Strategies for Implementing a Postpartum Lifestyle Intervention in WIC Clinics
NCT ID: NCT06116149
Last Updated: 2025-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
722 participants
INTERVENTIONAL
2023-12-12
2027-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
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
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Willing and able to provide space for the study
* 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
18 Years
FEMALE
Yes
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Pennington Biomedical Research Center
OTHER
University of Pennsylvania
OTHER
Tulane University
OTHER
Responsible Party
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Locations
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Tulane University School of Public Health and Tropical Medicine
New Orleans, Louisiana, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022-1294
Identifier Type: -
Identifier Source: org_study_id
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