NCT03685123

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 26, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

February 12, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2020

Completed
4.3 years until next milestone

Results Posted

Study results publicly available

July 3, 2024

Completed
Last Updated

July 3, 2024

Status Verified

June 1, 2024

Enrollment Period

1.1 years

First QC Date

September 22, 2018

Results QC Date

August 9, 2022

Last Update Submit

June 10, 2024

Conditions

ObesitySedentary LifestyleInsulin Resistance

Keywords

Exercise trainingInsulin resistanceLipidsArterial stiffnessFitnessWeight maintenanceBody compositionEnergy expenditureWeight loss

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (15)

  • Change in Cardiorespiratory Fitness

    End of weight loss phase (week 10) to follow-up (week 28)

  • Change in Body Fat Percentage

    End of weight loss phase (week 10) to follow-up (week 28)

  • Change in Waist Circumference

    End of weight loss phase (week 10) to follow-up (week 28)

  • Changes in Blood Lipids Concentrations

    End of weight loss phase (week 10) to follow-up (week 28)

  • Change in Blood Pressure

    End of weight loss phase (week 10) to follow-up (week 28)

  • +10 more secondary outcomes

Other Outcomes (16)

  • Weight Loss Phase- Change in Weight (kg)

    Baseline to 10 weeks

  • Weight Loss Phase- Cardiorespiratory Fitness (L/Min)

    Baseline 0 to Week 10

  • Weight Loss Phase-Change in Body Fat (%)

    Baseline to Week (10)

  • +13 more other outcomes

Study Arms (3)

PA-REC

EXPERIMENTAL

After achieving clinically significant weight loss, participants will exercise at the minimum physical activity recommendations

Behavioral: Physical activity recommendations

WM-REC

EXPERIMENTAL

After achieving clinically significant weight loss, participants will exercise at the weight maintenance recommendations

Behavioral: Weight maintenance recommendations

Weight Loss Phase

EXPERIMENTAL

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

Interventions

Physical activity recommendationsBEHAVIORAL

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

PA-REC
Weight maintenance recommendationsBEHAVIORAL

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

WM-REC
OPTIFAST weight lossBEHAVIORAL

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

Weight Loss Phase

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

East Carolina University

Greenville, North Carolina, 27858, United States

Location

MeSH Terms

Conditions

ObesitySedentary BehaviorInsulin ResistanceWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesBody Weight Changes

Limitations and Caveats

Loss of participants due to the COVID-19 pandemic caused disenrollment of participants in the last cohort of the weight maintenance phase (e.g. shown in participant flow section). This may have limited our ability to detect significant differences between groups.

Results Point of Contact

Title
Damon Swift
Organization
University of Virginia
dls3s@virginia.edu
(434) 924-1436

Study Officials

  • Damon L Swift, Ph.D.

    East Carolina University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 22, 2018

First Posted

September 26, 2018

Study Start

February 12, 2019

Primary Completion

March 15, 2020

Study Completion

March 15, 2020

Last Updated

July 3, 2024

Results First Posted

July 3, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)