Overview
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 WIC clinics) vs. a multifaceted technology-assisted health coach implementation strategy (12 in-person sessions at WIC clinics supplemented by technology support) on implementation and health-related outcomes in postpartum women.
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 from WIC. In this effectiveness-implementation type III cluster-randomized trial, we will compare two implementation strategies for DPP delivery: an in-person health coach-led implementation strategy (standard 24 in-person sessions) vs. a multifaceted technology-assisted health coach implementation strategy (12 in-person sessions supplemented by technology tools).
Eighteen clinics will be randomized to the multifaceted technology-assisted health coach strategy and 18 to the in-person health coach-led strategy. A total of 900 postpartum participants (25 per clinic) will be recruited into the study and followed for 12 months for implementation and effectiveness outcomes. A post-intervention study visit will take place 6 months after the end of the 12-month intervention to evaluate the sustainability of the implementation strategies.
Eligibility
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