Using the Energy Gap to Prevent Weight Regain (Lose-It)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00429650
First received: January 30, 2007
Last updated: February 5, 2016
Last verified: February 2016
  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 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.

Condition Intervention
Obesity
Behavioral: increased exercise
Behavioral: diet
Behavioral: Exercise and Diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Using the Energy Gap to Prevent Weight Regain

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

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

Estimated Enrollment: 120
Study Start Date: July 2007
Estimated Study Completion Date: December 2017
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Increased amount of exercise to maintain weight loss.
Behavioral: increased exercise
Use prescribed number of minutes of exercise 5-6 days per week to maintain weight loss.
Experimental: 2
Combination of Exercise and Diet to maintain weight loss
Behavioral: Exercise and Diet
Use a combination of exercise and diet to maintain weight loss.
Active Comparator: 3
Use diet alone to maintain weight loss.
Behavioral: diet
Use a prescribed diet to maintain weight loss

  Eligibility

Ages Eligible for Study:   19 Years to 45 Years   (Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00429650

Locations
United States, Colorado
Center for Human Nutrition
Denver, Colorado, United States, 80262
Sponsors and Collaborators
University of Colorado, Denver
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Holly R. Wyatt, MD University of Colorado at Denver Health Sciences Center
  More Information

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00429650     History of Changes
Other Study ID Numbers: 06-0369  R01DK071692 
Study First Received: January 30, 2007
Last Updated: February 5, 2016
Health Authority: United States: Federal Government

Keywords provided by University of Colorado, Denver:
Weight maintenance
Weight loss

ClinicalTrials.gov processed this record on August 23, 2016