Strategies for Implementing a Postpartum Lifestyle Intervention in WIC Clinics

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obesity, Gestational Diabetes, Lifestyle, Healthy, Glucose Intolerance During Pregnancy, PreDiabetes, Hyperglycemia

Intervention / Treatment
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* Behavioral: In-person health coach delivery of the GLB
* Behavioral: Technology-assisted health coach delivery of the GLB


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cluster-randomization of 36 Women, Infants, and Children (WIC) clinics
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: In-person health coach strategy<br>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. | Behavioral: In-person health coach delivery of the GLB<br>* 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.<br>|
| Active Comparator: Multifaceted technology-assisted health coach implementation strategy<br>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. | Behavioral: Technology-assisted health coach delivery of the GLB<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in uptake (primary implementation outcome) | 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. | Measured from baseline to 12 months | 
| Difference in mean 12-month weight reduction (primary health-related outcome) | The primary health-related outcome will be difference in mean weight reduction from baseline to 12 months between study arms | Measured at 3, 6, 9 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fidelity | Percentage of sessions held | 12 months | 
| Acceptability | Acceptability scores for participants, DPP coordinators, DPP coaches, WIC clinic management. Measured by survey; higher score means better outcome. | Measured at baseline, 6, and 12 months | 
| Appropriateness | Appropriateness scores for participants, DPP coordinators, DPP coaches, WIC clinic management. Measured by survey; higher score means better outcome. | baseline | 
| Feasibility (suitability) | Feasibility scores for participants, DPP coordinators, DPP coaches, and WIC clinic management. Measured by survey; higher score means better outcome. | Baseline | 
| Adoption (WIC clinics) | Percentage of invited WIC clinics adopting the DPP program. Measured by study administrative data. | Baseline | 
| Adoption (WIC nutritionists) | Percentage of invited WIC nutritionists being trained. Measured by study administrative data. | Baseline | 
| Adoption (WIC health educators) | Percentage of invited WIC health educators being trained. Measured by study administrative data. | Baseline | 
| Penetrance (participants) | Percentage of enrolled participants receiving assigned intervention. Measured by study administrative data. | 12 months | 
| Penetrance (WIC DPP coordinators) | Percentage of percentage of trained WIC DPP coordinators supporting health coaches. Measured by study administrative data. | 12 months | 
| Penetrance (WIC health coaches) | Percentage of percentage of trained WIC DPP health coaches delivering the intervention. Measured by study administrative data. | 12 months | 
| Percentage of participants who were either eligible, screened, or contacted who were enrolled. | Reach | Baseline | 
| Cost-effectiveness | Incremental direct costs (intervention) per additional percentage of individuals reaching weight loss goal at 12 months | 12 months | 
| Difference in mean 12-month change in percent weight reduction | Difference in mean percent weight reduction from baseline to 12 months between study arms | Measured from baseline to 12 months | 
| Difference in mean 12-month change in physical activity | Difference in mean change in physical activity from baseline to 12 months between study arms, as assessed by metabolic equivalent (MET)-h/week (measured by validated questionnaire) | Measured from baseline to 12 months | 
| Difference in mean 12-month change in healthy eating index | Difference in mean change in healthy eating index from baseline to 12 months between study arms, as assessed by 24-hour dietary recalls (range 0 to 100; higher scores mean healthier eating pattern) | Measured from baseline to 12 months | 
| Difference in mean 12-month change in waist circumference | Difference in mean change in waist circumference from baseline to 12 months between study arms | Measured from baseline to 12 months | 
| Difference in mean 12-month change in hemoglobin A1c | Difference in mean change in hemoglobin A1c from baseline to 12 months between study arms | Measured from baseline to 12 months | 
| Difference in mean 12-month change in fasting glucose | Difference in mean change in fasting glucose from baseline to 12 months between study arms | Measured from baseline to 12 months | 
| Difference in mean 12-month change in systolic blood pressure | Difference in mean change in systolic blood pressure from baseline to 12 months between study arms | Measured from baseline to 12 months | 
| Difference in mean 12-month change in diastolic blood pressure | Difference in mean change in diastolic blood pressure from baseline to 12 months between study arms | Measured from baseline to 12 months | 
| Difference in mean 12-month change in total-to-high-density lipoprotein (HDL)-cholesterol ratio | Difference in mean change in total-to-high-density lipoprotein (HDL)-cholesterol ratio from baseline to 12 months between study arms | Measured from baseline to 12 months | 
| Difference in mean 12-month change in triglycerides | Difference in mean change in triglycerides from baseline to 12 months between study arms | Measured from baseline to 12 months | 
| Difference in mean 12-month change in health-related quality of life (HRQoL) | Difference in mean change in health-related quality of life (HRQoL) from baseline to 12 months between study arms (assessed by short form (SF)-12, validated survey) | Measured from baseline to 12 months | 
| Difference in proportion of participants meeting intervention goals at 12 months | Assessed by validated questionnaires, 24-hour dietary recalls, and weight measurements | Measured from baseline to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Prevention Program