Gestational DiabetesNCT03766256
Shared Decision Making in Diabetes Prevention for Women With a History of GDM
A study testing Shared decision-making with pharmacists in people with Gestational Diabetes, run by University of California, Los Angeles at 20 sites in United States.
Trial summary
Gestational diabetes mellitus (GDM) is a risk factor for the development of Type 2 diabetes. Lifestyle change and metformin are equally effective in preventing diabetes in patients with a history of GDM, so these women should choose a strategy based on their preferences and values, which may vary by race/ethnicity. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Shared decision-making with pharmacists
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 20 sitesUnited States
- Study dates
- 1 Mar 2019to 28 Dec 2019
- 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 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Overweight or obese (BMI >25 or >23 if Asian American)
- at least 6 weeks post-partum
- have a history of gestational diabetes mellitus
Who cannot join
- Currently pregnant,
- not a UCLA Health patient
- any history of a Type 2 diabetes diagnosis, based on billing codes, laboratory values, or taking any antiglycemic medications
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Toluca Lake Health Center
Burbank, California, 91505
100 Medical Plaza Primary Care Suites 455 & 490
Los Angeles, California, 90024
Internal Medicine Women's Health Clinic Suites 250 & 290
Los Angeles, California, 90024
UCLA Internal Medicine Family Westwood Suite 465
Los Angeles, California, 90024
UCLA Internal Medicine Geriatrics Suite 365 & 420
Los Angeles, California, 90024
CPN Brentwood
Los Angeles, California, 90049
CPN West Washington Internal Medicine
Los Angeles, California, 90066
Pacific Palisades
Pacific Palisades, California, 90272
12th Street Clinic
Santa Monica, California, 90401
Wilshire Office
Santa Monica, California, 90401
CPN Santa Monica 15th Street Family Medicine Practice
Santa Monica, California, 90404
CPN/Santa Monica Parkside
Santa Monica, California, 90404
Santa Moica Bay Physicians/20th Street 10th Floor
Santa Monica, California, 90404
Santa Monica Bay Physicians Plaza
Santa Monica, California, 90404
Santa Monica Bay Physicians/20th Street 3rd Floor
Santa Monica, California, 90404
Santa Monica Internal Medicine
Santa Monica, California, 90404
UCLA Family Health Clinic
Santa Monica, California, 90404
Santa Moica Bay Physicians Ocean Park
Santa Monica, California, 90405
Jack H. Skirball Health Center
Woodland Hills, California, 91364
CPN Woodland Hills Practice
Woodland Hills, California, 91367
About this study
Official title: Pilot Study of Pharmacist-Coordinated Implementation of the Diabetes Prevention Program (DPP) for Women With a History of Gestational Diabetes Mellitus (GDM)
Gestational diabetes mellitus (GDM) is a risk factor for the development of Type 2 diabetes. Lifestyle change and metformin are equally effective in preventing diabetes in patients with a history of GDM, so these women should choose a strategy based on their preferences and values, which may vary by race/ethnicity. This proposal will engage 32 women in shared decision making about diabetes prevention.
Read the detailed description
The Diabetes Prevention Program (DPP) demonstrated that intensive lifestyle change and metformin both prevent or delay Type 2 diabetes (T2DM), but uptake of either approach has been minimal. The research team is implementing a shared decision-making (SDM) intervention for diabetes prevention funded by the National Institute of Diabetes and Digestive and Kidney Disease (NIDDK; R18 DK105464). In this clinic-based pragmatic trial, the Prediabetes Informed Decisions and Education (PRIDE) study, pharmacists engage patients with prediabetes in evidence-based diabetes prevention using an SDM framework. The research team reached the recruitment goal (n=350) more than 15 months ahead of schedule and enrolled 1.5 times the number of projected participants (n=515), including 56% from racial/ethnic minority groups. PRIDE has been highly successful in treatment engagement, as 85% of participants chose either lifestyle change or metformin. Furthermore, among patients who have reached 12-month follow-up, PRIDE participants as a group have lost more weight than matched controls (-5.2 lbs. vs. -0.29 lbs., p<0.001).
PRIDE targets both men and women with prediabetes. Only five PRIDE participants had a history of gestational diabetes mellitus (GDM) during a prior pregnancy. GDM is more common among minority women and a history of a GDM diagnosis is one of the most significant risk factors for incident type 2 diabetes, increasing the risk of developing T2DM upwards of sevenfold. The research team is planning to pilot an SDM intervention for women with a history of GDM. This project would advance a patient-centered approach to increase uptake of both evidence-based diabetes prevention strategies among the subgroup of minority women at the highest risk of progression to T2DM.
In the proposed project, the research team plans to enroll women with a history of GDM in a pilot study, tracking their choice of diabetes prevention strategy and their weight change over time. Importantly, the pilot will enable the research team to estimate the sample size for a future, multi-center study to engage women with a history of GDM in SDM for diabetes prevention. The project's specific aim is as follows:
In a pilot study, to deliver the tailored intervention to a diverse sample of 32 women with a history of GDM and hemoglobin A1c from 5.7-6.4% who have not yet developed Type 2 diabetes, with a sample divided equally between whites, African Americans, Latinas and Asian Americans
- Conditions
- Gestational Diabetes
- Being tested
- Shared decision-making with pharmacists
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shared decision-making with pharmacistsBehavioural
Pharmacist will engage patient with history of gestational diabetes mellitus using Healthwise (TM) Decision Tool to help match their personal preferences and values with treatment options, specifically lifestyle change will be referred to a CDC (Center for Disease Control and Prevention) approved diabetes prevention program, and pharmacists will coordinate with primary care providers to prescribe metformin for patients interested in this treatment.
| Study group | Role | What they receive |
|---|---|---|
| Shared decision-making with pharmacists | Experimental | Pharmacist-coordinated shared decision making about treatment for history of gestational diabetes mellitus (lifestyle change and/or metformin), using a decision tool Receives: Behavioral: Shared decision-making with pharmacists |
What is being measured
The primary outcome is the main question the study is designed to answer.
Choice of evidence-based diabetes prevention (lifestyle change or metformin)
One of four participant decisions: 1) choosing to attend a Centers for Disease Control and Prevention (CDC)-certified diabetes prevention program, 2) choosing to start metformin as diabetes prevention, 3) choosing both the diabetes prevention program and metformin, 4) choosing NOT to start either the diabetes prevention program or start metformin.
Measured: 2 weeks
Secondary outcomes (3)
Weight change
Change of weight as measured in the EHR
Measured: 9 months
Systolic blood pressure
Change in systolic blood pressure as measured in the EHR
Measured: 9 months
Decisional conflict
Three collaboRATE items that measure decisional conflict
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start1 Mar 2019
- Primary completion28 Dec 2019
- Study completion28 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenrik Duru, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03766256
- Sponsor's protocol ID
- IRB#18-001058
- Status last verified
- Feb 2020
- First submitted
- 5 Nov 2018
- Last updated
- 21 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Madievsky R, Vu A, Cheng F, Chon J, Turk N, Krueger A, Krong J, Maranon R, Liu S, Han CS, Norris KC, Mangione C, Page J, Thomas S, Duru OK, Moin T. A randomized controlled trial of a shared decision making intervention for diabetes prevention for women with a history of gestational diabetes mellitus: The Gestational diabetes Risk Attenuation for New Diabetes (GRAND study). Contemp Clin Trials. 2023 Jan;124:107007. doi: 10.1016/j.cct.2022.107007. Epub 2022 Nov 13.
PubMed 36384219
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Pharmacist-Coordinated Implementation of the Diabetes Prevention Program (DPP) for Women With a History of Gestational Diabetes Mellitus (GDM)
- ClinicalTrials.gov ID
- NCT03766256
- Acronym / sponsor ID
- IRB#18-001058
- Conditions
- Gestational Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 28 Dec 2019 (actual)
- Study completion
- 28 Dec 2019 (actual)
- First posted
- 6 Dec 2018 (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.
Gestational diabetes mellitus (GDM) is a risk factor for the development of Type 2 diabetes. Lifestyle change and metformin are equally effective in preventing diabetes in patients with a history of GDM, so these women should choose a strategy based on their preferences and values, which may vary by race/ethnicity. This proposal will engage 32 women in shared decision making about diabetes prevention.
Detailed description
The Diabetes Prevention Program (DPP) demonstrated that intensive lifestyle change and metformin both prevent or delay Type 2 diabetes (T2DM), but uptake of either approach has been minimal. The research team is implementing a shared decision-making (SDM) intervention for diabetes prevention funded by the National Institute of Diabetes and Digestive and Kidney Disease (NIDDK; R18 DK105464). In this clinic-based pragmatic trial, the Prediabetes Informed Decisions and Education (PRIDE) study, pharmacists engage patients with prediabetes in evidence-based diabetes prevention using an SDM framework. The research team reached the recruitment goal (n=350) more than 15 months ahead of schedule and enrolled 1.5 times the number of projected participants (n=515), including 56% from racial/ethnic minority groups. PRIDE has been highly successful in treatment engagement, as 85% of participants chose either lifestyle change or metformin. Furthermore, among patients who have reached 12-month follow-up, PRIDE participants as a group have lost more weight than matched controls (-5.2 lbs. vs. -0.29 lbs., p<0.001).
PRIDE targets both men and women with prediabetes. Only five PRIDE participants had a history of gestational diabetes mellitus (GDM) during a prior pregnancy. GDM is more common among minority women and a history of a GDM diagnosis is one of the most significant risk factors for incident type 2 diabetes, increasing the risk of developing T2DM upwards of sevenfold. The research team is planning to pilot an SDM intervention for women with a history of GDM. This project would advance a patient-centered approach to increase uptake of both evidence-based diabetes prevention strategies among the subgroup of minority women at the highest risk of progression to T2DM.
In the proposed project, the research team plans to enroll women with a history of GDM in a pilot study, tracking their choice of diabetes prevention strategy and their weight change over time. Importantly, the pilot will enable the research team to estimate the sample size for a future, multi-center study to engage women with a history of GDM in SDM for diabetes prevention. The project's specific aim is as follows:
In a pilot study, to deliver the tailored intervention to a diverse sample of 32 women with a history of GDM and hemoglobin A1c from 5.7-6.4% who have not yet developed Type 2 diabetes, with a sample divided equally between whites, African Americans, Latinas and Asian Americans
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shared decision-making with pharmacists | Experimental | Behavioral: Shared decision-making with pharmacistsPharmacist-coordinated shared decision making about treatment for history of gestational diabetes mellitus (lifestyle change and/or metformin), using a decision tool |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Overweight or obese (BMI >25 or >23 if Asian American)
- at least 6 weeks post-partum
- have a history of gestational diabetes mellitus
Key exclusion criteria (3 listed)
- Currently pregnant,
- not a UCLA Health patient
- any history of a Type 2 diabetes diagnosis, based on billing codes, laboratory values, or taking any antiglycemic medications
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 |
|---|---|---|
| Shared decision-making with pharmacistsPharmacist will engage patient with history of gestational diabetes mellitus using Healthwise (TM) Decision Tool to help match their personal preferences and values with treatment options, specifically lifestyle change will be referred to a CDC (Center for Disease Control and Prevention) approved diabetes prevention program, and pharmacists will coordinate with primary care providers to prescribe metformin for patients interested in this treatment. | Behavioural | Shared decision-making with pharmacists |
Primary outcome
Choice of evidence-based diabetes prevention (lifestyle change or metformin)
Time frame: 2 weeks
One of four participant decisions: 1) choosing to attend a Centers for Disease Control and Prevention (CDC)-certified diabetes prevention program, 2) choosing to start metformin as diabetes prevention, 3) choosing both the diabetes prevention program and metformin, 4) choosing NOT to start either the diabetes prevention program or start metformin.
3 secondary outcomes
Weight change
Time frame: 9 months
Systolic blood pressure
Time frame: 9 months
Decisional conflict
Time frame: 2 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 21 Feb 2020.
- Derived from this study: PubMed 36384219Madievsky R, Vu A, Cheng F, Chon J, Turk N, Krueger A, Krong J, Maranon R, Liu S, Han CS, Norris KC, Mangione C, Page J, Thomas S, Duru OK, Moin T. A randomized controlled trial of a shared decision making intervention for diabetes prevention for women with a history of gestational diabetes mellitus: The Gestational diabetes Risk Attenuation for New Diabetes (GRAND study). Contemp Clin Trials. 2023 Jan;124:107007. doi: 10.1016/j.cct.2022.107007. Epub 2022 Nov 13.
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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.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shared decision-making with pharmacists in people with Gestational Diabetes, run by University of California, Los Angeles at 20 sites 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 3 inclusion and 3 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 21 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites 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?
Choice of evidence-based diabetes prevention (lifestyle change or metformin) (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03766256, which also lists 1 linked publication.
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 21 Feb 2020.