Restorative and Supportive Meals at HomeCare

NCT ID: NCT07283926

Last Updated: 2025-12-16

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-03
• Study Completion Date: 2026-11-30

Brief Summary

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.

Conditions

Chronic Kidney Disease on Hemodialysis; Meals; Medical Nutrition Therapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Single Arm

Sequential single arm crossover intervention study:

1. Phase 1 (menu design and cost analysis)

• Menu planning for tailored MNT diet suitable for elderly patients with chronic kidney disease on hemodialysis
• Pilot testing of newly developed menu including sensory evaluation
• Finalise standard recipes including nutrients, cost and hygiene analysis

2. Phase 2 (intervention)

a) Participant's enrolment Interested participants will undergo screening and selection based on the inclusion criteria and exclusion criteria b) Time-point and Data collection Participants will undergo testing at each time-point of baseline (0 month), after 4 weeks (1 month), and 8 weeks (2 month): food insecurity tool, malnutrition assessment tool, body composition assessment, clinical assessment and dietary assessment c) Participants will provide satisfaction assessment (SERQUAL questionnaire) d) Participants will follow usual diet for 4 weeks (control period), followed by 4 weeks on the MNT meals

Group Type: EXPERIMENTAL

Medical Nutrition Therapy + Meal Delivery

Intervention Type: OTHER

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 safety.

Interventions

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 safety.

Intervention Type: OTHER

Other Intervention Names

RASA (Restorative And Supportive Meals At HomeCare)

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universiti Putra Malaysia

OTHER

Sponsor Role: lead

Responsible Party

Wai Yew Yang

Senior Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wai Yew Yang, PhD; MMedSci; BSc

Role: PRINCIPAL_INVESTIGATOR

Universiti Putra Malaysia

Locations

NKF Good Health (Kampung Pandan)

Kuala Lumpur, Kuala Lumpur, Malaysia

NKF Calvary

Kuala Lumpur, Kuala Lumpur, Malaysia

NKF Rotary Damansara (Selayang)

Batu Caves, Selangor, Malaysia

NKF Charis

Cheras, Wilayah Persekutuan Kuala Lumpu, Malaysia

Countries

Malaysia

Other Identifiers

VOT 6300570

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

JKEUPM-2025-321

Identifier Type: -

Identifier Source: org_study_id