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Promotion of Weight Management (POWER-VET)

Primary Purpose

Overweight

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weight Maintenance
Weight Maintenance + Intermittent Fasting
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight focused on measuring Exercise, Diet, Obesity

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Veteran
  • 50-75 years of age
  • BMI: 25-40 kg/m2
  • Postmenopausal status for women

Exclusion Criteria:

  • Uncontrolled diabetes (HbA1c >10% or the current use of insulin)
  • Neurologic, musculoskeletal, or other condition that limits subject's ability to complete study physical assessments
  • Active inflammatory, autoimmune, infectious, hepatic, gastrointestinal, malignant, and psychiatric disease
  • Weight change within the past month of >5 kg
  • Self-reported alcohol or drug abuse
  • Anti-coagulant medication for muscle biopsies only Impaired renal function (creatinine > 1.5 mg/dl) History or evidence of serious liver disease (LFTs > 2.5 x WNL)

Sites / Locations

  • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MDRecruiting
  • South Texas Health Care System, San Antonio, TXRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Weight Maintenance

Weight Maintenance + Intermittent Fasting

Arm Description

Heart Healthy nutrition, walking, resistance band exercise

Heart Healthy nutrition, walking, resistance band exercise and intermittent fasting (2 small meals per day) one day per week for 24 weeks.

Outcomes

Primary Outcome Measures

Change in Body Weight
weight in kg

Secondary Outcome Measures

Change in Gait Speed
Fastest comfortable walking speed over 4 meters. Units are m/sec
Change in body fat
abdominal fat area, in cm2
Change in LPL
skeletal muscle lipoprotein lipase in nmol/min/ mg protein

Full Information

First Posted
October 16, 2019
Last Updated
January 11, 2023
Sponsor
VA Office of Research and Development
Collaborators
Baltimore VA Medical Center, South Texas Veterans Health Care System
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1. Study Identification

Unique Protocol Identification Number
NCT04131647
Brief Title
Promotion of Weight Management
Acronym
POWER-VET
Official Title
Promotion of Successful Weight Management in Overweight and Obese Veterans
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
July 5, 2025 (Anticipated)
Study Completion Date
January 7, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
Baltimore VA Medical Center, South Texas Veterans Health Care System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The identification of intermittent fasting as an alternative method to traditional weight maintenance protocols could have a significant impact on preventing body weight regain common after successful weight loss, and potentially lead to a reduction in pharmaceutical and clinical costs related to the care of overweight and obese adults.
Detailed Description
The research will examine the impact of intermittent fasting to promote long term body weight maintenance following successful weight loss in overweight and obese Veterans. This research is especially relevant to the majority of Veterans who struggle with obesity and maintaining weight loss. Obesity increases the risk for storing excess calories in ectopic depots, including skeletal muscle. Intramuscular fat is related to altered substrate utilization (metabolic inflexibility) and defects in insulin sensitivity, ultimately leading to type 2 diabetes mellitus and cardiovascular disease. The objective of this proposal is to test in a randomized clinical trial the effectiveness of an intensive weight management program with and without intermittent fasting (IF) to combat weight regain and the obesity crisis in our Veterans. Further, this application proposes to examine the role of several enzymes involved in skeletal muscle fatty acid oxidation as a mechanism for efficacious long term weight management.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
Keywords
Exercise, Diet, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Weight management program
Masking
Participant
Allocation
Randomized
Enrollment
154 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Weight Maintenance
Arm Type
Active Comparator
Arm Description
Heart Healthy nutrition, walking, resistance band exercise
Arm Title
Weight Maintenance + Intermittent Fasting
Arm Type
Experimental
Arm Description
Heart Healthy nutrition, walking, resistance band exercise and intermittent fasting (2 small meals per day) one day per week for 24 weeks.
Intervention Type
Other
Intervention Name(s)
Weight Maintenance
Intervention Description
Following a 12-week weight loss and exercise program, subjects will participate in a weight maintenance program of Heart Healthy nutrition, walking, and resistance band exercise
Intervention Type
Other
Intervention Name(s)
Weight Maintenance + Intermittent Fasting
Intervention Description
Following a 12-week weight loss and exercise program, subjects will participate in a weight maintenance program of Heart Healthy nutrition, walking, resistance band exercise and intermittent fasting (2 small meals per day) one day per week for 24 weeks.
Primary Outcome Measure Information:
Title
Change in Body Weight
Description
weight in kg
Time Frame
Baseline, after 12 weeks of weight loss+exercise, at 36-week weight maintenance, and 48-week follow-up
Secondary Outcome Measure Information:
Title
Change in Gait Speed
Description
Fastest comfortable walking speed over 4 meters. Units are m/sec
Time Frame
Baseline, after 12 weeks of weight loss+exercise, at 36-week weight maintenance, and 48-week follow-up
Title
Change in body fat
Description
abdominal fat area, in cm2
Time Frame
Baseline, after 12 weeks of weight loss+exercise, and at 36-week weight maintenance
Title
Change in LPL
Description
skeletal muscle lipoprotein lipase in nmol/min/ mg protein
Time Frame
Baseline, after 12 weeks of weight loss+exercise, and at 36-week weight maintenance

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Veteran 50-75 years of age BMI: 25-40 kg/m2 Postmenopausal status for women Exclusion Criteria: Uncontrolled diabetes (HbA1c >10% or the current use of insulin) Neurologic, musculoskeletal, or other condition that limits subject's ability to complete study physical assessments Active inflammatory, autoimmune, infectious, hepatic, gastrointestinal, malignant, and psychiatric disease Weight change within the past month of >5 kg Self-reported alcohol or drug abuse Anti-coagulant medication for muscle biopsies only Impaired renal function (creatinine > 1.5 mg/dl) History or evidence of serious liver disease (LFTs > 2.5 x WNL)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alice S Ryan, PhD
Phone
(410) 605-7851
Email
Alice.Ryan@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Kristina Marcus, MS
Phone
(410) 605-7000
Email
kristina.marcus@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alice S. Ryan, PhD
Organizational Affiliation
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lynda C Robey
Phone
410-605-7000
Ext
5446
Email
lynda.robey@va.gov
First Name & Middle Initial & Last Name & Degree
Alice S. Ryan, PhD
Facility Name
South Texas Health Care System, San Antonio, TX
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica Serra, PhD
Phone
210-949-9759
Email
monica.serra@va.gov

12. IPD Sharing Statement

Plan to Share IPD
No

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