Effectiveness of Dietitian-led Dietary Approach to Management of Diabetes (DIAM-D)
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

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
    

Intervention name(s): Dietitian-led dietary approach to management of diabetes
Intervention type(s): Behavioral
Intervention description(s): In the intervention phase, the educational and diet plan package will be developed. All the intervention packages will be approved by a multi-disciplinary expert team comprising an endocrinologist and dietitian prior to the intervention. Patients in the usual care arm will receive routine care as to how he/she is practicing in their daily life. Routine care includes general knowledge on diabetes disease process, blood glucose monitoring, a healthy lifestyle, preventing treating diabetes complications and developing personalized strategies for the decision-making process[27]. The intervention package will include mainly two-phase, nutritional counseling emphasis on lifestyle modification of diabetes patients and individual basis diet plan for each T2DM patients for intervention arm. The nutrition education and counseling and individual diet plan will be applied by trained dietitians.
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Dietitian; Dietary approach; Management; Diabetes; Nepal