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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00943215

Acronym

CALERIE2-FU

Enrollment

Registered

2009-07-22

Start date

2009-07-31

Completion date

2015-03-31

Last updated

2016-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Excessive Diet Restriction

Keywords

CALERIE II Follow-up

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)

Interventions

None listed

Study design

Observational model

CASE_ONLY

Eligibility

Sex/Gender

ALL

Age

21 Years to 50 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Outcome results