Effect of Nutrition Counselling on Dietary Adherence, Clinical Outcomes, and Nutrition-Related Quality of Life Among Patients With Cardiometabolic Multimorbidity in South Wollo, Northeast Ethiopia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 308
- 试验地点
- 1
- 主要终点
- Dietary Adherence
研究概览
简要总结
Background: Cardiometabolic multimorbidity is rising globally and in Ethiopia, yet many patients still receive little or no structured dietary education in chronic care settings. Although nutrition counselling has been studied in single conditions such as diabetes or hypertension, no prior research has evaluated its effectiveness among patients with cardiometabolic multimorbidity. Because people living with multiple chronic diseases have more complex dietary needs and greater self-management challenges, evidence from single-disease groups cannot be assumed to apply to them. In Ethiopia, it remains unknown whether nutrition counselling can improve dietary adherence, clinical outcomes, or nutrition related quality of life in this population.
Objective: To examine the effect of nutrition counselling on dietary adherence, clinical outcomes, and nutrition related quality of life among patients with cardiometabolic multimorbidity in South Wollo, Northeast Ethiopia.
Methods: A two-arm, parallel, cluster randomized controlled trial across 14 hospitals, with seven hospitals assigned to the intervention arm and seven to the control arm will be conducted. Adult patients diagnosed with two chronic conditions (type 2 diabetes and hypertension) will be recruited using systematic random sampling, resulting in a total sample size of 308 participants. The intervention group will receive nutrition counselling guided by the COM-B Model and adapted from national and international dietary guidelines. Six individualized counselling sessions will be delivered over a period of three months. The control group will continue to receive routine care. Dietary adherence, clinical parametres, and nutrition related quality of life will be outcome variables. Generalized structural equation modeling will be used to analyze dietary adherence, while structural equation modeling will be applied for clinical parametres and nutrition related quality of life. Results will be presented as adjusted estimates with 95% confidence intervals.
Expected outcomes: This study is expected to generate evidence showing whether nutrition counselling can improve dietary adherence, clinical outcomes, and nutrition related quality of life among patients with cardiometabolic multimorbidity. The intervention is anticipated to enhance patients' dietary practices, support better control of blood pressure and fasting blood glucose, and contribute to improved quality of life.
详细描述
Introduction Cardiometabolic multimorbidity (CMM), commonly involving T2DM and hypertension, represents the most prevalent and burdensome cluster of chronic diseases (1-3). These conditions are interrelated through shared lifestyle risk factors, and their co-occurrence significantly increases the risk of cardiovascular complications, disability, and premature mortality (4, 5). Nutrition plays a central role in the prevention and management of these conditions, yet dietary adherence among patients remains poor, contributing to uncontrolled blood glucose and blood pressure(6, 7). Nutrition counselling may improve patients' dietary behaviors by enhancing knowledge, self-management skills, and adherence to recommended diets(7); however, evidence on its effect among patients with multiple chronic conditions is limited.
In Ethiopia, national NCD guidelines do not provide specific dietary recommendations for patients with coexisting diabetes and hypertension, and nutrition counselling is poorly integrated into routine chronic care services (8-10). Patients are often managed mainly with medications, with limited structured dietary support, resulting in poor disease control and increased risk of complications, polypharmacy, and hospital utilization(9, 10). Generating context-specific evidence on the effect of nutrition counselling on clinical outcomes is therefore essential to strengthen nutrition care integration and inform guideline development.
Beyond clinical outcomes, patients with CMM frequently experience emotional distress, dietary limitations, and social challenges that negatively affect their well-being and functional capacity (11, 12). Nutrition-related quality of life (NQoL) is particularly compromised in this group due to the complexity of managing multiple dietary restrictions alongside heavy medication loads and symptom burden (13, 14). Structured nutrition counselling might have the potential to improve self-efficacy, psychosocial well-being, and patient satisfaction by addressing the multidimensional impact of diet on daily life. No study has evaluated the effect of nutrition counselling on NQoL among patients with CMM. Generating such evidence is vital to demonstrate the broader value of nutrition counselling, support its integration into Ethiopia's routine NCD services, and inform policies aimed at improving patient-centered outcomes.
Methods This study will be conducted in South Wollo Zone, Amhara Regional State, Northeast Ethiopia, involving all 14 public hospitals as study clusters.
A two-arm parallel cluster randomized controlled trial will be conducted to evaluate the effect of nutrition counselling on dietary adherence, clinical outcomes (blood pressure, fasting blood glucose (FBG), and low-density lipoprotein (LDL), and NQoL among patients with CMM. Fourteen public hospitals will be included, with seven randomly assigned to the intervention group and seven to the control group. A total of 308 adults with coexisting type 2 diabetes and hypertension will be recruited using systematic random sampling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older. Diagnosed with both type 2 diabetes mellitus (T2DM) and hypertension. Receiving chronic care at one of the participating public hospitals.
排除标准
- •Pregnant women. Lactating women.
结局指标
主要结局
Dietary Adherence
时间窗: From enrollment to the end of intervention at 3 months
Perceived dietary adherence will be assessed using 11 items questionnaire adapted from the Perceived Dietary Adherence Questionnaire (PDAQ) and tailored to align with the core principles of the Dietary Approaches to Stop Hypertension (DASH) diet. It includes 11 items covering consumption of fruits, vegetables, whole grains, high-fiber foods, low-glycemic index carbohydrates, fish and other omega-3 rich foods, healthy oils, sugary foods and drinks, high-fat or fried foods, salt intake, and overall adherence to dietary recommendations. Participants will be categorized as good adherence if they achieve a total score of 44 or higher (following recommended dietary practices on four or more days per week for all 11 items) and poor adherence if they score less than 44 (fewer than four days per week).
Fasting Blood Glucose
时间窗: From enrollment to the end of intervention at 3 months
To test fasting blood glucose(FBG), a 5 ml venous blood sample will be drawn in the morning after overnight fasting for at least 8 hours. Laboratory's venipuncture and specimen handling SOPs will be followed during sample collection. Blood samples will be collected using sterile tubes and handled using standard infection prevention and control procedures. FBG will be analyzed using biochemistry analyzers, following the manufacturer's SOP and laboratory quality assurance guidelines. Calibration and internal quality control procedures will be performed daily. The FBG test will be conducted under the supervision of senior medical laboratory technologists to ensure accuracy and adherence to SOPs. Higher values indicate poorer glycemic control.
Blood pressure
时间窗: From enrollment to the end of intervention at 3 months
Blood pressure will be measured in accordance with the Ethiopian National NCD protocol. Participants will be seated comfortably with their back supported and legs uncrossed, and will remain relaxed for at least five minutes prior to measurement. They will be instructed to remain silent during and between measurements. Two blood pressure readings will be taken using a calibrated digital sphygmomanometer, with measurements spaced at five-minute intervals. The average of the systolic and diastolic readings will be used for analysis. Higher readings indicate poorer blood pressure control.
次要结局
- Nutrition-related Quality of Life(From baseline to 2 weeks after completion of the 3-month intervention period.)
研究者
Foziya Mohammed Hussien
Mrs
Bahir Dar University