Blood Glucose, Cognition and Wellbeing @ Work

Healthy Clinical Trial

Official title:

Blood Glucose Monitoring, Cognition, and Wellbeing in Relation to Food Intake @ Work - a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03295578
• Other study ID #: P9663
• Status: Completed
• Phase: N/A
• Start date: October 2, 2017
• Est. completion date: December 22, 2017

Study information

• Verified date: March 2020
• Source: TNO
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 22, 2017
• Est. primary completion date: November 17, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 67 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• PreDiabetes
• Prediabetic State

Intervention

Other:
• Personalized feedback
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 feedback
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.

Device:
• Continuous glucose monitoring device
This is not an intervention, but a measurement device used during the study. Added here as intervention to avoid errors in the system.

Locations

Country	Name	City	State
Netherlands	Jumbo Supermarkten BV.	Veghel	Noord-Brabant

Sponsors (5)

Lead Sponsor	Collaborator
TNO	Google Inc., Jumbo Supermarkten Bv., Noldus Information Technology B.V., Wageningen University and Research

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Focus on future consequences	validated questionnaire from Joireman et al (2012). Output will be used as input for formulating the personalized feedback	baseline
Other	Subjective health	• Subjective health is measured with two items that are rated on seven-point scales from 'very unhealthy' (1) to 'very healthy' (7).	Baseline and after eight weeks (end of study)
Other	Eating habits (at the workplace)	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.	Baseline and after eight weeks (end of study)
Other	Physical activity	the Dutch Norm for Healthy Physical Activity.	Baseline and after eight weeks (end of study)
Other	BMI	calculated based on self-reported height and weight	Baseline and after eight weeks (end of study)
Primary	Daily glucose levels	measured using a continuous glucose monitoring device	Continous (sampled every 15 minutes for a duration of 14 days)
Primary	Daily food intake	measured using a food intake application	daily registration of food intake during working hours for a duration of 14 days (during both the two week measurement periods)..
Primary	Cognition tests	via Smartphone application. Tests include direct recall, free recall & delayed recall.	twice per day (before and after lunch) at working days for a duration of 14 days, during both the two week measurement periods
Primary	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'	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	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'.	baseline and after eight weeks (end of study)
Secondary	Quantitative user experiences	Self-efficacy towards maintaining a healthy diet and type of motivation to eat healthy	baseline and after eight weeks (end of study)
Secondary	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.	four short surveys (baseline, day 1, after two weeks, after eight weeks) and in focus groups after eight weeks