Back to results

Exercise After Clinically Significant Weight Loss (PREVAIL-P)

Primary Purpose

Obesity, Sedentary Lifestyle, Insulin Resistance

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Physical activity recommendations

Weight maintenance recommendations

OPTIFAST weight loss

About this trial

This is an interventional prevention trial for Obesity focused on measuring Exercise training, Insulin resistance, Lipids, Arterial stiffness, Fitness, Weight maintenance, Body composition, Energy expenditure, Weight loss

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

East Carolina University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

PA-REC

WM-REC

Arm Description

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

This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the weight maintenance recommendations

Outcomes

Primary Outcome Measures

Change in weight

Weight will measured in a hospital gown

Secondary Outcome Measures

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 body composition

Dual-energy X-ray absorptiometry will be used to measure changes in fat and lean mass.

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.

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

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.

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.

Changes in lipoprotien class/size

Full lipoprotein class/size analysis will be preformed by Liposcience

Change in systemic inflammation

High sensitivity c-reactive protein will be measured

Change in insulin sensitivity

Insulin sensitivity will be measured using an intravenous glucose tolerance test

Change in arterial stiffness

Arterial stiffness will be measured using pulse wave velocity

Change in blood pressure

Brachial and aortic blood pressure will be measured using a sphygmocor XCEL

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).

Change in resting metabolic rate

Resting metabolic rate will be measured using indirect calorimetry

Full Information

NCT ID

NCT03685123

First Posted

September 22, 2018

Last Updated

June 18, 2021

Sponsor

East Carolina University

Collaborators

Pennington Biomedical Research Center

1. Study Identification

Unique Protocol Identification Number

NCT03685123

Brief Title

Exercise After Clinically Significant Weight Loss

Acronym

PREVAIL-P

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Completed

Study Start Date

February 12, 2019 (Actual)

Primary Completion Date

March 15, 2020 (Actual)

Study Completion Date

March 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

East Carolina University

Collaborators

Pennington Biomedical Research Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Sedentary Lifestyle, Insulin Resistance

Keywords

Exercise training, Insulin resistance, Lipids, Arterial stiffness, Fitness, Weight maintenance, Body composition, Energy expenditure, Weight loss

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

39 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PA-REC

Arm Type

Experimental

Arm Description

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

Arm Title

WM-REC

Arm Type

Experimental

Arm Description

This group will participate in an OPTIFAST weight loss program. After achieving clinically significant weight loss, participants will exercise at the weight maintenance recommendations

Intervention Type

Behavioral

Intervention Name(s)

Physical activity recommendations

Intervention Description

Participants in the PA-REC group will exercise at 550 MET min. per week in a supervised format

Intervention Type

Behavioral

Intervention Name(s)

Weight maintenance recommendations

Intervention Description

Participants in the WM-REC group will exercise at 970 MET min. per week in a supervised format

Intervention Type

Behavioral

Intervention Name(s)

OPTIFAST weight loss

Intervention Description

Participants will participant in an OPTIFAST medical weight loss program and exercise training

Primary Outcome Measure Information:

Title

Change in weight

Description

Weight will measured in a hospital gown

Time Frame