A 12-Week Double-Blind of Diabetes Nutrition Education in T2D
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- HbA1c and Fasting blood glucose
研究概览
简要总结
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 Subjects also have the right to be withdrawn after listening explanation of the investigators to seeking the potential participants based on inclusion criteria.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.
详细描述
Phase I: Needs Assessment Research Design This is a descriptive statistics study and the aims are to determine the current practice of managing diabetes mellitus among nutritionists. The need for having DM nutrition education among individual with T2DM will be conducted following Cross-sectional study.
Subjects The need assessment will be conducted among all nutritionists at all PHC and individual with T2DM at selected PHC at Padang city.
Sampling The nutritionists will be recruited at all of PHC in Padang City and there are 50 nutritionists. PHC will be recruited using multiple random sampling among districts. Then, individual with T2DM will be selected using simple random sampling among selected PHC. One PHC will be selected at each district. Regarding sample size calculation use HbA1c Standard Deviation, the subjects can be gained, are 158. Therefore, 158 subjects are divided into 11 Districts. There are 12 T2DM patients that will be selected each selected PHC in every district using Random Block. Subjects will be selected following visiting individual with T2DM at PHC.
The study will be conducted at all Public Health Center (PHC) in Padang City. An individual with T2DM will be selected based on inclusion and exclusion criteria, multiply random sampling following a city (Padang), simple random sampling in every district and PHC. One PHC will be selected in every district following the highest number of T2DM patients in each district.
Statistical Analysis Descriptive statistics will be used to examine socio-demographic and current management among nutritionists. The need DM nutrition education among individual with T2DM data, the mean and Standard Deviation (SD) will be calculated for normally distributed continuous variables and frequency (f) and percentage (%) for nominal variables. Pearson's chi-square test will be used to examine independent variables.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Individual with T2DM in both of groups will not know their groups (single blind), but the researcher knows
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •T2DM patients with stroke and complication
- •T2DM patients who are pregnant and breastfeeding women
结局指标
主要结局
HbA1c and Fasting blood glucose
时间窗: 3 months
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.
Statistical analyses for HbA1c and Fasting blood glucose
时间窗: 3 months
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.
次要结局
- Blood Pressure(3 months)
- Statistical analyses for quality of life(3 months)
- Knowledge-Attitude-Practice DM questionnaire(3 months)
- Waist Circumference (WC)(3 months)
- Body Mass Index (BMI), assessed by Seca-Tanita scale(3 months)
- Statistical analyses for Blood Pressure(3 months)
- Statistical analyses for Body Mass Index (BMI)(3 months)
- Statistical analyses for knowledge-attitude-practice DM(3 months)
- Quality of life, assessed by DM Quality of Life questionnaire(3 months)
- Statistical analyses for Waist Circumference(3 months)
研究者
ICE YOLANDA PURI
Principle Investigator
Andalas University