How Participants Behave and Respond on Their Own After Completing a 2-year Intervention of Calorie Restriction (CALERIE2-FU)

January 13, 2016 updated by: Eric Ravussin, Pennington Biomedical Research Center

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

42

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pennington Biomedical Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

July 20, 2009

First Submitted That Met QC Criteria

July 21, 2009

First Posted (Estimate)

July 22, 2009

Study Record Updates

Last Update Posted (Estimate)

January 14, 2016

Last Update Submitted That Met QC Criteria

January 13, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PBRC 29012
  • NIH U01 AG20478 (Other Identifier: NIA)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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