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N/A N=39 Randomized Prevention

Exercise After Clinically Significant Weight Loss

Obesity · Sedentary Lifestyle · Insulin Resistance

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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