Comparing two ways to deliver a postpartum lifestyle intervention in WIC clinics
Strategies for Implementing a Postpartum Lifestyle Intervention in WIC Clinics: A Cluster Randomized Trial
This study is testing two different ways to help new moms at WIC clinics manage their health after having a baby to see which method works better and lasts longer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 722 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Tulane University Academic / other |
| Locations | 1 site (New Orleans, Louisiana) |
| Trial ID | NCT06116149 on ClinicalTrials.gov |
What this trial studies
This project aims to evaluate the effectiveness and sustainability of two different strategies for delivering the Diabetes Prevention Program (DPP) to postpartum women receiving services from WIC. One strategy involves standard in-person health coaching with 24 sessions, while the other combines 12 in-person sessions with technology-assisted support. The study will randomly assign 36 clinics to one of the two strategies and recruit 900 postpartum participants to assess implementation and health-related outcomes over a 12-month period. A follow-up visit will occur 6 months after the intervention to evaluate the sustainability of the strategies.
Who should consider this trial
Good fit: Ideal candidates are postpartum women aged 18 or older who gave birth within the past 6 weeks to 12 months and have obesity or a history of gestational diabetes.
Not a fit: Patients who are currently pregnant or planning to become pregnant in the next 6 months will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the health outcomes of postpartum women at risk for obesity and diabetes.
How similar studies have performed: Other studies have shown success with similar lifestyle intervention approaches, indicating potential for positive outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
New Orleans, Louisiana
- Tulane University School of Public Health and Tropical Medicine — New Orleans, Louisiana, United States (Recruiting)
Study contacts
- Study coordinator: Tara Dobson, BA
- Email: tdobson@tulane.edu
- Phone: 504.988.9922
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.