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Chronic DiseaseNCT03216161

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

An observational study of Chronic Disease, run by German Institute of Human Nutrition.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 35 to 64 years
Conditions the study is for
Chronic Disease
How many people
816 participants
Where
No sites listed yet
Study dates
Aug 2010to Dec 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

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.

Who may be able to join

  • 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

Who cannot join

  • Not meeting the above stated criteria

About this study

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

Read the 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.

Conditions
Chronic Disease
Medical subject headings
Chronic Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 4-24 months

Secondary outcomes (6)

  1. Body weight

    In kilograms. For the purpose of achieving improved and more detailed assessment of anthropometric measeures

    Measured: Appointment at the study center at beginning of study

  2. Skinfold thickness

    In millimeters. For the purpose of achieving improved and more detailed assessment of anthropometric measeures

    Measured: Appointment at the study center at beginning of study

  3. 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.

    Measured: Within 4 weeks after first visit to the study center

  4. 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

    Measured: Appointment at the study center at beginning of study

  5. 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.

    Measured: 1 week

  6. 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).

    Measured: 12 months (retrospective questionnaire)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2017
  2. Study startAug 2010
  3. Primary completionDec 2012
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
816 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03216161
Sponsor's protocol ID
01ER0808
Status last verified
Oct 2017
First submitted
23 Jun 2017
Last updated
24 Oct 2017
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 24626110

  • 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.

    PubMed 24642812

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Disease, run by German Institute of Human Nutrition.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improved and more detailed assessment of food intake (time frame: 4-24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03216161, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2017.

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