Diabetes, GestationalNCT00998595
Gestational Diabetes Follow Up Study
A study testing Promotora in people with Diabetes, Gestational and Postpartum Period, run by University of Southern California at 1 site in United States.
Trial summary
The primary hypothesis underlying this proposal is that the introduction of a Promotora to provide education and proactive follow-up to women with GDM will increase compliance with postpartum glucose tolerance testing. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Gestational, Postpartum Period
- What is being tested?
- Promotora
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Oct 2011
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosed with diabetes for the first time during the most recent pregnancy
- Completed pregnancy >20 weeks duration
- Has access to a telephone
- Is willing to be contacted by the Promotora
- Is willing to follow-up at LAC+USC for postpartum visit
- Able to give informed consent
Show all 9Show fewer
- Age ≥18 years
- Residence within 60 miles of LAC+USC
- ON INPATIENT WARD AT LAC+USC AT TIME OF RECRUITMENT
Who cannot join
- Diagnosis of diabetes prior to most recent pregnancy (pre-gestational diabetes)
- Current ICU admission during delivery hospitalization that would interfere with recruitment and participation in the study
- Currently residing in jail or inpatient psychiatric facility
- Postpartum day #1-2, any Fasting Blood Glucose ≥126mg/dL or random BG≥200mg/dL
- Plans postpartum follow-up at non-participating postpartum clinic location
- A Medical Record Abstraction Only Cohort is a third group of patients who live within 60 miles of LAC+USC, plan to obtain postpartum care at LAC+USC, and completed a GDM affected pregnancy but refuse participation or do not qualify based on the following: elevated glucose consistent with diagnosis of T2DM or maintained on insulin postpartum, incarceration or resides in inpatient psychiatric facility, age <18, no telephone, unwilling to be contacted by Promotora, or are unable to consent for participation.This cohort can not be enrolled in the study but data is abstracted from the medical records to compare demographics and follow up in our study to all patients with GDM who deliver at LAC+USC.
Trial locations and contacts
1 site in 1 country.
United States1 site
Los Angeles County + University of Southern California Medical Center
Los Angeles, California, 90033
About this study
Official title: Es Mejor Saber: A Proactive Approach to Gestational Diabetes Follow Up
The primary hypothesis underlying this proposal is that the introduction of a Promotora to provide education and proactive follow-up to women with GDM will increase compliance with postpartum glucose tolerance testing. The secondary hypothesis is that the Promotora will improve participation in referral visits for diabetes or preventive care. We will develop the promotora program and begin pilot implementation.
Read the detailed description
As Los Angeles County + University of Southern California Medical Center (LAC+USC) serves an indigent Latino population at increased risk for developing Type 2 Diabetes Mellitus (T2DM), Gestational Diabetes Mellitus (GDM) complicated 13% of deliveries at LAC+USC between 2006-2007. While over 50% of GDM patients will develop overt diabetes mellitus within a decade of the incident pregnancy, less than half of these patients ever return for even one post-partum follow up visit at this institution (45%). Lifestyle Interventions and medications have been shown to delay or prevent the onset of T2DM. However, prevention is only possible if patients follow-up and individual risk assessment is made. While identifying the 2-hour glucose tolerance test as the appropriate postpartum screening technique for patients with a history of GDM, the Fifth International Workshop-Conference on Gestational Diabetes Mellitus did not identify strategies to improve follow up among this patient population. Promotoras (bi-lingual, bi-cultural lay community health workers representative of the Latino community base) have been successful in improving follow up for other areas of diabetes and women's preventive services but have not been studies in the context of GDM. We will develop the Es Mejor Saber training materials and program and pilot a randomized control trial (RCT),a total 216 subjects completing a GDM affected pregnancy will be randomized on the postpartum ward to the standard-of-care versus proactive follow-up with a Promotora. The Promotora will provide education, address barriers to follow-up, remind subjects of their appointments, and call them to reschedule if they miss appointments. In the first phase of the study, these appointments will include the OGTT and the initial postpartum visit. In the second phase, these visits will include referrals to internal medicine (for those diagnosed with T2DM) or nutrition counseling (for those found not to have diabetes). The primary hypothesis underlying this proposal is that the introduction of a Promotora providing education and pro-active follow-up into postpartum GDM management will result improve post-partum follow-up for screening, treatment, and preventive services when compared with the standard of care.
- Conditions
- Diabetes, Gestational, Postpartum Period
- Being tested
- Promotora
- Keywords
- Diabetes, Gestational, Postpartum Period, Reproductive Health Services, Health Promotion, Health Personnel
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PromotoraOther
Also called Community Health Worker, Lay Community Worker
The Promotora will deliver education regarding postpartum follow-up and steps to take to decrease the risk for developing type 2 diabetes. The Promotora will clarify misperceptions and answer questions related to risk of developing diabetes and contraception. If the subject has barriers to accessing care with transportation or childcare, she will help the subjects to access existing resources. The Promotora will give the subject her contact information and will also contact the subject to remind her of her appointments and reschedule if she missed an appointment.
| Study group | Role | What they receive |
|---|---|---|
| Promotora | Experimental | This group receives additional education and proactive follow-up by removing barriers to already existing services and reminders by a lay community health workers (Promotora) Receives: Other: Promotora |
| Standard of Care | No intervention | These subjects receive the routine standard of postpartum care |
What is being measured
The primary outcome is the main question the study is designed to answer.
the fraction of each group that participates in postpartum follow up and glucose tolerance testing 4-12 weeks post partum.
Measured: 4-12 weeks post partum
Secondary outcomes (1)
the fraction of women in each group that attends a referral visit
Measured: within 8 weeks following referral
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2009 (estimated)
- Study startJun 2009
- Primary completionFeb 2011
- Study completionOct 2011
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 Diabetes, GestationalStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Association of American Medical Colleges
- Responsible party
- Sponsor
- Investigators
- Penina Segall-Gutierrez, M.D., M.Sc., Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00998595
- Sponsor's protocol ID
- MM-1107-09/09 (AAMC-CDC)
- Status last verified
- Sep 2011
- First submitted
- 19 Oct 2009
- Last updated
- 31 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Zaman A, Ovalle B, Reyes C, Segall-Gutierrez P. Enhanced Participation in Diabetes Screening and Care After Gestational Diabetes Through Community Health Workers: Results from the Es Mejor Saber Randomized Controlled Trial. J Immigr Minor Health. 2024 Feb;26(1):45-53. doi: 10.1007/s10903-023-01547-5. Epub 2023 Oct 25.
PubMed 37878217
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Es Mejor Saber: A Proactive Approach to Gestational Diabetes Follow Up
- ClinicalTrials.gov ID
- NCT00998595
- Acronym / sponsor ID
- MM-1107-09/09 (AAMC-CDC)
- Conditions
- Diabetes, Gestational, Postpartum Period
- Keywords
- Diabetes, Gestational, Postpartum Period, Reproductive Health Services, Health Promotion, Health Personnel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Association of American Medical Colleges
- Study start
- Jun 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 20 Oct 2009 (estimated)
- 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 primary hypothesis underlying this proposal is that the introduction of a Promotora to provide education and proactive follow-up to women with GDM will increase compliance with postpartum glucose tolerance testing. The secondary hypothesis is that the Promotora will improve participation in referral visits for diabetes or preventive care. We will develop the promotora program and begin pilot implementation.
Detailed description
As Los Angeles County + University of Southern California Medical Center (LAC+USC) serves an indigent Latino population at increased risk for developing Type 2 Diabetes Mellitus (T2DM), Gestational Diabetes Mellitus (GDM) complicated 13% of deliveries at LAC+USC between 2006-2007. While over 50% of GDM patients will develop overt diabetes mellitus within a decade of the incident pregnancy, less than half of these patients ever return for even one post-partum follow up visit at this institution (45%). Lifestyle Interventions and medications have been shown to delay or prevent the onset of T2DM. However, prevention is only possible if patients follow-up and individual risk assessment is made. While identifying the 2-hour glucose tolerance test as the appropriate postpartum screening technique for patients with a history of GDM, the Fifth International Workshop-Conference on Gestational Diabetes Mellitus did not identify strategies to improve follow up among this patient population. Promotoras (bi-lingual, bi-cultural lay community health workers representative of the Latino community base) have been successful in improving follow up for other areas of diabetes and women's preventive services but have not been studies in the context of GDM. We will develop the Es Mejor Saber training materials and program and pilot a randomized control trial (RCT),a total 216 subjects completing a GDM affected pregnancy will be randomized on the postpartum ward to the standard-of-care versus proactive follow-up with a Promotora. The Promotora will provide education, address barriers to follow-up, remind subjects of their appointments, and call them to reschedule if they miss appointments. In the first phase of the study, these appointments will include the OGTT and the initial postpartum visit. In the second phase, these visits will include referrals to internal medicine (for those diagnosed with T2DM) or nutrition counseling (for those found not to have diabetes). The primary hypothesis underlying this proposal is that the introduction of a Promotora providing education and pro-active follow-up into postpartum GDM management will result improve post-partum follow-up for screening, treatment, and preventive services when compared with the standard of care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Promotora | Experimental | Other: PromotoraThis group receives additional education and proactive follow-up by removing barriers to already existing services and reminders by a lay community health workers (Promotora) |
| Standard of Care | No intervention | –These subjects receive the routine standard of postpartum care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosed with diabetes for the first time during the most recent pregnancy
- Completed pregnancy >20 weeks duration
- Has access to a telephone
- Is willing to be contacted by the Promotora
- Is willing to follow-up at LAC+USC for postpartum visit
Key exclusion criteria (6 listed)
- Diagnosis of diabetes prior to most recent pregnancy (pre-gestational diabetes)
- Current ICU admission during delivery hospitalization that would interfere with recruitment and participation in the study
- Currently residing in jail or inpatient psychiatric facility
- Postpartum day #1-2, any Fasting Blood Glucose ≥126mg/dL or random BG≥200mg/dL
- Plans postpartum follow-up at non-participating postpartum clinic location
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 |
|---|---|---|
| PromotoraAlso: Community Health Worker, Lay Community WorkerThe Promotora will deliver education regarding postpartum follow-up and steps to take to decrease the risk for developing type 2 diabetes. The Promotora will clarify misperceptions and answer questions related to risk of developing diabetes and contraception. If the subject has barriers to accessing care with transportation or childcare, she will help the subjects to access existing resources. The Promotora will give the subject her contact information and will also contact the subject to remind her of her appointments and reschedule if she missed an appointment. | Other | Promotora |
Primary outcome
the fraction of each group that participates in postpartum follow up and glucose tolerance testing 4-12 weeks post partum.
Time frame: 4-12 weeks post partum
1 secondary outcome
the fraction of women in each group that attends a referral visit
Time frame: within 8 weeks following referral
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 31 Mar 2017.
- Derived from this study: PubMed 37878217Zaman A, Ovalle B, Reyes C, Segall-Gutierrez P. Enhanced Participation in Diabetes Screening and Care After Gestational Diabetes Through Community Health Workers: Results from the Es Mejor Saber Randomized Controlled Trial. J Immigr Minor Health. 2024 Feb;26(1):45-53. doi: 10.1007/s10903-023-01547-5. Epub 2023 Oct 25.
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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.
Penina Segall-Gutierrez, M.D., M.Sc. principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Promotora in people with Diabetes, Gestational and Postpartum Period, run by University of Southern California 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 9 inclusion and 6 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 31 Mar 2017. 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?
the fraction of each group that participates in postpartum follow up and glucose tolerance testing 4-12 weeks post partum. (time frame: 4-12 weeks post partum). 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 NCT00998595, 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 31 Mar 2017.