Using the Energy Gap to Prevent Weight Regain

Study Overview
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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.

Official Title
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Using the Energy Gap to Prevent Weight Regain

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: increased exercise
* Behavioral: diet
* Behavioral: Exercise and Diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All ethnic groups and both genders Age: Lower age limit: 19 years; Upper age limit: 45 years 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%) A negative treadmill stress test or subsequent follow up cardiac testing for cardiac ischemia. Exclusion Criteria: History of cardiovascular disease, including coronary artery disease, congestive heart failure, & unstable angina, or uncontrolled hypertension ( > 140/90 mm Hg) Currently smoking or stopped smoking in the last 12 months Medications affecting weight, energy intake, or energy expenditure in the last 6 months Use of oral steroids within the last 12 months History of stroke or seizures, thyroid disease, type 1 or 2 diabetes, Cushings syndrome, cerebrovascular, renal disease, hepatic disease, arrhythmias Cancer requiring treatment in the past 5 years, with the exception of skin cancers other than melanoma Infectious diseases: Self-reported HIV positivity or Active tuberculosis Weight loss or weight gain of > 5% in past 6 months for any reason except post-partum weight loss Likely to move away in next 1.5 years Inability to adhere to the program such as inability to increase walking Currently pregnant, lactating or less than 6 months post-partum 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) Current depression by history or Beck Depression Inventory (BDI) Currently being treated for psychological condition

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Increased amount of exercise to maintain weight loss. | Behavioral: increased exercise<br>* Use prescribed number of minutes of exercise 5-6 days per week to maintain weight loss.<br>|
| Experimental: 2<br>Combination of Exercise and Diet to maintain weight loss | Behavioral: Exercise and Diet<br>* Use a combination of exercise and diet to maintain weight loss.<br>|
| Active Comparator: 3<br>Use diet alone to maintain weight loss. | Behavioral: diet<br>* Use a prescribed diet to maintain weight loss<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Weight |  | 18 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Weight maintenance, Weight loss