Strategies for Implementing a Postpartum Lifestyle Intervention in WIC Clinics

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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
• Поведенческое 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

Первичные конечные точки

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

Вторичные конечные точки (12)

• Fidelity [Срок оценки: 12 months]
• Acceptability [Срок оценки: Measured at baseline, 6, and 12 months]
• Appropriateness [Срок оценки: baseline]
• Feasibility (suitability) [Срок оценки: Baseline]
• Adoption (WIC clinics) [Срок оценки: Baseline]
• Adoption (WIC nutritionists) [Срок оценки: Baseline]
• Adoption (WIC health educators) [Срок оценки: Baseline]
• Penetrance (participants) [Срок оценки: 12 months]
• Penetrance (WIC DPP coordinators) [Срок оценки: 12 months]
• Penetrance (WIC health coaches) [Срок оценки: 12 months]
• Percentage of participants who were either eligible, screened, or contacted who were enrolled. [Срок оценки: Baseline]
• Cost-effectiveness [Срок оценки: 12 months]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Tulane University School of Public Health and Tropical Medicine — New Orleans

Идентификаторы

NCT: NCT06116149 · 2022-1294 · OT2HL158287

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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