NCT03216161

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
816

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2010

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

June 23, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 13, 2017

Completed
Last Updated

October 24, 2017

Status Verified

October 1, 2017

Enrollment Period

2.3 years

First QC Date

June 23, 2017

Last Update Submit

October 23, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Body weight

    Appointment at the study center at beginning of study

  • Skinfold thickness

    Appointment at the study center at beginning of study

  • Magnetic resonance imaging (MRT)

    Within 4 weeks after first visit to the study center

  • Other anthropometric measures

    Appointment at the study center at beginning of study

  • Physical activity level (PAL)

    1 week

  • +1 more secondary outcomes

Eligibility Criteria

Age35 Years - 64 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsPotential participants were drawn from the cohort study population in the EPIC-Potsdam Study based on a gender- and age-stratified random sample and invited successively. First stage: gender (male / female, 300 each) Second stage: the age at recruitment to EPIC Potsdam (35-44y/ 45-54y/ 55-64; 100 each)
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • Not meeting the above stated criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 24626110BACKGROUND
  • 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.

    PMID: 24642812BACKGROUND

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Department of Epidemiology

Study Record Dates

First Submitted

June 23, 2017

First Posted

July 13, 2017

Study Start

August 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

October 24, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share