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

Completed

• Conditions: Excessive Diet Restriction

• Registration Number: NCT00943215
• Lead Sponsor: Pennington Biomedical Research Center

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)

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-20
• Study First Submitted QC: 2009-07-21
• Study First Posted: 2009-07-22
• Primary Completion: 2015-02
• Study Completion: 2015-03
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-13
• Last Update Posted: 2016-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Calorie Restriction	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.