Blood Glucose, Cognition and Wellbeing @ Work
Condition: Healthy; PreDiabetes
MeSH terms: Prediabetic State
Study type: Interventional

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.
    

Detailed description: 
      Many people in the Western world have an unhealthy lifestyle, including an unhealthy dietary
      pattern. Numerous approaches have been taken to stimulate people to maintain a more healthy
      diet, but results are highly variable across studies and subjects. One explanation for this
      is that in many approaches the individuals' specific needs and the context they live and work
      in are not sufficiently taken into account. For an approach to be more effective, personal
      characteristics need to be taken into account. In other words, the approach needs to be
      tailored or personalised. When focussing on personalized nutrition and health in the work
      environment, the aspects of health that are included in the study should also be relevant for
      the work environment. Three main parameters of interest are selected: (postprandial) blood
      glucose levels, cognition and (subjective) wellbeing.

      Objective:

      The primary objective of this pilot study is to investigate the relationship between glucose
      and cognition and wellbeing, as well as food intake in an at-work setting.

      Secondary objectives are :1) Does self-monitoring and feedback about food intake and health
      stimulate individuals to make healthier choices? 2) What are the user experiences of
      employees to perform self-monitoring of and receive feedback on, glucose, wellbeing and
      cognition in the workplace?

      Study design:

      This study will be designed as a randomized controlled trial with 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.

      Study population:

      Forty participants, both men and women, will be recruited from the staff at the head-quarters
      of Jumbo supermarkets in Veghel. Inclusion criteria are presence at head-quarters for at
      least 4 days per week and frequent visitors of the company lunch restaurant. Exclusion
      criteria are shift work, diabetic patients, neurological or psychiatric complaints and
      specific food-related allergies.

      Intervention:

      The intervention consists of standardized meals and personalized feedback. During the first
      two-week measurement period study participants will be asked to consume standardized lunches
      at work days in the company restaurant. In between the two measurement periods, the feedback
      group will receive personalized feedback on their self-measured data (interstitial glucose,
      cognition, wellbeing, and food intake). At the end of the second measurement period both the
      feedback group and the control group will receive a personalized feedback form, including a
      debriefing about the study.

      Main study parameters/endpoints:

      Primary endpoints are self-monitored daily food intake, glucose levels, cognitive
      performance, and wellbeing.
    

Intervention name(s): Personalized feedback; Generic feedback; Continuous glucose monitoring device
Intervention type(s): Other; Other; Device
Intervention description(s): 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.; 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.; This is not an intervention, but a measurement device used during the study. Added here as intervention to avoid errors in the system.
Other intervention name(s): personalized feedback report; Generic feedback report; Abbott FreeStyle Libre Pro
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial with two parallel arms.
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: employees; continuous glucose monitoring; personalized feedback; cognition; wellbeing