Using the Energy Gap to Prevent Weight Regain

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

COMPLETED

Clinical Phase

NA

Total Enrollment

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2014-01-31

Brief Summary

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The major challenge in obesity treatment is not producing weight loss but in preventing that weight from being regained. There are many different methods to lose weight, but there are no recommendations for how you can best achieve long-term weight loss maintenance. Despite the method used to reduce one's body weight, very few of these individuals are able to keep their weight off permanently. This project aims to identify how much activity is necessary to prevent weight regain after weight loss.

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Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Increased amount of exercise to maintain weight loss.

Group Type EXPERIMENTAL

increased exercise

Intervention Type BEHAVIORAL

Use prescribed number of minutes of exercise 5-6 days per week to maintain weight loss.

2

Combination of Exercise and Diet to maintain weight loss

Group Type EXPERIMENTAL

Exercise and Diet

Intervention Type BEHAVIORAL

Use a combination of exercise and diet to maintain weight loss.

3

Use diet alone to maintain weight loss.

Group Type ACTIVE_COMPARATOR

diet

Intervention Type BEHAVIORAL

Use a prescribed diet to maintain weight loss

Interventions

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increased exercise

Use prescribed number of minutes of exercise 5-6 days per week to maintain weight loss.

Intervention Type BEHAVIORAL

diet

Use a prescribed diet to maintain weight loss

Intervention Type BEHAVIORAL

Exercise and Diet

Use a combination of exercise and diet to maintain weight loss.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. All ethnic groups and both genders
2. Age: Lower age limit: 19 years; Upper age limit: 45 years
3. Body-mass Index: Lower BMI limit: 30 kg/m2; Upper BMI limit: 40 kg/m2 and weight stable within +/- 5 pounds in the last 6 months, and currently at maximum non pregnant body weight (+/- 5%)
4. A negative treadmill stress test or subsequent follow up cardiac testing for cardiac ischemia.

Exclusion Criteria

1. History of cardiovascular disease, including coronary artery disease, congestive heart failure, \& unstable angina, or uncontrolled hypertension ( \> 140/90 mm Hg)
2. Currently smoking or stopped smoking in the last 12 months
3. Medications affecting weight, energy intake, or energy expenditure in the last 6 months
4. Use of oral steroids within the last 12 months
5. History of stroke or seizures, thyroid disease, type 1 or 2 diabetes, Cushings syndrome, cerebrovascular, renal disease, hepatic disease, arrhythmias
6. Cancer requiring treatment in the past 5 years, with the exception of skin cancers other than melanoma
7. Infectious diseases: Self-reported HIV positivity or Active tuberculosis
8. Weight loss or weight gain of \> 5% in past 6 months for any reason except post-partum weight loss
9. Likely to move away in next 1.5 years
10. Inability to adhere to the program such as inability to increase walking
11. Currently pregnant, lactating or less than 6 months post-partum
12. Major psychiatric disorder: Exclusions related to medications -Antipsychotic agents (these include, but are not limited to: Haldol, Loxitane, Mellaril, Navane, Prolixin, Stelazine, Thorazine, and Trilafon)
13. Current depression by history or Beck Depression Inventory (BDI)
14. Currently being treated for psychological condition

Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes