Recruiting

Postpartum Intervention

Sponsor:

Tulane University

Code:

NCT06116149

Conditions

Obesity

Gestational Diabetes

Lifestyle, Healthy

Glucose Intolerance During Pregnancy

PreDiabetes

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

In-person health coach delivery of the GLB

Technology-assisted health coach delivery of the GLB

Study Details

Brief 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.

Conditions

Obesity

Gestational Diabetes

Lifestyle, Healthy

Glucose Intolerance During Pregnancy

PreDiabetes

Study ID

NCT06116149

Start date

Dec 12, 2023

Status verified date

Jul, 2025

Completion date

Apr, 2027

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

722 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

In-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.

Technology-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.

Primary outcome measure

  • Difference in uptake (primary implementation outcome) [ Time Frame: Measured from baseline to 12 months ]
  • Difference in mean 12-month weight reduction (primary health-related outcome) [ Time Frame: Measured at 3, 6, 9 and 12 months ]

Central Contacts and Locations

Central contacts

Tara Dobson, BA

504.988.9922tdobson@tulane.edu

Kirsten Dorans, ScD

504.988.0883kdorans@tulane.edu

Locations

Tulane University School of Public Health and Tropical Medicine

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Tara Dobson, BA

504-988-9922tdobson@tulane.edu

Kirsten Dorans, ScD

504.988.0883kdorans@tulane.edu

More Information

Sponsor

Tulane University

Last update posted

Jul 25, 2025

Last verified

Jul, 2025

Keywords

  • Diabetes Prevention Program

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by Tulane University on 2025-07-25. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.