Hospital Foodservice Satisfaction; Hospital Meals Satisfaction; Elderly, Nutrition, Malnutrition in Elderly, MalnutritionNCT04858165
A Logical Framework for Tailor-made Paradigm Shift Hospital Foodservice to Prevent Malnutrition Among Geriatric Patients in Hospitals
A study testing MY GERYFS PROTOCOL in people with Hospital Foodservice Satisfaction; Hospital Meals Satisfaction; Elderly, Nutrition, Malnutrition in Elderly, Malnutrition, run by Universiti Putra Malaysia at 5 sites in Malaysia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hospital Foodservice Satisfaction; Hospital Meals Satisfaction; Elderly, Nutrition, Malnutrition in Elderly, Malnutrition
- What is being tested?
- MY GERYFS PROTOCOL
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 5 sitesMalaysia
- Study dates
- 1 Sep 2020to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients who are mentally disturbed
- Critically ill patients
- Patients who are on full enteral or parenteral feeding
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Malaysia5 sites, 5 recruiting
- Recruiting
Hospital Selayang
Batu Caves, Selangor, 68100
Adlin Natasya Mohd Said, Dietitian, +60361263333, adlinn@selayanghospitals.gov.my
- Recruiting
Hospital Tengku Ampuan Rahimah Klang
Klang, Selangor, 41200
Jamilah Zakaria, Dietitian, 03-3375 7000 ext. 1053, jamienizam.282@gmail.com
- Recruiting
Hospital Kuala lumpur
Kuala Lumpur, Kuala Lumpur, 50586
Wan Nur Khairunnisa Wan Kozil, Dietitian, 603-26156011, wnknisa12@gmail.com
- Not yet recruiting
Hospital Pengajar Universiti Putra Malaysia
Serdang, Selangor, 43400
- Recruiting
Hospital Sungai Buloh
Sungai Buloh, Selangor, 47000
Noor Shidah Yussof, Dietitian, 03-61454333 ext. 7104, shidahyussof@gmail.com
Noor Shidah Yussof, dietetics
About this study
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.
- Being tested
- MY GERYFS PROTOCOL
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MY GERYFS PROTOCOLProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| CONTROL | No intervention | without MY GERYFS |
| INTERVENTION | Other | with MY GERYFS Receives: Procedure: MY GERYFS PROTOCOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutritional Status
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).
Measured: 8 minutes
Secondary outcomes (9)
Medical Background
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.
Measured: 5 minutes
Anthropometry Measurements
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).
Measured: 8 minutes
Hand Grip Strength
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.
Measured: 2 minutes
Feeding Assistance
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.
Measured: 30 seconds
Visual Ability
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.
Measured: 30 seconds
Dental Status
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.
Measured: 2 minutes
Dietary Intake
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.
Measured: 10 minutes
Mealtime Barriers
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.
Measured: 5 minutes
Hospital Foodservice Satisfaction
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.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start1 Sep 2020
- Primary completion30 Nov 2022 (estimated)
- Study completion30 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hospital Foodservice Satisfaction; Hospital Meals Satisfaction; Elderly, Nutrition, Malnutrition in Elderly, MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noraida Binti Omar, Universiti Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04858165
- Sponsor's protocol ID
- 283284-331068
- Status last verified
- Jun 2021
- First submitted
- 30 Mar 2021
- Last updated
- 29 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Omar N, Shafiee SI, Nor'hisham SH, Ibrahim Z, Jamaluddin R, Rahamat S, Mohd Yusof BN, Minhat HS, Sallehuddin H, Mazlan NS. A Logical Framework (MYGERYFS) for Hospital Foodservice to Prevent Malnutrition Among Geriatric Patients in Hospitals, Malaysia: Protocol for a Feasibility Study. JMIR Res Protoc. 2023 Jan 31;12:e42496. doi: 10.2196/42496.
PubMed 36719732
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Logical Framework for Tailor-made Paradigm Shift Hospital Foodservice to Prevent Malnutrition Among Geriatric Patients in Hospitals
- ClinicalTrials.gov ID
- NCT04858165
- Acronym / sponsor ID
- 283284-331068
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 26 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CONTROL | No intervention | –without MY GERYFS |
| INTERVENTION | Other | Procedure: MY GERYFS PROTOCOLwith MY GERYFS |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Patients who are mentally disturbed
- Critically ill patients
- Patients who are on full enteral or parenteral feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MY GERYFS PROTOCOLThe 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. | Procedure or surgery | INTERVENTION |
Primary outcome
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).
9 secondary outcomes
Medical Background
Time frame: 5 minutes
Anthropometry Measurements
Time frame: 8 minutes
Hand Grip Strength
Time frame: 2 minutes
Feeding Assistance
Time frame: 30 seconds
Visual Ability
Time frame: 30 seconds
Dental Status
Time frame: 2 minutes
Dietary Intake
Time frame: 10 minutes
Mealtime Barriers
Time frame: 5 minutes
Hospital Foodservice Satisfaction
Time frame: 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2021.
- Derived from this study: PubMed 36719732Omar N, Shafiee SI, Nor'hisham SH, Ibrahim Z, Jamaluddin R, Rahamat S, Mohd Yusof BN, Minhat HS, Sallehuddin H, Mazlan NS. A Logical Framework (MYGERYFS) for Hospital Foodservice to Prevent Malnutrition Among Geriatric Patients in Hospitals, Malaysia: Protocol for a Feasibility Study. JMIR Res Protoc. 2023 Jan 31;12:e42496. doi: 10.2196/42496.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MY GERYFS PROTOCOL in people with Hospital Foodservice Satisfaction; Hospital Meals Satisfaction; Elderly, Nutrition, Malnutrition in Elderly, Malnutrition, run by Universiti Putra Malaysia at 5 sites in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Noraida Omar, PhD (+60192252902, noraidaomar@upm.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutritional Status (time frame: 8 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04858165, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2021.