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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00429650
Recruitment Status : Active, not recruiting
First Posted : February 1, 2007
Last Update Posted : May 10, 2018
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: increased exercise Behavioral: diet Behavioral: Exercise and Diet Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Using the Energy Gap to Prevent Weight Regain
Study Start Date : July 2007
Actual Primary Completion Date : December 2013
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Change in Weight [ Time Frame: 18 Months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00429650

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)
Principal Investigator: Holly R. Wyatt, MD University of Colorado at Denver Health Sciences Center

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Colorado, Denver Identifier: NCT00429650     History of Changes
Other Study ID Numbers: 06-0369
R01DK071692 ( U.S. NIH Grant/Contract )
First Posted: February 1, 2007    Key Record Dates
Last Update Posted: May 10, 2018
Last Verified: May 2018

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

Additional relevant MeSH terms:
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents