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Using the Energy Gap to Prevent Weight Regain (Lose-It)
This study is currently recruiting participants.
Verified by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), December 2008
Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00429650
  Purpose

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 ones 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.


Condition Intervention
Obesity
Behavioral: Weight maintenance
Behavioral: Exercise
Behavioral: Exercise and Diet

MedlinePlus related topics: Exercise and Physical Fitness Obesity Weight Control
Drug Information available for: Benzocaine
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
Official Title: Using the Energy Gap to Prevent Weight Regain

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • Weight [ Time Frame: 18 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: July 2007
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Increased amount of exercise to maintain weight loss.
Behavioral: Weight maintenance
Use prescribed number of minutes of exercise 5-6 days per week to maintain weigh loss.
2: Experimental
Exercise and Diet
Behavioral: Exercise and Diet
Use a combination of exercise and diet to maintain weight loss.
3: Active Comparator
Use diet alone to maintain weight loss.
Behavioral: Exercise
Use a prescribed diet to prevent weight regain after weight loss.

  Eligibility

Ages Eligible for Study:   19 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00429650

Contacts
Contact: Carrie Brill 303-315-4087 ext 5
Contact: Emily Schwall emily.schwall@uchsc.edu

Locations
United States, Colorado
Center for Human Nutrition Recruiting
Denver, Colorado, United States, 80262
Contact: Emily Schwall         emily.schwall@uchsc.edu    
Sponsors and Collaborators
Investigators
Principal Investigator: Holly R. Wyatt, MD University of Colorado at Denver Health Sciences Center
  More Information

Responsible Party: University of Colorado at Denver ( Holly Wyatt, MD )
Study ID Numbers: DK71692
Study First Received: January 30, 2007
Last Updated: December 1, 2008
ClinicalTrials.gov Identifier: NCT00429650  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Weight maintenance
Weight loss

Study placed in the following topic categories:
Body Weight
Signs and Symptoms
Obesity
Weight Loss
Benzocaine
Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on January 16, 2009