Clinical trial NCT03295578: Blood Glucose, Cognition and Wellbeing @ Work
Official title: Blood Glucose Monitoring, Cognition, and Wellbeing in Relation to Food Intake @ Work - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
PreDiabetes
Keywords: employees
continuous glucose monitoring
personalized feedback
cognition
wellbeing
Lead sponsor: TNO
Sponsor class: OTHER
Collaborators: name: Wageningen University and Research
name: Jumbo Supermarkten Bv.
name: Noldus Information Technology B.V.
name: Google LLC.
First posted: 2017-09-28
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial with two parallel arms.
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 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), with a minimum of three times per week
* Having giving written informed consent
* Willing to comply with all study procedures

Exclusion Criteria:

* 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

Primary outcomes:
measure: Daily glucose levels
timeFrame: Continous (sampled every 15 minutes for a duration of 14 days)
measure: Daily food intake
timeFrame: daily registration of food intake during working hours for a duration of 14 days (during both the two week measurement periods)..
measure: Cognition tests
timeFrame: twice per day (before and after lunch) at working days for a duration of 14 days, during both the two week measurement periods
measure: Wellbeing
timeFrame: 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 for two times 14 days.
Secondary outcomes:
measure: Intention to eat healthy
timeFrame: baseline and after eight weeks (end of study)
measure: Quantitative user experiences
timeFrame: baseline and after eight weeks (end of study)
measure: Qualitative user experiences
timeFrame: four short surveys (baseline, day 1, after two weeks, after eight weeks) and in focus groups after eight weeks
Other outcomes:
measure: Focus on future consequences
timeFrame: baseline
measure: Subjective health
timeFrame: Baseline and after eight weeks (end of study)
measure: Eating habits (at the workplace)
timeFrame: Baseline and after eight weeks (end of study)
measure: Physical activity
timeFrame: Baseline and after eight weeks (end of study)
measure: BMI
timeFrame: Baseline and after eight weeks (end of study)
Locations:
city: Veghel
country: Netherlands
facility: Jumbo Supermarkten BV.
state: Noord-Brabant
Study officials:
affiliation: TNO (Netherlands Organization for Applied Scientific Research)
name: Iris M de Hoogh, Msc
role: PRINCIPAL_INVESTIGATOR
References: