Electronic-Nutrition-Optimizer for Personalized Prevention

NCT04866264 | Completed

• 1 other identifier: 2019-02379
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Hypertension; Frailty; Dementia; Cardiovascular Diseases

Keywords

Mediterranean Diet; MIND Diet; Healthy Aging

Outcome Measures

Primary Outcomes (2)

• Perception questionnaire using system usability scale

  Feasibility Study (in- and outpatient group) Scale from 1 to 5, indicating 1 "not true", 5 "very true"

  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"

  month 3 to 6

Secondary Outcomes (18)

• 24h diet recalls

  month 4 to 6

• blood marker Non-HDL cholesterol (mmol/l)

  6 months

• blood marker HDL cholesterol (mmol/l)

  6 months

• blood marker Triglycerides (mmol/l)

  6 months

• blood marker HbA1C (%)

  6 months

Study Arms (2)

Outpatient Group

ACTIVE COMPARATOR

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

Inpatient Group

ACTIVE COMPARATOR

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

Interventions

eNutrition Optimizer DEVICE

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.

Inpatient Group; Outpatient Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Heike Bischoff-Ferrari: lead

Study Sites (1)

Centre on Aging and Mobility, University of Zurich

Zurich, Canton of Zurich, 8037, Switzerland

Location

MeSH Terms

Conditions

Diabetes Mellitus; Hypertension; Frailty; Dementia; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Heike Bischoff-Ferrari, MD,DrPH

  Center on Aging and Monbility, University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Geriatric Clinic, University Hospital Zurich

Model Details: Pilot study (exploratory case-crossover study) for user feasibility and validation of the eNutrition Optimizer

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: April 29, 2021
• Study Start: November 11, 2021
• Primary Completion: May 23, 2024
• Study Completion: May 23, 2024
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)