Blood Glucose, Cognition and Wellbeing @ Work

NCT03295578 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2020-03-24

No results posted yet for this study

Summary

This randomized controlled pilot study has as a main aim to investigate the relationship between glucose and cognition and wellbeing, as well as food intake in an at-work setting. Additionally, the continuous glucose data collected in the study will be used to investigate the inter- and intraindividual variability in glucose response to foods/meal in a real-life setting.

Finally, the study aims to determine if self-monitoring and feedback about food intake and health stimulate individuals to make healthier choices.

This study will have two groups, the feedback group and the control group. The study will consist of two self-monitoring periods of two weeks. In between these two self-monitoring periods, the participants in the feedback group will be given feedback on their measurement data. The control group will not get any feedback.

Conditions

Interventions

OTHER

Personalized feedback

The personalized feedback report will contain a general explanation about glucose, cognition and wellbeing, healthy cut-offs and/or benchmark values, and why these measures are relevant for personal health and wellbeing. Also, a general explanation will be given about how glucose levels can be influenced. Also, the personalized feedback will contain the individual glucose response profiles, as well as graphs showing the wellbeing scores over time. The registered food intake will be mapped and linked to the glucose and wellbeing profiles. The results of the wellbeing questionnaire will also be shown and will be linked to the individual profiles and food intake.

OTHER

Generic feedback

The generic feedback will contain a generic explanation about glucose, cognition wellbeing and food intake and their relationship. The generic feedback will not include personal results.

DEVICE

Continuous glucose monitoring device

This is not an intervention, but a measurement device used during the study. Added here as intervention to avoid errors in the system.

Sponsors & Collaborators

  • Wageningen University and Research

    collaborator OTHER
  • Jumbo Supermarkten Bv.

    collaborator UNKNOWN
  • Noldus Information Technology B.V.

    collaborator UNKNOWN
  • Google LLC.

    collaborator INDUSTRY
  • TNO

    lead OTHER

Principal Investigators

  • Iris M de Hoogh, Msc · TNO (Netherlands Organization for Applied Scientific Research)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
67 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-02
Primary Completion
2017-11-17
Completion
2017-12-22
FDA Device
Yes

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03295578 on ClinicalTrials.gov