Strategies for Implementing a Postpartum Lifestyle Intervention in WIC Clinics

RECRUITING

I'm interested ...!!

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.

Conditions:

🦠 Obesity 🦠 Gestational Diabetes 🦠 Lifestyle, Healthy 🦠 Glucose Intolerance During Pregnancy 🦠 PreDiabetes 🦠 Hyperglycemia

🗓️ Study Start (Actual) 12 December 2023

🗓️ Primary Completion (Estimated) October 2026

✅ Study Completion (Estimated) April 2027

👥 Enrollment (Estimated) 900

🔬 Study Type INTERVENTIONAL

📊 Phase NA

Locations:

📍 New Orleans, Louisiana, United States

📋 Eligibility Criteria

Description

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

Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)

Sexes Eligible for Study: FEMALE

Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 29 September 2023
First Submitted that Met QC Criteria 2 November 2023
First Posted 3 November 2023

Study Record Updates