Restorative and Supportive Meals at HomeCare

NCT07283926 | Enrolling By Invitation DMC

• 2 other identifiers: JKEUPM-2025-321VOT 6300570
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 4

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.

Conditions

Medical Nutrition Therapy; Chronic Kidney Disease on Hemodialysis; Meals

Keywords

medical nutrition therapy; meal delivery; hemodialysis; elderly; food security; socioeconomic

Outcome Measures

Primary Outcomes (1)

• Nutritional status

  The nutritional status of hemodialysis patients is assessed based on the presence of protein-energy wasting (PEW), categorised as either "yes" or "no." PEW is diagnosed according to the diagnostic criteria established by International Society of Renal Nutrition and Metabolism (ISRNM). Four main categories will be evaluated to diagnose PEW: (1) Serum chemistry; (2) Body mass; (3) Muscle mass; and (4) Dietary intake. The subject is diagnosed with PEW if at least three out of these four listed categories are met, with at least one diagnostic test conducted within each category

  From enrollment to the end of intervention at 8 weeks

Secondary Outcomes (17)

• Blood Profile (Hemoglobin)

  From enrollment to the end of intervention at 8 weeks

• Blood Profile (Albumn)

  From enrollment to the end of intervention at 8 weeks

• Blood Profile (Sodium)

  From enrollment to the end of intervention at 8 weeks

• Blood Profile (Potassium)

  From enrollment to the end of intervention at 8 weeks

• Blood Profile (Phosphate)

  From enrollment to the end of intervention at 8 weeks

Study Arms (1)

Single Arm

EXPERIMENTAL

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

Other: Medical Nutrition Therapy + Meal Delivery

Interventions

Medical Nutrition Therapy + Meal Delivery 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.

Also known as: RASA (Restorative And Supportive Meals At HomeCare)

Single Arm

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Putra Malaysia: lead

Study Sites (4)

NKF Good Health (Kampung Pandan)

Kuala Lumpur, Kuala Lumpur, 55100, Malaysia

Location

NKF Calvary

Kuala Lumpur, Kuala Lumpur, 56000, Malaysia

Location

NKF Rotary Damansara (Selayang)

Batu Caves, Selangor, 68100, Malaysia

Location

NKF Charis

Cheras, Wilayah Persekutuan Kuala Lumpu, 56000, Malaysia

Location

MeSH Terms

Interventions

Nutrition Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Wai Yew Yang, PhD; MMedSci; BSc

  Universiti Putra Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Model Details: This study is designed as a sequential single arm crossover intervention study of phase 1 (menu design and cost analysis) and phase 2 (intervention).

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 16, 2025
• Study Start: November 3, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-11

Locations

MY (4)