NCT06116149NARecruitingAccepts Healthy Volunteers

Strategies for Implementing a Postpartum Lifestyle Intervention in WIC Clinics

Tulane University

Start Date

12/12/2023

Completion Date

4/1/2027

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 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.

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 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). Nineteen clinics will be randomized to the multifaceted technology-assisted health coach strategy and 19 to the in-person health coach-led strategy. A total of 722 postpartum participants (19 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 Criteria

Age Range: 18 years to No maximum

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

Interventions

BEHAVIORAL

In-person health coach delivery of the GLB

BEHAVIORAL

Technology-assisted health coach delivery of the GLB

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Conditions

ObesityGestational DiabetesLifestyle, HealthyGlucose Intolerance During PregnancyPreDiabetesHyperglycemia

Locations

Tulane University School of Public Health and Tropical Medicine

New Orleans, Louisiana 70112

United States