Blood Glucose, Cognition and Wellbeing @ Work

NCT ID: NCT03295578

Last Updated: 2020-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-02
• Study Completion Date: 2017-12-22

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.

Conditions

Healthy; PreDiabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: EXPERIMENTAL

Personalized feedback

Intervention Type: OTHER

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.

Continuous glucose monitoring device

Intervention Type: DEVICE

This is not an intervention, but a measurement device used during the study. Added here as intervention to avoid errors in the system.

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.

Group Type: PLACEBO_COMPARATOR

Generic feedback

Intervention Type: OTHER

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 device

Intervention Type: DEVICE

This is not an intervention, but a measurement device used during the study. Added here as intervention to avoid errors in the system.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

Intervention Type: DEVICE

Other Intervention Names

personalized feedback report; Generic feedback report; Abbott FreeStyle Libre Pro

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 67 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wageningen University and Research

OTHER

Sponsor Role: collaborator

Jumbo Supermarkten Bv.

UNKNOWN

Sponsor Role: collaborator

Noldus Information Technology B.V.

UNKNOWN

Sponsor Role: collaborator

Google LLC.

INDUSTRY

Sponsor Role: collaborator

TNO

OTHER

Sponsor Role: lead

Responsible Party

Iris de Hoogh

Research Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Iris M de Hoogh, Msc

Role: PRINCIPAL_INVESTIGATOR

TNO (Netherlands Organization for Applied Scientific Research)

Locations

Jumbo Supermarkten BV.

Veghel, North Brabant, Netherlands

Countries

Netherlands

Other Identifiers

P9663

Identifier Type: -

Identifier Source: org_study_id