1型糖尿病儿童和青少年护理人员结构化营养教育课程在改善血糖和饮食结局方面的有效性:一项集群随机对照试验方案

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL
N. B. Ndahura, J. Munga, J. Kimiywe, E. Mupere
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引用次数: 0

摘要

目的:本研究旨在评估为1型糖尿病儿童和青少年(T1DM)的照顾者提供结构化的营养教育课程是否有助于改善他们孩子的血糖控制、饮食摄入和多样性。研究设计和方法:该研究将是一项集群随机对照试验,在乌干达10个已建立T1DM诊所的卫生机构进行。这些设施将包括:穆拉戈国家转诊医院、圣弗朗西斯医院、卢巴加医院、姆巴莱地区转诊医院、索罗蒂地区转诊医院、神圣无辜者医院、维里卡医院、卡甘多医院、尼亚基巴莱医院和瓦基索第四保健中心。这些设施将按1:1的比例随机分配到对照或干预组。总共将招募100对看护人-儿童对。对照组的参与者将继续接受常规医疗护理,而干预组的参与者将接受常规医疗护理并参加有组织的群体营养教育课程。该课程将在3个月内交付,它将包括8个面对面的会议,每次会议持续45分钟。由糖尿病专家、护士和营养师组成的两人小组将指导这些会议。每节课每周进行一次,每两节课后举行一次问答环节。主要终点是糖化血红蛋白(HbA1c)的变化,次要终点是护理者对一般和糖尿病特异性营养知识的知识水平、儿童饮食多样性评分以及儿童平均能量、蛋白质和脂肪摄入量,将在基线、3个月和6个月时进行评估。将进行意向治疗分析。数据将根据分组随机试验的综合报告标准(CONSORT)声明进行报告。该试验已在泛非临床试验登记处注册(PACTR201902548129842)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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
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).
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来源期刊
Open Access Journal of Clinical Trials
Open Access Journal of Clinical Trials MEDICINE, RESEARCH & EXPERIMENTAL-
CiteScore
3.90
自引率
0.00%
发文量
2
审稿时长
16 weeks
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