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
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Date
2023-02-16
Authors
Ndahura, Nicholas Bari
Munga, Judith
Kimiywe, Judith
Mupere, Ezekiel
Journal Title
Journal ISSN
Volume Title
Publisher
Taylor and Francis
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 diabetesspecific 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).
Description
Article
Keywords
glycated hemoglobin, diabetes, glycemic control, caregivers, Uganda
Citation
Ndahura, N. B., Munga, J., Kimiywe, J., & Mupere, E. (2021). 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. Open Access Journal of Clinical Trials, 1-10.