Status:
COMPLETED
Using the Energy Gap to Prevent Weight Regain
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Obesity
Eligibility:
All Genders
19-45 years
Phase:
NA
Brief Summary
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 recommendatio...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT00429650
Start Date
July 1 2007
End Date
January 1 2014
Last Update
June 28 2019
Active Locations (1)
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1
Center for Human Nutrition
Denver, Colorado, United States, 80262