Clinical trial NCT06116149: Strategies for Implementing a Postpartum Lifestyle Intervention in WIC Clinics
Official title: Strategies for Implementing a Postpartum Lifestyle Intervention in WIC Clinics: A Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Gestational Diabetes
Lifestyle, Healthy
Glucose Intolerance During Pregnancy
PreDiabetes
Hyperglycemia
Keywords: Diabetes Prevention Program
Lead sponsor: Tulane University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Pennington Biomedical Research Center
name: University of Pennsylvania
First posted: 2023-11-03
Enrollment: 900
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster-randomization of 36 Women, Infants, and Children (WIC) clinics
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Difference in uptake (primary implementation outcome)
timeFrame: Measured from baseline to 12 months
measure: Difference in mean 12-month weight reduction (primary health-related outcome)
timeFrame: Measured at 3, 6, 9 and 12 months
Secondary outcomes:
measure: Fidelity
timeFrame: 12 months
measure: Acceptability
timeFrame: Measured at baseline, 6, and 12 months
measure: Appropriateness
timeFrame: baseline
measure: Feasibility (suitability)
timeFrame: Baseline
measure: Adoption (WIC clinics)
timeFrame: Baseline
measure: Adoption (WIC nutritionists)
timeFrame: Baseline
measure: Adoption (WIC health educators)
timeFrame: Baseline
measure: Penetrance (participants)
timeFrame: 12 months
measure: Penetrance (WIC DPP coordinators)
timeFrame: 12 months
measure: Penetrance (WIC health coaches)
timeFrame: 12 months
measure: Percentage of participants who were either eligible, screened, or contacted who were enrolled.
timeFrame: Baseline
measure: Cost-effectiveness
timeFrame: 12 months
measure: Difference in mean 12-month change in percent weight reduction
timeFrame: Measured from baseline to 12 months
measure: Difference in mean 12-month change in physical activity
timeFrame: Measured from baseline to 12 months
measure: Difference in mean 12-month change in healthy eating index
timeFrame: Measured from baseline to 12 months
measure: Difference in mean 12-month change in waist circumference
timeFrame: Measured from baseline to 12 months
measure: Difference in mean 12-month change in hemoglobin A1c
timeFrame: Measured from baseline to 12 months
measure: Difference in mean 12-month change in systolic blood pressure
timeFrame: Measured from baseline to 12 months
measure: Difference in mean 12-month change in diastolic blood pressure
timeFrame: Measured from baseline to 12 months
measure: Difference in mean 12-month change in health-related quality of life (HRQoL)
timeFrame: Measured from baseline to 12 months
measure: Difference in proportion of participants meeting intervention goals at 12 months
timeFrame: Measured from baseline to 12 months
Other outcomes:
measure: Sustainability (DPP coordinators): comparison of perceived sustainability of the two implementation strategies among WIC staff
timeFrame: 18 months
measure: Sustainability (Participants): comparison of the proportion of participants maintaining DPP goals at six months after their participation in the DPP has ended
timeFrame: 18 months
Locations:
city: New Orleans
country: United States
facility: Tulane University School of Public Health and Tropical Medicine
state: Louisiana
Study officials:
References: