Gestational DiabetesNCT03240289
Texting for Diabetes Success in Pregnancy
A study testing Texting group in people with Gestational Diabetes and Pregnancy in Diabetics, run by Northwestern University.
Trial summary
Diabetes during pregnancy can be a challenging circumstance requiring extensive patient learning and self-care. The purpose of this study is to develop and pilot test a patient-centered diabetes education and self-care tool using text messaging to provide supportive messaging and education to underserved women with a… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes, Pregnancy in Diabetics
- What is being tested?
- Texting group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- Dec 2013to Dec 2016
- 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
- Pregnant
- English-speaking
- Have gestational diabetes mellitus, type 2 diabetes mellitus, or type 1 diabetes mellitus
- Age 18 years or older
- Access to a phone that can receive text messages
Who cannot join
- Gestational age greater than 30 weeks
- Women not meeting the above inclusion criteria
About this study
Official title: Use of Text Messaging to Reduce Barriers to Self-care for Low-income Pregnant Women With Diabetes
Diabetes during pregnancy can be a challenging circumstance requiring extensive patient learning and self-care. The purpose of this study is to develop and pilot test a patient-centered diabetes education and self-care tool using text messaging to provide supportive messaging and education to underserved women with a pregnancy complicated by diabetes.
Read the detailed description
Low-income, pregnant women in the Chicago area are frequently affected by obesity or diabetes. The addition of a disease in pregnancy amplifies the requirements for optimal self-care during pregnancy. This load of information poses a significant burden, particularly for women with additional socioeconomic barriers to self-care. Preliminary work suggests patients must overcome a number of social, psychological, and knowledge-based barriers to achieve successful diabetic control in pregnancy.
This project involves development and preliminary evaluation of a patient-centered education and self-care tool for use with women whose pregnancies are complicated by diabetes. The study begins with development of a text messaging curriculum to provide motivational and educational support. We will use a one-way, non-interactive text-based educational platform to provide supportive and educational messages to a cohort of 40 women with diabetes. Women receive 3-5 text messages per week until delivery. The goal is to develop a program that can be expanded to a clinical trial in which perinatal outcomes are assessed.
The primary outcome is patient satisfaction and opinions about the texting program, as measured via a qualitative interview upon study completion. Participants underwent an enrollment survey to assess health literacy/numeracy, diabetes self-efficacy, diabetes knowledge, personality, and social hassles. They underwent a baseline in-depth one-on-one interview focusing on barriers to successful self-care with pregnancy and diabetes. Follow-up surveys and an exit interview elicited information about their opinions of the texting program. Additional goals included determining feasibility for future expansion as a trial.
- Conditions
- Gestational Diabetes, Pregnancy in Diabetics
- Being tested
- Texting group
- Medical subject headings
- Diabetes, Gestational, Pregnancy in Diabetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Texting groupBehavioural
Women receive text messages to aid in their diabetes self-care tasks during pregnancy; these included appointment reminders, motivational messages, and nutrition/exercise tips.
| Study group | Role | What they receive |
|---|---|---|
| Texting | Other | Texting group Receives: Behavioral: Texting group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction and feedback
A single qualitative interview of patient perspectives and areas for improvement in the text messaging program. Interview takes place between 35 weeks gestation and discharge after delivery (postpartum day 2)
Measured: Up to 42 weeks
Secondary outcomes (4)
Diabetes self-efficacy (Measured using the Diabetes Empowerment Scale-Short Form)
Assessment of diabetes self-efficacy. Survey takes place after 35 weeks gestation and before discharge after delivery (postpartum day 2)
Measured: Up to 42 weeks
Barriers and facilitators of diabetes self-management
Qualitative interview of patient experiences regarding having diabetes during pregnancy
Measured: Study enrollment
Study feasibility (as measured by number of participants retained in the study)
Ability to recruit and retain participants
Measured: Up to 42 weeks
Diabetes self-efficacy (Measured using the Perceived Diabetes Self-Management Scale)
Assessment of diabetes self-efficacy. Survey takes place after 35 weeks gestation and before discharge after delivery (postpartum day 2)
Measured: Up to 42 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study startDec 2013
- Primary completionDec 2015
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm feasibility and pilot testing study of a curriculum
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melissa A Simon, MD, MPH, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03240289
- Sponsor's protocol ID
- STU00084353
- Status last verified
- Oct 2023
- First submitted
- 14 Jul 2017
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Text Messaging to Reduce Barriers to Self-care for Low-income Pregnant Women With Diabetes
- ClinicalTrials.gov ID
- NCT03240289
- Acronym / sponsor ID
- STU00084353
- Conditions
- Gestational Diabetes, Pregnancy in Diabetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Dec 2013 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 7 Aug 2017 (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.
Diabetes during pregnancy can be a challenging circumstance requiring extensive patient learning and self-care. The purpose of this study is to develop and pilot test a patient-centered diabetes education and self-care tool using text messaging to provide supportive messaging and education to underserved women with a pregnancy complicated by diabetes.
Detailed description
Low-income, pregnant women in the Chicago area are frequently affected by obesity or diabetes. The addition of a disease in pregnancy amplifies the requirements for optimal self-care during pregnancy. This load of information poses a significant burden, particularly for women with additional socioeconomic barriers to self-care. Preliminary work suggests patients must overcome a number of social, psychological, and knowledge-based barriers to achieve successful diabetic control in pregnancy.
This project involves development and preliminary evaluation of a patient-centered education and self-care tool for use with women whose pregnancies are complicated by diabetes. The study begins with development of a text messaging curriculum to provide motivational and educational support. We will use a one-way, non-interactive text-based educational platform to provide supportive and educational messages to a cohort of 40 women with diabetes. Women receive 3-5 text messages per week until delivery. The goal is to develop a program that can be expanded to a clinical trial in which perinatal outcomes are assessed.
The primary outcome is patient satisfaction and opinions about the texting program, as measured via a qualitative interview upon study completion. Participants underwent an enrollment survey to assess health literacy/numeracy, diabetes self-efficacy, diabetes knowledge, personality, and social hassles. They underwent a baseline in-depth one-on-one interview focusing on barriers to successful self-care with pregnancy and diabetes. Follow-up surveys and an exit interview elicited information about their opinions of the texting program. Additional goals included determining feasibility for future expansion as a trial.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm feasibility and pilot testing study of a curriculum
| Arm | Type | Receives |
|---|---|---|
| Texting | Other | Behavioral: Texting groupTexting group |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pregnant
- English-speaking
- Have gestational diabetes mellitus, type 2 diabetes mellitus, or type 1 diabetes mellitus
- Age 18 years or older
- Access to a phone that can receive text messages
Key exclusion criteria (2 listed)
- Gestational age greater than 30 weeks
- Women not meeting the above inclusion criteria
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 |
|---|---|---|
| Texting groupWomen receive text messages to aid in their diabetes self-care tasks during pregnancy; these included appointment reminders, motivational messages, and nutrition/exercise tips. | Behavioural | Texting |
Primary outcome
Patient satisfaction and feedback
Time frame: Up to 42 weeks
A single qualitative interview of patient perspectives and areas for improvement in the text messaging program. Interview takes place between 35 weeks gestation and discharge after delivery (postpartum day 2)
4 secondary outcomes
Diabetes self-efficacy (Measured using the Diabetes Empowerment Scale-Short Form)
Time frame: Up to 42 weeks
Barriers and facilitators of diabetes self-management
Time frame: Study enrollment
Study feasibility (as measured by number of participants retained in the study)
Time frame: Up to 42 weeks
Diabetes self-efficacy (Measured using the Perceived Diabetes Self-Management Scale)
Time frame: Up to 42 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Gestational Diabetes
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Metformin for the Treatment of Microvascular Dysfunction After Gestational Diabetes
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Fueling Labor: Protein Supplementation for Intrapartum Glucose Control
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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.
Melissa A Simon, MD, MPH principal investigator
Northwestern University
Questions about this trial
What is this clinical trial studying?
A study testing Texting group in people with Gestational Diabetes and Pregnancy in Diabetics, run by Northwestern University.
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 5 inclusion and 2 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: finished, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction and feedback (time frame: Up to 42 weeks). 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 2 Nov 2023.