Healthy Clinical Trial
Official title:
Blood Glucose Monitoring, Cognition, and Wellbeing in Relation to Food Intake @ Work - a Pilot Study
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.
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.
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