Gestational Diabetes Mellitus in PregnancyNCT06148688
Effect of Digital Storytelling Intervention on Diabetes Self-Management in Pregnant Women With Gestational Diabetes
A study testing Digital Story in people with Gestational Diabetes Mellitus in Pregnancy and Diabetes Self Management, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the effect of digital storytelling intervention on diabetes self-management in women with gestational diabetes. It is a quasi-experimental study with a pretest-posttest control group. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes Mellitus in Pregnancy, Diabetes Self Management
- What is being tested?
- Digital Story
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Mar 2023to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being 18 years or older
- Being diagnosed with Gestational Diabetes
- 24-32. being between weeks of pregnancy
- Having a treatment plan made after gestational diabetes diagnosis
- Volunteering to participate in the study
- Knowing how to read and write Turkish
- Not having any pregnancy complications other than Gestational Diabetes
- Having a smart phone
Who cannot join
- -Pregnant women who do not meet the inclusion criteria will be excluded from the study. Moreover; Pregnant women whose blood sugar monitoring was terminated by the doctor during the follow-up, who did not continue hospital checks during the research period or could not be reached, and who experienced preterm labor before the end of the follow-up will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Izmir Katip Celebi University
Çiğli, İzmir, 35620
Gülşen Işık
About this study
The aim of this study is to evaluate the effect of digital storytelling intervention on diabetes self-management in women with gestational diabetes. It is a quasi-experimental study with a pretest-posttest control group.
The main hypotheses of the study are:
Digital storytelling has an impact on women with gestational diabetes' perception of diabetes self-management.
Digital storytelling has an impact on the diabetes self-efficacy levels of women with gestational diabetes.
Read the detailed description
Women with gestational diabetes who apply to the obstetrics outpatient clinic of the hospital where the study is conducted or who have been hospitalized in the obstetrics clinic and who meet the inclusion criteria will be included in the study. As a result of the G-power analysis, the sample consisted of 21 interventions and 21 control groups. Pre-test data will be collected from pregnant women in both the control and intervention groups through scales.
In the hospital where the study was conducted, pregnant women with gestational diabetes are directed to the Endocrine outpatient clinic and receive standard training by the diabetes team. Pregnant women in the intervention group will be shown videos created in addition to the standard training of the institution where the research data were collected.
Pregnant women in the intervention group will be shown videos created in addition to the standard training of the institution where the research data were collected. Pregnant women participating in the study will be followed for four weeks. Pre-test data will be collected from pregnant women who meet the sampling criteria within the first week and how the research will proceed will be explained. Four separate videos, created specifically for each determined topic, will be sent to women daily via online environments during the first week and they will be made available for viewing. Once a week, short videos will be sent to the pregnant woman as a reminder and she will be allowed to watch them. Women will be asked to keep records of their blood sugar monitoring results for four weeks. In the fourth week, post-test data from women will be collected through scales.
Scales to be used in the research
- Introductory Information Form (pre-test)
- Diabetes Self-Efficacy Scale (pre-test/post-test)
- Perceived Diabetes Self-Management Scale (pre-test/post-test)
- International Physical Activity Questionnaire (pre-test/post-test)
- Blood Sugar Monitoring Form (post-test)
- Being tested
- Digital Story
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital StoryOther
Digital storytelling; It is used in education and training, business marketing, non-profit organizations such as libraries, community centers and museums, and health sciences education. Digital storytelling in health sciences can be a tool for patients and health science professionals to share their experiences, cope with diseases, and add a human element to health problems.
In the study, digital stories were created to increase the self-management of pregnant women with gestational diabetes. In creating a digital story; Qualitative studies involving the self-management experiences of women with gestational diabetes have been examined in the literature. Using the results of the studies, scenarios were created that included factors that facilitate and complicate diabetes self-management. The created scenarios were used in the digital storytelling initiative. A total of four long and four short digital story videos were prepared.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | In addition to the standard training, digital story videos were watched in the intervention group. Digital story videos created in line with four main topics related to diabetes self-management were sent to women via online platforms. During the follow-up period, reminder videos were sent once a week regarding the topics. Pre-test and post-test were administered face to face. Receives: Other: Digital Story |
| Control Group | No intervention | The control group received only standard training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Diabetes Self-Management Scale
The Turkish adaptation of the scale, which was adapted and validated by Wallston et al. (2007), was made by Bayındır Çevik (2010).The scale consists of 7 items and is of 5-point likert type.A high total score indicates that the individual's awareness of diabetes management is very good.
Measured: before and end of the interventions (fourth weeks)
Diabetes Self-Efficacy Scale
This scale was developed by Lorig et al. in 2009 to determine the self-efficacy of individuals with diabetes and was adapted into Turkish by Mankan et al. in 2017.The Likert type scale consists of 8 items. The items of the scale have a numbering system between 1 and 10 (1-I do not feel safe at all, 10-I am completely confident).The scale has no cut-off point. As individuals' total scale scores increase, their self-efficacy also increases.
Measured: before and end of the interventions (fourth weeks)
International Physical Activity Questionnaire
The International Physical Activity Questionnaire was designed to detect the physical activity and sedentary lifestyles of adults. Craig et al. (2003) and the Turkish validity and reliability of the questionnaire developed by Öztürk (2005). The questionnaire is recommended for adults aged 18-69. The short-form questionnaire consists of four separate sections and a total of seven questions. The questionnaire includes questions about physical activity performed for at least 10 minutes in the last seven days.
Calculation of the total score of the short form includes the sum of the duration (minutes) and frequency (days) of walking, moderate activity and vigorous activity. From these calculations, a score in MET-minutes is obtained. One MET-minute; It is calculated by multiplying the minutes of activity performed by the MET score. Walk = 3.3 METs, Moderate physical activity = 4.0 METs, Vigorous physical activity = 8.0 METs
Measured: before and end of the interventions (fourth weeks)
Secondary outcomes (1)
Blood Sugar Monitoring Form
Women in the sample group will be asked to record their fasting and 1-hour postprandial blood sugar results in the morning, noon and evening for 4 weeks. The blood sugar monitoring form was prepared by the researcher.
Measured: first week, second week, third week and fourth week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start27 Mar 2023
- Primary completionNov 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes Mellitus in PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Collaborators
- Ege University
- Responsible party
- Principal investigator, Gulsen Isık, Izmir Katip Celebi University
- Investigators
- Gülşen Işık, Principal investigator, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06148688
- Sponsor's protocol ID
- 21-2.1T/39
- Status last verified
- Nov 2023
- First submitted
- 20 Nov 2023
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Digital Storytelling Intervention on Diabetes Self-Management in Pregnant Women With Gestational Diabetes
- ClinicalTrials.gov ID
- NCT06148688
- Acronym / sponsor ID
- 21-2.1T/39
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Collaborators
- Ege University
- Study start
- 27 Mar 2023 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 28 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the effect of digital storytelling intervention on diabetes self-management in women with gestational diabetes. It is a quasi-experimental study with a pretest-posttest control group.
The main hypotheses of the study are:
Digital storytelling has an impact on women with gestational diabetes' perception of diabetes self-management.
Digital storytelling has an impact on the diabetes self-efficacy levels of women with gestational diabetes.
Detailed description
Women with gestational diabetes who apply to the obstetrics outpatient clinic of the hospital where the study is conducted or who have been hospitalized in the obstetrics clinic and who meet the inclusion criteria will be included in the study. As a result of the G-power analysis, the sample consisted of 21 interventions and 21 control groups. Pre-test data will be collected from pregnant women in both the control and intervention groups through scales.
In the hospital where the study was conducted, pregnant women with gestational diabetes are directed to the Endocrine outpatient clinic and receive standard training by the diabetes team. Pregnant women in the intervention group will be shown videos created in addition to the standard training of the institution where the research data were collected.
Pregnant women in the intervention group will be shown videos created in addition to the standard training of the institution where the research data were collected. Pregnant women participating in the study will be followed for four weeks. Pre-test data will be collected from pregnant women who meet the sampling criteria within the first week and how the research will proceed will be explained. Four separate videos, created specifically for each determined topic, will be sent to women daily via online environments during the first week and they will be made available for viewing. Once a week, short videos will be sent to the pregnant woman as a reminder and she will be allowed to watch them. Women will be asked to keep records of their blood sugar monitoring results for four weeks. In the fourth week, post-test data from women will be collected through scales.
Scales to be used in the research
- Introductory Information Form (pre-test)
- Diabetes Self-Efficacy Scale (pre-test/post-test)
- Perceived Diabetes Self-Management Scale (pre-test/post-test)
- International Physical Activity Questionnaire (pre-test/post-test)
- Blood Sugar Monitoring Form (post-test)
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Digital StoryIn addition to the standard training, digital story videos were watched in the intervention group. Digital story videos created in line with four main topics related to diabetes self-management were sent to women via online platforms. During the follow-up period, reminder videos were sent once a week regarding the topics. Pre-test and post-test were administered face to face. |
| Control Group | No intervention | –The control group received only standard training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Being 18 years or older
- Being diagnosed with Gestational Diabetes
- 24-32. being between weeks of pregnancy
- Having a treatment plan made after gestational diabetes diagnosis
- Volunteering to participate in the study
Key exclusion criteria (1 listed)
- -Pregnant women who do not meet the inclusion criteria will be excluded from the study. Moreover; Pregnant women whose blood sugar monitoring was terminated by the doctor during the follow-up, who did not continue hospital checks during the research period or could not be reached, and who experienced preterm labor before the end of the follow-up will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital StoryDigital storytelling; It is used in education and training, business marketing, non-profit organizations such as libraries, community centers and museums, and health sciences education. Digital storytelling in health sciences can be a tool for patients and health science professionals to share their experiences, cope with diseases, and add a human element to health problems. In the study, digital stories were created to increase the self-management of pregnant women with gestational diabetes. In creating a digital story; Qualitative studies involving the self-management experiences of women with gestational diabetes have been examined in the literature. Using the results of the studies, scenarios were created that included factors that facilitate and complicate diabetes self-management. The created scenarios were used in the digital storytelling initiative. A total of four long and four short digital story videos were prepared. | Other | Intervention Group |
Primary outcome
Perceived Diabetes Self-Management Scale
Time frame: before and end of the interventions (fourth weeks)
The Turkish adaptation of the scale, which was adapted and validated by Wallston et al. (2007), was made by Bayındır Çevik (2010).The scale consists of 7 items and is of 5-point likert type.A high total score indicates that the individual's awareness of diabetes management is very good.
Diabetes Self-Efficacy Scale
Time frame: before and end of the interventions (fourth weeks)
This scale was developed by Lorig et al. in 2009 to determine the self-efficacy of individuals with diabetes and was adapted into Turkish by Mankan et al. in 2017.The Likert type scale consists of 8 items. The items of the scale have a numbering system between 1 and 10 (1-I do not feel safe at all, 10-I am completely confident).The scale has no cut-off point. As individuals' total scale scores increase, their self-efficacy also increases.
International Physical Activity Questionnaire
Time frame: before and end of the interventions (fourth weeks)
The International Physical Activity Questionnaire was designed to detect the physical activity and sedentary lifestyles of adults. Craig et al. (2003) and the Turkish validity and reliability of the questionnaire developed by Öztürk (2005). The questionnaire is recommended for adults aged 18-69. The short-form questionnaire consists of four separate sections and a total of seven questions. The questionnaire includes questions about physical activity performed for at least 10 minutes in the last seven days. Calculation of the total score of the short form includes the sum of the duration (minutes) and frequency (days) of walking, moderate activity and vigorous activity. From these calculations, a score in MET-minutes is obtained. One MET-minute; It is calculated by multiplying the minutes of activity performed by the MET score. Walk = 3.3 METs, Moderate physical activity = 4.0 METs, Vigorous physical activity = 8.0 METs
1 secondary outcome
Blood Sugar Monitoring Form
Time frame: first week, second week, third week and fourth week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gülşen Işık principal investigator
Izmir Katip Celebi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Story in people with Gestational Diabetes Mellitus in Pregnancy and Diabetes Self Management, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gülşen Işık (+902323293535, glsen20@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Diabetes Self-Management Scale (time frame: before and end of the interventions (fourth weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.