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The Effects of Short Message Notifications on Middle-Aged Diabetic Patients

Primary Purpose

Type2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Informative messages
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type2 Diabetes Mellitus focused on measuring Diabetes mellitus, Public health

Eligibility Criteria

40 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of Type 2 Diabetes Mellitus (T2DM) between the last 1 and 10 years
  • Being aged between 40 and 64 years old,
  • Is treated for a minimum of 1 year with at least one oral antidiabetic drug.

Exclusion Criteria:

  • Clinical diagnosis of T2DM for less than 1 year or more than 10 years.
  • Those who have had surgery or a cardiac event in the last 3 months or during the investigation.
  • Those under 40 and over 64 years of age.
  • Patients with T2DM that have not been treated with oral antidiabetic medication.
  • Volunteers who once did not participate in the control examinations in both groups were excluded from the evaluation.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    SMS Group

    Control Group

    Arm Description

    In addition to traditional treatment received three to four informative SMS messages per week during the 6-month period

    Followed in accordance with the traditional treatment schedule

    Outcomes

    Primary Outcome Measures

    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).
    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).
    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).
    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.
    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
    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
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.

    Secondary Outcome Measures

    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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
    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
    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.
    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.
    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.
    Baseline Energy Intake
    From the last three days' food intake form the average calories (kcal) of macro and micronutrients are calculated.
    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.
    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.

    Full Information

    First Posted
    January 16, 2021
    Last Updated
    January 28, 2021
    Sponsor
    Istanbul University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04733612
    Brief Title
    The Effects of Short Message Notifications on Middle-Aged Diabetic Patients
    Official Title
    Effects of Short-Message Notifications on Medication Adherence, Physical Activity and Fasting Blood Glucose Control and Correlation of These With the Health-Related Quality of Life in Mid-aged Diabetic Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    June 30, 2016 (Actual)
    Primary Completion Date
    December 20, 2017 (Actual)
    Study Completion Date
    February 26, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Istanbul University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type2 Diabetes Mellitus
    Keywords
    Diabetes mellitus, Public health

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    125 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    SMS Group
    Arm Type
    Experimental
    Arm Description
    In addition to traditional treatment received three to four informative SMS messages per week during the 6-month period
    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    Followed in accordance with the traditional treatment schedule
    Intervention Type
    Other
    Intervention Name(s)
    Informative messages
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Fasting blood glucose
    Description
    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
    Title
    Change from Baseline Fasting blood glucose at 3 months
    Description
    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
    Title
    Change from Baseline Fasting blood glucose at 6 months
    Description
    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
    Title
    Glycated hemoglobin A (HbA1c)
    Description
    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
    Title
    Change from Baseline of Glycated hemoglobin A (HbA1c) at 3 months
    Description
    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
    Title
    Change from Baseline of Glycated hemoglobin A (HbA1c) at 6 months
    Description
    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
    Title
    Physical Activity level
    Description
    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
    Title
    Change from Baseline Physical Activity at 3 months
    Description
    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
    Title
    Change from Baseline Physical Activity at 6 months
    Description
    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
    Title
    Drug Adherence
    Description
    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
    Title
    Change from Baseline Drug Adherence at 3 months
    Description
    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
    Title
    Change from Baseline Drug Adherence at 6 months
    Description
    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
    Title
    Quality of Life Assessed by SF-36v2
    Description
    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
    Title
    Change from Baseline Quality of Life Assessed by SF-36v2 at 3 months
    Description
    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
    Title
    Change from Baseline Quality of Life Assessed by SF-36v2 at 6 months
    Description
    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
    Secondary Outcome Measure Information:
    Title
    Baseline blood pressure
    Description
    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
    Title
    Change from Baseline blood pressure at 3 months
    Description
    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
    Title
    Change from Baseline blood pressure at 6 months
    Description
    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
    Title
    Baseline heart rate
    Description
    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
    Title
    Change from Baseline heart rate at 3 months
    Description
    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
    Title
    Change from Baseline heart rate at 6 months
    Description
    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
    Title
    Baseline Body Mass Index
    Description
    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
    Title
    Change from Baseline Body Mass Index at 3 months
    Description
    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
    Title
    Change from Baseline Body Mass Index at 6 months
    Description
    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
    Title
    Baseline body fat ratios
    Description
    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
    Title
    Change from Baseline Body Fat Ratios at 3 Months
    Description
    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
    Title
    Change from Baseline Body Fat Ratios at 6 Months
    Description
    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
    Title
    Baseline waist/hip ratio
    Description
    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
    Title
    Change from Baseline waist/hip ratio at 3 Months
    Description
    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
    Title
    Baseline Diet and Nutritional Habits
    Description
    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
    Title
    Change from Baseline Diet and Nutritional Habits at 3 months
    Description
    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
    Title
    Change from Baseline Diet and Nutritional Habits at 6 months
    Description
    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
    Title
    Baseline Energy Intake
    Description
    From the last three days' food intake form the average calories (kcal) of macro and micronutrients are calculated.
    Time Frame
    Beginning
    Title
    Change from Baseline Energy Intake at 3 months
    Description
    From the last three days' food intake form the average calories (kcal) of macro and micronutrients are calculated.
    Time Frame
    3 months after Beginning
    Title
    Change from Baseline Energy Intake at 6 months
    Description
    From the last three days' food intake form the average calories (kcal) of macro and micronutrients are calculated.
    Time Frame
    6 months after Beginning

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    64 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Clinical diagnosis of Type 2 Diabetes Mellitus (T2DM) between the last 1 and 10 years Being aged between 40 and 64 years old, Is treated for a minimum of 1 year with at least one oral antidiabetic drug. Exclusion Criteria: Clinical diagnosis of T2DM for less than 1 year or more than 10 years. Those who have had surgery or a cardiac event in the last 3 months or during the investigation. Those under 40 and over 64 years of age. Patients with T2DM that have not been treated with oral antidiabetic medication. Volunteers who once did not participate in the control examinations in both groups were excluded from the evaluation.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Suphi Vehid, Prof. Dr.
    Organizational Affiliation
    Istanbul University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    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.
    Citations:
    PubMed Identifier
    35330570
    Citation
    Tahirbegolli B, Tahirbegolli IA, Cakmak R, Idiz C, Cavdar S, Bagdemir E, Vehid S. Effects of Short-message Notifications on Type 2 Diabetes Management in Middle-aged Turkish Patients: A Randomized Trial. Balkan Med J. 2022 Mar 14;39(2):161-162. doi: 10.4274/balkanmedj.galenos.2021.2021-10-47. No abstract available.
    Results Reference
    derived

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    The Effects of Short Message Notifications on Middle-Aged Diabetic Patients

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