Sub-study for the Validation and Calibration of Data Regarding Physical Activity, Anthropometry and Diet

Study Overview
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Brief Summary
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This study was an update and amplification of exposure measurements of the EPIC-Potsdam Study, which started in 1994-1998.

Detailed Description
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The sub-study was conducted in the German Institute of Human Nutrition according to an approved study protocol. The study program included comprehensive surveys on diet and lifestyle (smoking, physical activity, and anthropometry). The aim was to achieve repeated measurements in a sub-cohort of about 600 people to validate (measurement error correction) and calibrate (adjustment of insufficient data collected to the actual data location) existing baseline data in the entire cohort (EPIC-Potsdam cohort). To this end, within age groups and by gender, active EPIC participants were then randomly selected in the years 2009 to 2012 from the cohort, contacted and invited to re-visit the respective study center. 816 subjects were acquired for re-examination, participation rate was 56.4%. Each participant gave informed consent. The study protocol has been approved by the Ethics Committee of the Medical Association of the State of Brandenburg, Cottbus, on 18/12/2009. The information in this section are study hypothesis and contains no results or conclusions.

Official Title
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Sub-study for the Validation and Calibration of Data Regarding Physical Activity, Anthropometry and Diet

Conditions
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Chronic Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants in the EPIC study who meet the following three conditions were eligible for invitation to the re-examination: actively participating in the EPIC-Potsdam follow-up current address in Brandenburg or Berlin phone number known Exclusion Criteria: Not meeting the above stated criteria

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved and more detailed assessment of food intake | Repeated 24 hour dietary recalls. Every participant provided up to three (mean = 2.99) 24 hour dietary recalls at baseline (cross-sectional analysis). The recalls were performed by trained interviewers using EPIC-Soft program and were collected within a period of 4-24 months (mean = 7). The first recall took place in person during the participants' first visit to the study center. The following two recalls took place on random days over the telephone. Food consumption was recorded in 11 eating occasions (before breakfast, breakfast, after breakfast, during morning, lunch, after lunch, during the afternoon, before dinner, dinner, after dinner, during evening) and was recorded for each food in grams per eating occasion. | 4-24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight | In kilograms. For the purpose of achieving improved and more detailed assessment of anthropometric measeures | Appointment at the study center at beginning of study | 
| Skinfold thickness | In millimeters. For the purpose of achieving improved and more detailed assessment of anthropometric measeures | Appointment at the study center at beginning of study | 
| Magnetic resonance imaging (MRT) | The measurements were performed with a 1.5T MRT scanner (Magnetom Avanto, Siemens, Erlangen, Germany) and the Vibe Dixon sequence. The Vibe-Dixon sequence is a special MRT protocol fornbody fat analysis which separates the fat from tissue water. Fat tissue is displayed brightly, while the remaining tissue appears dark. | Within 4 weeks after first visit to the study center | 
| Other anthropometric measures | Height, circumference of hip and waist, depth and width of chest (all in centimeters). For the purpose of achieving improved and more detailed assessment of anthropometric measeures | Appointment at the study center at beginning of study | 
| Physical activity level (PAL) | A heart rate monitor and integrated accelerometer (Actiheart CamNtech, Cambridge, UK) was work for a week of everyday life. The Actiheart software calculated physical activity based on the individual calibration models in the form of Physical Activity Levels, which is the ratio of the total energy expenditure for resting enery expenditure. | 1 week | 
| Physical activity questionnaire | Participants also filled in a questionnaire on physical activity (physical activity during the past 12 months and activities in the last 4 weeks). | 12 months (retrospective questionnaire) |