Effectiveness of Dietitian-led Dietary Approach to Management of Diabetes (DIAM-D)

NCT04267367 | Completed DMC

• 1 other identifier: PurbanchalU
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Keywords

Dietitian; Dietary approach; Management; Diabetes; Nepal

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c level

  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.

  six months

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention will include a dietitian-led nutrition education, counseling session and individual basis diet plan emphasis on glycemic control diet targeted to T2DM patients attending during the OPD visits in hospital.

Behavioral: Dietitian-led dietary approach to management of diabetes

Usual care

NO INTERVENTION

The usual care arm will be only provided general education.

Interventions

Dietitian-led dietary approach to management of diabetes BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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%)

Sponsors & Collaborators

• Purbanchal University: lead

Study Sites (1)

Asian College for Advance Studies, Purbanchal University

Lalitpur, Bagmati, 44700, Nepal

Location

Related Publications (12)

• 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.

  PMID: 29898883 BACKGROUND

• 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.

  PMID: 28236962 RESULT

• 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.

  PMID: 24630390 RESULT

• 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.

  PMID: 29496507 RESULT

• 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.

  PMID: 22630043 RESULT

• 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.

  PMID: 26613684 RESULT

• 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.

  PMID: 20098585 RESULT

• 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.

  PMID: 24405646 RESULT

• 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.

  PMID: 30800684 RESULT

• 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.

  PMID: 26834976 RESULT

• 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.

  PMID: 31735938 RESULT

• Sunuwar DR, Nayaju S, Dhungana RR, Karki K, Singh Pradhan PM, Poudel P, Nepal C, Thapa M, Shakya NS, Sayami M, Shrestha PK, Yadav R, Singh DR. Effectiveness of a dietician-led intervention in reducing glycated haemoglobin among people with type 2 diabetes in Nepal: a single centre, open-label, randomised controlled trial. Lancet Reg Health Southeast Asia. 2023 Sep 25;18:100285. doi: 10.1016/j.lansea.2023.100285. eCollection 2023 Nov.

  PMID: 38028163 DERIVED

Related Links

• World Health Organization (WHO). The top 10 causes of death. 2018.
• Kafle N, Poudel R, Shrestha S. Noncompliance to Diet and Medication among Patients with Type 2 Diabetes Mellitus in Selected Hospitals of Kathmandu, Nepal. J Soc Heal Diabetes.
• Nepal Health Research Council. Population Based Prevalence of Selected Non-Communicable Disease in Nepal. 2019.
• Ministry of Health and Population. Nepal Health Sector Strategy 2015-2020, Kathmandu. 2015.

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Devendra Raj Singh, MScHPPH

  Asian College for Advance Studies, Purbanchal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 6, 2020
• First Posted: February 12, 2020
• Study Start: August 1, 2021
• Primary Completion: April 30, 2022
• Study Completion: May 15, 2022
• Last Updated: March 3, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)