) | Health-related Quality of Life SF-36 - Physical Component Summary (PCS) Score | Month 6 | 42.569 score on a scale | Standard Error 2.245 |
Comparison: Month 3p-value: 0.721ANCOVA
Comparison: Month 6p-value: 0.851ANCOVA
Secondary
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Health-related Quality of Life SF-36 - Physical Component Summary (PCS) Score | 37.97 score on a scale | Standard Deviation 10.51 |
| Rehab+Weight Loss (WL) | Health-related Quality of Life SF-36 - Physical Component Summary (PCS) Score | 37.30 score on a scale | Standard Deviation 10.17 |
Comparison: Baselinep-value: 0.844t-test, 2 sided
Secondary
Hemoglobin A1c
Hemoglobin A1c was measured in whole blood using a turbidimetric inhibition immunoassay.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Hemoglobin A1c | 6.36 percentage of hemoglobin glycated | Standard Deviation 0.97 |
| Rehab+Weight Loss (WL) | Hemoglobin A1c | 5.94 percentage of hemoglobin glycated | Standard Deviation 0.96 |
Comparison: Baselinep-value: 0.188t-test, 2 sided
Secondary
Hemoglobin A1c
Hemoglobin A1c was measured in whole blood using a turbidimetric inhibition immunoassay.
Time frame: Months 3 and 6
Population: All available follow-up data were included. Rehab Only: 2 subjects dropped out prior to follow-up testing; 2 did not complete Month 3 testing due to a broken foot (n=1) and could not be reached (n=1); 5 did not complete Month 6 testing due to a COVID related pause on in-person research. Rehab+WL: 1 subject did not complete Month 6 testing due to a COVID related pause on in-person research.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Hemoglobin A1c | Month 3 | 6.046 percentage of hemoglobin glycated | Standard Error 0.143 |
| All Participants | Hemoglobin A1c | Month 6 | 6.033 percentage of hemoglobin glycated | Standard Error 0.163 |
| Rehab+Weight Loss (WL) | Hemoglobin A1c | Month 3 | 6.239 percentage of hemoglobin glycated | Standard Error 0.134 |
| Rehab+Weight Loss (WL) | Hemoglobin A1c | Month 6 | 6.190 percentage of hemoglobin glycated | Standard Error 0.148 |
Comparison: Month 3p-value: 0.338ANCOVA
Comparison: Month 6p-value: 0.484ANCOVA
Secondary
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Mobility - MAT-sf | 64.87 score on a scale | Standard Deviation 8.72 |
| Rehab+Weight Loss (WL) | Mobility - MAT-sf | 61.47 score on a scale | Standard Deviation 8.44 |
Comparison: Baselinep-value: 0.23063t-test, 2 sided
Secondary
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.
Time frame: Months 3 and 6
Population: All available follow-up data were included. Rehab Only: 2 subjects dropped out prior to follow-up testing; 3 did not complete Month 3 testing due to a broken foot (n=1), could not be reached (n=1), and technical difficulties (n=1); 5 did not complete Month 6 testing due to a COVID related pause on in-person research. Rehab+WL: 1 subject did not complete Month 6 testing due to a COVID related pause on in-person research.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Mobility - MAT-sf | Month 3 | 64.839 score on a scale | Standard Deviation 1.484 |
| All Participants | Mobility - MAT-sf | Month 6 | 64.613 score on a scale | Standard Deviation 2.144 |
| Rehab+Weight Loss (WL) | Mobility - MAT-sf | Month 3 | 65.212 score on a scale | Standard Deviation 1.332 |
| Rehab+Weight Loss (WL) | Mobility - MAT-sf | Month 6 | 65.069 score on a scale | Standard Deviation 1.848 |
Comparison: Month 3p-value: 0.854ANCOVA
Comparison: Month 6p-value: 0.874ANCOVA