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How Participants Behave and Respond on Their Own After Completing a 2-year Intervention of Calorie Restriction

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Eric Ravussin, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT00943215
First received: July 20, 2009
Last updated: August 8, 2014
Last verified: August 2014

July 20, 2009
August 8, 2014
July 2009
February 2015   (final data collection date for primary outcome measure)
Calorie Restriction [ Time Frame: 2-year ] [ Designated as safety issue: No ]
The purpose of this study is to gain knowledge about how participants behave and respond on their own after completing a 2-year intervention of calorie restriction.
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Complete list of historical versions of study NCT00943215 on ClinicalTrials.gov Archive Site
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How Participants Behave and Respond on Their Own After Completing a 2-year Intervention of Calorie Restriction
The Proposed Study Entails a Follow-up of All the Completers for 2 Years With Visits Timed 3, 6, 12 and 24 Months After Completion of the 2-year CALERIE II Intervention.

The purpose of this study is to gain knowledge about how participants behave and respond on their own after completing a 2-year intervention of calorie restriction.

You will not be assigned to any particular group during the Follow-Up Study. In the Follow-Up study there is no diet intervention. You will not be asked to follow a calorie-restricted diet or any other diet.

Month 3 and Month 6 (Outpatient Visits)following procedures performed:

  • Blood pressure, heart rate, temperature, Weight & Waist Measurement
  • Medication and medical history
  • Blood draw (approximately ½ cup)
  • DEXA and QuickScan
  • Psychological assessment questionnaires reviewed for completeness
  • Body Acceptability Morph Test (BAM)
  • Review of 7-day food diary

Month 12 and Month 24 (Outpatient Visits) procedures performed:

  • Collection of 4 urine samples
  • Dosing with doubly labeled water (DLW)
  • DEXA and QuickScan
  • Eat breakfast and lunch
  • Receive 7-day food diary
  • Psychological assessment questionnaires
  • Body Acceptability Morph Test (BAM)

Fourteen days after Month 12 and Month 24 (Overnight Inpatient Visits) following procedures performed:

  • Collection of 2 urine samples
  • Blood pressure, heart rate, temperature, Weight & Waist Measurement
  • Blood draw (approximately ½ cup)
  • Medication and medical history
  • Review of 7-day food diary
  • Metabolic Chamber
  • Resting Metabolic Rate (RMR)
Observational
Observational Model: Case-Only
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Non-Probability Sample

Participants that completeded the CALERIE II study at Pennington Biomedical Research Center.

Caloric Restriction
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Lam YY, Redman LM, Smith SR, Bray GA, Greenway FL, Johannsen D, Ravussin E. Determinants of sedentary 24-h energy expenditure: equations for energy prescription and adjustment in a respiratory chamber. Am J Clin Nutr. 2014 Apr;99(4):834-42. doi: 10.3945/ajcn.113.079566. Epub 2014 Feb 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
65
March 2015
February 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • You may qualify to participate in this study only if you completed the CALERIE II study at Pennington Biomedical Research Center.

Exclusion Criteria:

  • If you were not a participant in CALERIE II at Pennington Biomedical Research Center, you are ineligible.
Both
21 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00943215
29012 CALERIE II 2y Follow-Up, NIA U01 AG20478
No
Eric Ravussin, Pennington Biomedical Research Center
Pennington Biomedical Research Center
Not Provided
Principal Investigator: Eric Ravussin, PhD Pennington Biomedical Research Center
Pennington Biomedical Research Center
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP