Total Energy Expenditure,Total Energy IntakeNCT01746186
The Energy Balance Study
An observational study of Total Energy Expenditure,Total Energy Intake, run by University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Total Energy Expenditure,Total Energy Intake
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Carolina
Columbia, South Carolina, 29202
About this study
The purpose of this study if to determine the specific contributions of energy intake and energy expenditure to changes in body weight and fat.
Read the detailed description
- Changes in body weight and fat will be positively associated with increases in total energy intake.
- Changes in body weight and fat will be positively associated with decreases in total energy expenditure.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
variation in total energy expenditure and variation in total energy intake contribute to changes in body weight and fat among young adults
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2012 (estimated)
- Study startOct 2010
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Total Energy Expenditure,Total Energy IntakeStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Schumacher, University of South Carolina
- Investigators
- Steven Blair, Ph.D, Principal investigator, University of South CarolinaGreg Hand, Ph.D, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01746186
- Sponsor's protocol ID
- Pro00009704
- Status last verified
- Feb 2023
- First submitted
- 26 Nov 2012
- Last updated
- 13 Feb 2023
- Results posted
- No
Publications
Meyer JD, Ellingson LD, Buman MP, Shook RP, Hand GA, Blair SN. Current and 1-Year Psychological and Physical Effects of Replacing Sedentary Time With Time in Other Behaviors. Am J Prev Med. 2020 Jul;59(1):12-20. doi: 10.1016/j.amepre.2020.02.018. Epub 2020 May 14.
PubMed 32418803Shook RP, Hand GA, Drenowatz C, Hebert JR, Paluch AE, Blundell JE, Hill JO, Katzmarzyk PT, Church TS, Blair SN. Low levels of physical activity are associated with dysregulation of energy intake and fat mass gain over 1 year. Am J Clin Nutr. 2015 Dec;102(6):1332-8. doi: 10.3945/ajcn.115.115360. Epub 2015 Nov 11.
PubMed 26561620Shook RP, Gribben NC, Hand GA, Paluch AE, Welk GJ, Jakicic JM, Hutto B, Burgess S, Blair SN. Subjective Estimation of Physical Activity Using the International Physical Activity Questionnaire Varies by Fitness Level. J Phys Act Health. 2016 Jan;13(1):79-86. doi: 10.1123/jpah.2014-0543. Epub 2015 Apr 21.
PubMed 25898394Shook RP, Hand GA, Paluch AE, Wang X, Moran R, Hebert JR, Lavie CJ, Blair SN. Moderate cardiorespiratory fitness is positively associated with resting metabolic rate in young adults. Mayo Clin Proc. 2014 Jun;89(6):763-71. doi: 10.1016/j.mayocp.2013.12.017. Epub 2014 May 5.
PubMed 24809761
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Energy Balance Study
- ClinicalTrials.gov ID
- NCT01746186
- Acronym / sponsor ID
- Pro00009704
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 10 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study if to determine the specific contributions of energy intake and energy expenditure to changes in body weight and fat.
Detailed description
- Changes in body weight and fat will be positively associated with increases in total energy intake.
- Changes in body weight and fat will be positively associated with decreases in total energy expenditure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 21 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- Currently on medications to lose weight
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Derived from this study: PubMed 32418803Meyer JD, Ellingson LD, Buman MP, Shook RP, Hand GA, Blair SN. Current and 1-Year Psychological and Physical Effects of Replacing Sedentary Time With Time in Other Behaviors. Am J Prev Med. 2020 Jul;59(1):12-20. doi: 10.1016/j.amepre.2020.02.018. Epub 2020 May 14.
- Derived from this study: PubMed 26561620Shook RP, Hand GA, Drenowatz C, Hebert JR, Paluch AE, Blundell JE, Hill JO, Katzmarzyk PT, Church TS, Blair SN. Low levels of physical activity are associated with dysregulation of energy intake and fat mass gain over 1 year. Am J Clin Nutr. 2015 Dec;102(6):1332-8. doi: 10.3945/ajcn.115.115360. Epub 2015 Nov 11.
- Derived from this study: PubMed 25898394Shook RP, Gribben NC, Hand GA, Paluch AE, Welk GJ, Jakicic JM, Hutto B, Burgess S, Blair SN. Subjective Estimation of Physical Activity Using the International Physical Activity Questionnaire Varies by Fitness Level. J Phys Act Health. 2016 Jan;13(1):79-86. doi: 10.1123/jpah.2014-0543. Epub 2015 Apr 21.
- Derived from this study: PubMed 24809761Shook RP, Hand GA, Paluch AE, Wang X, Moran R, Hebert JR, Lavie CJ, Blair SN. Moderate cardiorespiratory fitness is positively associated with resting metabolic rate in young adults. Mayo Clin Proc. 2014 Jun;89(6):763-71. doi: 10.1016/j.mayocp.2013.12.017. Epub 2014 May 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Blair, Ph.D principal investigator
University of South Carolina
Greg Hand, Ph.D principal investigator
University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Energy Expenditure,Total Energy Intake, run by University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01746186, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2023.