Using the Energy Gap to Prevent Weight Regain
This trial is active, not recruiting.
|Treatments||increased exercise, diet, exercise and diet|
|Sponsor||University of Colorado, Denver|
|Collaborator||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|
|Start date||July 2007|
|End date||December 2013|
|Trial size||120 participants|
|Trial identifier||NCT00429650, 06-0369, R01DK071692|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
Change in Weight
time frame: 18 Months
Male or female participants from 19 years up to 45 years old.
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
|Official title||Using the Energy Gap to Prevent Weight Regain|
|Principal investigator||Holly R. Wyatt, MD|
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