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Patient Navigation Program for Postpartum Women with Gestational Diabetes (SWEET Trial)

N/A
Waitlist Available
Led By Lynn M Yee, MD, MPH
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4-12 weeks and 1 year postpartum
Awards & highlights

SWEET Trial Summary

This trial will assess whether a patient navigation intervention can improve health outcomes for women with a history of gestational diabetes.

Who is the study for?
The SWEET trial is for women aged 16 or older who had gestational diabetes during a pregnancy that reached at least 30 weeks. They must be English- or Spanish-speaking and have been patients at Northwestern Medicine's obstetrics and gynecology practices. Women planning to move from Chicago, with weight loss during pregnancy, previous bariatric surgery, pre-gestational diabetes, or enrolled in conflicting studies can't participate.Check my eligibility
What is being tested?
This study tests the 'SWEET' intervention against usual care in women who've had gestational diabetes. It aims to see if personalized patient navigation services improve health one year postpartum. The program includes logistical support, psychosocial support, and health education through the first year after giving birth.See study design
What are the potential side effects?
Since this trial involves non-medical interventions like patient navigation programs rather than drugs or medical procedures, it does not have typical side effects associated with medications; however, participants may experience varying levels of satisfaction with the service.

SWEET Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4-12 weeks and 1 year postpartum
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4-12 weeks and 1 year postpartum for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Postpartum weight retention
Secondary outcome measures
Abdominal circumference
Assessment of postpartum glycemic control
Blood pressure
+7 more
Other outcome measures
Dropout rate
Health care providers experiences with SWEET
Participant adherence with navigation
+8 more

SWEET Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Navigation GroupExperimental Treatment1 Intervention
Women who are randomized into SWEET will be assigned to a patient navigator. The navigator will meet women during hospitalization, at postpartum appointments, during primary care appointments, and as needed. At these face-to-face meetings, the navigator will perform education about the postpartum OGTT, post-GDM management plan, diabetes mellitus risks, lifestyle modification, and primary care transition. The navigator will facilitate the development of an individualized GDM Care Plan in conjunction with the patient and the medical team. The navigator will assess individual barriers to T2DM screening and prevention. At appointments, the navigator will also ensure a woman understands her diabetes-related care plan and will perform health education and barrier-reducing tasks as needed.
Group II: Non-navigation cohortActive Control1 Intervention
No navigation will be provided; women will receive usual care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Patient Navigation Program
2018
N/A
~110

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,357 Previous Clinical Trials
4,315,146 Total Patients Enrolled
Northwestern UniversityLead Sponsor
1,585 Previous Clinical Trials
917,191 Total Patients Enrolled
Lynn M Yee, MD, MPH4.8136 ReviewsPrincipal Investigator - Northwestern University
Medical School - Eastern Virginia Medical School, Doctor of Medicine
University of Southern California, Residency in Internal Medicine
2 Previous Clinical Trials
485 Total Patients Enrolled
5Patient Review
Superlative

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there currently any open enrollment slots for this research study?

"Clinicaltrials.gov confirms that this medical research is not recruiting any more participants, which were initially sought on December 1st 2020 and last updated October 7th 2022. However, at the moment there are 108 other trials taking on new enrollees."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
SWEET: Postpartum Navigation After GDM
Lynn M Yee 2020. "SWEET: Postpartum Navigation After GDM". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04583839.
~9 spots leftby Apr 2025
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