Clinical trial NCT00429650: Using the Energy Gap to Prevent Weight Regain
Official title: Using the Energy Gap to Prevent Weight Regain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Weight maintenance
Weight loss
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2007-02-01
Enrollment: 175
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Weight
timeFrame: 18 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Center for Human Nutrition
state: Colorado
Study officials:
affiliation: University of Colorado at Denver Health Sciences Center
name: Holly R. Wyatt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Polsky S, Garratt Ogden L, Scown Maclean P, Danielle Giles E, Brill C, Roxanna Wyatt H. Biomarker Profile Does Not Predict Weight Loss Success in Successful and Unsuccessful Diet-Reduced Obese Individuals: a Prospective Study. ISRN Obes. 2013 Jan 1;2013:804129. doi: 10.1155/2013/804129.