Clinical trial

Strategies for Implementing a Postpartum Lifestyle Intervention in WIC Clinics

Recruiting now · Not applicable · 1 countries · Registry ID NCT06116149

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexFemale

Healthy volunteersAccepted

ConditionObesity, Gestational Diabetes, Lifestyle, Healthy, Glucose Intolerance During Pregnancy, PreDiabetes, Hyperglycemia

Full registry 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

Treatments and study arms

In-person health coach delivery of the GLB

Behavioral

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

Behavioral

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 outcomes

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

Study locations

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Tulane University School of Public Health and Tropical Medicine🇺🇸 New Orleans, Louisiana, United States

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Tara Dobson, BAContact

Email · Call 504-988-9922

Kirsten Dorans, ScDContact

Email · Call 504.988.0883