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OpenTrials
Completed

NCT Number: NCT00429650

Using the Energy Gap to Prevent Weight Regain

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.

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Key information

Age range

19 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Human Nutrition

Denver, Colorado, 80262, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All ethnic groups and both genders
  • Age: Lower age limit: 19 years; Upper age limit: 45 years
  • 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%)
  • A negative treadmill stress test or subsequent follow up cardiac testing for cardiac ischemia.

Exclusion criteria

  • History of cardiovascular disease, including coronary artery disease, congestive heart failure, & unstable angina, or uncontrolled hypertension ( > 140/90 mm Hg)
  • Currently smoking or stopped smoking in the last 12 months
  • Medications affecting weight, energy intake, or energy expenditure in the last 6 months
  • Use of oral steroids within the last 12 months
  • History of stroke or seizures, thyroid disease, type 1 or 2 diabetes, Cushings syndrome, cerebrovascular, renal disease, hepatic disease, arrhythmias
  • Cancer requiring treatment in the past 5 years, with the exception of skin cancers other than melanoma
  • Infectious diseases: Self-reported HIV positivity or Active tuberculosis
  • Weight loss or weight gain of > 5% in past 6 months for any reason except post-partum weight loss
  • Likely to move away in next 1.5 years
  • Inability to adhere to the program such as inability to increase walking
  • Currently pregnant, lactating or less than 6 months post-partum
  • 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)
  • Current depression by history or Beck Depression Inventory (BDI)
  • Currently being treated for psychological condition

Treatment and study plan

increased exercise

Behavioral

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

Diet

Behavioral

Use a prescribed diet to maintain weight loss

exercise and diet

Behavioral

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

Primary outcomes

  1. Change in Weight

    Time frame: 18 Months

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Acronym: Lose-It

Important dates

Study start
2007
Primary completion
2014
Study completion
2014
First posted
Feb 1, 2007
Registry last updated
Jun 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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