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Clinical Trials/NCT00943215
NCT00943215
Completed
Not Applicable

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.

Pennington Biomedical Research Center0 sites42 target enrollmentJuly 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Excessive Diet Restriction
Sponsor
Pennington Biomedical Research Center
Enrollment
42
Primary Endpoint
Calorie Restriction
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

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.

Detailed Description

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)

Registry
clinicaltrials.gov
Start Date
July 2009
End Date
March 2015
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Eric Ravussin

Princiapal Investigator

Pennington Biomedical Research Center

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Calorie Restriction

Time Frame: 2-year

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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