- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04858165
A Logical Framework for Tailor-made Paradigm Shift Hospital Foodservice to Prevent Malnutrition Among Geriatric Patients in Hospitals
June 23, 2021 updated by: Noraida Binti Omar, Universiti Putra Malaysia
Hospital Food service is important for patient recovery by providing necessary aid with adequate meal consumption.
Overall, hospital experience can influence patients' satisfaction for the foodservice quality.
Thus, it is important to evaluate patient satisfaction with food service to meet consumers' needs in order to prevent malnutrition.
The aim of the studies is to develop the Malaysian geriatric patients' hospital foodservice protocol (My GERYFS).
There are 3 Phases in this research which is phase 1 is a multicentre cohort study conducted among elderly and healthcare professionals involved in Klang Valley Hospitals.
Phase 2 for To develop a tailor-made hospital foodservice protocol for Malaysian geriatric patients with healthcare professional input and phase 3 is to determine the feasibility and cost-effectiveness of MY GERYFS protocol in a Malaysian hospital.
Effectiveness of this study protocol can bring benefits to elderly to prevent malnutrition in the hospitals via foodservice.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
350
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Noraida Omar, PhD
- Phone Number: +60192252902
- Email: noraidaomar@upm.edu.my
Study Contact Backup
- Name: Siti Hazimah Norhisham, BSc (Dietetics)
- Phone Number: +60189424625
- Email: hazimahshn@gmail.com
Study Locations
-
-
Selangor
-
Batu Caves, Selangor, Malaysia, 68100
- Recruiting
- Hospital Selayang
-
Contact:
- Adlin Natasya Mohd Said, Dietitian
- Phone Number: +60361263333
- Email: adlinn@selayanghospitals.gov.my
-
Klang, Selangor, Malaysia, 41200
- Recruiting
- Hospital Tengku Ampuan Rahimah Klang
-
Contact:
- Jamilah Zakaria, Dietitian
- Phone Number: 1053 03-3375 7000
- Email: jamienizam.282@gmail.com
-
Serdang, Selangor, Malaysia, 43400
- Not yet recruiting
- Hospital Pengajar Universiti Putra Malaysia
-
Sungai Buloh, Selangor, Malaysia, 47000
- Recruiting
- Hospital Sungai Buloh
-
Contact:
- Noor Shidah Yussof, Dietitian
- Phone Number: 7104 03-61454333
- Email: shidahyussof@gmail.com
-
Sub-Investigator:
- Noor Shidah Yussof, dietetics
-
-
Wilayah Persekutuan Kuala Lumpur
-
Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia, 50586
- Recruiting
- Hospital Kuala Lumpur
-
Contact:
- Wan Nur Khairunnisa Wan Kozil, Dietitian
- Phone Number: 603-26156011
- Email: wnknisa12@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients aged 60 years and older
- Able to understand and speak Malay or English or both
- Patients who are on oral diet or on Oral Nutrition Support (ONS) or both
- Patients who are admitted for more than 48 hours
Exclusion Criteria:
- Patients who are mentally disturbed
- Critically ill patients
- Patients who are on full enteral or parenteral feeding
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: CONTROL
without MY GERYFS
|
|
|
Other: INTERVENTION
with MY GERYFS
|
The MY GERYFS will be introduced through a guideline document, dissemination through the department of nursing, notices on the intranet and provision of large signs indicating that MY GERYFS are in progress and the times of meals for each ward.
The developed protocol in phase 1 and 2 will be tested in single-centre in a before and after study for its feasibility and safety.
In the pre-study, patients will be given usual care.
In the post-study, patients will care according to the developed protocol.
Clinical outcomes such as malnutrition risk, medical background, anthropometry data, nutrition-focused physical findings, dietary intake, mealtime barrier, Hospital Foodservices satisfaction will be recorded.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Nutritional Status
Time Frame: 8 minutes
|
Malnutrition assessment of the elderly will be done using Mini Nutritional Assessment-Short Form (MNA-SF).
This 7-item questionnaire includes dimensions from food intake, weight status, mobility status, presence of psychological problems and neurological stress level.
The total score is categorised into three which are normal nutritional status (12-14 points), at risk of malnutrition (8-11 points) and malnourished (0-7 points).
|
8 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Medical Background
Time Frame: 5 minutes
|
Medical background of the patients will be obtained through patients' medical records and interviewing method.
The medical history of the patients includes reasons of admission, date of admission, date of discharge, days of hospitalisation, types and numbers of comorbidities, numbers of drugs prescription, previous hospitalisation and whether the patient has encountered a dietitian visit during hospitalisation.
All of these data will be recorded in the self-developed questionnaire.
|
5 minutes
|
|
Anthropometry Measurements
Time Frame: 8 minutes
|
Anthropometry measurements of the patients include current and previous body weight, percentage of body weight change, height, body mass index (BMI), mid upper arm circumference (MUAC), calf circumference, triceps skin fold (TSF) and body fat percentage.
The body weight of hospitalised patients will be measured using Digital Weighing Scale OMRON HBF-357 and recorded in kilogram (kg) to the nearest 0.1 kg Weight estimation is done to geriatric patients who are unable to stand without assistance or non-ambulatory.
The outcome measured will be in Body Mass Index (kg/The Body Mass Index classification will be used as stated in WHO (2004) which is underweight (<18.5kg/m1),
normal weight (18.5 to 24.9kg/m2), overweight (25.0 to 29.9kg/m2) and obesity (>30.0kg/m2).
|
8 minutes
|
|
Hand Grip Strength
Time Frame: 2 minutes
|
The hand-grip strength test used Jamar Plus+Digital Handgrip Dynamometer as tools of assessment to evaluate muscle strength.
The cut-off point recommended for the hadgrip strength is < 26kg/force (men) and <18kg/force (women) consider low strength.
While, > 26kg/force (men) and >18kg/force (women) consider normal strength.
|
2 minutes
|
|
Feeding Assistance
Time Frame: 30 seconds
|
The respondents' level of feeding assistance will be acquired directly from the patients or caregivers via interviewing method using self-developed questionnaire.
The researchers are required to assess the respondents' feeding assistance level during main meals.
The level of feeding assistance is classified into four.
The level of feeding assistance is classified into dependent, moderate dependent (≥5 minutes), minimal dependent (<5 minutes), and independent.
|
30 seconds
|
|
Visual Ability
Time Frame: 30 seconds
|
The respondents' information on visual ability will be acquired via self- reported.
The researchers are required to observe if the respondents wear glasses during mealtimes.
|
30 seconds
|
|
Dental Status
Time Frame: 2 minutes
|
The dental status will be assessed using Geriatric Oral Health Assessement Index (GOHAI) instrument) 12 questions were developed to evaluate three dimensions of oral health-related quality of life (QoL).
These include physical function during eating, psychosocial function including worry or concern about oral health, dissatisfaction with appearance, self-consciousness about oral health an avoidance of social contacts because of oral problems and pain or discomfort including the use of medication to relieve pain or discomfort from the mouth.
Each question is given a score 1 to 5. A higher GOHAI score (≥57) indicates better self-reported oral health status and high perception towards oral health, 51 and 56 (average), 12 - 50 (low perception) towards oral health.
|
2 minutes
|
|
Dietary Intake
Time Frame: 10 minutes
|
Dietary intake will be obtained by using 24-hour dietary recall for 2 days in the hospital.
The dietary intake will be taken among patients who are admitted for ≥ 48 hours and have taken at least two hospital meals.
The estimated amount of food will then be converted into grams and later finalised into subject's total energy, macronutrients (protein, carbohydrates and fat) , micronutrients (fat-soluble vitamins, water-soluble vitamins, potassium, sodium, calcium, phosphate, zinc and iron) as well as fibre.
The respondents' energy and protein requirements will be estimated above 70% energy and 80% protein consider adequate.
This will be done by Nutritionist Pro software.
|
10 minutes
|
|
Mealtime Barriers
Time Frame: 5 minutes
|
Mealtime Audit Tool (MAT) instrument is used to measure the respondents' mealtime barriers/issues.
This instrument consists of two distinct parts which are Part 1: observation of the time of meal tray arrival (completed by the researcher) and Part 2: list of key challenges or barriers individual patients may experience (completed by the patients).
MAT scoring is based on the total of 'NO' responses.
The higher the score, the more barriers experienced by the patient.
|
5 minutes
|
|
Hospital Foodservice Satisfaction
Time Frame: 5 minutes
|
The Acute Care Hospital Foodservice Patient Satisfaction (ACHFPSQ) questionnaire will be used.
Other than that, the statements were grouped into four main dimensions (food quality, meal service quality, staff/service issues, and physical environment) to know the factor scores of the dimensions.
The questionnaire uses a 5-point Likert scale (Always = 5, Often = 4, Sometimes = 3, Rarely = 2, and Never =1).
This grouping was to measure the highest and lowest score factors affecting satisfaction with hospital foodservice.
The relationship between foodservice dimensions with overall satisfaction was assessed with Multiple Linear Regression Analysis.
Statements that were worded negatively were scored using the reverse scoring method.
The higher the mean score, the better the results were.
|
5 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2020
Primary Completion (Anticipated)
November 30, 2022
Study Completion (Anticipated)
November 30, 2022
Study Registration Dates
First Submitted
March 30, 2021
First Submitted That Met QC Criteria
April 20, 2021
First Posted (Actual)
April 26, 2021
Study Record Updates
Last Update Posted (Actual)
June 29, 2021
Last Update Submitted That Met QC Criteria
June 23, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 283284-331068
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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