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

Completed

• Conditions: Chronic Disease

• Registration Number: NCT03216161
• Lead Sponsor: German Institute of Human Nutrition

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 Timeline

• Study Start: 2010-08
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Study First Submitted: 2017-06-23
• Study First Submitted QC: 2017-07-10
• Study First Posted: 2017-07-13
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-23
• Last Update Posted: 2017-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 816

Inclusion Criteria

• Participants in the EPIC study who meet the following three conditions were eligible for invitation to the re-examination:

  1. actively participating in the EPIC-Potsdam follow-up
  2. current address in Brandenburg or Berlin
  3. phone number known

Exclusion Criteria

• Not meeting the above stated criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improved and more detailed assessment of food intake	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 Outcome Measures

Name	Time	Method
Physical activity level (PAL)	1 week	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.
Skinfold thickness	Appointment at the study center at beginning of study	In millimeters. For the purpose of achieving improved and more detailed assessment of anthropometric measeures
Physical activity questionnaire	12 months (retrospective questionnaire)	Participants also filled in a questionnaire on physical activity (physical activity during the past 12 months and activities in the last 4 weeks).
Other anthropometric measures	Appointment at the study center at beginning of study	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
Body weight	Appointment at the study center at beginning of study	In kilograms. For the purpose of achieving improved and more detailed assessment of anthropometric measeures
Magnetic resonance imaging (MRT)	Within 4 weeks after first visit to the study center	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.