The Energy Balance Study

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: NCT01746186
Recruitment Status : Completed
First Posted : December 10, 2012
Last Update Posted : May 11, 2016
Information provided by (Responsible Party):
University of South Carolina

Brief Summary:
The purpose of this study if to determine the specific contributions of energy intake and energy expenditure to changes in body weight and fat.

Condition or disease
Total Energy Expenditure,Total Energy Intake

Detailed Description:
  1. Changes in body weight and fat will be positively associated with increases in total energy intake.
  2. Changes in body weight and fat will be positively associated with decreases in total energy expenditure.

Study Type : Observational
Actual Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : October 2010
Primary Completion Date : June 2015
Study Completion Date : June 2015

21-35 years of age
200 Men and 200 women: Ages 21-27 and Ages 28-35, BMI: 20-35,living in the Columbia, SC area.

Primary Outcome Measures :
  1. variation in total energy expenditure and variation in total energy intake contribute to changes in body weight and fat among young adults [ Time Frame: two years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
A total of 400 participants will take part in the Energy Balance Study; 200 men and 200 women from 2 age groups: Ages 21-27 and Ages 28-35. A subsample of 200 will be randomized for doubly labeled water recruitment.

Inclusion Criteria:

  • BMI: 20-35 *Note : For participants that come to Orientation, we are allowing participants with a variance of 0.1 either way in the BMI range: 19.9 - 35.1

    • 21-35 years of age
    • Men and women
    • Email address
    • Access to a phone

Exclusion Criteria:

  • Currently on medications to lose weight

    • >90th percentile on the Brief Symptom Inventory (BSI)
    • Planning to move from the Greater Columbia area in the next 15 months
    • Other medical, psychiatric or behavioral factors that in the judgment of the principal investigator may interfere with study participation or the ability to follow the intervention protocol.
    • Changed birth control status in past 3 months
    • Currently taking birth control but plan to stop taking it within the next 12 months or are planning to start taking birth control in the next 12 months
    • Planning to have weight loss surgery
    • Started or stopped smoking in the past 6 months
    • Blood pressure ≥ 150/90
    • Blood glucose ≥ 145 mg/dL @ orientation
    • Blood glucose ≥ 126 mg/dL @ B3
    • Total cholesterol ≥ 240 mg/dl with LDL-C ≥ 190 mg/dl or Triglyceride levels ≥ 300 mg/dL
    • Currently diagnosed with or taking medications for a major chronic health condition
    • Presence of an eating disorder
    • Currently participating in another study

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): NCT01746186

United States, South Carolina
University of South Carolina
Columbia, South Carolina, United States, 29202
Sponsors and Collaborators
University of South Carolina
Principal Investigator: Steven Blair, Ph.D University of South Carolina
Principal Investigator: Greg Hand, Ph.D University of South Carolina