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Using the Energy Gap to Prevent Weight Regain

Using the Energy Gap to Prevent Weight Regain

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00429650
Acronym
Lose-It
Enrollment
175
Registered
2007-02-01
Start date
2007-07-31
Completion date
2014-01-31
Last updated
2019-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Weight maintenance, Weight loss

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.

Interventions

BEHAVIORALincreased exercise

Use prescribed number of minutes of exercise 5-6 days per week to maintain weight loss.

BEHAVIORALdiet

Use a prescribed diet to maintain weight loss

Use a combination of exercise and diet to maintain weight loss.

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
University of Colorado, Denver
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to 45 Years
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

Design outcomes

Primary

MeasureTime frame
Change in Weight18 Months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026