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

Chronic Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03216161
• Other study ID #: 01ER0808
• Status: Completed
• Phase: N/A
• First received: June 23, 2017
• Last updated: October 23, 2017
• Start date: August 2010
• Est. completion date: December 2012

Study information

• Verified date: October 2017
• Source: German Institute of Human Nutrition
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 816
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
German Institute of Human Nutrition	German Federal Ministry of Education and Research

References & Publications (2)

Neamat-Allah J, Wald D, Hüsing A, Teucher B, Wendt A, Delorme S, Dinkel J, Vigl M, Bergmann MM, Feller S, Hierholzer J, Boeing H, Kaaks R. Validation of anthropometric indices of adiposity against whole-body magnetic resonance imaging--a study within the German European Prospective Investigation into Cancer and Nutrition (EPIC) cohorts. PLoS One. 2014 Mar 13;9(3):e91586. doi: 10.1371/journal.pone.0091586. eCollection 2014. — View Citation

Wientzek A, Vigl M, Steindorf K, Brühmann B, Bergmann MM, Harttig U, Katzke V, Kaaks R, Boeing H. The improved physical activity index for measuring physical activity in EPIC Germany. PLoS One. 2014 Mar 18;9(3):e92005. doi: 10.1371/journal.pone.0092005. eCollection 2014. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)