Blood Glucose Monitoring, Cognition, and Wellbeing in Relation to Food Intake @ Work - a Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Daily food intake
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Masking Description
Participants will be assigned to the personalised feedback group or generic feedback group (control) by an independent researcher that is not involved in the study. Assignment will be random and balanced for gender and age. To avoid subjects being aware of the group they are in, both groups will receive some sort of feedback, either generic or personalised. Subjects will be informed that they should not discuss their feedback with other study participants.
Eligibility Criteria
- Ages
- 18 Years to 67 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Personalized feedback group
In between the two measurement periods, the personalized feedback group will receive an explanation and personalized feedback on their self-measured data (interstitial glucose, cognition, wellbeing and food intake).
Intervention: Personalized feedback (Other)
Personalized feedback group
In between the two measurement periods, the personalized feedback group will receive an explanation and personalized feedback on their self-measured data (interstitial glucose, cognition, wellbeing and food intake).
Intervention: Continuous glucose monitoring device (Device)
General feedback group
The generic feedback group will receive a generic explanation about glucose, cognition wellbeing and food intake and their relationship. The generic feedback will not include personal results.
Intervention: Generic feedback (Other)
General feedback group
The generic feedback group will receive a generic explanation about glucose, cognition wellbeing and food intake and their relationship. The generic feedback will not include personal results.
Intervention: Continuous glucose monitoring device (Device)
Outcomes
Primary Outcomes
Daily food intake
Time Frame: daily registration of food intake during working hours for a duration of 14 days (during both the two week measurement periods)..
measured using a food intake application
Daily glucose levels
Time Frame: Continous (sampled every 15 minutes for a duration of 14 days)
measured using a continuous glucose monitoring device
Cognition tests
Time Frame: twice per day (before and after lunch) at working days for a duration of 14 days, during both the two week measurement periods
via Smartphone application. Tests include direct recall, free recall \& delayed recall.
Wellbeing
Time Frame: 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.
via Smartphone application. Includes VAS scales for including five questions for 'feeling energetic - tired, 'feeling focused - distracted', 'feeling positive - negative' , 'feeling motivated - unmotivated' , 'feeling relaxed - stressed'
Secondary Outcomes
- Quantitative user experiences(baseline and after eight weeks (end of study))
- Qualitative user experiences(four short surveys (baseline, day 1, after two weeks, after eight weeks) and in focus groups after eight weeks)
- Intention to eat healthy(baseline and after eight weeks (end of study))
Investigators
Iris de Hoogh
Research Scientist
TNO