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

NCT ID: NCT00943215

Last Updated: 2016-01-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 42 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2015-03-31

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)

Conditions

Excessive Diet Restriction

Study Design

• Observational Model Type: CASE_ONLY

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pennington Biomedical Research Center

OTHER

Sponsor Role: lead

Responsible Party

Eric Ravussin

Princiapal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eric Ravussin, PhD

Role: PRINCIPAL_INVESTIGATOR

Pennington Biomedical Research Center

References

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.

Reference Type: DERIVED

PMID: 28275127 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24500151 (View on PubMed)

Other Identifiers

NIH U01 AG20478

Identifier Type: OTHER

Identifier Source: secondary_id

PBRC 29012

Identifier Type: -

Identifier Source: org_study_id