An interventional study of Personalized feedback and Generic feedback in Healthy and PreDiabetes, sponsored by TNO. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 67 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-24.
Sponsored by TNO · Not applicable, Interventional, and Prevention
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.
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.
Exclusion Criteria:
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
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
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
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
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
Daily glucose levels
measured using a continuous glucose monitoring device
Time frame: Continous (sampled every 15 minutes for a duration of 14 days)
Daily food intake
measured using a food intake application
Time frame: 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.
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
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'
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.
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'.
Time frame: 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
Time frame: 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.
Time frame: four short surveys (baseline, day 1, after two weeks, after eight weeks) and in focus groups after eight weeks
Focus on future consequences
validated questionnaire from Joireman et al (2012). Output will be used as input for formulating the personalized feedback
Time frame: baseline
Subjective health
• Subjective health is measured with two items that are rated on seven-point scales from 'very unhealthy' (1) to 'very healthy' (7).
Time frame: Baseline and after eight weeks (end of study)
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.
Time frame: Baseline and after eight weeks (end of study)
Physical activity
the Dutch Norm for Healthy Physical Activity.
Time frame: Baseline and after eight weeks (end of study)
BMI
calculated based on self-reported height and weight
Time frame: Baseline and after eight weeks (end of study)
Plan to share: No
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This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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