Trial Outcomes & Findings for Exercise After Clinically Significant Weight Loss (NCT NCT03685123)

NCT ID: NCT03685123

Last Updated: 2024-07-03

Results Overview

Weight will measured in a hospital gown on a balance beam scale. Change in weight will be calculated as the participant weight change from the end of the weight loss phase to the end of the weight maintenance phase (week 28 weight subtracted from the week 10 weight). A positive value indicates an increase in weight and a negative value indicates a reduction in weight

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 39 participants
• Primary outcome timeframe: End of weight loss phase (week 10) to follow-up (week 28)
• Results posted on: 2024-07-03

Participant Flow

Prior to participants being randomized, they participated in a weight loss intervention. Thirty-nine participants were enrolled in that component of the trial as specified per protocol. Participants that obtained a weight loss goal of 7% were subsequently randomized to study groups. 36 participants completed the weight loss phase, and 33 of those individuals made the weight loss goal.

Participants have to make a weight loss goal in order to be assigned to be randomized in the present study. All participants completed an Optifast weight loss program after completing screening for inclusion/exclusion criteria. Participants that were able to obtain at least 7% weight loss were available for randomization in the present study

Participant milestones

Measure	Weight Loss Phase Prior to randomization into the groups, participants completed a weight loss phase. Only participants who were able to obtain 7% weight loss in the intervention proceeded to the study randomization groups (This is represented only in period 1 of this report)	PA-REC This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the minimum physical activity recommendations Physical activity recommendations: Participants in the PA-REC group will exercise at 550 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training	WM-REC This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the weight maintenance recommendations Weight maintenance recommendations: Participants in the WM-REC group will exercise at 970 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training
Weight Loss Phase STARTED	39	0	0
Weight Loss Phase COMPLETED	33	0	0
Weight Loss Phase NOT COMPLETED	6	0	0
Weight Maintenance Phase STARTED	0	16	17
Weight Maintenance Phase COMPLETED	0	12	9
Weight Maintenance Phase NOT COMPLETED	0	4	8

Reasons for withdrawal

Measure	Weight Loss Phase Prior to randomization into the groups, participants completed a weight loss phase. Only participants who were able to obtain 7% weight loss in the intervention proceeded to the study randomization groups (This is represented only in period 1 of this report)	PA-REC This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the minimum physical activity recommendations Physical activity recommendations: Participants in the PA-REC group will exercise at 550 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training	WM-REC This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the weight maintenance recommendations Weight maintenance recommendations: Participants in the WM-REC group will exercise at 970 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training
Weight Loss Phase Withdrawal by Subject	1	0	0
Weight Loss Phase Did not obtain weight loss goal	3	0	0
Weight Loss Phase Lost to Follow-up	1	0	0
Weight Loss Phase PI removal due to subject lack of compliance	1	0	0
Weight Maintenance Phase Covid Pandemic	0	4	5
Weight Maintenance Phase Withdrawal by Subject	0	0	3

Baseline Characteristics

Exercise After Clinically Significant Weight Loss

Baseline characteristics by cohort

Measure	Weight Loss Phase n=39 Participants All participants complete a weight loss phase prior to randomization to study groups. Participants participate in an optifast weight loss program where the goal is to lose 7% of their body weight. Participants who meet this goal are then randomized to the PA-REC or the WM-REC groups. (39 participants began the weight loss phase and 33 completed with 7% weight loss)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	39 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	45.8 years STANDARD_DEVIATION 10.7 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	39 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	13 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	39 participants n=5 Participants
Weight	95.0 kilograms STANDARD_DEVIATION 2.0 • n=5 Participants
Body Mass Index	34.4 kg/m^2 STANDARD_DEVIATION 0.6 • n=5 Participants
Body Fat perecntage	41.7 Percent of total body composition STANDARD_DEVIATION 0.9 • n=5 Participants
Lean Mass (kg)	53.6 kg STANDARD_DEVIATION 1.7 • n=5 Participants
Visceral fat mass	698.7 grams STANDARD_DEVIATION 33.5 • n=5 Participants
Absolute Fitness (unadjusted for body weight)	2.0 L/min of oxygen consumption STANDARD_DEVIATION 0.1 • n=5 Participants
Relative Fitness (fitness adjusted by body weight)	21.4 ml/kg/min of oxygen consumption STANDARD_DEVIATION 0.7 • n=5 Participants
Systolic blood pressure	117.0 mmHg STANDARD_DEVIATION 2.4 • n=5 Participants
Diastolic blood pressure	74.9 mmHg STANDARD_DEVIATION 1.7 • n=5 Participants
Glucose	95.9 mg/dL STANDARD_DEVIATION 1.5 • n=5 Participants
Insulin	16.6 ulU/mL STANDARD_DEVIATION 1.3 • n=5 Participants
LDL Cholesterol	114.3 mg/dL STANDARD_DEVIATION 4.6 • n=5 Participants
HDL Cholesterol	52.4 mg/dL STANDARD_DEVIATION 2.0 • n=5 Participants
Resting metabolic rate	1545.2 kcals/day STANDARD_DEVIATION 42.8 • n=5 Participants

PRIMARY outcome

Timeframe: End of weight loss phase (week 10) to follow-up (week 28)

Weight will measured in a hospital gown on a balance beam scale. Change in weight will be calculated as the participant weight change from the end of the weight loss phase to the end of the weight maintenance phase (week 28 weight subtracted from the week 10 weight). A positive value indicates an increase in weight and a negative value indicates a reduction in weight

Outcome measures

Measure	PA-REC n=12 Participants This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the minimum physical activity recommendations Physical activity recommendations: Participants in the PA-REC group will exercise at 550 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training	WM-REC n=9 Participants This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the weight maintenance recommendations Weight maintenance recommendations: Participants in the WM-REC group will exercise at 970 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training
Change in Weight	0.7 kg Standard Deviation 4.13	-1.5 kg Standard Deviation 4.65

SECONDARY outcome

Timeframe: End of weight loss phase (week 10) to follow-up (week 28)

Fitness will be measured using a modified Balke protocol on a treadmill. Participants will walk at an initial speed of 2.0 mph with 0% grade for the first 3 minutes after which the treadmill speed will increase to 3.0 mph for the next 3 minutes. The treadmill grade will be increased by 2.5% every 3 minutes until volitional exhaustion. Respiratory gases (VO2, CO2) and ventilation will be measured continuously using a True Max 2400 Metabolic Measurement Cart. Change in fitness will be quantified as the value at follow-up (week 28) subtracted from the value at week 10. An increase value will indicate an increase in fitness, while a decrease in the value will indicate a reduction in fitness

Outcome measures

Measure	PA-REC n=12 Participants This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the minimum physical activity recommendations Physical activity recommendations: Participants in the PA-REC group will exercise at 550 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training	WM-REC n=9 Participants This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the weight maintenance recommendations Weight maintenance recommendations: Participants in the WM-REC group will exercise at 970 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training
Change in Cardiorespiratory Fitness	0.05 L/min of oxygen consumption Standard Deviation 0.094	0.16 L/min of oxygen consumption Standard Deviation 0.12

SECONDARY outcome

Timeframe: End of weight loss phase (week 10) to follow-up (week 28)

Dual-energy X-ray absorptiometry will be used to measure changes in fat mass and lean mass. Body fat will be quantified as the percent of fat relative to the total body mass. Lean mass will be quantified as the percent of lean tissue relative to the total body composition. This will be calculated at week 10 and at week 28. Change in these variables will be quantified as by subtracting the week 10 value from the week 28 value. Thus, a change in positive direction is associated with an increase in body fat or lean mass and a negative value represents a decrease.

Outcome measures

Measure	PA-REC n=12 Participants This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the minimum physical activity recommendations Physical activity recommendations: Participants in the PA-REC group will exercise at 550 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training	WM-REC n=9 Participants This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the weight maintenance recommendations Weight maintenance recommendations: Participants in the WM-REC group will exercise at 970 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training
Change in Body Fat Percentage	0.89 percentage of total body composition Standard Deviation 4.13	-1.54 percentage of total body composition Standard Deviation 2.3

SECONDARY outcome

Timeframe: End of weight loss phase (week 10) to follow-up (week 28)

Waist circumference will be measured at the natural waist (midway between the inferior border of the rib cage and the superior aspect of the iliac crest) with a gulick tape measure. Both landmarks (the inferior border of the ribcage and the superior aspect of the iliac crest) will be marked and the distance will be measured to determine the appropriate measurement site. Staff will confirm that: 1) the measurement tape remains horizontal; 2) the tape touches the entire circumference of the participant; 3) abdominal tissue is not compressed; 3) the tape measure is not within abdominal folds; 4) the measurement is taken at the end of normal respiration. The measurement will be repeated an additional time, and the reported value will be the average of these measurements. Both measurements must be within 0.5 cm to be considered acceptable for data purposes. The change in waist circumference will be quantified as the the week 28 value subtracted from the week 10 value.

Outcome measures

Measure	PA-REC n=12 Participants This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the minimum physical activity recommendations Physical activity recommendations: Participants in the PA-REC group will exercise at 550 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training	WM-REC n=9 Participants This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the weight maintenance recommendations Weight maintenance recommendations: Participants in the WM-REC group will exercise at 970 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training
Change in Waist Circumference	0.48 cm Standard Deviation 3.1	-2.4 cm Standard Deviation 3.5

SECONDARY outcome

Timeframe: End of weight loss phase (week 10) to follow-up (week 28)

A fasting blood sample will be used to measure low density lipoprotein, high density lipoprotein, total cholesterol, and triglycerides will be measured. It will be quantified as the specific amount of the lipoprotein within the blood in mg/dL for all lipid variables. Participants will be fasted at least 12 hours prior to the blood draw. Change will be quantified as the week 28 value subtracted from the week 10 value. A positive value indicates an increase in the blood lipid variable and a negative value is associated with a reduction in the variable.

Outcome measures

Measure	PA-REC n=12 Participants This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the minimum physical activity recommendations Physical activity recommendations: Participants in the PA-REC group will exercise at 550 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training	WM-REC n=9 Participants This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the weight maintenance recommendations Weight maintenance recommendations: Participants in the WM-REC group will exercise at 970 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training
Changes in Blood Lipids Concentrations LDL cholesterol	4.9 mg/dL Standard Deviation 18.7	5.4 mg/dL Standard Deviation 23.9
Changes in Blood Lipids Concentrations HDL cholesterol	11.2 mg/dL Standard Deviation 10.7	7.5 mg/dL Standard Deviation 11.8
Changes in Blood Lipids Concentrations Total Cholesterol	21.2 mg/dL Standard Deviation 14.7	15.5 mg/dL Standard Deviation 32.1
Changes in Blood Lipids Concentrations Triglycerides	3.3 mg/dL Standard Deviation 15.5	13.1 mg/dL Standard Deviation 36.8

SECONDARY outcome

Timeframe: End of weight loss phase (week 10) to follow-up (week 28)

Brachial and aortic blood pressure will be measured using a sphygmocor XCEL. Blood pressure is quantified in mmHg and will be taken in the seated position after a 5 minute rest. Change in blood pressure is quantified by subtracting the week 28 value from the week 10 value. Thus, a positive number is associated with an increase in blood pressure across the time point and a decrease indicates a decrease in blood pressure

Outcome measures

Measure	PA-REC n=12 Participants This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the minimum physical activity recommendations Physical activity recommendations: Participants in the PA-REC group will exercise at 550 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training	WM-REC n=9 Participants This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the weight maintenance recommendations Weight maintenance recommendations: Participants in the WM-REC group will exercise at 970 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training
Change in Blood Pressure Systolic blood pressure	7.4 mmHg Standard Deviation 9.6	9.2 mmHg Standard Deviation 17.5
Change in Blood Pressure Diastolic blood pressure	4.0 mmHg Standard Deviation 5.9	6.37 mmHg Standard Deviation 9.08
Change in Blood Pressure Aortic Systolic Blood Pressure	6.6 mmHg Standard Deviation 8.9	8.1 mmHg Standard Deviation 14.6
Change in Blood Pressure Aortic diastolic blood pressure	4.2 mmHg Standard Deviation 6.4	6.1 mmHg Standard Deviation 8.8

SECONDARY outcome

Timeframe: End of weight loss phase (week 10) to follow-up (week 28)

Change in fasting glucose level. Fasting glucose level refers to the concentration of glucose within the blood (mg/dL). The change in fasting glucose level is quantified by subtracting the week 28 value from the week 10 value. Thus, a positive value indicates an increase in glucose level and a negative value indicates a decrease in glucose.

Outcome measures

Measure	PA-REC n=12 Participants This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the minimum physical activity recommendations Physical activity recommendations: Participants in the PA-REC group will exercise at 550 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training	WM-REC n=9 Participants This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the weight maintenance recommendations Weight maintenance recommendations: Participants in the WM-REC group will exercise at 970 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training
Change in Fasting Glucose Level	2.1 mg/dL Standard Deviation 5.7	2.5 mg/dL Standard Deviation 6.4

SECONDARY outcome

Timeframe: End of weight loss phase (week 10) to follow-up (week 28)

Fasting insulin represents the concentration of insulin in the blood. A positive value represents an increase in insulin concentration and a negative value represents a decrease in insulin concentration.

Outcome measures

Measure	PA-REC n=12 Participants This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the minimum physical activity recommendations Physical activity recommendations: Participants in the PA-REC group will exercise at 550 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training	WM-REC n=9 Participants This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the weight maintenance recommendations Weight maintenance recommendations: Participants in the WM-REC group will exercise at 970 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training
Change in Fasting Insulin Level	2.1 ulU/mL Standard Deviation 5.48	178 ulU/mL Standard Deviation 5.5

SECONDARY outcome

Timeframe: End of weight loss phase (week 10) to follow-up (week 28)

High sensitivity c-reactive protein is a marker of systemic inflammation and is quantified in mg/L. A postive value indicates an increase in c-reactive protein and a negative value represents a decrease in c-reactive protein.

Outcome measures

Measure	PA-REC n=12 Participants This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the minimum physical activity recommendations Physical activity recommendations: Participants in the PA-REC group will exercise at 550 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training	WM-REC n=9 Participants This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the weight maintenance recommendations Weight maintenance recommendations: Participants in the WM-REC group will exercise at 970 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training
Change in Systemic Inflammation	-0.48 mg/L Standard Deviation 0.78	-0.43 mg/L Standard Deviation 0.866

SECONDARY outcome

Timeframe: End of weight loss phase (week 10) to follow-up (week 28)

Resting metabolic rate (RMR) was measured in a quiet, temperature-controlled room using indirect calorimetry (TrueOne 2400, Parvo Medics, Salt Lake City, UT) with a clear ventilated canopy and dilution pump. Initially, participants rested in the seated position for 20 minutes. Participants then rested in the supine position in the dimly lit room for at least 20 additional minutes with the hood covering their head. RMR was determined from approximately 10 minutes of data at the end of the procedure when the FECO2 dilution was steadily maintained in the range of 1.0 and 1.2%. RMR data was considered valid when the coefficient of variations for resting energy expenditure, VO2 and VCO2, were ≤10% RMR will be expressed as the estimated amount of calories needed for a given a day (kcals/day). Change in RMR will be quantified as the week 28 value subtracted by the week 10 value. An increase in the value reflects an increase in RMR and a negative value represent a decrease.

Outcome measures

Measure	PA-REC n=12 Participants This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the minimum physical activity recommendations Physical activity recommendations: Participants in the PA-REC group will exercise at 550 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training	WM-REC n=9 Participants This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the weight maintenance recommendations Weight maintenance recommendations: Participants in the WM-REC group will exercise at 970 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training
Change in Resting Metabolic Rate	75.2 kcals per day Standard Deviation 56.6	-66.8 kcals per day Standard Deviation 65.4

SECONDARY outcome

Timeframe: End of Weight loss phase (week 10) to follow-up (week 28)

Insulin sensitivity will be measured using an oral glucose tolerance test. With the results of the oral glucose tolerance test at baseline, insulin sensitivity was calculated with the Matsuda index. Insulin sensitivity was calculated with Matsuda index: [10,000 / √glucose minute 0 x insulin minute 0) (mean glucose (OGTT) x mean insulin OGTT)]. A higher result is better.

Outcome measures

Measure	PA-REC n=12 Participants This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the minimum physical activity recommendations Physical activity recommendations: Participants in the PA-REC group will exercise at 550 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training	WM-REC n=9 Participants This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the weight maintenance recommendations Weight maintenance recommendations: Participants in the WM-REC group will exercise at 970 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training
Change in Insulin Sensitivity	-1.16 Index Standard Deviation 2.8	-3.4 Index Standard Deviation 11.0

SECONDARY outcome

Timeframe: End of weight loss phase (week 10) to follow-up (week 28)

This measure describes the average size of the low density lipoprotein particles and high density lipoprotein participles

Outcome measures

Measure	PA-REC n=12 Participants This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the minimum physical activity recommendations Physical activity recommendations: Participants in the PA-REC group will exercise at 550 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training	WM-REC n=9 Participants This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the weight maintenance recommendations Weight maintenance recommendations: Participants in the WM-REC group will exercise at 970 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training
Changes in Lipoprotein Size LDL Size	-0.04 nm Standard Deviation 0.30	0.01 nm Standard Deviation 0.27
Changes in Lipoprotein Size HDL size	0.21 nm Standard Deviation 0.18	0.04 nm Standard Deviation 0.30

SECONDARY outcome

Timeframe: End of weight loss phase (week 10) to follow-up (week 28)

Arterial stiffness will be measured using pulse wave velocity. Participants will refrain from large meals and caffeine for at least 2 hours and alcohol, vigorous exercise and vasoactive medication for at least 12 hours. Testing will occur in a quiet temperature controlled room. Carotid to femoral pulse wave velocity (PWV) and aortic blood pressure parameters will be measured using a SphygmoCor XCEL (Itasca, IL). PWV will be obtained in the supine position after a 15-minute rest. Investigators will measure the speed of the pulse from the carotid (artery in neck) to the femoral artery (artery in the leg). PWV parameters will be obtained in duplicate in concert with current guidelines and will be quantified in m/sec.

Outcome measures

Measure	PA-REC n=8 Participants This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the minimum physical activity recommendations Physical activity recommendations: Participants in the PA-REC group will exercise at 550 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training	WM-REC n=8 Participants This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the weight maintenance recommendations Weight maintenance recommendations: Participants in the WM-REC group will exercise at 970 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training
Change in Arterial Stiffness (Pulse Wave Velocity)	0.40 m/sec Interval -0.294934 to 1.108859	0.436787 m/sec Interval -0.265109 to 1.138684

SECONDARY outcome

Timeframe: Baseline to follow-up (week 28)

Participants will wear an ActivPal accelerometer for seven consecutive days, 24-hrs/day. The amount of time spent sitting and standing and steps will be calculated

Outcome measures

Measure	PA-REC n=12 Participants This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the minimum physical activity recommendations Physical activity recommendations: Participants in the PA-REC group will exercise at 550 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training	WM-REC n=9 Participants This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the weight maintenance recommendations Weight maintenance recommendations: Participants in the WM-REC group will exercise at 970 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training
Changes in Physical Activity Levels	-437.02 steps per day Standard Deviation 818.5	511.0 steps per day Standard Deviation 2369.17

SECONDARY outcome

Timeframe: End of weight loss phase (week 10) to Follow-up (week 28)

Quality of life (QOL) will be measured by the short form health survey (SF-36). SF36 consists of 36 questions that measure patient's HRQoL in 8 domains: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH) that represent the physical HRQoL, vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH) that represent the mental HRQoL. Each domain is scored from 0 (worst health status) to 100 (best health status).

The SF-36 also produces a measure of overall physical health (physical component score [PCS]) and overall mental health (mental component score [MCS]). Scoring of these items are standardized using means and standard deviations from the general US population. Aggregate PCS and MCS scores are standardized using a linear T-Score transformation to have a mean of 50 and a standard deviation of 10.

Outcome measures

Measure	PA-REC n=12 Participants This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the minimum physical activity recommendations Physical activity recommendations: Participants in the PA-REC group will exercise at 550 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training	WM-REC n=9 Participants This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the weight maintenance recommendations Weight maintenance recommendations: Participants in the WM-REC group will exercise at 970 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training
Change in Quality of Life: SF-36 SF-36 General Health (GH)	-2.7 score on a scale Standard Deviation 3.4	-0.19 score on a scale Standard Deviation 1.6
Change in Quality of Life: SF-36 SF-36 Physical Health (PH)	-0.2 score on a scale Standard Deviation 1.66	0.71 score on a scale Standard Deviation 1.41
Change in Quality of Life: SF-36 SF-36 Role Physical (RP)	0.45 score on a scale Standard Deviation 2.76	0.00 score on a scale Standard Deviation 0.0
Change in Quality of Life: SF-36 SF-36 Bodily Pain (BP)	-5.2 score on a scale Standard Deviation 6.36	-2.41 score on a scale Standard Deviation 4.49
Change in Quality of Life: SF-36 SF-36 Vitality (VT)	-0.60 score on a scale Standard Deviation 6.53	-2.21 score on a scale Standard Deviation 6.33
Change in Quality of Life: SF-36 SF-36 Social Function (SF)	-1.0 score on a scale Standard Deviation 2.11	-0.63 score on a scale Standard Deviation 1.77
Change in Quality of Life: SF-36 SF-36 Mental Health (MH)	-1.31 score on a scale Standard Deviation 4.29	0.33 score on a scale Standard Deviation 8.08
Change in Quality of Life: SF-36 SF-36 Role Emotional (RE)	-2.4 score on a scale Standard Deviation 5.2	-0.44 score on a scale Standard Deviation 1.24
Change in Quality of Life: SF-36 SF-36 Mental health	-1.61 score on a scale Standard Deviation 4.73	-0.63 score on a scale Standard Deviation 4.88
Change in Quality of Life: SF-36 SF-36 Physical	-1.48 score on a scale Standard Deviation 2.60	-0.54 score on a scale Standard Deviation 2.88

SECONDARY outcome

Timeframe: Baseline to follow-up (week 28)

Food Frequency Questionnaire (FFQ) contains approximately 105 items grouped by categories and is completed for both frequency of consumption as well as portion size selections by the individual. The questionnaire, upon completion, provides estimated daily intake values for selected nutrients (kilocalories, macronutrients, and micronutrients) and provides information on food group servings.

Outcome measures

Measure	PA-REC n=36 Participants This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the minimum physical activity recommendations Physical activity recommendations: Participants in the PA-REC group will exercise at 550 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training	WM-REC This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the weight maintenance recommendations Weight maintenance recommendations: Participants in the WM-REC group will exercise at 970 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training
Weight Loss Phase- Change in Dietary Composition	-1320.9 Kcals Standard Deviation 169.7	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 10 weeks

The participants are weighed on scale in a hospital gown

Outcome measures

Measure	PA-REC n=36 Participants This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the minimum physical activity recommendations Physical activity recommendations: Participants in the PA-REC group will exercise at 550 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training	WM-REC This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the weight maintenance recommendations Weight maintenance recommendations: Participants in the WM-REC group will exercise at 970 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training
Weight Loss Phase- Change in Weight (kg)	-8.8 kg Standard Deviation 0.6	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline 0 to Week 10

Fitness will be measured using a modified Balke protocol on a treadmill. Participants will walk at an initial speed of 2.0 mph with 0% grade for the first 3 minutes after which the treadmill speed will increase to 3.0 mph for the next 3 minutes. The treadmill grade will be increased by 2.5% every 3 minutes until volitional exhaustion. Respiratory gases (VO2, CO2) and ventilation will be measured continuously using a True Max 2400 Metabolic Measurement Cart. Change in fitness will be quantified as the value at follow-up (week 28) subtracted from the value at week 10. An increase value will indicate an increase in fitness, while a decrease in the value will indicate a reduction in fitness

Outcome measures

Measure	PA-REC n=36 Participants This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the minimum physical activity recommendations Physical activity recommendations: Participants in the PA-REC group will exercise at 550 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training	WM-REC This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the weight maintenance recommendations Weight maintenance recommendations: Participants in the WM-REC group will exercise at 970 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training
Weight Loss Phase- Cardiorespiratory Fitness (L/Min)	2.0 l/min Standard Deviation 0.0	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to Week (10)

Dual-energy X-ray absorptiometry will be used to measure changes in fat mass and lean mass. Body fat will be quantified as the percent of fat relative to the total body composition. Lean mass will be quantified as the percent of lean tissue relative to the total body composition. Change in these variables will be quantified as by subtracting the week 10 value from the week 28 value. Thus, a change in positive direction is associated with an increase in body fat or lean mass and a negative value represent a decrease.

Outcome measures

Measure	PA-REC n=36 Participants This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the minimum physical activity recommendations Physical activity recommendations: Participants in the PA-REC group will exercise at 550 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training	WM-REC This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the weight maintenance recommendations Weight maintenance recommendations: Participants in the WM-REC group will exercise at 970 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training
Weight Loss Phase-Change in Body Fat (%)	-2.1 % body fat Standard Deviation 0.3	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to Week 10

Waist circumference will be measured at the natural waist (midway between the inferior border of the rib cage and the superior aspect of the iliac crest) with a gulick tape measure. Both landmarks (the inferior border of the ribcage and the superior aspect of the iliac crest) will be marked and the distance will be measured to determine the appropriate measurement site. Staff will confirm that: 1) the measurement tape remains horizontal; 2) the tape touches the entire circumference of the participant; 3) abdominal tissue is not compressed; 3) the tape measure is not within abdominal folds; 4) the measurement is taken at the end of normal respiration. The measurement will be repeated an additional time, and the reported value will be the average of these measurements. Both measurements must be within 0.5 cm to be considered acceptable for data purposes. The change in waist circumference will be quantified as the the week 28 value subtracted from the week 10 value.

Outcome measures

Measure	PA-REC n=36 Participants This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the minimum physical activity recommendations Physical activity recommendations: Participants in the PA-REC group will exercise at 550 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training	WM-REC This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the weight maintenance recommendations Weight maintenance recommendations: Participants in the WM-REC group will exercise at 970 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training
Weight Loss Phase- Change in Waist Circumference (cm)	-8.6 cm Standard Deviation 0.8	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to Week 10

A fasting blood sample will be used to measure low density lipoprotein, high density lipoprotein, total cholesterol, and triglycerides will be measured. It will be quantified as the specific amount of the lipoprotein within the blood in mg/dL for all lipid variables. Participants will be fasted at least 12 hours prior to the blood draw. Change will be quantified as the week 10 value subtracted from the week baseline value

Outcome measures

Measure	PA-REC n=36 Participants This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the minimum physical activity recommendations Physical activity recommendations: Participants in the PA-REC group will exercise at 550 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training	WM-REC This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the weight maintenance recommendations Weight maintenance recommendations: Participants in the WM-REC group will exercise at 970 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training
Weight Loss Phase-Changes in Blood Lipids Concentrations (mg/dL) Low density lipoprotein (LDL)	-8.3 mg/dL Standard Deviation 2.7	—
Weight Loss Phase-Changes in Blood Lipids Concentrations (mg/dL) High density lipoprotein (HDL)	-2.4 mg/dL Standard Deviation 1.1	—
Weight Loss Phase-Changes in Blood Lipids Concentrations (mg/dL) Triglycerides	-24.1 mg/dL Standard Deviation 6.3	—
Weight Loss Phase-Changes in Blood Lipids Concentrations (mg/dL) Total Cholesterol	-15.6 mg/dL Standard Deviation 3.2	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to Week 10

Brachial and aortic blood pressure will be measured using a sphygmocor XCEL. Blood pressure is quantified in mmHg and will be taken in the seated position after a 5 minute rest. Change in blood pressure is quantified by subtracting the week 10 value from the baseline value. Thus, a positive number is associated with an increase in blood pressure across the time point and a decrease indicates a decrease in blood pressure

Outcome measures

Measure	PA-REC n=36 Participants This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the minimum physical activity recommendations Physical activity recommendations: Participants in the PA-REC group will exercise at 550 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training	WM-REC This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the weight maintenance recommendations Weight maintenance recommendations: Participants in the WM-REC group will exercise at 970 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training
Weight Loss Phase- Changes in Blood Pressure (mmHg) Brachial systolic blood pressure	-6.8 mmHg Standard Deviation 0.46	—
Weight Loss Phase- Changes in Blood Pressure (mmHg) Brachial diastolic blood pressure	-5.9 mmHg Standard Deviation 1.6	—
Weight Loss Phase- Changes in Blood Pressure (mmHg) Aortic systolic blood pressure	-8.3 mmHg Standard Deviation 8.9	—
Weight Loss Phase- Changes in Blood Pressure (mmHg) Aortic diastolic blood pressure	-5.8 mmHg Standard Deviation 6.3	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to week 10

Change in fasting glucose level. Fasting glucose level refers to the concentration of glucose within the blood (mg/dL). The change in fasting glucose level is quantified by subtracting the week 10 value from the baseline value. Thus, a positive value indicates an increase in glucose level and a negative value indicates a decrease in glucose.

Outcome measures

Measure	PA-REC n=36 Participants This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the minimum physical activity recommendations Physical activity recommendations: Participants in the PA-REC group will exercise at 550 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training	WM-REC This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the weight maintenance recommendations Weight maintenance recommendations: Participants in the WM-REC group will exercise at 970 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training
Weight Loss Phase-Change in Blood Glucose	-11.0 mg/dL Standard Deviation 1.3	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to Week 10

Fasting insulin represents the concentration of insulin in the blood. A positive value represents an increase in insulin concentration and a negative value represents a decrease in insulin concentration.

Outcome measures

Measure	PA-REC n=36 Participants This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the minimum physical activity recommendations Physical activity recommendations: Participants in the PA-REC group will exercise at 550 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training	WM-REC This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the weight maintenance recommendations Weight maintenance recommendations: Participants in the WM-REC group will exercise at 970 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training
Weight Loss Phase- Change in Insulin	-10.5 (ulU/mL) Standard Deviation 1.1	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to Week 10

High sensitivity c-reactive protein is a marker of systemic inflammation and is quantified in mg/L. A positive value indicates an increase in c-reactive protein and a negative value represents a decrease in c-reactive protein.

Outcome measures

Measure	PA-REC n=36 Participants This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the minimum physical activity recommendations Physical activity recommendations: Participants in the PA-REC group will exercise at 550 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training	WM-REC This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the weight maintenance recommendations Weight maintenance recommendations: Participants in the WM-REC group will exercise at 970 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training
Weight Loss Phase-Change in Systemic Inflammation	-0.3 mg/L Standard Deviation 0.3	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to Week 10

Resting metabolic rate (RMR) was measured in a quiet, temperature-controlled room using indirect calorimetry (TrueOne 2400, Parvo Medics, Salt Lake City, UT) with a clear ventilated canopy and dilution pump. Initially, participants rested in the seated position for 20 minutes. Participants then rested in the supine position in the dimly lit room for at least 20 additional minutes with the hood covering their head. RMR was determined from approximately 10 minutes of data at the end of the procedure when the FECO2 dilution was steadily maintained in the range of 1.0 and 1.2%. RMR data was considered valid when the coefficient of variations for resting energy expenditure, VO2 and VCO2, were ≤10% RMR will be expressed as the estimated amount of calories needed for a given a day (kcals/day). Change in RMR will be quantified as the week 10 value subtracted by the baseline. An increase in the value reflects an increase in RMR and a negative value represent a decrease.

Outcome measures

Measure	PA-REC n=36 Participants This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the minimum physical activity recommendations Physical activity recommendations: Participants in the PA-REC group will exercise at 550 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training	WM-REC This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the weight maintenance recommendations Weight maintenance recommendations: Participants in the WM-REC group will exercise at 970 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training
Weight Loss Phase- Change in Resting Metabolic Rate	-111 kcal/day Standard Deviation 25.7	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to Week 10

Insulin sensitivity will be measured using an oral glucose tolerance test. With the results of the oral glucose tolerance test at baseline, insulin sensitivity was calculated with the Matsuda index.

Insulin sensitivity was calculated with Matsuda index: [10,000 / √glucose minute 0 x insulin minute 0) (mean glucose (OGTT) x mean insulin OGTT)]. A higher result is better.

Outcome measures

Measure	PA-REC n=36 Participants This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the minimum physical activity recommendations Physical activity recommendations: Participants in the PA-REC group will exercise at 550 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training	WM-REC This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the weight maintenance recommendations Weight maintenance recommendations: Participants in the WM-REC group will exercise at 970 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training
Weight Loss Phase-Change in Insulin Sensitivity	3.7 Index Standard Deviation 0.9	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to Week 10

Central Arterial stiffness will be measured using a SphygmoCor XCEL (Itasca, IL). Participants will refrain from large meals and caffeine for at least 2 hours and alcohol, vigorous exercise and vasoactive medication for at least 12 hours. Testing will occur in a quiet temperature controlled room in the seated position after a 5 minute rest. Augmentation index represent central arterial stiffness and will be quantified via augmentation index (%). The augmentation index (AIx) is a measure of systemic arterial stiffness, and is defined as the ratio of augmentation (Δ P) to central pulse pressure and expressed as percent. AIx = (ΔP/PP) x 100, where P = pressure and PP = Pulse Pressure. A lower value indicates better stiffness

Outcome measures

Measure	PA-REC n=34 Participants This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the minimum physical activity recommendations Physical activity recommendations: Participants in the PA-REC group will exercise at 550 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training	WM-REC This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the weight maintenance recommendations Weight maintenance recommendations: Participants in the WM-REC group will exercise at 970 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training
Weight Loss Phase- Change in Augmentation Index	-4.5 Percent Standard Deviation 1.5	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to Week 10

Participants will wear an ActivPal accelerometer for seven consecutive days, 24-hrs/day. The amount of time spent sitting and standing and steps will be calculated

Outcome measures

Measure	PA-REC n=36 Participants This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the minimum physical activity recommendations Physical activity recommendations: Participants in the PA-REC group will exercise at 550 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training	WM-REC This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the weight maintenance recommendations Weight maintenance recommendations: Participants in the WM-REC group will exercise at 970 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training
Weight Loss Phase- Change in Physical Activity Levels	1562.4 steps per day Standard Deviation 1890.3	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to Week 10

Quality of life (QOL) will be measured by the short form health survey (SF-36). SF36 consists of 36 questions that measure patient's HRQoL in 8 domains: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH) that represent the physical HRQoL, vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH) that represent the mental HRQoL. Each domain is scored from 0 (worst health status) to 100 (best health status).

The SF-36 also produces a measure of overall physical health (physical component score [PCS]) and overall mental health (mental component score [MCS]). Scoring of these items are standardized using means and standard deviations from the general US population. Aggregate PCS and MCS scores are standardized using a linear T-Score transformation to have a mean of 50 and a standard deviation of 10.

Outcome measures

Measure	PA-REC n=36 Participants This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the minimum physical activity recommendations Physical activity recommendations: Participants in the PA-REC group will exercise at 550 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training	WM-REC This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the weight maintenance recommendations Weight maintenance recommendations: Participants in the WM-REC group will exercise at 970 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training
Weight Loss Phase- Change in Quality of Life: SF-36 Global health	4.6 score on a scale Standard Deviation 1.1	—
Weight Loss Phase- Change in Quality of Life: SF-36 Physical Health	5.3 score on a scale Standard Deviation 1.0	—
Weight Loss Phase- Change in Quality of Life: SF-36 Role physical	3.4 score on a scale Standard Deviation 1.4	—
Weight Loss Phase- Change in Quality of Life: SF-36 Bodily Pain	4.4 score on a scale Standard Deviation 1.0	—
Weight Loss Phase- Change in Quality of Life: SF-36 Vitality	6.6 score on a scale Standard Deviation 1.2	—
Weight Loss Phase- Change in Quality of Life: SF-36 Social Functioning	4.2 score on a scale Standard Deviation 1.2	—
Weight Loss Phase- Change in Quality of Life: SF-36 Mental Health	2.9 score on a scale Standard Deviation 1.1	—
Weight Loss Phase- Change in Quality of Life: SF-36 Role Emotional	5 score on a scale Standard Deviation 1.1	—
Weight Loss Phase- Change in Quality of Life: SF-36 Mental health Components (Sum)	4.0 score on a scale Standard Deviation 1.1	—
Weight Loss Phase- Change in Quality of Life: SF-36 Physical health components (Sum)	4.8 score on a scale Standard Deviation 1.2	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to Week 10

Food Frequency Questionnaire (FFQ) contains approximately 105 items grouped by categories and is completed for both frequency of consumption as well as portion size selections by the individual. The questionnaire, upon completion, provides estimated daily intake values for selected nutrients (kilocalories, macronutrients, and micronutrients) and provides information on food group servings.

Outcome measures

Measure	PA-REC n=36 Participants This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the minimum physical activity recommendations Physical activity recommendations: Participants in the PA-REC group will exercise at 550 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training	WM-REC This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the weight maintenance recommendations Weight maintenance recommendations: Participants in the WM-REC group will exercise at 970 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training
Weight Loss Phase-Change in Dietary Composition	-1320.9 kcals Standard Deviation 169	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to Week 10

LDL particle Size. This measure describes the average size of the Low density lipoprotein particles

Outcome measures

Measure	PA-REC n=36 Participants This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the minimum physical activity recommendations Physical activity recommendations: Participants in the PA-REC group will exercise at 550 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training	WM-REC This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the weight maintenance recommendations Weight maintenance recommendations: Participants in the WM-REC group will exercise at 970 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training
Changes in Lipoprotein Class/Size LDL particle size	0 nm Standard Deviation 0	—
Changes in Lipoprotein Class/Size HDL particle size	-0.1 nm Standard Deviation 0.0	—

Adverse Events

Weight Loss Phase

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PA-REC

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

WM-REC

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Weight Loss Phase n=39 participants at risk OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training. The exercise training component of the PA-REDC	PA-REC n=16 participants at risk After achieving clinically significant weight loss, participants will exercise at the minimum physical activity recommendations. Physical activity recommendations: Participants in the PA-REC group will exercise at 550 MET min. per week in a supervised format	WM-REC n=17 participants at risk After achieving clinically significant weight loss, participants will exercise at the weight maintenance recommendations Weight maintenance recommendations: Participants in the WM-REC group will exercise at 970 MET min. per week in a supervised format OPTIFAST weight loss: Participants will participant in an OPTIFAST medical weight loss program and exercise training
Gastrointestinal disorders Nausea	0.00% 0/39 • Information on adverse events were collected over the entire research study (e.g. assessment measures, weight loss phase, weight maintenance phase). The weight loss phase of the intervention was 10 weeks. The weight maintenance phase (where participants were randomized to the PA-REC or WM-REC groups) lasted for 18 additional weeks.	6.2% 1/16 • Number of events 1 • Information on adverse events were collected over the entire research study (e.g. assessment measures, weight loss phase, weight maintenance phase). The weight loss phase of the intervention was 10 weeks. The weight maintenance phase (where participants were randomized to the PA-REC or WM-REC groups) lasted for 18 additional weeks.	0.00% 0/17 • Information on adverse events were collected over the entire research study (e.g. assessment measures, weight loss phase, weight maintenance phase). The weight loss phase of the intervention was 10 weeks. The weight maintenance phase (where participants were randomized to the PA-REC or WM-REC groups) lasted for 18 additional weeks.
Cardiac disorders Lightheadedness	0.00% 0/39 • Information on adverse events were collected over the entire research study (e.g. assessment measures, weight loss phase, weight maintenance phase). The weight loss phase of the intervention was 10 weeks. The weight maintenance phase (where participants were randomized to the PA-REC or WM-REC groups) lasted for 18 additional weeks.	6.2% 1/16 • Number of events 1 • Information on adverse events were collected over the entire research study (e.g. assessment measures, weight loss phase, weight maintenance phase). The weight loss phase of the intervention was 10 weeks. The weight maintenance phase (where participants were randomized to the PA-REC or WM-REC groups) lasted for 18 additional weeks.	0.00% 0/17 • Information on adverse events were collected over the entire research study (e.g. assessment measures, weight loss phase, weight maintenance phase). The weight loss phase of the intervention was 10 weeks. The weight maintenance phase (where participants were randomized to the PA-REC or WM-REC groups) lasted for 18 additional weeks.

Additional Information

Damon Swift

University of Virginia

Phone: (434) 924-1436

Email: dls3s@virginia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place