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Electronic-Nutrition-Optimizer for Personalized Prevention (eNO)

Primary Purpose

Diabetes, Hypertension, Frailty

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
eNutrition Optimizer
Sponsored by
Heike Bischoff-Ferrari
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes focused on measuring Mediterranean Diet, MIND Diet, Healthy Aging

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Centre on Aging and Mobility, University of Zurich and City Hospital Waid and TriemliRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Outpatient Group

Inpatient Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 1, 2021
Last Updated
May 12, 2023
Sponsor
Heike Bischoff-Ferrari
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1. Study Identification

Unique Protocol Identification Number
NCT04866264
Brief Title
Electronic-Nutrition-Optimizer for Personalized Prevention
Acronym
eNO
Official Title
Electronic-Nutrition-Optimizer for Personalized Prevention
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 11, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Heike Bischoff-Ferrari

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Hypertension, Frailty, Dementia, Cardiovascular Diseases
Keywords
Mediterranean Diet, MIND Diet, Healthy Aging

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Pilot study (exploratory case-crossover study) for user feasibility and validation of the eNutrition Optimizer
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Outpatient Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Inpatient Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
eNutrition Optimizer
Intervention Description
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.
Primary Outcome Measure Information:
Title
Perception questionnaire using system usability scale
Description
Feasibility Study (in- and outpatient group) Scale from 1 to 5, indicating 1 "not true", 5 "very true"
Time Frame
Baseline
Title
Subjective effectiveness questionnaire of eNutrition Optimizer
Description
Feasibility Study (in- and outpatient group) Scale from 1 to 5, indicating 1 "not true", 5 "very true"
Time Frame
month 3 to 6
Secondary Outcome Measure Information:
Title
24h diet recalls
Description
Validation Study (outpatient group)
Time Frame
month 4 to 6
Title
blood marker Non-HDL cholesterol (mmol/l)
Description
Validation Study (outpatient group)
Time Frame
6 months
Title
blood marker HDL cholesterol (mmol/l)
Description
Validation Study (outpatient group)
Time Frame
6 months
Title
blood marker Triglycerides (mmol/l)
Description
Validation Study (outpatient group)
Time Frame
6 months
Title
blood marker HbA1C (%)
Description
Validation Study (outpatient group)
Time Frame
6 months
Title
blood marker Fasting glucose (mmol/l)
Description
Validation Study (outpatient group)
Time Frame
6 months
Title
blood marker Vitamin B12 (ng/l)
Description
Validation Study (outpatient group)
Time Frame
6 months
Title
blood marker Folate (µg/l)
Description
Validation Study (outpatient group)
Time Frame
6 months
Title
blood marker Iron (µmol/l)
Description
Validation Study (outpatient group)
Time Frame
6 months
Title
blood marker Transferrin (µmol/l)
Description
Validation Study (outpatient group)
Time Frame
6 months
Title
blood marker Soluble transferrin receptor (mg/l)
Description
Validation Study (outpatient group)
Time Frame
6 months
Title
blood marker Ferritin (µg/l)
Description
Validation Study (outpatient group)
Time Frame
6 months
Title
blood marker high sensitive-CRP (mg/l)
Description
Validation Study (outpatient group)
Time Frame
6 months
Title
blood marker Interleukin-6 (pg/ml)
Description
Validation Study (outpatient group)
Time Frame
6 months
Title
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
Description
Change in diet (outpatient group)
Time Frame
6 months
Title
BMI
Description
Change in diet (outpatient group) and safety (outpatient group)
Time Frame
6 months
Title
waist-to-hip ratio
Description
Change in diet (outpatient group) and safety (outpatient group)
Time Frame
6 months
Title
systolic and diastolic blood pressure
Description
Change in diet (outpatient group)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Stable inpatients from the Department of heart surgery, or Center for senior trauma patient at the university hospital Zurich (inpatient group) Ambulatory volunteers who can visit the center for aging and mobility (CAM) independently ("outpatients" group) ≥50 years Exclusion Criteria: If already involved in another ongoing interventional clinical trial, except an interaction with this intervention can be excluded People with an impaired short-term memory (MMSE <24) 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) Outpatients: HbA1C ≥6.5% Inpatients: HbA1C ≥6.5% or diagnosed diabetes mellitus if HbA1C is not available in KISIM BMI > 30 kg/m2 Individuals per se not willing to change diet Instable clinical conditions (e.g. acute infection) at enrolment Patients with active cancer (except non-melanoma skin cancer) or current cancer treatment or any other advanced severe disease Living in a nursing home and/or receiving prepared meals (i.e. usually not eating home cooked meals) Inability to read and or speak German necessary to understand the instructions
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heike Bischoff-Ferrari, MD,DrPH
Phone
+41442552527
Email
heike.bischoff@usz.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heike Bischoff-Ferrari, MD,DrPH
Organizational Affiliation
University of Zurich and City Hospital Waid and Triemli Zurich, ZH, Switzerland, 8037
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre on Aging and Mobility, University of Zurich and City Hospital Waid and Triemli
City
Zurich
State/Province
ZH
ZIP/Postal Code
8037
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heike A Bischoff-Ferrari, MD, DrPH
Phone
+41 44 255 27 57
Email
Heike.Bischoff@usz.ch
First Name & Middle Initial & Last Name & Degree
Michèle Mattle, MSc, MPH
Phone
+49444172217
Email
michele.mattle@usz.ch
First Name & Middle Initial & Last Name & Degree
Heike A Bischoff-Ferrari, MD, DrPH

12. IPD Sharing Statement

Plan to Share IPD
No

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