Restorative and Supportive Meals at HomeCare
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Medical Nutrition Therapy + Meal Delivery.
- Who it may be relevant to
- Registry conditions: Chronic Kidney Disease on Hemodialysis, Meals, Medical Nutrition Therapy. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Malaysia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Tailored Medical Nutrition Therapy Meal Delivery for the Vulnerable Food Insecure Elderly Patients With End Stage Kidney Disease on Haemodialysis: A Feasibility Pilot Study
Overview
The pilot intervention study is designed to evaluate the feasibility of implementing a tailored medical nutrition therapy (MNT) meal-delivery for 25 elderly, low-income food insecure patients with end-stage kidney disease undergoing maintenance hemodialysis at dialysis centers. Following comprehensive baseline assessments, participants will first maintain their usual dietary patterns for a 4-week control period to establish baseline nutritional and clinical parameters. This will be followed by a 4-week intervention period during which participants will receive individually tailored MNT meals designed to meet their renal-specific nutritional requirements, including energy, protein, potassium, phosphate and sodium intake. Weekly monitoring during dialysis sessions will include assessment of adherence, dietary intake, and clinical tolerance, providing detailed insights into the feasibility, safety, and potential clinical impact of the tailored nutrition intervention in this vulnerable population.
Detailed description
Background Malaysia is expecting population ageing with a projection of 15% of Malaysia's population will be over 65 years by 2030. Older adults often face challenges related to food insecurity and chronic disease management, which affect their overall well-being. In 2018, 10.4% of older adults were classified as food insecure, and this number is projected to escalate with the growing older adult population. On the other hand, those suffering from chronic kidney disease (CKD) face one of the most difficult diets among clinical patients. With economic constraints, the elderly's abilities to acquire the right food could be limited, predisposing them to increased morbidity and mortality. While much work is needed to ascertain the complex interplay between food insecurity, chronic disease management, and well-being in this population, a tailored intervention programme could help improve food security and health status, yet it is not well researched.
Problem Statement Food insecure elderly patients with end-stage renal disease (ESRD) on haemodialysis (HD) in Malaysia have low adherence on renal diet and are at the highest risk of malnutrition and food-borne illness predisposing them to increased morbidity and mortality.
Justification of Study At present, there is limited evidence on availability of a tailored medical nutrition therapy (MNT) meal delivery specific for HD patients in Malaysia. While much work is needed to ascertain the complex interplay between food insecurity, chronic disease management, and well-being, a tailored intervention programme could help improve the food security and health status of elderly population in Malaysia.
Research Question(s) Can tailored MNT meal delivery improve food safety, food insecurity and nutritional status of food insecure malnourished elderly patients with ESRD on HD?
Research objectives
General Objective:
To determine the feasibility of tailored medical nutrition therapy meal delivery intervention programme for elderly patients undergoing haemodialysis
Specific Objectives:
To examine the effectiveness of tailored MNT meal delivery on food safety, food insecurity and nutritional status of food insecure elderly patients with end stage kidney disease on haemodialysis
Research methodology To accomplish the objective, a single arm crossover study is proposed to be conducted over a one-year period divided into two phases: Phase One (menu planning) and Phase Two (intervention) among food insecure malnourished elderly patients on haemodialysis. Data will be collected at 3-time points on food insecurity, nutritional status and meal satisfaction.
Expected outcomes
1. Potentially improve nutritional intake among food insecure elderly patients on haemodialysis by using self-grown vegetables that follows good practices in Malaysian Good Agricultural Practices with good handling of post-harvest management; 2. Extend the understanding of interplay between food insecurity, chronic disease management, and well-being of older adults, and; 3. Establish link between community, university and industry on affordable, tailored therapeutic meals for vulnerable populations.
Interventions
- Other Medical Nutrition Therapy + Meal Delivery
The tailored medical nutrition therapy menu is planned to meet the requirement of elderly chronic kidney disease patients on hemodialysis following the needs assessment on their existing nutritional status. The menu planning is completed by registered dietitians, and the vegetables are planted and supplied by certified agriculturist adhering to the local farming standards. The recipes are analysed with the nutrients, cost and hygiene to ensure its practicality, accessibility, affordability and s
Primary outcome measures
- Nutritional status [Time frame: From enrollment to the end of intervention at 8 weeks]
Secondary outcome measures (12)
- Blood Profile (Hemoglobin) [Time frame: From enrollment to the end of intervention at 8 weeks]
- Blood Profile (Albumn) [Time frame: From enrollment to the end of intervention at 8 weeks]
- Blood Profile (Sodium) [Time frame: From enrollment to the end of intervention at 8 weeks]
- Blood Profile (Potassium) [Time frame: From enrollment to the end of intervention at 8 weeks]
- Blood Profile (Phosphate) [Time frame: From enrollment to the end of intervention at 8 weeks]
- Blood Profile (Calcium) [Time frame: From enrollment to the end of intervention at 8 weeks]
- Blood Profile (Lipid Profile) [Time frame: From enrollment to the end of intervention at 8 weeks]
- Blood Profile (Glycated hemoglobin - HbA1C) [Time frame: From enrollment to the end of intervention at 8 weeks]
- Blood Profile (Total Iron Binding Capacity) [Time frame: From enrollment to the end of intervention at 8 weeks]
- Anthropometry markers (weight) [Time frame: From enrollment to the end of intervention at 8 weeks]
- Anthropometry markers (height) [Time frame: From enrollment to the end of intervention at 8 weeks]
- Body Composition (Mid-arm circumference) [Time frame: From enrollment to the end of intervention at 8 weeks]
Eligibility criteria
Inclusion criteria
- Elderly patients with chronic kidney disease on hemodialysis aged 60 and above (receiving hemodialysis treatment ≥3 days/week, dialysis vintage ≥3 months), and received at least one nutrition consultation by dietitian;
- From the low-income households based on the Malaysia's Department of Statistics criteria and food insecure;
- With co-morbidities of hypertension and cardiovascular disease;
- Consent to participate for 2 months period
Exclusion criteria
- Patients with chronic kidney disease on hemodialysis aged 59 and below, patients undergoing peritoneal dialysis/alternate hemodialysis and peritoneal dialysis/ dialysis vintage <3 months), and have not received at least one nutrition consultation by dietitian;
- From non low-income households based on the Malaysia's Department of Statistics criteria and food insecure
- With co-morbidities aside from those mentioned above (i.e. diabetes, cancer, gastrointestinal disorders, liver disease or any chronic diseases requiring specialised medical nutrition therapy)
- Patients diagnosed with food allergies or intolerance
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Malaysia · 4 centers
- NKF Good Health (Kampung Pandan) — Kuala Lumpur
- NKF Calvary — Kuala Lumpur
- NKF Rotary Damansara (Selayang) — Batu Caves
- NKF Charis — Cheras
Identifiers
NCT: NCT07283926 · JKEUPM-2025-321 · VOT 6300570