Sub-study for the Validation and Calibration of Data Regarding Physical Activity, Anthropometry and Diet
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 816
- Primary Endpoint
- Improved and more detailed assessment of food intake
Study Overview
Brief Summary
This study was an update and amplification of exposure measurements of the EPIC-Potsdam Study, which started in 1994-1998.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 35 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Improved and more detailed assessment of food intake
Time Frame: 4-24 months
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.
Secondary Outcomes
- Physical activity level (PAL)(1 week)
- Skinfold thickness(Appointment at the study center at beginning of study)
- Physical activity questionnaire(12 months (retrospective questionnaire))
- Other anthropometric measures(Appointment at the study center at beginning of study)
- Body weight(Appointment at the study center at beginning of study)
- Magnetic resonance imaging (MRT)(Within 4 weeks after first visit to the study center)
Investigators
Heiner Boeing
Head of the Department of Epidemiology
German Institute of Human Nutrition