Promotion of Weight Management

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2026-10-01

Brief Summary

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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.

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Detailed Description

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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

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Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Weight management program

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Weight Maintenance

Heart Healthy nutrition, walking, resistance band exercise

Group Type ACTIVE_COMPARATOR

Weight Maintenance

Intervention Type OTHER

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 Fasting

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

Group Type EXPERIMENTAL

Weight Maintenance + Intermittent Fasting

Intervention Type OTHER

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.

Interventions

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Weight Maintenance

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

Weight Maintenance + Intermittent Fasting

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.

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes