Nutrition Counselling for Cardiometabolic Multimorbidity

Official title

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

Overview

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.

Detailed description

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.

Participants in the intervention group will receive six individualized nutrition counselling sessions over three months, guided by the COM-B Model, while the control group will receive routine care. Intervention fidelity will be assessed using the five domains of the NIH Behavior Change Consortium framework. Data will be collected at baseline and post-intervention. Perceived dietary adherence will be assessed using a questionnaire adapted from the Perceived Dietary Adherence Questionnaire (PDAQ) and aligned with DASH diet principles. Clinical outcomes, including blood pressure, FBG, and LDL levels, will be measured using standardized national and laboratory procedures. Fasting venous blood samples will be collected and analyzed following established specimen handling and quality assurance protocols. Mixed-effects regression models will be used to evaluate intervention effects while accounting for clustering and relevant covariates.

Interventions

• Behavioral COM-B Model-Based Nutrition Counselling
  The intervention is a theory-informed, individualized nutrition counselling program specifically designed for adults with cardiometabolic multimorbidity. The counselling is based on the Capability, Opportunity, Motivation-Behaviour (COM-B) model, which systematically identifies and addresses behavioral determinants of dietary adherence. Unlike routine nutrition advice provided during outpatient care, the intervention incorporates a structured counselling protocol that targets participants' psyc

Primary outcome measures

• Dietary Adherence [Time frame: From enrollment to the end of intervention at 3 months]
• Fasting Blood Glucose [Time frame: From enrollment to the end of intervention at 3 months]
• Blood pressure [Time frame: From enrollment to the end of intervention at 3 months]

Secondary outcome measures (1)

• Nutrition-related Quality of Life [Time frame: From baseline to 2 weeks after completion of the 3-month intervention period.]

Eligibility criteria

Inclusion criteria

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.

Exclusion criteria

Pregnant women. Lactating women.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Ethiopia · 1 center

• Dessie Comprehensive Specialized Hospital — Dessie

Publications

• Hussien FM, Hassen AM, Asfaw ZA, Ahmed AY, Hassen HY. The effect of mobile text messages on knowledge and perception towards cancer and behavioral risks among college students, Northeast Ethiopia: A randomized controlled trial protocol. PLoS One. 2021 Jul 9;16(7):e0253839. doi: 10.1371/journal.pone.0253839. eCollection 2021. PMID 34242256

Identifiers

NCT: NCT07712900 · 5087/20256

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗