Actively Recruiting
Strategies for Implementing a Postpartum Lifestyle Intervention in WIC Clinics: A Cluster Randomized Trial
Led by Tulane University · Updated on 2025-07-25
722
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
T
Tulane University
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how to best deliver the Diabetes Prevention Program (DPP) to postpartum women receiving services from WIC clinics. This trial compares two strategies: one with 24 in-person health coaching sessions and another with 12 in-person sessions supplemented by technology support. The study aims to evaluate which method is better for implementation, effectiveness, and sustainability in helping women improve their health after childbirth. The study involves 38 WIC clinics randomized into two groups. One group delivers the standard 24 in-person health coaching sessions over one year, focusing on diet, physical activity, and weight management. The other group delivers 12 in-person sessions combined with technology tools that support self-monitoring and connection with coaches and participants asynchronously. Both use the Group Lifestyle Balance (GLB) behavioral intervention adapted from the Diabetes Prevention Program for community settings. Participants will be followed for 12 months during the intervention, with measurements taken at baseline, 3, 6, 9, and 12 months, including weight changes and other health-related outcomes. A follow-up visit 6 months after the intervention will assess how well the programs are sustained. Researchers will monitor implementation outcomes like uptake, fidelity, acceptability, and cost-effectiveness, as well as health outcomes such as weight reduction, physical activity, diet quality, blood pressure, hemoglobin A1c, and quality of life.
CONDITIONS
Brief Title
Strategies for Implementing a Postpartum Lifestyle Intervention in WIC Clinics
Who Can Participate
Eligibility Criteria
You may qualify if you...
- WIC clinics serving many postpartum participants
- Willing and able to provide space for the study
- Women aged 18 or older
- Gave birth in the past 6 weeks to 12 months
- Obesity (BMI ≥30 kg/m²) or history of gestational diabetes with BMI ≥25 kg/m²
- No self-reported diabetes other than gestational diabetes
- Hemoglobin A1c less than 6.5%
- Not currently pregnant or planning pregnancy in next 6 months
- No plans to move outside the study area in next 12 months
- Access to a smartphone
- Willing and able to participate and give consent
- Not immediate family of WIC clinic staff
- Able to meet trial requirements as judged by the study team
You will not qualify if you...
- Self-reported diagnosis of diabetes (other than gestational diabetes)
- Currently pregnant or planning to become pregnant within 6 months
- Plans to move out of the study region within 12 months
- Immediate family member of WIC clinic staff
- Any other concerns affecting ability to meet trial requirements as determined by study team
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants receive health coaching sessions focused on improving diet, physical activity, and promoting moderate weight loss through behavioral change including self-monitoring. They will either attend 24 in-person coaching sessions or 12 in-person sessions supplemented by technology tools over one year.
Up to 24 in-person sessions over 12 months depending on assigned strategy
Duration - 6 months
Participants are assessed 6 months after the end of the intervention to evaluate the sustainability of the implementation strategies.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Tulane University School of Public Health and Tropical Medicine
New Orleans, Louisiana, United States, 70112
Actively Recruiting
Research Team
T
Tara Dobson, BA
K
Kirsten Dorans, ScD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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