N/A
N=39
Exercise After Clinically Significant Weight Loss
Obesity · Sedentary Lifestyle · Insulin Resistance
Bottom Line
View on ClinicalTrials.gov: NCT03685123 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Change in Weight — 0.7; -1.5 kg — p=0.256
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Physical activity recommendations (Behavioral); Weight maintenance recommendations (Behavioral); OPTIFAST weight loss (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- East Carolina University
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Weight |
0.7; -1.5 | 0.256 |
| SECONDARY Change in Cardiorespiratory Fitness |
0.05; 0.16 | 0.089 |
| SECONDARY Change in Body Fat Percentage |
0.89; -1.54 | 0.244 |
| SECONDARY Change in Waist Circumference |
0.48; -2.4 | 0.064 |
| SECONDARY Changes in Blood Lipids Concentrations |
4.9; 5.4; 11.2; 7.5; 21.2; 15.5 | 0.983 |
| SECONDARY Change in Blood Pressure |
7.4; 9.2; 4.0; 6.37; 6.6; 8.1 | 0.72 |
| SECONDARY Change in Fasting Glucose Level |
2.1; 2.5 | 0.965 |
| SECONDARY Change in Fasting Insulin Level |
2.1; 178 | 0.857 |
| SECONDARY Change in Systemic Inflammation |
-0.48; -0.43 | 0.825 |
| SECONDARY Change in Resting Metabolic Rate |
75.2; -66.8 | 0.061 |
| SECONDARY Change in Insulin Sensitivity |
-1.16; -3.4 | — |
| SECONDARY Changes in Lipoprotein Size |
-0.04; 0.01; 0.21; 0.04 | 0.105 |
| SECONDARY Change in Arterial Stiffness (Pulse Wave Velocity) |
0.40; 0.436787 | — |
| SECONDARY Changes in Physical Activity Levels |
-437.02; 511.0 | 0.278 |
| SECONDARY Change in Quality of Life: SF-36 |
-2.7; -0.19; -0.2; 0.71; 0.45; 0.00 | 0.238 |
| SECONDARY Weight Loss Phase- Change in Dietary Composition |
-1320.9 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03685123). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.