Effectiveness of a structured nutrition education course for caregivers of children and adolescents with type 1 diabetes in improving glycemic and dietary outcomes: A cluster-randomized controlled trial protocol

Abstract

Purpose: This study will aim to evaluate whether the provision of a structured nutrition education course to caregivers of children and adolescents with type 1 diabetes mellitus (T1DM) will help improve their children’s glycemic control, dietary intake, and diversity. Research Design and Methods: The study will be a cluster randomized controlled trial conducted at 10 health facilities with established T1DM clinics in Uganda. The facilities will include: Mulago National Referral Hospital, St. Francis Hospital, Lubaga Hospital, Mbale Regional Referral Hospital, Soroti Regional Referral Hospital, Holy innocents’ Hospital, Virika Hospital, Kagando Hospital, Nyakibale Hospital, and Wakiso Health Centre IV. The facilities will be randomized to control or intervention at a ratio of 1:1. A total of 100 caregiver-child pairs will be recruited. The participants in the control group will continue to receive routine medical care, while those in the intervention group will receive routine medical care and attend a structured group nutrition education course. The course will be delivered over 3 months, it will consist of a total of 8 face-to-face sessions lasting 45 minutes each. A two-member team of a diabetes specialist nurse and dietician will conduct the sessions. Each session will be conducted once a week and a question-and-answer session held every after 2 sessions. The primary outcome which is a change in glycated hemoglobin (HbA1c) and secondary outcomes (caregivers’ level of knowledge on general and diabetes-specific nutrition knowledge, children’s dietary diversity score, and children’s mean intake of energy, protein, and fat) will be assessed at baseline, 3, and 6 months. Intention-to-treat analysis will be conducted. Data will be reported according to the Consolidated Standards of Reporting Trials (CONSORT) statement for cluster-randomized trials. The trial is registered with the Pan African Clinical Trials Registry (PACTR201902548129842).