OverweightPOWER-VETNCT04131647
Promotion of Weight Management
A study testing Weight Maintenance and Weight Maintenance + Intermittent Fasting in people with Overweight, run by VA Office of Research and Development at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- Weight Maintenance and Weight Maintenance + Intermittent Fasting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Mar 2021to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Veteran
- 50-75 years of age
- BMI: 25-40 kg/m2
- Postmenopausal status for women
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201
South Texas Health Care System, San Antonio, TX
San Antonio, Texas, 78229
About this study
Official title: Promotion of Successful Weight Management in Overweight and Obese Veterans
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.
Read the 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.
- Conditions
- Overweight
- Being tested
- Weight Maintenance, Weight Maintenance + Intermittent Fasting
- Keywords
- Exercise, Diet, Obesity
- Medical subject headings
- Overweight, Motor Activity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight MaintenanceOther
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
Weight Maintenance + Intermittent FastingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Weight Maintenance | Active comparator | Heart Healthy nutrition, walking, resistance band exercise Receives: Other: Weight Maintenance |
| Weight Maintenance + Intermittent Fasting | Experimental | Heart Healthy nutrition, walking, resistance band exercise and intermittent fasting (2 small meals per day) one day per week for 24 weeks. Receives: Other: Weight Maintenance + Intermittent Fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Weight
weight in kg
Measured: Baseline, after 12 weeks of weight loss+exercise, at 36-week weight maintenance, and 48-week follow-up
Secondary outcomes (3)
Change in Gait Speed
Fastest comfortable walking speed over 4 meters. Units are m/sec
Measured: Baseline, after 12 weeks of weight loss+exercise, at 36-week weight maintenance, and 48-week follow-up
Change in body fat
abdominal fat area, in cm2
Measured: Baseline, after 12 weeks of weight loss+exercise, and at 36-week weight maintenance
Change in LPL
skeletal muscle lipoprotein lipase in nmol/min/ mg protein
Measured: Baseline, after 12 weeks of weight loss+exercise, and at 36-week weight maintenance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start1 Mar 2021
- Primary completion30 Sep 2025
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Weight management program
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Baltimore VA Medical Center, South Texas Veterans Health Care System
- Responsible party
- Sponsor
- Investigators
- Alice S. Ryan, PhD, Principal investigator, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04131647
- Sponsor's protocol ID
- ENDA-013-19S
- Acronym
- POWER-VET
- Status last verified
- Jan 2026
- First submitted
- 16 Oct 2019
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promotion of Successful Weight Management in Overweight and Obese Veterans
- ClinicalTrials.gov ID
- NCT04131647
- Acronym / sponsor ID
- POWER-VET / ENDA-013-19S
- Conditions
- Overweight
- Keywords
- Exercise, Diet, Obesity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 175 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Baltimore VA Medical Center, South Texas Veterans Health Care System
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 18 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Weight management program
| Arm | Type | Receives |
|---|---|---|
| Weight Maintenance | Active comparator | Other: Weight MaintenanceHeart Healthy nutrition, walking, resistance band exercise |
| Weight Maintenance + Intermittent Fasting | Experimental | Other: Weight Maintenance + Intermittent FastingHeart Healthy nutrition, walking, resistance band exercise and intermittent fasting (2 small meals per day) one day per week for 24 weeks. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Veteran
- 50-75 years of age
- BMI: 25-40 kg/m2
- Postmenopausal status for women
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weight MaintenanceFollowing 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 | Other | Weight Maintenance |
| Weight Maintenance + Intermittent FastingFollowing 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. | Other | Weight Maintenance + Intermittent Fasting |
Primary outcome
Change in Body Weight
Time frame: Baseline, after 12 weeks of weight loss+exercise, at 36-week weight maintenance, and 48-week follow-up
weight in kg
3 secondary outcomes
Change in Gait Speed
Time frame: Baseline, after 12 weeks of weight loss+exercise, at 36-week weight maintenance, and 48-week follow-up
Change in body fat
Time frame: Baseline, after 12 weeks of weight loss+exercise, and at 36-week weight maintenance
Change in LPL
Time frame: Baseline, after 12 weeks of weight loss+exercise, and at 36-week weight maintenance
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alice S. Ryan, PhD principal investigator
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight Maintenance and Weight Maintenance + Intermittent Fasting in people with Overweight, run by VA Office of Research and Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Weight (time frame: Baseline, after 12 weeks of weight loss+exercise, at 36-week weight maintenance, and 48-week follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.