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

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Obesity

Treatments: Behavioral: diet; Behavioral: Exercise and Diet; Behavioral: increased exercise

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00429650

06-0369

R01DK071692 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 175 patients

Sex: All

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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175 participants in 3 patient groups

1

Experimental group

Description:

Increased amount of exercise to maintain weight loss.

Treatment:

Behavioral: increased exercise

2

Experimental group

Description:

Combination of Exercise and Diet to maintain weight loss

Treatment:

Behavioral: Exercise and Diet

3

Active Comparator group

Description:

Use diet alone to maintain weight loss.

Treatment:

Behavioral: diet