Blood Glucose, Cognition and Wellbeing @ Work

NCT03295578 | Completed FDA Device

• 1 other identifier: P9663
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; PreDiabetes

Keywords

employees; continuous glucose monitoring; personalized feedback; cognition; wellbeing

Outcome Measures

Primary Outcomes (4)

• Daily glucose levels

  measured using a continuous glucose monitoring device

  Continous (sampled every 15 minutes for a duration of 14 days)

• 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)..

• 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

• 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 Outcomes (3)

• Intention to eat healthy

  baseline and after eight weeks (end of study)

• Quantitative user experiences

  baseline and after eight weeks (end of study)

• Qualitative user experiences

  four short surveys (baseline, day 1, after two weeks, after eight weeks) and in focus groups after eight weeks

Other Outcomes (5)

• Focus on future consequences

  baseline

• Subjective health

  Baseline and after eight weeks (end of study)

• Eating habits (at the workplace)

  Baseline and after eight weeks (end of study)

Study Arms (2)

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).

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.

Other: Generic feedback; Device: Continuous glucose monitoring device

Interventions

Personalized feedback 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.

Also known as: personalized feedback report

Personalized feedback group

Generic feedback 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.

Also known as: Generic feedback report

General feedback group

Continuous glucose monitoring device DEVICE

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

Also known as: Abbott FreeStyle Libre Pro

General feedback group; Personalized feedback group

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• TNO: lead
• Wageningen University and Research: collaborator
• Jumbo Supermarkten Bv.: collaborator
• Noldus Information Technology B.V.: collaborator
• Google LLC.: collaborator

Study Sites (1)

Jumbo Supermarkten BV.

Veghel, North Brabant, 5462 CE, Netherlands

Location

MeSH Terms

Conditions

Prediabetic State

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Iris M de Hoogh, Msc

  TNO (Netherlands Organization for Applied Scientific Research)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Model Details: Randomized controlled trial with two parallel arms.

Study Record Dates

• First Submitted: September 12, 2017
• First Posted: September 28, 2017
• Study Start: October 2, 2017
• Primary Completion: November 17, 2017
• Study Completion: December 22, 2017
• Last Updated: March 24, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)