Clinical trial NCT00943215: How Participants Behave and Respond on Their Own After Completing a 2-year Intervention of Calorie Restriction
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Excessive Diet Restriction
Keywords: CALERIE II Follow-up
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2009-07-22
Enrollment: 42
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants that completeded the CALERIE II study at 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)

Eligibility criteria: 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.

Primary outcomes:
measure: Calorie Restriction
timeFrame: 2-year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pennington Biomedical Research Center
name: Eric Ravussin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marlatt KL, Redman LM, Burton JH, Martin CK, Ravussin E. Persistence of weight loss and acquired behaviors 2 y after stopping a 2-y calorie restriction intervention. Am J Clin Nutr. 2017 Apr;105(4):928-935. doi: 10.3945/ajcn.116.146837. Epub 2017 Mar 8.
citation: Lam YY, Redman LM, Smith SR, Bray GA, Greenway FL, Johannsen D, Ravussin E. Determinants of sedentary 24-h energy expenditure: equations for energy prescription and adjustment in a respiratory chamber. Am J Clin Nutr. 2014 Apr;99(4):834-42. doi: 10.3945/ajcn.113.079566. Epub 2014 Feb 5.