NCT00943215

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.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 42 (actual)
• Sponsor: Pennington Biomedical Research Center · Academic / Other
• Sex: All
• Age: 21 Years – 50 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Excessive Diet Restriction

Timeline

• Start date: 2009-07-01
• Primary completion: 2015-02-01
• Completion: 2015-03-01
• First posted: 2009-07-22
• Last updated: 2016-01-14