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Diabetes Nutrition Education With Glycemic Control

NCT04440319 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2022-02-16

No results posted yet for this study

Summary

T2DM in Indonesia has increased dramatically from 7.0% in 2017 to 10.9% in 2018. In Padang, West Sumatra, diabetes prevalence was 1.3% in 2013 and increased slowly in 2018. Majority of T2DM were not able to achieve optimal glycaemic glucose control measured using HbA1c with a target of less than \< 6.5% based on WHO recommendation.

Problem Statement NCD guidelines provided management DM in general. Pedoman Gizi Seimbang was for healthy people. It is crucial to update the guideline following the current issues even the Indonesian consensus in 2015 provided a T2DM management diet.

Study Hypotheses There is a significant difference in glycemic control (HbA1c and FBG) nutritional status, knowledge, attitude, practice, quality of life, acceptability and adherence behavior among individuals with T2DM in intervention group.

Procedures Subjects will be divided into Intervention and control groups after they finished reading, signed a letter of agreement and informed consent. Subjects also have the right to be withdrawn after listening explanation of the investigators to seeking the potential participants based on inclusion criteria.

The individual with T2DM (intervention group) will follow the Diabetes Mellitus Nutrition Education (DNE) program based on the curriculum of DNE modules properly and certain measurements. There is a selected nutritionist at each PHC who will convey the DNE program. DM nutrition education counseling will be delivered every week for 30 minutes.

Individual with T2DM

* Baseline An individual with T2DM will be asked to fill the questionnaire and follow all of the measurements (Nutritional Status, Biochemical, Clinical, and Dietary Intake).
* Intervention (3 months) All of the subjects will follow the DM Nutrition Education program for 3 months which will be delivered by nutritionists in PHC.
* Follow up (3 months) All of the subjects will continue the program independently in 3 months. Then, the subjects will do the same activity as a baseline to compare the data between baselines, intervention and follow up Control The individual with T2DM in the control group will still follow the conventional DM nutrition education. After the DNE program finished, the material will also be distributed to the individual with T2DM in the control group.

Conditions

  • Type2 Diabetes Mellitus

Interventions

BEHAVIORAL

Intervention group

Intervention group is individual with T2DM who will receive DM Nutrition education for 3 months. There are 75 subjects in Intervention group at 2 districts and 4 Public Health Care (PHC).

Sponsors & Collaborators

  • Universiti Putra Malaysia

    collaborator OTHER

  • Andalas University

    lead OTHER

Principal Investigators

  • ICE Y PURI · Andalas University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2021-01-30
Completion
2021-03-31

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04440319 on ClinicalTrials.gov