Gestational Diabetes Follow Up Study

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.

Study Overview

• Status: Completed
• Conditions: Diabetes, Gestational; Postpartum Period
• Intervention / Treatment: Other: Promotora

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 Type: Interventional
• Enrollment (Actual): 216
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • Los Angeles County + University of Southern California Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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
• Age ≥18 years
• Residence within 60 miles of LAC+USC
• ON INPATIENT WARD AT LAC+USC AT TIME OF RECRUITMENT

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Promotora; 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)	Other: Promotora; 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.; Other Names: Community Health Worker; Lay Community Worker
No Intervention: Standard of Care; These subjects receive the routine standard of postpartum care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the fraction of each group that participates in postpartum follow up and glucose tolerance testing 4-12 weeks post partum.	4-12 weeks post partum

Secondary Outcome Measures

Outcome Measure	Time Frame
the fraction of women in each group that attends a referral visit	within 8 weeks following referral

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: Centers for Disease Control and Prevention; Association of American Medical Colleges
• Investigators: Principal Investigator: Penina Segall-Gutierrez, M.D., M.Sc., University of Southern California

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: October 19, 2009
• First Submitted That Met QC Criteria: October 19, 2009
• First Posted (Estimate): October 20, 2009

Study Record Updates

• Last Update Posted (Actual): March 31, 2017
• Last Update Submitted That Met QC Criteria: March 29, 2017
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: Health Promotion; Health Personnel; Postpartum Period; Diabetes, Gestational; Reproductive Health Services
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes, Gestational
• Other Study ID Numbers: MM-1107-09/09 (AAMC-CDC)