Diabetes Mellitus, Type 2NCT03971838
Diabetes Prevention Programming for Women With a History of Gestational Diabetes
A study testing Positive Outcomes for Women in people with Diabetes Mellitus, Type 2, run by Indiana University at 1 site in United States.
Trial summary
The purpose of this study is to offer women with a history of gestational diabetes access to diabetes prevention programming; their children 10 and older can participate. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Positive Outcomes for Women
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2019to 30 Jun 2022
- 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 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of gestational diabetes in a previous pregnancy
- Age 18+
Who cannot join
- ·Currently pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Riley Hospital for Children
Indianapolis, Indiana, 46202
About this study
The purpose of this study is to offer women with a history of gestational diabetes access to diabetes prevention programming; their children 10 and older can participate.
Read the detailed description
The purpose of this study is to offer women with a history of gestational diabetes access to diabetes prevention programming; their children 10 and older can participate. There are two potential types of participants:
- Women and their children 10+ can consent to participate in the diabetes prevention programming offered through Dr. Hannon's center (called Encourage). Researchers will collect data at three time points, baseline, 4-6 months, and 12 months.
- Instead of participating in Encourage, women may participate in other diabetes prevention programming/weight management programming offered by other entities. Researchers will consent these women into the study to complete 3 data collection points, baseline, 4-6 months, and 12 months. Additionally, researchers will consent women to obtain data from their chosen program. For instance, if a woman chooses to do a Diabetes Prevention Program through the YMCA, researchers will ask women to self report their weekly attendance and weight.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Positive Outcomes for Women
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Outcomes for WomenBehavioural
Women and their children 10+ can consent to participate in the diabetes prevention programming offered through the research center. We will collect data at three time points, baseline, 4-6 months, and 12 months.
- Instead of participating in Encourage, women may participate in other diabetes prevention programming/weight management programming offered by other entities. Researchers will consent these women into the study to complete 3 data collection points, baseline, 4-6 months, and 12 months. Additionally, researchers will consent women to obtain data from their chosen program. For instance, if a woman chooses to do a Diabetes Prevention Program through the YMCA, researchers will ask women to self report their weekly attendance and weight.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Women with a history of gestational diabetes will be offered 4-6 months of a diabetes prevention program. Receives: Behavioral: Positive Outcomes for Women |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment and participation rates in a diabetes prevention intervention
Enrollment and participation rates in a diabetes prevention intervention
Measured: 12 months
Secondary outcomes (2)
HbA1c
HbA1c
Measured: 12 months
BMI
Height and weight combined to report as BMI
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start1 Jun 2019
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Indiana 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamara S. Hannon, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03971838
- Sponsor's protocol ID
- 1812789354
- Status last verified
- Aug 2022
- First submitted
- 24 May 2019
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Prevention Programming for Women With a History of Gestational Diabetes
- ClinicalTrials.gov ID
- NCT03971838
- Acronym / sponsor ID
- 1812789354
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 3 Jun 2019 (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 purpose of this study is to offer women with a history of gestational diabetes access to diabetes prevention programming; their children 10 and older can participate.
Detailed description
The purpose of this study is to offer women with a history of gestational diabetes access to diabetes prevention programming; their children 10 and older can participate. There are two potential types of participants:
- Women and their children 10+ can consent to participate in the diabetes prevention programming offered through Dr. Hannon's center (called Encourage). Researchers will collect data at three time points, baseline, 4-6 months, and 12 months.
- Instead of participating in Encourage, women may participate in other diabetes prevention programming/weight management programming offered by other entities. Researchers will consent these women into the study to complete 3 data collection points, baseline, 4-6 months, and 12 months. Additionally, researchers will consent women to obtain data from their chosen program. For instance, if a woman chooses to do a Diabetes Prevention Program through the YMCA, researchers will ask women to self report their weekly attendance and weight.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Positive Outcomes for WomenWomen with a history of gestational diabetes will be offered 4-6 months of a diabetes prevention program. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- History of gestational diabetes in a previous pregnancy
- Age 18+
Key exclusion criteria (1 listed)
- ·Currently pregnant
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 |
|---|---|---|
| Positive Outcomes for WomenWomen and their children 10+ can consent to participate in the diabetes prevention programming offered through the research center. We will collect data at three time points, baseline, 4-6 months, and 12 months. 2. Instead of participating in Encourage, women may participate in other diabetes prevention programming/weight management programming offered by other entities. Researchers will consent these women into the study to complete 3 data collection points, baseline, 4-6 months, and 12 months. Additionally, researchers will consent women to obtain data from their chosen program. For instance, if a woman chooses to do a Diabetes Prevention Program through the YMCA, researchers will ask women to self report their weekly attendance and weight. | Behavioural | Intervention Arm |
Primary outcome
Enrollment and participation rates in a diabetes prevention intervention
Time frame: 12 months
Enrollment and participation rates in a diabetes prevention intervention
2 secondary outcomes
HbA1c
Time frame: 12 months
BMI
Time frame: 12 months
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 3 Aug 2022.
- Individual participant dataSharing planned: Undecided. Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Outcomes for Women in people with Diabetes Mellitus, Type 2, run by Indiana University at 1 site in United States.
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 2 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: finished, as of the sponsor's last update on 3 Aug 2022. 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 United States. 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?
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?
Enrollment and participation rates in a diabetes prevention intervention (time frame: 12 months). 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 3 Aug 2022.