Clinical trial NCT04267367: Effectiveness of Dietitian-led Dietary Approach to Management of Diabetes (DIAM-D)
Official title: Effectiveness of Dietitian-led Dietary Approach to Management of Diabetes (DIAM-D) in Tertiary Care Hospital of Nepal: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: Dietitian
Dietary approach
Management
Diabetes
Nepal
Lead sponsor: Purbanchal University
Sponsor class: OTHER
First posted: 2020-02-12
Enrollment: 156
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The source of the population of the study in both intervention and control group will be known cases of T2DM and newly diagnosed cases of T2DM patients who are within 20-64 years of age group attending the OPD of the hospital.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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).

Dietary management is considered as the cornerstone of blood glucose level control in T2DM patients(Forouhi, Misra, Mohan, Taylor, \& Yancy, 2018). Nowadays, nutrition education and counseling are the widely accepted strategies for the management of diabetes(Zheng, Liu, Liu, \& Deng, 2019). Various studies have shown that T2DM patients are an association with nutrition education and improving dietary habits, nutritional knowledge and improving clinical outcomes such as lower blood glucose and HbA1c levels(Forouhi et al., 2018; Norris, Engelgau, \& Narayan, 2001; Zheng et al., 2019). Once the diagnosis is confirmed to T2DM, patients are managed by mainly three approaches such as diet alone, diet and drugs or diet and insulin(Mbhenyanea, 2017). Indeed, dietary factors are crucial for the management and prevention of T2DM (Forouhi et al., 2018). Furthermore, individualized nutrition education and counseling are effective strategies in adherence to diet recommendations and in improving glycemic control(Lim et al., 2009). Dietitian-led nutrition education and lifestyle intervention are effective in reducing body weight and glucose-related outcomes(Sun et al., 2018). However, limited studies have been carried out to examine the effectiveness of a dietary approach to the management of diabetes consulted by a dietitian in developing countries (Huang, Hsu, Wang, \& Shin, 2010; Trento et al., 2008). Therefore, there is still a lack of evidence on effective guidelines and protocols for a dietitian-led dietary approach to the prevention and management of T2DM patients.

Literature Review and Research Gaps:

Diabetes is one of the major public health problems globally with projected to increase the estimated prevalence is 425 million people in 2017 to 629 million by 2045(Forouhi et al., 2018). Most of the developing countries including Nepal are experienced and increasing the burden of non-communicable diseases such as diabetes mellitus(Gyawali et al., 2015). A recently published study showed 8.5% of peoples have diabetes in the context of Nepal with 5.5% living in rural areas and higher peoples 11.3% are living in urban areas(Nepal Health Research Council, 2019).

In the context of Nepal, most of the peoples are tend to consume a diet rich in simple sugar-containing foods rather than complex carbohydrate and dietary fiber and sedentary lifestyle resulting greatly increased the levels of lifestyle-related disease such as diabetes(Hills et al., 2018). Thus, changing dietary habits can shift a society's disease pattern from infectious, communicable diseases' dominance towards a status of double-burden disease with an increasing prevalence of obesity and non-communicable diseases (NCDs) such as diabetes mellitus(Bishwajit, 2015). Evidence from high-income countries (HICs) shows that healthy eating habits and dietary guidelines area good strategies for the management of diabetes(Forouhi et al., 2018). Therefore, the government of Nepal now prioritizes health promotion for NCDs(Ministry of Health and Population., 2015).

Dietitians can play an important role in the management of non-communicable diseases such as diabetes through nutritional counseling and dietary modification. Nowadays, the provision of nutritional counseling and individualized diet plan concept consulted by dietitians has been practicing in most of the hospital in Nepal. However, there is still lacking the evidence-based dietary guidelines in the Nepalese context. To our knowledge, the effectiveness of the management of diabetes consulted by dietitians has not been explored yet in Nepal. The investigators intended to examine the effectiveness of a dietitian-led dietary approach to management for diabetes mellitus among T2DM patients in tertiary care hospitals. The investigators also tried to examine the future direction for effective dietary and nutritional management approaches to manage T2DM and their implementation in the Nepalese context. Eventually, these outcomes of the study will bridge the evidence gap regarding the scope and provision of dietitians in every government and non-government hospital to the prevention and management of non-communicable diseases such as T2DM.

Research hypothesis:

Dietitian-led dietary approach to the management of diabetes will improve on HbA1c level, nutrition knowledge score and macronutrient intake level compared to usual care among type 2 diabetes mellitus patients in tertiary care hospital in Nepal.

General objectives :

The main objective of this study is to evaluate the effectiveness of the dietitian-led dietary approach to the management of diabetes on the reduction of HbA1c level, nutrition education score and macronutrient intake among T2DM patients in a tertiary care hospital in Kathmandu, Nepal.

Specific objectives :

To measure the change in HbA1c level among T2DM patients between the intervention and control/usual care arm.

To evaluate the change in macronutrient intake level among T2DM patients in the intervention and usual care arm.

To assess dietitian-led nutrition education and counseling on nutritional knowledge of diabetes among T2DM patients.

To evaluate the change in biochemical parameters among T2DM patients in the intervention and usual care arm.

To assess the nutritional status such as BMI and WHR among T2DM patients

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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%)

Primary outcomes:
measure: Change in HbA1c level
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Lalitpur
country: Nepal
facility: Asian College for Advance Studies, Purbanchal University
state: Bagmati
Study officials:
affiliation: Asian College for Advance Studies, Purbanchal University
name: Devendra Raj Singh, MScHPPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Forouhi NG, Misra A, Mohan V, Taylor R, Yancy W. Dietary and nutritional approaches for prevention and management of type 2 diabetes. BMJ. 2018 Jun 13;361:k2234. doi: 10.1136/bmj.k2234.
citation: Sun Y, You W, Almeida F, Estabrooks P, Davy B. The Effectiveness and Cost of Lifestyle Interventions Including Nutrition Education for Diabetes Prevention: A Systematic Review and Meta-Analysis. J Acad Nutr Diet. 2017 Mar;117(3):404-421.e36. doi: 10.1016/j.jand.2016.11.016.
citation: Guariguata L, Whiting DR, Hambleton I, Beagley J, Linnenkamp U, Shaw JE. Global estimates of diabetes prevalence for 2013 and projections for 2035. Diabetes Res Clin Pract. 2014 Feb;103(2):137-49. doi: 10.1016/j.diabres.2013.11.002. Epub 2013 Dec 1.
citation: Cho NH, Shaw JE, Karuranga S, Huang Y, da Rocha Fernandes JD, Ohlrogge AW, Malanda B. IDF Diabetes Atlas: Global estimates of diabetes prevalence for 2017 and projections for 2045. Diabetes Res Clin Pract. 2018 Apr;138:271-281. doi: 10.1016/j.diabres.2018.02.023. Epub 2018 Feb 26.
citation: Jayawardena R, Ranasinghe P, Byrne NM, Soares MJ, Katulanda P, Hills AP. Prevalence and trends of the diabetes epidemic in South Asia: a systematic review and meta-analysis. BMC Public Health. 2012 May 25;12:380. doi: 10.1186/1471-2458-12-380.
citation: Gyawali B, Sharma R, Neupane D, Mishra SR, van Teijlingen E, Kallestrup P. Prevalence of type 2 diabetes in Nepal: a systematic review and meta-analysis from 2000 to 2014. Glob Health Action. 2015 Nov 26;8:29088. doi: 10.3402/gha.v8.29088. eCollection 2015.
citation: Lim HM, Park JE, Choi YJ, Huh KB, Kim WY. Individualized diabetes nutrition education improves compliance with diet prescription. Nutr Res Pract. 2009 Winter;3(4):315-22. doi: 10.4162/nrp.2009.3.4.315. Epub 2009 Dec 31.
citation: Bhandari GP, Angdembe MR, Dhimal M, Neupane S, Bhusal C. State of non-communicable diseases in Nepal. BMC Public Health. 2014 Jan 10;14:23. doi: 10.1186/1471-2458-14-23.
citation: Zheng F, Liu S, Liu Y, Deng L. Effects of an Outpatient Diabetes Self-Management Education on Patients with Type 2 Diabetes in China: A Randomized Controlled Trial. J Diabetes Res. 2019 Jan 17;2019:1073131. doi: 10.1155/2019/1073131. eCollection 2019.
citation: Bishwajit G. Nutrition transition in South Asia: the emergence of non-communicable chronic diseases. F1000Res. 2015 Jan 12;4:8. doi: 10.12688/f1000research.5732.2. eCollection 2015.
citation: Dhimal M, Karki KB, Sharma SK, Aryal KK, Shrestha N, Poudyal A, Mahato NK, Karakheti A, Sijapati MJ, Khanal PR, Mehata S, Vaidya A, Yadav BK, Adhikary KP, Jha AK. Prevalence of Selected Chronic Non-Communicable Diseases in Nepal. J Nepal Health Res Counc. 2019 Nov 14;17(3):394-401. doi: 10.33314/jnhrc.v17i3.2327.