Clinical trial NCT03216161: Sub-study for the Validation and Calibration of Data Regarding Physical Activity, Anthropometry and Diet
Official title: Sub-study for the Validation and Calibration of Data Regarding Physical Activity, Anthropometry and Diet
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Disease
Lead sponsor: German Institute of Human Nutrition
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2017-07-13
Enrollment: 816
Sex: ALL
Minimum age (years): 35
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Participants of the EPIC-Potsdam cohort study were 35-64 years old at recruitment (1994-1998). For this study (re-examination 2010-2012), participants were 47-81 years old (mean age 65.5, were largely sedentary and with a mean BMI of 27.5 kg/m2). Participants were living in the state of Brandenburg or in Berlin, Germany.

The information in this section are study hypothesis and contains no results or conclusions.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Improved and more detailed assessment of food intake
timeFrame: 4-24 months
Secondary outcomes:
measure: Body weight
timeFrame: Appointment at the study center at beginning of study
measure: Skinfold thickness
timeFrame: Appointment at the study center at beginning of study
measure: Magnetic resonance imaging (MRT)
timeFrame: Within 4 weeks after first visit to the study center
measure: Other anthropometric measures
timeFrame: Appointment at the study center at beginning of study
measure: Physical activity level (PAL)
timeFrame: 1 week
measure: Physical activity questionnaire
timeFrame: 12 months (retrospective questionnaire)
Other outcomes:
Locations:
Study officials:
References:
citation: Neamat-Allah J, Wald D, Husing 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.
citation: Wientzek A, Vigl M, Steindorf K, Bruhmann 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.