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

Excessive Diet Restriction Clinical Trial

— CALERIE2-FU  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00943215
• Other study ID #: PBRC 29012
• Secondary ID: NIH U01 AG20478
• Status: Completed
• Phase: N/A
• First received: July 20, 2009
• Last updated: January 13, 2016
• Start date: July 2009
• Est. completion date: March 2015

Study information

• Verified date: January 2016
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: March 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 50 Years

Eligibility

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

Observational Model: Case-Only

Related Conditions & MeSH terms

• Excessive Diet Restriction

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calorie Restriction	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.	2-year	No