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Completed

NCT Number: NCT03216161

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

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

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Key information

Conditions

Chronic Disease Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

35 year–64 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Not meeting the above stated criteria

Treatment and study plan

Primary outcomes

  1. Improved and more detailed assessment of food intake

    Time frame: 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 outcomes

  1. Body weight

    Time frame: Appointment at the study center at beginning of study

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

  2. Skinfold thickness

    Time frame: Appointment at the study center at beginning of study

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

  3. Magnetic resonance imaging (MRT)

    Time frame: 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.

  4. Other anthropometric measures

    Time frame: 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

  5. Physical activity level (PAL)

    Time frame: 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.

  6. Physical activity questionnaire

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

German Institute of Human Nutrition

Other

Collaborators

  • German Federal Ministry of Education and Research

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jul 13, 2017
Registry last updated
Oct 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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