Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
81 participants
INTERVENTIONAL
2012-08-31
2014-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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High Energy Flux
Energy Flux Exercise Intervention: 7kcal/kg/day at 5 days/week of energy expenditure and matching energy intake
Energy Flux Exercise Intervention
Comparison of high, medium and low energy flux groups with all groups matching energy intake and expenditure
Medium Energy Flux
Energy Flux Exercise Intervention: 3.5kcal/kg/day at 5 days/week of energy expenditure and matching energy intake
Energy Flux Exercise Intervention
Comparison of high, medium and low energy flux groups with all groups matching energy intake and expenditure
Low Energy Flux
No Intervention: maintain normal lifestyle
No interventions assigned to this group
Interventions
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Energy Flux Exercise Intervention
Comparison of high, medium and low energy flux groups with all groups matching energy intake and expenditure
Eligibility Criteria
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Inclusion Criteria
* 21-45 years of age
* Fasting plasma glucose \<126 mg/dl
* Current medications must have been prescribed for 3 or more months and stable
* Internet access
* Able to participate in a somewhat strenuous physical exercise program
* Able to provide informed consent for participation in a research study
Exclusion Criteria
* Planning to have weight loss surgery
* Weight change \>5 lb in last 12 months
* Currently taking any of the following: hormone replacement therapy, beta blockers, allergy shots or systematic corticosteroids (except inhalers)
* Significant cardiovascular disease or disorders including but not limited to: serious arrhythmias, cardiomyopathy, congestive heart failure, stroke or transient ischemic cerebral attacks, peripheral vascular disease with intermittent claudication, acute, chronic or recurrent thrombophlebitis, Stage II or Stage III hypertension, myocardial infarction or abnormal exercise stress test.
* Medical history with presence of significant conditions or disease that may interfere with study, recent surgery
* Pregnant or actively trying to become pregnant
* Gave birth in the last 12 months or \<6 months post-lactation
* \> 90th percentile on the Brief Symptom Inventory \[BSI\]
* Planning to move from the area in the next 8 months
* Other medical, psychiatric or behavioral factors that in the judgment of the principal investigator may interfere with study participation or the ability ot follow the intervention protocol. Upon identification of individuals with suicidal ideation or other dangerous conditions, the individual will be contacted and told to immediately go to a medical emergency room.
21 Years
45 Years
ALL
Yes
Sponsors
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The Coca-Cola Company
INDUSTRY
University of South Carolina
OTHER
Responsible Party
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Sarah Schumacher
Director
Principal Investigators
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Gregory Hand, Ph.D
Role: PRINCIPAL_INVESTIGATOR
University of South Carolina
Steven Blair, Ph.D
Role: PRINCIPAL_INVESTIGATOR
University of South Carolina
Locations
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Public Health Research Center, University of South Carolina
Columbia, South Carolina, United States
Countries
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Other Identifiers
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Pro00018017
Identifier Type: -
Identifier Source: org_study_id
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