An interventional study of eNutrition Optimizer in Diabetes, Hypertension and Frailty, sponsored by Heike Bischoff-Ferrari. Completed at 1 site in Switzerland. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-07.
Sponsored by Heike Bischoff-Ferrari · Not applicable, Interventional, and Other
This study aims to develop and validate a tool for immediate nutrition assessment and to test its user feasibility in routine clinical practice for health promotion.
Small changes in diet have been shown to have an important impact on health and the risk of age-related chronic diseases, such as cardiovascular disease, diabetes, frailty and dementia. However, this knowledge has not yet been implemented into routine clinical practice, because practical tools that allow a comprehensive nutrition assessment in the clinical care setting are missing. In addition, doctors are generally not educated in giving nutritional advice to patients. In this pilot project, we aim to push forward and enable the potential of nutrition as a core primary prevention strategy for people at risk of developing chronic diseases. This will be achieved by using, as a stepping stone, the electronic 216-food-item food frequency questionnaire which was developed for the European DO-HEALTH study and was tested in over 2000 adults. The investigators want to extend this tool to not only capture the personal dietary intake, but also to produce an immediate report, comparing the personal diet to the Mediterranean and MIND diet patterns and providing a patient's intake of protein and other nutrients. The report will additionally indicate the patient's diet-related, personalized risks of cardio-vascular disease, diabetes, frailty and cognitive decline, and recommend dietary changes to reduce these risks.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 88 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Heike Bischoff-Ferrari is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
After signing the informed consent, outpatients will be invited for a clinical baseline visit at the Center on Aging and Mobility (CAM), where they will complete the dietary assessment with the eNutrition optimizer at the CAM guided by the study physicians, who will also interpret the immediate results and recommendations produced by the tool to the study participant. For validating the eNutrition-Optimizer tool, participants will be asked to report their dietary intake in the past 24h during a "24-h diet recall phone call" conducted by a trained interviewer on random days (weekday and weekend), so the participant cannot prepare or alter their habits. This 24h diet recall phone calls will be performed 4 times during the second half of the follow-up (month 4 to 6). In addition participants will complete the System Usability Scale at baseline and the subjective effectiveness questionnaire at month 6.
Device: eNutrition Optimizer
After signing the informed consent, inpatients (Senior trauma center/heart surgery) will do the dietary assessment with the eNutrition optimizer with supervision of a trained study physician to assess user feasibility in the inpatient setting. In addition they will have a follow-up phone call at month 3 to 6 to assess the subjective effectiveness of the eNO.
Device: eNutrition Optimizer
The eNutrition optimizer is based on the electronic food frequency questionnaire (FFQ) used in the multicentre randomized controlled trail DO-HEALTH \[56\] developed by the CAM. The FFQ is split up in sections of 33 food groups and contains 216 items. It asks the user on the relative frequency of consumption of the different foods showing a picture of the food in the portion size of interest. Within the eNutrition Optimizer, the FFQ will be extended to create an output of the user's adherence to the Mediterranean diet, the MIND diet and the adherence with the current dietary recommendations for micro- and macronutrients provided by the Swiss Society for Nutrition and the DACH-references, compare it to the DO-HEALTH population and give recommendations on how to improve the score.
Perception questionnaire using system usability scale
Feasibility Study (in- and outpatient group) Scale from 1 to 5, indicating 1 "not true", 5 "very true"
Time frame: Baseline
Subjective effectiveness questionnaire of eNutrition Optimizer
Feasibility Study (in- and outpatient group) Scale from 1 to 5, indicating 1 "not true", 5 "very true"
Time frame: month 3 to 6
24h diet recalls
Validation Study (outpatient group)
Time frame: month 4 to 6
blood marker Non-HDL cholesterol (mmol/l)
Validation Study (outpatient group)
Time frame: 6 months
blood marker HDL cholesterol (mmol/l)
Validation Study (outpatient group)
Time frame: 6 months
blood marker Triglycerides (mmol/l)
Validation Study (outpatient group)
Time frame: 6 months
blood marker HbA1C (%)
Validation Study (outpatient group)
Time frame: 6 months
blood marker Fasting glucose (mmol/l)
Validation Study (outpatient group)
Time frame: 6 months
blood marker Vitamin B12 (ng/l)
Validation Study (outpatient group)
Time frame: 6 months
blood marker Folate (µg/l)
Validation Study (outpatient group)
Time frame: 6 months
blood marker Iron (µmol/l)
Validation Study (outpatient group)
Time frame: 6 months
blood marker Transferrin (µmol/l)
Validation Study (outpatient group)
Time frame: 6 months
blood marker Soluble transferrin receptor (mg/l)
Validation Study (outpatient group)
Time frame: 6 months
blood marker Ferritin (µg/l)
Validation Study (outpatient group)
Time frame: 6 months
blood marker high sensitive-CRP (mg/l)
Validation Study (outpatient group)
Time frame: 6 months
blood marker Interleukin-6 (pg/ml)
Validation Study (outpatient group)
Time frame: 6 months
Dietary patterns assessed with the eNutrition Optimizer (based on a food frequency questionnaire), MIND diet score ranging from 0 to 15 with 0=worst, 15=best ; Med Diet score ranging from 0 to 55 with 0=worst, 15=best
Change in diet (outpatient group)
Time frame: 6 months
BMI
Change in diet (outpatient group) and safety (outpatient group)
Time frame: 6 months
waist-to-hip ratio
Change in diet (outpatient group) and safety (outpatient group)
Time frame: 6 months
systolic and diastolic blood pressure
Change in diet (outpatient group)
Time frame: 6 months
Plan to share: No
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Heike Bischoff-Ferrari