Electronic-Nutrition-Optimizer for Personalized Prevention

Not Applicable

Completed

• Conditions: Diabetes; Frailty; Cardiovascular Diseases; Hypertension; Dementia
• Interventions: Device: eNutrition Optimizer

• Registration Number: NCT04866264
• Lead Sponsor: Heike Bischoff-Ferrari

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2021-04-01
• Study First Submitted QC: 2021-04-27
• Study First Posted: 2021-04-29
• Study Start: 2021-11-11
• Primary Completion: 2024-05-23
• Study Completion: 2024-05-23
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

1. Stable inpatients from the Department of heart surgery, or Center for senior trauma patient at the university hospital Zurich (inpatient group)
2. Ambulatory volunteers who can visit the center for aging and mobility (CAM) independently ("outpatients" group)
3. ≥50 years

Exclusion Criteria

1. If already involved in another ongoing interventional clinical trial, except an interaction with this intervention can be excluded
2. People with an impaired short-term memory (MMSE <24)
3. Patients following a specific diet recommended by a medical professional, due to diseases such as diabetes, chronic diseases of the gastrointestinal tract, severe kidney disease, or patients allergic to the main components of the Mediterranean diet/MINDdiet (olive oil, nuts)
4. Outpatients: HbA1C ≥6.5% Inpatients: HbA1C ≥6.5% or diagnosed diabetes mellitus if HbA1C is not available in KISIM
5. BMI > 30 kg/m2
6. Individuals per se not willing to change diet
7. Instable clinical conditions (e.g. acute infection) at enrolment
8. Patients with active cancer (except non-melanoma skin cancer) or current cancer treatment or any other advanced severe disease
9. Living in a nursing home and/or receiving prepared meals (i.e. usually not eating home cooked meals)
10. Inability to read and or speak German necessary to understand the instructions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Inpatient Group	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.
Outpatient Group	eNutrition Optimizer	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.

Primary Outcome Measures

Name	Time	Method
Perception questionnaire using system usability scale	Baseline	Feasibility Study (in- and outpatient group) Scale from 1 to 5, indicating 1 "not true", 5 "very true"
Subjective effectiveness questionnaire of eNutrition Optimizer	month 3 to 6	Feasibility Study (in- and outpatient group) Scale from 1 to 5, indicating 1 "not true", 5 "very true"

Secondary Outcome Measures

Name	Time	Method
BMI	6 months	Change in diet (outpatient group) and safety (outpatient group)
waist-to-hip ratio	6 months	Change in diet (outpatient group) and safety (outpatient group)
systolic and diastolic blood pressure	6 months	Change in diet (outpatient group)
blood marker Non-HDL cholesterol (mmol/l)	6 months	Validation Study (outpatient group)
blood marker HbA1C (%)	6 months	Validation Study (outpatient group)
blood marker Folate (µg/l)	6 months	Validation Study (outpatient group)
blood marker Iron (µmol/l)	6 months	Validation Study (outpatient group)
blood marker Soluble transferrin receptor (mg/l)	6 months	Validation Study (outpatient group)
blood marker Vitamin B12 (ng/l)	6 months	Validation Study (outpatient group)
blood marker Ferritin (µg/l)	6 months	Validation Study (outpatient group)
24h diet recalls	month 4 to 6	Validation Study (outpatient group)
blood marker Triglycerides (mmol/l)	6 months	Validation Study (outpatient group)
blood marker Fasting glucose (mmol/l)	6 months	Validation Study (outpatient group)
blood marker Interleukin-6 (pg/ml)	6 months	Validation Study (outpatient group)
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	6 months	Change in diet (outpatient group)
blood marker HDL cholesterol (mmol/l)	6 months	Validation Study (outpatient group)
blood marker Transferrin (µmol/l)	6 months	Validation Study (outpatient group)
blood marker high sensitive-CRP (mg/l)	6 months	Validation Study (outpatient group)

Trial Locations

Locations (1)

Centre on Aging and Mobility, University of Zurich; 🇨🇭 Zurich, ZH, Switzerland