Blood Glucose, Cognition and Wellbeing @ Work

Netherlands Organisation for Applied Scientific Research (TNO)

Status: Completed

Conditions: Healthy; PreDiabetes

Treatments: Other: Personalized feedback; Other: Generic feedback; Device: Continuous glucose monitoring device

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03295578

P9663

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 67 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 2 patient groups, including a placebo group

Personalized feedback group

Experimental group

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).

Treatment:

Device: Continuous glucose monitoring device

Other: Personalized feedback

General feedback group

Placebo Comparator group

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.

Treatment:

Device: Continuous glucose monitoring device

Other: Generic feedback