RecruitingNot ApplicableNCT06116149

Strategies for Implementing a Postpartum Lifestyle Intervention in WIC Clinics

Strategies for Implementing a Postpartum Lifestyle Intervention in WIC Clinics: A Cluster Randomized Trial


Sponsor

Tulane University

Enrollment

722 participants

Start Date

Dec 12, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria13

  • Serve a large number of WIC postpartum participants
  • Willing and able to provide space for the study
  • 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

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Interventions

BEHAVIORALIn-person health coach delivery of the GLB

Delivery of 24 health coaching sessions in-person by health coaches over 1 year. Standard delivery of 24-sessions of the Group Lifestyle Balance (GLB) behavioral intervention in WIC clinics. The GLB was adapted from the original Lifestyle Balance behavioral intervention used in the original Diabetes Prevention Program trial for use in community translation and group settings. It focuses on improving diet and physical activity and promoting moderate weight loss through health coaching on behavioral change, including self-monitoring of food intake, physical activity, and weight.

BEHAVIORALTechnology-assisted health coach delivery of the GLB

Delivery of 12 health coaching GLB sessions in-person by health coaches over one year; supplemental technology support, including tools for self-monitoring, health coach monitoring, asynchronous delivery of intervention materials, and asynchronous coach and group connection. The GLB was adapted from the original Lifestyle Balance behavioral intervention used in the original Diabetes Prevention Program trial for use in community translation and group settings. It focuses on improving diet and physical activity and promoting moderate weight loss through health coaching on behavioral change, including self-monitoring of food intake, physical activity, and weight.


Locations(1)

Tulane University School of Public Health and Tropical Medicine

New Orleans, Louisiana, United States

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NCT06116149


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