Strategies for Implementing a Postpartum Lifestyle Intervention in WIC Clinics (STRIVE)

Strategies for Implementing a Postpartum Lifestyle Intervention in WIC Clinics: A Cluster Randomized Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Hyperglycemia; Obesity; PreDiabetes; Gestational Diabetes; Glucose Intolerance During Pregnancy; Lifestyle, Healthy
• Intervention / Treatment: Behavioral: In-person health coach delivery of the GLB; Behavioral: Technology-assisted health coach delivery of the GLB

Detailed Description

The overall objective of this project is to study the implementation, effectiveness, and sustainability of implementing the Diabetes Prevention Program (DPP) in postpartum women who receive services from WIC. In this effectiveness-implementation type III cluster-randomized trial, we will compare two implementation strategies for DPP delivery: an in-person health coach-led implementation strategy (standard 24 in-person sessions) vs. a multifaceted technology-assisted health coach implementation strategy (12 in-person sessions supplemented by technology tools).

Nineteen clinics will be randomized to the multifaceted technology-assisted health coach strategy and 19 to the in-person health coach-led strategy. A total of 722 postpartum participants (19 per clinic) will be recruited into the study and followed for 12 months for implementation and effectiveness outcomes. A post-intervention study visit will take place 6 months after the end of the 12-month intervention to evaluate the sustainability of the implementation strategies.

• Study Type: Interventional
• Enrollment (Estimated): 722
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tara Dobson, BA; Phone Number: 504.988.9922; Email: tdobson@tulane.edu
• Study Contact Backup: Name: Kirsten Dorans, ScD; Phone Number: 504.988.0883; Email: kdorans@tulane.edu

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Recruiting
      • Tulane University School of Public Health and Tropical Medicine
      • Contact: Kirsten Dorans, ScD; Phone Number: 504.988.0883; Email: kdorans@tulane.edu
      • Contact: Tara Dobson, BA; Phone Number: 504-988-9922; Email: tdobson@tulane.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: 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.
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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in uptake (primary implementation outcome)	The primary implementation outcome will be the difference between study arms in a composite uptake score, as defined by a composite score consisting of the percent of sessions attended and the percentage of times in which participants record weight, activity, and diet compared to what is recommended by the intervention.	Measured from baseline to 12 months
Difference in mean 12-month weight reduction (primary health-related outcome)	The primary health-related outcome will be difference in mean weight reduction from baseline to 12 months between study arms	Measured at 3, 6, 9 and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fidelity	Percentage of sessions held	12 months
Acceptability	Acceptability scores for participants, DPP coordinators, DPP coaches, WIC clinic management. Measured by survey; higher score means better outcome.	Measured at baseline, 6, and 12 months
Appropriateness	Appropriateness scores for participants, DPP coordinators, DPP coaches, WIC clinic management. Measured by survey; higher score means better outcome.	baseline
Feasibility (suitability)	Feasibility scores for participants, DPP coordinators, DPP coaches, and WIC clinic management. Measured by survey; higher score means better outcome.	Baseline
Adoption (WIC clinics)	Percentage of invited WIC clinics adopting the DPP program. Measured by study administrative data.	Baseline
Adoption (WIC nutritionists)	Percentage of invited WIC nutritionists being trained. Measured by study administrative data.	Baseline
Adoption (WIC health educators)	Percentage of invited WIC health educators being trained. Measured by study administrative data.	Baseline
Penetrance (participants)	Percentage of enrolled participants receiving assigned intervention. Measured by study administrative data.	12 months
Penetrance (WIC DPP coordinators)	Percentage of percentage of trained WIC DPP coordinators supporting health coaches. Measured by study administrative data.	12 months
Penetrance (WIC health coaches)	Percentage of percentage of trained WIC DPP health coaches delivering the intervention. Measured by study administrative data.	12 months
Percentage of participants who were either eligible, screened, or contacted who were enrolled.	Reach	Baseline
Cost-effectiveness	Incremental direct costs (intervention) per additional percentage of individuals reaching weight loss goal at 12 months	12 months
Difference in mean 12-month change in percent weight reduction	Difference in mean percent weight reduction from baseline to 12 months between study arms	Measured from baseline to 12 months
Difference in mean 12-month change in physical activity	Difference in mean change in physical activity from baseline to 12 months between study arms, as assessed by metabolic equivalent (MET)-h/week (measured by validated questionnaire)	Measured from baseline to 12 months
Difference in mean 12-month change in healthy eating index	Difference in mean change in healthy eating index from baseline to 12 months between study arms, as assessed by 24-hour dietary recalls (range 0 to 100; higher scores mean healthier eating pattern)	Measured from baseline to 12 months
Difference in mean 12-month change in waist circumference	Difference in mean change in waist circumference from baseline to 12 months between study arms	Measured from baseline to 12 months
Difference in mean 12-month change in hemoglobin A1c	Difference in mean change in hemoglobin A1c from baseline to 12 months between study arms	Measured from baseline to 12 months
Difference in mean 12-month change in systolic blood pressure	Difference in mean change in systolic blood pressure from baseline to 12 months between study arms	Measured from baseline to 12 months
Difference in mean 12-month change in diastolic blood pressure	Difference in mean change in diastolic blood pressure from baseline to 12 months between study arms	Measured from baseline to 12 months
Difference in mean 12-month change in health-related quality of life (HRQoL)	Difference in mean change in health-related quality of life (HRQoL) from baseline to 12 months between study arms (assessed by short form (SF)-12, validated survey)	Measured from baseline to 12 months
Difference in proportion of participants meeting intervention goals at 12 months	Assessed by validated questionnaires, 24-hour dietary recalls, and weight measurements	Measured from baseline to 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sustainability (DPP coordinators): comparison of perceived sustainability of the two implementation strategies among WIC staff	Assessed by surveys and interviews	18 months
Sustainability (Participants): comparison of the proportion of participants maintaining DPP goals at six months after their participation in the DPP has ended	Assessed by validated questionnaires, 24-hour dietary recalls, and weight measurements	18 months

Collaborators and Investigators

• Sponsor: Tulane University
• Collaborators: University of Pennsylvania; National Heart, Lung, and Blood Institute (NHLBI); Pennington Biomedical Research Center

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: September 29, 2023
• First Submitted That Met QC Criteria: November 2, 2023
• First Posted (Actual): November 3, 2023

Study Record Updates

• Last Update Posted (Actual): July 25, 2025
• Last Update Submitted That Met QC Criteria: July 22, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Diabetes Prevention Program
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Pregnancy Complications; Glucose Metabolism Disorders; Diabetes Mellitus; Diabetes, Gestational; Hyperglycemia; Glucose Intolerance
• Other Study ID Numbers: 2022-1294; OT2HL158287 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Our study data sharing plan will comply with all NIH policies for data sharing. Data sharing will be implemented in a timely manner. Study data, including data from baseline and follow-up visits, will be prepared sharing. Data will be prepared by the study data manager/biostatistician. These data will be free of identifiers that allow identification of individual research participants either directly or through "deductive disclosure." We are very open to sharing data enthusiastically with the general scientific community, since we also believe in the added value of other investigators working on these data.
• IPD Sharing Time Frame: Data sets will be prepared for sharing no later than 3 years after the end of the final patient follow-up visit or 2 years after the main paper of the trial has been published, whichever comes first.
• IPD Sharing Access Criteria: We will offer opportunities for outside investigators to collaborate with us using complete study data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No