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临床试验/NCT04267367
NCT04267367已完成不适用

Effectiveness of Dietitian-led Dietary Approach to Management of Diabetes (DIAM-D) in Tertiary Care Hospital of Nepal: a Randomized Control Trial

Purbanchal University2 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2021年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
156
试验地点
2
主要终点
Change in HbA1c level

研究概览

简要总结

Background: Diabetes mellitus is one of the major intractable public health problems in developing countries including Nepal. The dietary approach is of paramount significance in the management of type 2 diabetes. The nutrition education and counseling (NEC) may be good strategies for the management of diabetes provided by dietitians. There is still a lack of evidence on a dietitian-led dietary approach to the management of T2DM patients in the Nepalese context. The aims of this study is to examine the effectiveness of dietitian-led dietary approach to management of diabetes on reduction of HbA1c level, nutrition education score and macronutrient intake among T2DM patients in a tertiary care hospital in Kathmandu, Nepal.

Methods: The Dietary Approach to the Management of Diabetes (DIAM-D) trial is a hospital-based, open-label, two-armed, randomized control trial. A total of 156 participants with T2DM having HbA1c >6.5% will be enrolled in the study. Participants will be consecutively enrolled and assigned to receive nutrition education and counseling (NEC) and diet plan in the intervention group (n=78) and usual routine care in the control group (n=78) randomly. The NEC will be provided to participants on group session and the diet plan will be face-to-face individual basis at the time of enrollment and follow-ups will be done every month. Baseline data will be collected using a structured questionnaire for an interview and the biochemical tests will be measured. Baseline data will be collected at the time of enrollment, midline in three months and end-line data collection in 6 months. The primary outcome of the study will be a difference in mean change (from baseline, midline to 6 months) in the HbA1c level between the two study arms from baseline to end line. The secondary outcomes measure will be changed in biochemical and clinical parameters between the two arms at baseline midline to six months. Data will be entered using Epidata Software and transferred to the STATA/MP version 14.1 for further analysis. Data will be analyzed using an intention-to-treat basis. Independent sampele t-test and difference in the difference (DID) models will be used to estimates changes between the intervention and usual care arms.

详细描述

Background:

Diabetes mellitus (DM) refers to the metabolic syndrome characterized by high blood glucose levels considering major public health problems globally (Sun et al., 2018). The global prevalence of diabetes in adults has been increasing over the decades (Guariguata et al., 2014). According to the world health organization (WHO), diabetes is the sixth leading cause of death accounting for 1.59 million deaths in 2016 (World Health Organization (WHO)., 2018). According to the International Diabetes Federation (IDF) data, it was estimated that among 18-99 years, there are 451 million people with diabetes globally. The number projected to increase to 693 million by 2045 (Cho et al., 2018). The rapid change of diabetes prevalence in many countries specially developing countries have been influenced by rapid urbanization and drastically changes towards the sedentary lifestyle(Guariguata et al., 2014). Similarly, an increase in the prevalence of diabetes is characterized by various modifiable and non-modifiable risk factors, modifiable risk factors include changes in dietary habits and sedentary lifestyle which contributed to overweight/ obesity and non-modifiable risk factors including genetic cause and age (Hussain, Claussen, Ramachandran, & Williams, 2007).

The prevalence of diabetes mellitus in the south Asian region was a rapid increase over the last two decades (R.Jayawardena et al., 2012). According to the International Diabetes Federation (IDF) data for Nepal, the prevalence of T2DM in the 20-79 years age group was 4% in 2017 and the predicted number of undiagnosed cases was 532,100. IDF estimates the prevalence projected to increase by 6.1% and 1,264,200 undiagnosed cases in 2045 in Nepal(IDF Diabetes Atlas 9th edition 2019, n.d.). Evidence from systematic review and meta-analysis done by Gyawali et al, (2014) also reported that the prevalence of diabetes is a major public health problem with a prevalence rate of 8.4% (Gyawali et al., 2015). Dhimal et al. conducted a nationwide cross-sectional population-based study carried out from 2016-1018 found that the prevalence of diabetes was 8.5%(Dhimal et al., 2019). Diabetes is the third most common non-communicable disease in Nepal, which causes 12% of all hospitalizations(Bhandari, Angdembe, Dhimal, Neupane, & Bhusal, 2014).

Problem Statement:

The prevalence of type 2 diabetes mellitus (T2DM) has drastically increased in recent years in Nepal(Kafle, Poudel, & Shrestha, 2018). T2DM is accompanied by complications such as dyslipidemia, hypertension, and obesity. Several studies have shown that these complications can be prevented if lowering the HbA1c level and which has to be maintained within normal limits(Lim, Park, Choi, Huh, & Kim, 2009).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
20 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosed cases of type 2 diabetes with (as defined by an HbA1c>48 mmol/mol (6.5%) at time of diagnosis)
  • Male or female aged ≥20 years and visited in OPD of target hospital
  • Those who give consent to participate in our intervention study

排除标准

  • Those who are pregnant women, lactating women or planning to become pregnant during the course of study.
  • Those who are severely ill or more than two comorbidities
  • Those who have any plan to migrate from the study area for at least 1 year
  • HbA1c ≥93mmol/mol (10.5%)

结局指标

主要结局

Change in HbA1c level

时间窗: six months

The primary outcome of this study will be the change in mean HbA1c between the intervention and control/usual care groups from baseline to end line.

次要结局

未报告次要终点

研究者

发起方
Purbanchal University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Devendra Raj Singh

Assistant Professor

Purbanchal University

研究点 (2)

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