The Energy Balance Study

February 8, 2023 updated by: Sarah Schumacher, University of South Carolina
The purpose of this study if to determine the specific contributions of energy intake and energy expenditure to changes in body weight and fat.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

400

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
    • South Carolina
      • Columbia, South Carolina, United States, 29202
        • University of South Carolina

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

21 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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

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

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
two years

Collaborators and Investigators

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

Sponsor

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

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

October 1, 2010

Primary Completion (ACTUAL)

June 1, 2015

Study Completion (ACTUAL)

June 1, 2015

Study Registration Dates

First Submitted

November 26, 2012

First Submitted That Met QC Criteria

December 6, 2012

First Posted (ESTIMATE)

December 10, 2012

Study Record Updates

Last Update Posted (ACTUAL)

February 13, 2023

Last Update Submitted That Met QC Criteria

February 8, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Pro00009704

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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