Strategies for Implementing a Postpartum Lifestyle Intervention in WIC Clinics
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: In-person health coach delivery of the GLB, Technology-assisted health coach delivery of the GLB.
- Who it may be relevant to
- Registry conditions: Obesity, Gestational Diabetes, Lifestyle, Healthy, Glucose Intolerance During Pregnancy. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Strategies for Implementing a Postpartum Lifestyle Intervention in WIC Clinics: A Cluster Randomized Trial
Overview
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).
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.
Interventions
- 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 behavio - 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 ph
Primary outcome measures
- 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]
Secondary outcome measures (12)
- Fidelity [Time frame: 12 months]
- Acceptability [Time frame: Measured at baseline, 6, and 12 months]
- Appropriateness [Time frame: baseline]
- Feasibility (suitability) [Time frame: Baseline]
- Adoption (WIC clinics) [Time frame: Baseline]
- Adoption (WIC nutritionists) [Time frame: Baseline]
- Adoption (WIC health educators) [Time frame: Baseline]
- Penetrance (participants) [Time frame: 12 months]
- Penetrance (WIC DPP coordinators) [Time frame: 12 months]
- Penetrance (WIC health coaches) [Time frame: 12 months]
- Percentage of participants who were either eligible, screened, or contacted who were enrolled. [Time frame: Baseline]
- Cost-effectiveness [Time frame: 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Tulane University School of Public Health and Tropical Medicine — New Orleans
Identifiers
NCT: NCT06116149 · 2022-1294 · OT2HL158287