Status:
RECRUITING
Strategies for Implementing a Postpartum Lifestyle Intervention in WIC Clinics
Lead Sponsor:
Tulane University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Pennington Biomedical Research Center
Conditions:
Obesity
Gestational Diabetes
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The primary objective of the STRIVE study is to compare two implementation strategies for Diabetes Prevention Program delivery: an in-person health coach strategy (standard 24 in-person sessions at WI...
Detailed Description
The overall objective of this project is to study the implementation, effectiveness, and sustainability of implementing the Diabetes Prevention Program (DPP) in postpartum women who receive services f...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Clinics:
- Serve a large number of WIC postpartum participants
- Willing and able to provide space for the study
- Inclusion Criteria for Participants:
- Age 18 or older
- Gave birth in the past 6 weeks to 12 months
- Obesity or history of gestational diabetes mellitus (Current BMI ≥30 kg/m², OR Medical-record documented history of gestational diabetes mellitus and BMI ≥25 kg/m²)
- No self-reported diabetes (other than gestational diabetes)
- Hemoglobin A1c \<6.5%
- Not currently pregnant or planning to become pregnant in the next 6 months
- No plans to move outside of the study region in the next 12 months
- Access to a smartphone
- Willing and able to participate in the intervention and provide consent
- Not an immediate family member of the staff at the WIC clinic
- Other concerns regarding ability to meet trial requirements, at the discretion of the principal investigator or study coordinator
Exclusion
Key Trial Info
Start Date :
December 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
722 Patients enrolled
Trial Details
Trial ID
NCT06116149
Start Date
December 12 2023
End Date
April 1 2027
Last Update
July 25 2025
Active Locations (1)
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1
Tulane University School of Public Health and Tropical Medicine
New Orleans, Louisiana, United States, 70112