Diabetes Nutrition Education With Glycemic Control

NCT04440319 | Completed

• 1 other identifier: Andalas U
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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 Subjects also have the right to be withdrawn after listening explanation of the investigators to seeking the potential participants based on inclusion criteria.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

Keywords

DNE mddule; Glycemic control; Diabetes

Outcome Measures

Primary Outcomes (2)

• HbA1c and Fasting blood glucose

  HbA1c will be analyzed using high performance liquid chromatography, D-10. 158 subjects will be asked to fasting before fasting blood glucose measurement, which will be undertaken by trained clinical staff.

  3 months

• Statistical analyses for HbA1c and Fasting blood glucose

  Statistical analyses will be performed using the latest version of STATA. The data will be checked for normality. Descriptive statistics will be expressed as portions, mean (SD). The time trend for the treatment effect will be estimated from the General Linear Model (GLM). GLM is to determine the between-group difference at 3 months intervention. Differences between baseline, treatment 3 (three) months will be calculated for each outcome. Estimation within and between intervention and control groups will be tested using two way-ANOVA. Sociodemographic characteristic data will be expressed as proportions, mean and Standard Deviation (SD). One-way repeated measured ANOVA is to test the independent variable and a continuous (interval or ratio) dependent variable (within groups). Then, two-way repeated measured ANOVA to test the independent variable and dependent variable between groups.

  3 months

Secondary Outcomes (10)

• Blood Pressure

  3 months

• Statistical analyses for Blood Pressure

  3 months

• Body Mass Index (BMI), assessed by Seca-Tanita scale

  3 months

• Statistical analyses for Body Mass Index (BMI)

  3 months

• Knowledge-Attitude-Practice DM questionnaire

  3 months

Study Arms (2)

Intervention groups (4 PHC/clinics)

EXPERIMENTAL

Intervention group are individual with T2DM who will receive DM nutrition counseling at selected Public Health Care (PHC). There are 75 subjects in Intervention group at selected 2 districts by randomly and 4 PHC which is selected based on cluster. DM nutrition counseling will be delivered by a selected nutritionist at each PHC. Nutritionist will educate the subjects following DM nutrition education module properly. DM nutrition education will be delivered for 3 months and 30 minutes for each meeting.

Behavioral: Intervention group

Control groups (4 PHC/clinics)

EXPERIMENTAL

As the same with intervention group, the control group will have 75 subjects but at the different districts and PHC to avoid contaminant. Control group will follow conventional DM nutrition education. Therefore, there is a selected nutritionists will deliver DM counseling at each PHC.

Behavioral: Intervention group

Interventions

Intervention group BEHAVIORAL

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).

Control groups (4 PHC/clinics); Intervention groups (4 PHC/clinics)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Male and Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• T2DM Patients with new diagnosed at least 6 months
• Patients with range age 18-65 years old
• Male and female who can read and write
• Patients can communicate well

You may not qualify if:

• T2DM patients with stroke and complication
• T2DM patients who are pregnant and breastfeeding women

Sponsors & Collaborators

• Andalas University: lead
• Universiti Putra Malaysia: collaborator

Study Sites (1)

Ice Yolanda Puri

Padang, WEST Sumatera, 25142, Indonesia

Location

Related Publications (1)

• Barakatun Nisak MY, Ruzita AT, Norimah AK, Kamaruddin NA. Medical nutrition therapy administered by a dietitian yields favourable diabetes outcomes in individual with type 2 diabetes mellitus. Med J Malaysia. 2013;68(1):18-23.

  PMID: 23466761 RESULT

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Study Officials

• ICE Y PURI

  Andalas University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Individual with T2DM in both of groups will not know their groups (single blind), but the researcher knows
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: The study has a DM nutrition education module that will be determined to intervention group (individual with T2DM). While control group follow the conventional DM counseling.

Study Record Dates

• First Submitted: May 1, 2020
• First Posted: June 19, 2020
• Study Start: July 1, 2020
• Primary Completion: January 30, 2021
• Study Completion: March 31, 2021
• Last Updated: February 16, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Phase 1 is on June 2020 Phase 2 is on July and August 2020 Phase 3 is on September, October and November 2020
• Access Criteria: Data will be conducted following questionnaire.

Locations

ID (1)