The primary objective of this pilot study is to investigate the relationship between glucose and cognition and wellbeing in an at-work setting. Additionally, this study aims to investigate the variability in intra- and inter individual glucose…
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Health condition
algemeen welbevinden en gezondheid
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main outcome of this study is how food intake, glucose-levels, cognition
and wellbeing of employees in the office relate to each other. With *daily*
only week days, when employees are at the office, are meant. Participants are
not required to do any measurements in the weekends.
* Daily food intake: this will be monitored with a food intake application
(FatSecret) that can be accessed via smart phone or desktop. FatSecret converts
selected food items into energy and macronutrients. Respondents are asked to
keep track of their breakfast and food intake during working hours (incl.
drinks).
* Daily glucose levels: daily glucose levels will be monitored using a
continuous glucose monitoring device. Either the flash glucose monitoring
system from FreeStyle® Libre* (FSL) or the Dexcom Continuous Glucose Monitor
will be used. The choice will be made dependent on availability for the study.
Both devices are factory-calibrated interstitial glucose monitoring systems,
intended to be used instead of self-monitored blood glucose (Feldman et al.,
2003). The FSL or Dexcom sensor is placed on the skin (often upper arm) with a
small cannula inserted in the interstitial fluid. A single sensor can measure
glucose every 15 minutes for up to 14 days. Local storage is up to multiple
hours but the sensor can be 'read' with a device that is held close to the
sensor to obtain the data. The FSL and Dexcom sensor have been demonstrated to
be feasible in human subjects, including individuals with diabetes I and
provide an accurate estimation of blood glucose (Luijf et al. 2013; Bonora et
al., 2016). Parameters obtained from the glucose sensor will be:
o Fasting glucose levels (e.g. in the morning after 8 hours of fasting,
based on food intake reports)
o Glucose response profiles / postprandial glucose levels (peak, slopes,
area under the curve).
* Daily cognition tests: 5-minute cognition tests will be offered twice per day
(before lunch and one hour after lunch) via an online test platform. The tests
are designed to assess specific aspects of memory, including working memory and
memory recall. The specific tests include:
o Direct recall & delayed recall (1 minute): a task in which
participants are presented with a random list of 10 items (out of a possible
500 items) for 20 seconds (i.e. a shopping list) and afterwards they are asked
to write down the items that they remember from the list (immediate recall).
After doing another cognitive task (see below) they are again asked to write
down the items that they remembered from the list (delayed recall). This task
has previously been shown to be sensitive to macronutrient manipulation
(Hoyland et al., 2008). For each recall task the number of correct and
incorrect answers is scored.
o Free recall: out of the 26 letters of the alphabet 10 will be
randomly selected and presented to the participant in a stream (e.g. 0,5 sec
per letter). The participant gets 20-30 sec to enter the presented letters in
the right order. The number of correct and incorrect answers is scored.
* Wellbeing: this will be measured via visual analogue scales (VAS) /
ecological momentary assessment (EMA) questionnaire (smartphone), including
five questions for *feeling energetic - tired, *feeling focused * distracted*,
*feeling positive * negative* , *feeling motivated * unmotivated* , *feeling
relaxed * stressed*. Filling in takes max. 30 seconds.
This questionnaire will be administered five times per day; two times in the
morning, once five minutes before lunch (before with cognition test), once one
hour after lunch (before cognition test) and once in the afternoon.
Secondary outcome
The secondary study parameters include social-psychological concepts as well as
user evaluations. These will be measured mostly via questionnaires.
* Intention to eat healthy. It will be measured with three items (based on
Poínhos et al., 2014; Ajzen, 1991; Oliver et al., 1997; Melnyk et al., 2011)
that are rated on seven-point scales from totally disagree (1) to totally agree
(7). The items are *I*m planning on eating healthy*, *I would consider to eat
healthy* and *I*m absolutely going to eat healthy*.
* User experiences: user experiences will be measured in two ways,
quantitatively (sef-efficacy and type of motivation) and qualitatively.
o Quantitative: Self-efficacy towards maintaining a healthy diet (Glynn &
Ruderman, 1986) and type of motivation to eat healthy (intrinsic/extrinsic;
Williams, Ryan & Deci, 1996) will be measured at baseline and end. Previous
research shows that self-efficacy and intrinsic motivation are predictors of
healthy diets. Self-efficacy will most likely decrease during the study. Adding
external rewards can transform intrinsic motivation into extrinsic motivation.
o Qualitative assessment: measuring user experiences in four short
surveys (baseline, day 1, in between, end) and in focus groups at the end of
the study. Overall the survey includes self-constructed scales that measure
user experience with the research in general, self-monitoring devices and
personal feedback. Focus groups are needed to understand the reasoning behind
the answers that employees give in the surveys and to validate initial analysis
of the survey.
Background summary
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.
The proposed research is part of a research program on Personalized Nutrition
and Health (PNH). The ultimate goal of the program is to enhance the health and
wellbeing of people by empowering consumers to choose and maintain an optimal
personalized diet and lifestyle.
Study objective
The primary objective of this pilot study is to investigate the relationship
between glucose and cognition and wellbeing in an at-work setting.
Additionally, this study aims to investigate the variability in intra- and
inter individual glucose responses to a certain food product or meal.
Secondary Objective(s):
- Does self-monitoring and feedback about food intake and wellbeing stimulate
individuals to make healthier choices?
- What are the user experiences of employees to perform self-monitoring of and
receive feedback on, glucose, wellbeing, food intake 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. During the trial both groups will
self-monitor their glucose levels (using a continuous glucose monitor),
cognition (via online cognition tests) and their food intake and wellbeing (via
a Smartphone app).
The feedback group will be provided with a personal feedback report on their
collected data. The control group will do all measurements but will not get a
feedback report.
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 participants in the control
group will not get any feedback on their data. The control group is required to
see if only measuring is already causing an effect, and if providing feedback
on data has added value to participants.
At baseline (before the start of the first self-monitoring period), after the
first day of measuring, between the two self-monitoring periods and at the end
of the study, questionnaires will be administered. At the end of the study also
two focus groups will be organized to gather more in-depth experiences of study
participants.
At the end of the study (after the focus groups), both the feedback and the
control group will be debriefed and provided with a feedback report on their
personal data. Participants that do not take part in a focus group will be
provided with the debrief and feedback report via email.
Intervention
The intervention consists of standardized meals during lunch, and personalized
feedback.
Participants will be asked to consume standardized lunches at work days in the
company restaurant at working days. These lunches will consist of food products
that are regularly available at the company restaurant of the Jumbo
headquarters in Veghel. All lunches will be offered at least twice to each
participants, and the lunches will vary in macronutrient composition (e.g.
sandwich lunch, salad lunch, warm meal). This will enable comparison of blood
glucose responses with different types of meals between participants and within
participants. During the second two-week measurement period study participants
are free in their lunch choice in the company restaurant. Participants will be
asked to register their food choice and take a picture of their lunch.
In between the two measurement periods, the feedback group will receive
personalized feedback on their self-measured data. 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.
The personalized feedback 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 cognition test will also be shown as a mean score and will be
linked to the individual profiles and food intake.
Once the content of the personalised feedback is defined, the communication
form can be further aligned with personal socio-psychological characteristics.
Literature shows that individuals differ intheir "Consideration of Future
Consequences (CFC), i.e. whether they focus more on immediate or future
outcomes. Individuals with a low score on CFC were more persuaded when positive
consequences were short term and negative consequences were long term. The
opposite was true for individuals with a high score on CFC. In this study we
will use CFC to give either feedback with a focus on the future (e.g. your food
choices ensure low risk of physical health problems in the future) or a focus
on the present (e.g. your food choices give you energy to perform during the
day), based on their responses.
Furthermore there are other points that we will consider when formulating the
feedback, including mentioning benefits, gain vs. pain-framing, etc.
Study burden and risks
The risks associated with participation can be considered negligible and the
burden can be considered minimal. Glucose levels will be measured using a
validated, commercially available minimally invasive glucose monitoring sensor.
This sensor will be worn during each of the two two-week self-monitoring
periods. Benefits include that participants learn to associate their daily food
intake with glucose levels and with indicators of wellbeing and cognitive
performance at their work place.
Nieuwe Kanaal 9a
Wageningen 6709PA
NL
Nieuwe Kanaal 9a
Wageningen 6709PA
NL
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Inclusion criteria
In order to be eligible to participate in this study, a subject:
* Must be present at Jumbo head-quarters during lunch at least four days/week and have access to their computer for one hour after lunch during the two 2-week self-monitoring periods.
* Must be frequent visitors of the company lunch restaurant (Jumbo food Café) (three or more times per week).
* Having giving written informed consent.
* Willing to comply with all study procedures.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
* Shift workers
* Diabetes type 2 patients
* Under treatment for neurological or psychiatric complaints, including eating disorders
* Specific dietary preferences, including vegan, raw food, paleo. Vegetarian, pescetarians and flexitarians can participate in the study.
* Allergies or intolerances, including coeliac disease, gluten intolerance, lactose intolerance, milk protein allergy
* Skin allergy or eczema
Design
Recruitment
Medical products/devices used
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In other registers
| Register | ID |
|---|---|
| CCMO | NL61725.028.17 |