Exercise After Clinically Significant Weight Loss

Obesity Clinical Trial

— PREVAIL-P  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03685123
• Other study ID #: 1R56HL132961-01A1
• Status: Completed
• Phase: N/A
• Start date: February 12, 2019
• Est. completion date: March 15, 2020

Study information

• Verified date: June 2021
• Source: East Carolina University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: March 15, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Insulin Resistance
• Obesity
• Sedentary Lifestyle
• Weight Loss

Intervention

Behavioral:
• Physical activity recommendations
Participants in the PA-REC group will exercise at 550 MET min. per week in a supervised format
• 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

Locations

Country	Name	City	State
United States	East Carolina University	Greenville	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
East Carolina University	Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in weight	Weight will measured in a hospital gown	Baseline, 10 weeks and 28 weeks
Secondary	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.	Baseline, 10 weeks and 28 weeks
Secondary	Change in body composition	Dual-energy X-ray absorptiometry will be used to measure changes in fat and lean mass.	Baseline, 10 weeks and 28 weeks
Secondary	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.	Baseline, 10 weeks and 28 weeks
Secondary	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, 10 weeks and 28 weeks
Secondary	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, 10 weeks and 28 weeks
Secondary	Changes in blood lipids concentrations	Low density lipoproteins, high density lipoproteins, total cholesterol, and triglycerides will be measured from baseline and 24 weeks from blood samples by Labcorp Inc.	Baseline, 10 weeks and 28 weeks
Secondary	Changes in lipoprotien class/size	Full lipoprotein class/size analysis will be preformed by Liposcience	Baseline, 10 weeks and 28 weeks
Secondary	Change in systemic inflammation	High sensitivity c-reactive protein will be measured	Baseline, 10 weeks and 28 weeks
Secondary	Change in insulin sensitivity	Insulin sensitivity will be measured using an intravenous glucose tolerance test	Baseline, 10 weeks and 28 weeks
Secondary	Change in arterial stiffness	Arterial stiffness will be measured using pulse wave velocity	Baseline, 10 weeks and 28 weeks
Secondary	Change in blood pressure	Brachial and aortic blood pressure will be measured using a sphygmocor XCEL	Baseline, 10 weeks and 28 weeks
Secondary	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 scores of these domains are summarized into the physical component score (PCS) and mental component score (MCS).	Baseline, 10 weeks and 28 weeks
Secondary	Change in resting metabolic rate	Resting metabolic rate will be measured using indirect calorimetry	Baseline, 10 weeks and 28 weeks