Strategies for Implementing a Postpartum Lifestyle Intervention in WIC Clinics

Part of paid clinical trials in New Orleans, Louisiana.

Sponsor
Tulane University
Study ID
NCT06116149
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • In-person health coach delivery of the GLB — BEHAVIORAL
    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.
  • Technology-assisted health coach delivery of the GLB — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Dec 12, 2023
Status verified
Jul 2025
Primary completion
Oct 31, 2026
Completion
Apr 30, 2027

Study Design

Enrollment
722 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: In-person health coach strategy
    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.
  • Active Comparator: Multifaceted technology-assisted health coach implementation strategy
    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.

Primary Outcome Measure

Difference in uptake (primary implementation outcome) [ Time Frame: Measured from baseline to 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Tulane University School of Public Health and Tropical MedicineNew OrleansLouisiana70112
Tara Dobson, BA
[email protected]
504-988-9922
Kirsten Dorans, ScD
[email protected]
504.988.0883

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By research site
Tulane University School of Public Health and Tropical Medicine· New Orleans, LA

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