HealthyNCT03295578
Blood Glucose, Cognition and Wellbeing @ Work
A study testing Personalized feedback, Generic feedback and Continuous glucose monitoring device in people with Healthy and PreDiabetes, run by TNO at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, PreDiabetes
- What is being tested?
- Personalized feedback, Generic feedback and Continuous glucose monitoring device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteNetherlands
- Study dates
- 2 Oct 2017to 22 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Healthy, PreDiabetes
- Being tested
- Personalized feedback, Generic feedback, Continuous glucose monitoring device
- Keywords
- employees, continuous glucose monitoring, personalized feedback, cognition, wellbeing
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized feedbackOther
Also called personalized feedback report
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.
Generic feedbackOther
Also called Generic feedback report
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.
Continuous glucose monitoring deviceDevice
Also called Abbott FreeStyle Libre Pro
This is not an intervention, but a measurement device used during the study. Added here as intervention to avoid errors in the system.
| Study group | Role | What they receive |
|---|---|---|
| Personalized feedback group | Experimental | 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). Receives: Other: Personalized feedback; Device: Continuous glucose monitoring device |
| General feedback group | Placebo comparator | 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. Receives: Other: Generic feedback; Device: Continuous glucose monitoring device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily glucose levels
measured using a continuous glucose monitoring device
Measured: Continous (sampled every 15 minutes for a duration of 14 days)
Daily food intake
measured using a food intake application
Measured: daily registration of food intake during working hours for a duration of 14 days (during both the two week measurement periods)..
Cognition tests
via Smartphone application. Tests include direct recall, free recall \& delayed recall.
Measured: twice per day (before and after lunch) at working days for a duration of 14 days, during both the two week measurement periods
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'
Measured: 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 (3)
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'.
Measured: baseline and after eight weeks (end of study)
Quantitative user experiences
Self-efficacy towards maintaining a healthy diet and type of motivation to eat healthy
Measured: baseline and after eight weeks (end of study)
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.
Measured: four short surveys (baseline, day 1, after two weeks, after eight weeks) and in focus groups after eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study start2 Oct 2017
- Primary completion17 Nov 2017
- Study completion22 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial with two parallel arms.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- TNO
- Sponsor type
- University, hospital or other
- Collaborators
- Wageningen University and Research, Jumbo Supermarkten Bv., Noldus Information Technology B.V., Google LLC.
- Responsible party
- Principal investigator, Iris de Hoogh, TNO
- Investigators
- Iris M de Hoogh, Msc, Principal investigator, TNO (Netherlands Organization for Applied Scientific Research)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03295578
- Sponsor's protocol ID
- P9663
- Status last verified
- Mar 2020
- First submitted
- 12 Sep 2017
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Glucose Monitoring, Cognition, and Wellbeing in Relation to Food Intake @ Work - a Pilot Study
- ClinicalTrials.gov ID
- NCT03295578
- Acronym / sponsor ID
- P9663
- Conditions
- Healthy, PreDiabetes
- Keywords
- employees, continuous glucose monitoring, personalized feedback, cognition, wellbeing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- TNOUniversity, hospital or other
- Collaborators
- Wageningen University and Research, Jumbo Supermarkten Bv., Noldus Information Technology B.V., Google LLC.
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 17 Nov 2017 (actual)
- Study completion
- 22 Dec 2017 (actual)
- First posted
- 28 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized controlled trial with two parallel arms.
| Arm | Type | Receives |
|---|---|---|
| Personalized feedback group | Experimental | Other: Personalized feedback, Device: Continuous glucose monitoring deviceIn 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). |
| General feedback group | Placebo comparator | Other: Generic feedback, Device: Continuous glucose monitoring deviceThe 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. |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized feedbackAlso: personalized feedback reportThe 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. | Other | Personalized feedback group |
| Generic feedbackAlso: Generic feedback reportThe 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. | Other | General feedback group |
| Continuous glucose monitoring deviceAlso: Abbott FreeStyle Libre ProThis is not an intervention, but a measurement device used during the study. Added here as intervention to avoid errors in the system. | Device | General feedback group, Personalized feedback group |
Primary outcome
Daily glucose levels
Time frame: Continous (sampled every 15 minutes for a duration of 14 days)
measured using a continuous glucose monitoring device
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
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'
3 secondary outcomes
Intention to eat healthy
Time frame: baseline and after eight weeks (end of study)
Quantitative user experiences
Time frame: baseline and after eight weeks (end of study)
Qualitative user experiences
Time frame: four short surveys (baseline, day 1, after two weeks, after eight weeks) and in focus groups after eight weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Individual participant dataSharing planned: No
Related trials for Healthy
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
Recruiting
Effect of a Fermented Dairy Protein With Prebiotic Fiber on GI Complaints
Digestive Health, Quality of Life
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iris M de Hoogh, Msc principal investigator
TNO (Netherlands Organization for Applied Scientific Research)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized feedback, Generic feedback and Continuous glucose monitoring device in people with Healthy and PreDiabetes, run by TNO at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily glucose levels (time frame: Continous (sampled every 15 minutes for a duration of 14 days)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.