Strategies for Implementing a Postpartum Lifestyle Intervention in WIC Clinics
- Conditions
- HyperglycemiaObesityLifestyle, HealthyGlucose Intolerance During PregnancyGestational DiabetesPreDiabetes
- Interventions
- Behavioral: In-person health coach delivery of the GLBBehavioral: Technology-assisted health coach delivery of the GLB
- Registration Number
- NCT06116149
- Lead Sponsor
- Tulane University
- 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.
- 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).
Eighteen clinics will be randomized to the multifaceted technology-assisted health coach strategy and 18 to the in-person health coach-led strategy. A total of 900 postpartum participants (25 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 900
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description In-person health coach strategy 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. Multifaceted technology-assisted health coach implementation strategy 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 Measures
Name Time Method Difference in uptake (primary implementation outcome) Measured from baseline to 12 months 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.
Difference in mean 12-month weight reduction (primary health-related outcome) Measured at 3, 6, 9 and 12 months The primary health-related outcome will be difference in mean weight reduction from baseline to 12 months between study arms
- Secondary Outcome Measures
Name Time Method Penetrance (WIC DPP coordinators) 12 months Percentage of percentage of trained WIC DPP coordinators supporting health coaches. Measured by study administrative data.
Fidelity 12 months Percentage of sessions held
Adoption (WIC clinics) Baseline Percentage of invited WIC clinics adopting the DPP program. Measured by study administrative data.
Penetrance (WIC health coaches) 12 months Percentage of percentage of trained WIC DPP health coaches delivering the intervention. Measured by study administrative data.
Acceptability Measured at baseline, 6, and 12 months Acceptability scores for participants, DPP coordinators, DPP coaches, WIC clinic management. Measured by survey; higher score means better outcome.
Appropriateness baseline Appropriateness scores for participants, DPP coordinators, DPP coaches, WIC clinic management. Measured by survey; higher score means better outcome.
Feasibility (suitability) Baseline Feasibility scores for participants, DPP coordinators, DPP coaches, and WIC clinic management. Measured by survey; higher score means better outcome.
Adoption (WIC nutritionists) Baseline Percentage of invited WIC nutritionists being trained. Measured by study administrative data.
Adoption (WIC health educators) Baseline Percentage of invited WIC health educators being trained. Measured by study administrative data.
Penetrance (participants) 12 months Percentage of enrolled participants receiving assigned intervention. Measured by study administrative data.
Percentage of participants who were either eligible, screened, or contacted who were enrolled. Baseline Reach
Difference in mean 12-month change in systolic blood pressure Measured from baseline to 12 months Difference in mean change in systolic blood pressure from baseline to 12 months between study arms
Difference in proportion of participants meeting intervention goals at 12 months Measured from baseline to 12 months Assessed by validated questionnaires, 24-hour dietary recalls, and weight measurements
Cost-effectiveness 12 months Incremental direct costs (intervention) per additional percentage of individuals reaching weight loss goal at 12 months
Difference in mean 12-month change in percent weight reduction Measured from baseline to 12 months Difference in mean percent weight reduction from baseline to 12 months between study arms
Difference in mean 12-month change in physical activity Measured from baseline to 12 months 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)
Difference in mean 12-month change in healthy eating index Measured from baseline to 12 months 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)
Difference in mean 12-month change in waist circumference Measured from baseline to 12 months Difference in mean change in waist circumference from baseline to 12 months between study arms
Difference in mean 12-month change in hemoglobin A1c Measured from baseline to 12 months Difference in mean change in hemoglobin A1c from baseline to 12 months between study arms
Difference in mean 12-month change in diastolic blood pressure Measured from baseline to 12 months Difference in mean change in diastolic blood pressure from baseline to 12 months between study arms
Difference in mean 12-month change in health-related quality of life (HRQoL) Measured from baseline to 12 months 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)
Trial Locations
- Locations (1)
Tulane University School of Public Health and Tropical Medicine
🇺🇸New Orleans, Louisiana, United States