Overview

This trial is active, not recruiting.

Condition obesity
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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Increased amount of exercise to maintain weight loss.
increased exercise
Use prescribed number of minutes of exercise 5-6 days per week to maintain weight loss.
(Experimental)
Combination of Exercise and Diet to maintain weight loss
exercise and diet
Use a combination of exercise and diet to maintain weight loss.
(Active Comparator)
Use diet alone to maintain weight loss.
diet
Use a prescribed diet to maintain weight loss

Primary Outcomes

Measure
Change in Weight
time frame: 18 Months

Eligibility Criteria

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

Additional Information

Official title Using the Energy Gap to Prevent Weight Regain
Principal investigator Holly R. Wyatt, MD
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by University of Colorado, Denver.