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

June 26, 2019 updated by: University of Colorado, Denver
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

175

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80262
        • Center for Human Nutrition

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Weight
Time Frame: 18 Months
18 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

January 30, 2007

First Submitted That Met QC Criteria

January 31, 2007

First Posted (Estimate)

February 1, 2007

Study Record Updates

Last Update Posted (Actual)

June 28, 2019

Last Update Submitted That Met QC Criteria

June 26, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 06-0369
  • R01DK071692 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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