Blood Glucose, Cognition and Wellbeing @ Work
Primary Purpose
Healthy, PreDiabetes
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Personalized feedback
Generic feedback
Continuous glucose monitoring device
Sponsored by
About this trial
This is an interventional prevention trial for Healthy focused on measuring employees, continuous glucose monitoring, personalized feedback, cognition, 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
Sites / Locations
- Jumbo Supermarkten BV.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Personalized feedback group
General feedback group
Arm Description
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).
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.
Outcomes
Primary Outcome Measures
Daily glucose levels
measured using a continuous glucose monitoring device
Daily food intake
measured using a food intake application
Cognition tests
via Smartphone application. Tests include direct recall, free recall & delayed recall.
Wellbeing
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 Outcome Measures
Intention to eat healthy
measured with three items 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'.
Quantitative user experiences
Self-efficacy towards maintaining a healthy diet and type of motivation to eat healthy
Qualitative user experiences
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.
Full Information
NCT ID
NCT03295578
First Posted
September 12, 2017
Last Updated
March 23, 2020
Sponsor
TNO
Collaborators
Wageningen University and Research, Jumbo Supermarkten Bv., Noldus Information Technology B.V., Google LLC.
1. Study Identification
Unique Protocol Identification Number
NCT03295578
Brief Title
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
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
October 2, 2017 (Actual)
Primary Completion Date
November 17, 2017 (Actual)
Study Completion Date
December 22, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
TNO
Collaborators
Wageningen University and Research, Jumbo Supermarkten Bv., Noldus Information Technology B.V., Google LLC.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, PreDiabetes
Keywords
employees, continuous glucose monitoring, personalized feedback, cognition, wellbeing
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial with two parallel arms.
Masking
ParticipantInvestigator
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.
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Personalized feedback group
Arm Type
Experimental
Arm Description
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).
Arm Title
General feedback group
Arm Type
Placebo Comparator
Arm Description
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 Type
Other
Intervention Name(s)
Personalized feedback
Other Intervention Name(s)
personalized feedback report
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Generic feedback
Other Intervention Name(s)
Generic feedback report
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Continuous glucose monitoring device
Other Intervention Name(s)
Abbott FreeStyle Libre Pro
Intervention Description
This is not an intervention, but a measurement device used during the study. Added here as intervention to avoid errors in the system.
Primary Outcome Measure Information:
Title
Daily glucose levels
Description
measured using a continuous glucose monitoring device
Time Frame
Continous (sampled every 15 minutes for a duration of 14 days)
Title
Daily food intake
Description
measured using a food intake application
Time Frame
daily registration of food intake during working hours for a duration of 14 days (during both the two week measurement periods)..
Title
Cognition tests
Description
via Smartphone application. Tests include direct recall, free recall & delayed recall.
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
Title
Wellbeing
Description
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'
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.
Secondary Outcome Measure Information:
Title
Intention to eat healthy
Description
measured with three items 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'.
Time Frame
baseline and after eight weeks (end of study)
Title
Quantitative user experiences
Description
Self-efficacy towards maintaining a healthy diet and type of motivation to eat healthy
Time Frame
baseline and after eight weeks (end of study)
Title
Qualitative user experiences
Description
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.
Time Frame
four short surveys (baseline, day 1, after two weeks, after eight weeks) and in focus groups after eight weeks
Other Pre-specified Outcome Measures:
Title
Focus on future consequences
Description
validated questionnaire from Joireman et al (2012). Output will be used as input for formulating the personalized feedback
Time Frame
baseline
Title
Subjective health
Description
• Subjective health is measured with two items that are rated on seven-point scales from 'very unhealthy' (1) to 'very healthy' (7).
Time Frame
Baseline and after eight weeks (end of study)
Title
Eating habits (at the workplace)
Description
mapped via a questionnaire, concerning how often one eats breakfast and snacks, how often one eats in the company restaurant at work, how often one brings their own lunch or buys their lunch, how often one goes on lunch walks etc.
Time Frame
Baseline and after eight weeks (end of study)
Title
Physical activity
Description
the Dutch Norm for Healthy Physical Activity.
Time Frame
Baseline and after eight weeks (end of study)
Title
BMI
Description
calculated based on self-reported height and weight
Time Frame
Baseline and after eight weeks (end of study)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iris M de Hoogh, Msc
Organizational Affiliation
TNO (Netherlands Organization for Applied Scientific Research)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jumbo Supermarkten BV.
City
Veghel
State/Province
Noord-Brabant
ZIP/Postal Code
5462 CE
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
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Blood Glucose, Cognition and Wellbeing @ Work
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