An interventional study of Informative messages in Type2 Diabetes Mellitus, sponsored by Istanbul University. Completed. Open to participants aged 40 Years to 64 Years. Per ClinicalTrials.gov, last updated 2021-02-02.
Sponsored by Istanbul University · Not applicable, Interventional, and Prevention
The objective of our study was to assess awareness-raising of medication adherence (MA), physical activity (PA), fasting blood glucose (FBG), and glycated hemoglobin A (HbA1c) values by providing information on diabetes via short message (SMS) technology.
The study investigates T2DM patients who have not had surgery or cardiac event in the last 3 months, between the ages of 40 and 64 years, with T2DM diagnosis between the last 1 and 10 years and oral antidiabetic therapy for at least 1 The study design is a single-blinded randomized, controlled study, and was conducted in the Diabetes Polyclinic of the Istanbul University Medical Faculty Hospital.
Patients randomly assigned to the intervention group, in addition to traditional treatment received three to four informative SMS messages per week during the 6-month period, while the control group was followed in accordance with the traditional treatment schedule.
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Exclusion Criteria:
In addition to traditional treatment received three to four informative SMS messages per week during the 6-month period
Other: Informative messages
Followed in accordance with the traditional treatment schedule
In addition to their standard treatments, an informative SMS (text message) on diabetes was sent to the intervention group three to four times a week for six months. The short messages were in the form of a short sentence for the subject and the predicate. The messages sent have been prepared in such a way that they do not exceed 1 SMS quota and are less than 160 characters on mobile phones.
Fasting blood glucose
After 8 hours of fasting in the morning, venous whole blood samples were taken to yellow capped tubes for fasting blood glucose (mmol/dL).
Time frame: Beginning
Change from Baseline Fasting blood glucose at 3 months
After 8 hours of fasting in the morning, venous whole blood samples were taken to yellow capped tubes for fasting blood glucose (mmol/dL).
Time frame: 3 months after beginning
Change from Baseline Fasting blood glucose at 6 months
After 8 hours of fasting in the morning, venous whole blood samples were taken to yellow capped tubes for fasting blood glucose (mmol/dL).
Time frame: 6 months after beginning
Glycated hemoglobin A (HbA1c)
In the HbA1c evaluation (%), after 8 hours of fasting by volunteers, venous whole blood samples were taken in purple tubes (EDTA) between 08:00 and 10:00 a.m. and evaluated by the HPLC method.
Time frame: Beginning
Change from Baseline of Glycated hemoglobin A (HbA1c) at 3 months
In the HbA1c evaluation (%), after 8 hours of fasting by volunteers, venous whole blood samples were taken in purple tubes (EDTA) between 08:00 and 10:00 a.m. and evaluated by the HPLC method
Time frame: 3 months after beginning
Change from Baseline of Glycated hemoglobin A (HbA1c) at 6 months
In the HbA1c evaluation (%), after 8 hours of fasting by volunteers, venous whole blood samples were taken in purple tubes (EDTA) between 08:00 and 10:00 a.m. and evaluated by the HPLC method
Time frame: 6 months after beginning
Physical Activity level
The International Physical Activity Questionnaire (IPAQ) was used to evaluate the physical activity level of the participants at the beginning of the study. This measure assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting. The higher scores mean a better outcome.
Time frame: Beginning
Change from Baseline Physical Activity at 3 months
The International Physical Activity Questionnaire (IPAQ) was used to evaluate the physical activity level of the participants at at 3 months after the beginning of the study. This measure assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting. The higher scores mean a better outcome.
Time frame: 3 months from beginning
Change from Baseline Physical Activity at 6 months
The International Physical Activity Questionnaire (IPAQ) was used to evaluate the change in physical activity level of the participants at at 6 months after the beginning of the study. This measure assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting. The higher scores mean a better outcome.
Time frame: 6 months from beginning
Drug Adherence
The Morisky Medication Adherence Scale (MMAS-8) was used to assess the compliance of patients with drug treatment. If the patient scores higher on the scale, they will be assessed as more adherent. If they score lower on the scale, they are presumed to be struggling with non-adherence.
Time frame: Beginning
Change from Baseline Drug Adherence at 3 months
The Morisky Medication Adherence Scale was used to assess the compliance of patients with drug treatment. If the patient scores higher on the scale, they will be assessed as more adherent. If they score lower on the scale, they are presumed to be struggling with non-adherence.
Time frame: 3 months after beginning
Change from Baseline Drug Adherence at 6 months
The Morisky Medication Adherence Scale (MMAS-8) was used to assess the compliance of patients with drug treatment. If the patient scores higher on the scale, they will be assessed as more adherent. If they score lower on the scale, they are presumed to be struggling with non-adherence.
Time frame: 6 months after beginning
Quality of Life Assessed by SF-36v2
The Short-Form Health Survey (SF-36v2) is used to asses the quality of life of volunteers'. It has 36 items grouped in 8 dimensions: physical functioning, physical and emotional limitations, social functioning, bodily pain, general and mental health. The higher scores mean a better outcome.
Time frame: Beginning
Change from Baseline Quality of Life Assessed by SF-36v2 at 3 months
The Short-Form Health Survey (SF-36v2) is used to asses the quality of life of volunteers'. It has 36 items grouped in 8 dimensions: physical functioning, physical and emotional limitations, social functioning, bodily pain, general and mental health. The higher scores mean a better outcome.
Time frame: 3 months after beginning
Change from Baseline Quality of Life Assessed by SF-36v2 at 6 months
The Short-Form Health Survey (SF-36v2) is used to asses the quality of life of volunteers'. It has 36 items grouped in 8 dimensions: physical functioning, physical and emotional limitations, social functioning, bodily pain, general and mental health. The higher scores mean a better outcome.
Time frame: 6 months after beginning
Baseline blood pressure
The volunteers' systolic and diastolic blood pressure (mmHg) was measured by a physician through a manual cuff and stethoscope after sitting for at least 5 minutes, from the left arm at the level of the heart, as suggested in the literature.
Time frame: Beginning
Change from Baseline blood pressure at 3 months
The volunteers' systolic and diastolic blood pressure (mmHg) was measured by a physician through a manual cuff and stethoscope after sitting for at least 5 minutes, from the left arm at the level of the heart, as suggested in the literature.
Time frame: 3 months after beginning
Change from Baseline blood pressure at 6 months
The volunteers' systolic and diastolic blood pressure (mmHg) was measured by a physician through a manual cuff and stethoscope after sitting for at least 5 minutes, from the left arm at the level of the heart, as suggested in the literature.
Time frame: 6 months after beginning
Baseline heart rate
The volunteers' heart rate count was measured by a finger-type pulse oximeter, from the index finger of the right or left hand after resting for at least 5 minutes.
Time frame: Beginning
Change from Baseline heart rate at 3 months
The volunteers' heart rate count was measured by a finger-type pulse oximeter, from the index finger of the right or left hand after resting for at least 5 minutes.
Time frame: 3 Months After Beginning
Change from Baseline heart rate at 6 months
The volunteers' heart rate count was measured by a finger-type pulse oximeter, from the index finger of the right or left hand after resting for at least 5 minutes.
Time frame: 6 Months After Beginning
Baseline Body Mass Index
The height (cm) of the volunteers was obtained in the morning, after 8 hours of fasting, without shoes, standing upright, by measuring the distance from the top of the head to the floor with a calibrated stadiometer. Body weight (kg) were measured in the morning after 8 hours of fasting, with light clothing and bare feet, with a calibrated and valid 'Tanita Body Composition Analyzer TBF-410GS' brand bioelectrical impedance analyzer. Body Mass Index (BMI) is calculated using a person's height and weight as shown in formula: BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in meter square.
Time frame: Beginning
Change from Baseline Body Mass Index at 3 months
The height (cm) of the volunteers was obtained in the morning, after 8 hours of fasting, without shoes, standing upright, by measuring the distance from the top of the head to the floor with a calibrated stadiometer. Body weight (kg) were measured in the morning after 8 hours of fasting, with light clothing and bare feet, with a calibrated and valid 'Tanita Body Composition Analyzer TBF-410GS' brand bioelectrical impedance analyzer. Body Mass Index (BMI) is calculated using a person's height and weight as shown in formula: BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in meter square.
Time frame: 3 months after Beginning
Change from Baseline Body Mass Index at 6 months
The height (cm) of the volunteers was obtained in the morning, after 8 hours of fasting, without shoes, standing upright, by measuring the distance from the top of the head to the floor with a calibrated stadiometer. Body weight (kg) were measured in the morning after 8 hours of fasting, with light clothing and bare feet, with a calibrated and valid 'Tanita Body Composition Analyzer TBF-410GS' brand bioelectrical impedance analyzer. Body Mass Index (BMI) is calculated using a person's height and weight as shown in formula: BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in meter square.
Time frame: 6 months after Beginning
Baseline body fat ratios
The body fat ratios were measured in the morning after 8 hours of fasting, with light clothing and bare feet, with a calibrated and valid 'Tanita Body Composition Analyzer TBF-410GS' brand bioelectrical impedance analyzer.
Time frame: Beginning
Change from Baseline Body Fat Ratios at 3 Months
The body fat ratios were measured in the morning after 8 hours of fasting, with light clothing and bare feet, with a calibrated and valid 'Tanita Body Composition Analyzer TBF-410GS' brand bioelectrical impedance analyzer.
Time frame: 3 Months After Beginning
Change from Baseline Body Fat Ratios at 6 Months
The body fat ratios were measured in the morning after 8 hours of fasting, with light clothing and bare feet, with a calibrated and valid 'Tanita Body Composition Analyzer TBF-410GS' brand bioelectrical impedance analyzer.
Time frame: 6 Months After Beginning
Baseline waist/hip ratio
The volunteers waist and hip circumference and waist/hip ratio were measured by tape measure after 8 hours of fasting in the morning with thin clothes on them. Waist circumference (cm) was measured at the level of the umbilicus and hip circumference (cm) at the level of the femur trochanter major. Waist/hip ratio (WHR) were were calculated as follows waist/hip ratio= waist circumference / hip circumference
Time frame: Beginning
Change from Baseline waist/hip ratio at 3 Months
The volunteers waist and hip circumference and waist/hip ratio were measured by tape measure after 8 hours of fasting in the morning with thin clothes on them. Waist circumference (cm) was measured at the level of the umbilicus and hip circumference (cm) at the level of the femur trochanter major. Waist/hip ratio (WHR) were were calculated as follows waist/hip ratio= waist circumference / hip circumference
Time frame: 3 Months after Beginning
Baseline Diet and Nutritional Habits
The last three days' food intake form is used to collect the information about daily nutritional habits of volunteers'. The amount of food and the frequency are marked.
Time frame: Beginning
Change from Baseline Diet and Nutritional Habits at 3 months
The last three days' food intake form is used to collect the information about daily nutritional habits of volunteers'. The amount of food and the frequency are marked.
Time frame: 3 Months after Beginning
Change from Baseline Diet and Nutritional Habits at 6 months
The last three days' food intake form is used to collect the information about daily nutritional habits of volunteers'. The amount of food and the frequency are marked.
Time frame: 6 Months after Beginning
Baseline Energy Intake
From the last three days' food intake form the average calories (kcal) of macro and micronutrients are calculated.
Time frame: Beginning
Change from Baseline Energy Intake at 3 months
From the last three days' food intake form the average calories (kcal) of macro and micronutrients are calculated.
Time frame: 3 months after Beginning
Change from Baseline Energy Intake at 6 months
From the last three days' food intake form the average calories (kcal) of macro and micronutrients are calculated.
Time frame: 6 months after Beginning
No study locations are listed for this record.
Plan to share: No — Since the start date of the study is before 18 January 2017, individual participant data (IPD) will only be available to other researchers on a reasonable request.
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Istanbul University