Tailored Medical Nutrition Therapy Meal Delivery for the Vulnerable Food Insecure Elderly Patients With End Stage Kidney Disease on Haemodialysis: A Feasibility Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 25
- 试验地点
- 8
- 主要终点
- Nutritional status
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Nutritional status
时间窗: From enrollment to the end of intervention at 8 weeks
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
次要结局
- 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 (Lipid Profile)(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)
- Blood Profile (Calcium)(From enrollment to the end of intervention at 8 weeks)
- Anthropometry markers (weight)(From enrollment to the end of intervention at 8 weeks)
- Anthropometry markers (height)(From enrollment to the end of intervention at 8 weeks)
- Body Composition (Body fat percentage)(From enrollment to the end of intervention at 8 weeks)
- Blood Profile (Glycated hemoglobin - HbA1C)(From enrollment to the end of intervention at 8 weeks)
- Body Composition (Mid-arm circumference)(From enrollment to the end of intervention at 8 weeks)
- Body Composition (Triceps skinfold)(From enrollment to the end of intervention at 8 weeks)
- Blood Profile (Total Iron Binding Capacity)(From enrollment to the end of intervention at 8 weeks)
- Body Composition (Skeletal muscle)(From enrollment to the end of intervention at 8 weeks)
- Food Insecurity (FIES)(From enrollment to the end of intervention at 8 weeks)
- Dietary Intake(From enrollment to the end of intervention at 8 weeks)
研究者
Wai Yew Yang
Senior Lecturer
Universiti Putra Malaysia