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The Energy Balance Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of South Carolina
ClinicalTrials.gov Identifier:
NCT01746186
First received: November 26, 2012
Last updated: December 18, 2012
Last verified: December 2012
History of Changes
  Purpose

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
Total Energy Expenditure,Total Energy Intake

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Further study details as provided by University of South Carolina:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 400
Study Start Date: October 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.
  Eligibility

Ages Eligible for Study:   21 Years to 35 Years
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01746186

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

No publications provided

Responsible Party: University of South Carolina
ClinicalTrials.gov Identifier: NCT01746186     History of Changes
Other Study ID Numbers: EB2010
Study First Received: November 26, 2012
Last Updated: December 18, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on June 18, 2013