Exercise After Clinically Significant Weight Loss (PREVAIL-P)

Prescribed Exercise to Reduce Recidivism After Weight Loss Pilot (PREVAIL-P)

The Prescribed Exercise to Reduce Recidivism After Weight Loss Pilot (PREVAIL-P) study will evaluate the effect of aerobic exercise training amount on weight maintenance following clinically significant weight loss.

Study Overview

• Status: Completed
• Conditions: Obesity; Sedentary Lifestyle; Insulin Resistance
• Intervention / Treatment: Behavioral: Physical activity recommendations; Behavioral: OPTIFAST weight loss; Behavioral: Weight maintenance recommendations

Detailed Description

The Prescribed Exercise to Reduce Recidivism After Weight Loss Pilot (PREVAIL-P) study will evaluate the effect of aerobic exercise training amount on weight maintenance following clinically significant weight loss (CWL). Overweight and obese (BMI: 25-40 kg/m2) men and women (18-65 years old) complete an OPTIFAST diet (7%-10% weight loss). Participants that obtain CWL will be subsequently randomized to aerobic exercise training consistent with the minimum physical activity guidelines (~150 min of moderate intensity exercise) or weight maintenance guidelines (200-300 min per wk. at moderate intensity) for 9 additional months.

Specific Aim 1: To demonstrate the efficacy of the weight loss program in producing CWL and retention/adherence of the exercise intervention. Overweight and obese adults (N=39) will participate in an OPTIFAST weight loss program and supervised aerobic exercise training (~550 metabolic equivalents minutes [MET min. per week.]) for 10 weeks. Participants who obtain CWL will be subsequently randomized to 16 weeks of aerobic training consistent with the minimum physical activity recommendations (~550 MET min per week.) or weight maintenance guidelines (~970 MET min per week). The percentage of participants that obtain at least 7% weight loss following OPTIFAST treatment, retention rates in the weight loss program, adherence to exercise levels, and changes in weight and cardiometabolic risk factors in response to the intervention will be evaluated.

Specific Aim 2: To test the hypothesis that exercise levels consistent with weight maintenance recommendations leads to greater weight maintenance after CWL compared to the minimum physical activity recommendation levels. Overweight and obese adults (N=30) enrolled in VIDANT health's OPTIFAST program and have achieved at least 7% weight loss will be randomized to 36 weeks of aerobic exercise training consistent with the minimum public health guidelines for physical activity (~550 MET min. per week.) or weight maintenance levels (~970 MET min per week). The effect of the intervention will be evaluated on weight (primary) as well as main secondary measures (e.g. body fat, visceral fat, lipids, lipoprotein particles size/class, insulin sensitivity, blood pressure, arterial stiffness, systemic inflammation, fitness, and quality of life). The aforementioned cardiometabolic risk factors were selected because they can be improved specifically by weight loss and thus may respond differently to weight maintenance or regain.

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Greenville, North Carolina, United States, 27858
      • East Carolina University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Men and women 18-65 years of age (postmenopausal females permitted)
• Body mass index: 25-39.9 kg/m2 at enrollment
• The capability and willingness to provide written informed consent
• Willingness to accept group assignment from randomization
• No resistance training and no structured aerobic exercise for > 20 minutes per day, 3+ days per week, for the last 6 months
• Conditions that are contraindicated for exercise training

Exclusion Criteria:

• Resting blood pressure > 180 mm Hg systolic and/or >100 mm Hg diastolic (individuals on blood pressure medications meeting the blood pressure criteria are eligible)
• Diagnosis of type 1 or 2 diabetes, and/or fasting glucose >125 mg/dL
• Medication for the treatment of type 1 or type 2 diabetes
• Bariatric surgery including gastric banding or bypass (potential effects on energy intake)
• Factors that may limit adherence to intervention or affect conduct of the trial
• Unable or unwilling to communicate with staff
• Failure to complete run-in or baseline testing
• Hospitalization for depression or severe mental illness in the last 6 months
• Not physically capable of performing the exercise required of the study protocol
• Consuming more than 14 alcoholic beverages per week
• Plan to be away from the Pitt County area more than 3 weeks in the next 3 months
• Lack support from a primary health care provider or family members
• Significant weight loss in the past year (> 20 pounds) or are currently using weight loss medications.
• Current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder
• Other temporary intervening event, such as sick spouse, or bereavement
• Other medical, psychiatric, or behavioral limitations that may interfere with study participation or the ability to follow the intervention protocol
• Underlying diseases or conditions likely to limit lifespan and/or affect the safety of the intervention
• Cancer requiring treatment in the past 5 years with anything but excellent prognosis
• Self-reported HIV, tuberculosis, Hepatitis B, or Hepatitis C
• History or evidence of serious arrhythmias, cardiomyopathy, congestive heart failure, aortic aneurism, myocardial infarction or heart transplantation
• Renal disease: urine protein > 100 mg/dl, serum creatinine ≥ 1.5 mg/dl or currently receiving dialysis.
• Auto-immune diseases (such as Lupus, Multiple Sclerosis, Graves' disease, or Rheumatoid arthritis)
• Chronic obstructive lung disease, peripheral vascular disease or angina that limits ability to follow exercise protocol
• History of stroke or transient ischemic attack
• History of vascular aneurysms
• History of bleeding disorders
• Pregnancy or plans to become pregnant
• Any other medical condition or disease that is life threatening or that can interfere with or be aggravated by exercise.
• Do not own smartphone for MyFitnessPal and Centrepoint Apps.
• Lack of an internet connection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PA-REC; After achieving clinically significant weight loss, participants will exercise at the minimum physical activity recommendations	Behavioral: Physical activity recommendations; Participants in the PA-REC group will exercise at 550 MET min. per week in a supervised format
Experimental: WM-REC; After achieving clinically significant weight loss, participants will exercise at the weight maintenance recommendations	Behavioral: Weight maintenance recommendations; Participants in the WM-REC group will exercise at 970 MET min. per week in a supervised format
Experimental: Weight Loss Phase; All participant prior to randomization will undergo a weight loss phase. This will include weight loss with Optifast and supervised aerobic exercise training (2-3 times per week). The goal of participants are to lose 7% of body weight. After the weight loss phase, participants will be randomized to the study arms (PA-REC, WM-REC)	Behavioral: OPTIFAST weight loss; Participants will participant in an OPTIFAST medical weight loss program and exercise training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Weight	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	End of weight loss phase (week 10) to follow-up (week 28)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Cardiorespiratory Fitness	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	End of weight loss phase (week 10) to follow-up (week 28)
Change in Body Fat Percentage	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.	End of weight loss phase (week 10) to follow-up (week 28)
Change in Waist Circumference	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.	End of weight loss phase (week 10) to follow-up (week 28)
Changes in Blood Lipids Concentrations	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.	End of weight loss phase (week 10) to follow-up (week 28)
Change in Blood Pressure	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	End of weight loss phase (week 10) to follow-up (week 28)
Change in Fasting Glucose Level	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.	End of weight loss phase (week 10) to follow-up (week 28)
Change in Fasting Insulin Level	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.	End of weight loss phase (week 10) to follow-up (week 28)
Change in Systemic Inflammation	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.	End of weight loss phase (week 10) to follow-up (week 28)
Change in Resting Metabolic Rate	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.	End of weight loss phase (week 10) to follow-up (week 28)
Change in Insulin Sensitivity	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.	End of Weight loss phase (week 10) to follow-up (week 28)
Changes in Lipoprotein Size	This measure describes the average size of the low density lipoprotein particles and high density lipoprotein participles	End of weight loss phase (week 10) to follow-up (week 28)
Change in Arterial Stiffness (Pulse Wave Velocity)	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.	End of weight loss phase (week 10) to follow-up (week 28)
Changes in Physical Activity Levels	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	Baseline to follow-up (week 28)
Change in Quality of Life: SF-36	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.	End of weight loss phase (week 10) to Follow-up (week 28)
Weight Loss Phase- Change in Dietary Composition	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.	Baseline to follow-up (week 28)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight Loss Phase- Change in Weight (kg)	The participants are weighed on scale in a hospital gown	Baseline to 10 weeks
Weight Loss Phase- Cardiorespiratory Fitness (L/Min)	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	Baseline 0 to Week 10
Weight Loss Phase-Change in Body Fat (%)	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.	Baseline to Week (10)
Weight Loss Phase- Change in Waist Circumference (cm)	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.	Baseline to Week 10
Weight Loss Phase-Changes in Blood Lipids Concentrations (mg/dL)	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	Baseline to Week 10
Weight Loss Phase- Changes in Blood Pressure (mmHg)	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	Baseline to Week 10
Weight Loss Phase-Change in Blood Glucose	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.	Baseline to week 10
Weight Loss Phase- Change in Insulin	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.	Baseline to Week 10
Weight Loss Phase-Change in Systemic Inflammation	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.	Baseline to Week 10
Weight Loss Phase- Change in Resting Metabolic Rate	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.	Baseline to Week 10
Weight Loss Phase-Change in Insulin Sensitivity	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.	Baseline to Week 10
Weight Loss Phase- Change in Augmentation Index	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	Baseline to Week 10
Weight Loss Phase- Change in Physical Activity Levels	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	Baseline to Week 10
Weight Loss Phase- Change in Quality of Life: SF-36	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.	Baseline to Week 10
Weight Loss Phase-Change in Dietary Composition	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.	Baseline to Week 10
Changes in Lipoprotein Class/Size	LDL particle Size. This measure describes the average size of the Low density lipoprotein particles	Baseline to Week 10

Collaborators and Investigators

• Sponsor: East Carolina University
• Collaborators: Pennington Biomedical Research Center
• Investigators: Principal Investigator: Damon L Swift, Ph.D., East Carolina University

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2019
• Primary Completion (Actual): March 15, 2020
• Study Completion (Actual): March 15, 2020

Study Registration Dates

• First Submitted: September 22, 2018
• First Submitted That Met QC Criteria: September 25, 2018
• First Posted (Actual): September 26, 2018

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: June 10, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Energy expenditure; Insulin resistance; Weight loss; Body composition; Arterial stiffness; Lipids; Fitness; Exercise training; Weight maintenance
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Body Weight; Hyperinsulinism; Body Weight Changes; Weight Loss; Insulin Resistance
• Other Study ID Numbers: 1R56HL132961-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No