Strategies for Implementing a Postpartum Lifestyle Intervention in WIC Clinics

Tulane University722 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

722

Conditions

Obesity

Interventions

In-person health coach delivery of the GLBBEHAVIORAL

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 GLBBEHAVIORAL

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

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: Measured at 3, 6, 9 and 12 months

Secondary Outcomes

Fidelity

Percentage of sessions held

Time frame: 12 months

Acceptability

Acceptability scores for participants, DPP coordinators, DPP coaches, WIC clinic management. Measured by survey; higher score means better outcome.

Time frame: 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.

Time frame: baseline

Feasibility (suitability)

Feasibility scores for participants, DPP coordinators, DPP coaches, and WIC clinic management. Measured by survey; higher score means better outcome.

Time frame: Baseline

Adoption (WIC clinics)

Percentage of invited WIC clinics adopting the DPP program. Measured by study administrative data.

Time frame: Baseline

Adoption (WIC nutritionists)

Percentage of invited WIC nutritionists being trained. Measured by study administrative data.

Time frame: Baseline

Adoption (WIC health educators)

Percentage of invited WIC health educators being trained. Measured by study administrative data.

Time frame: Baseline

Penetrance (participants)

Percentage of enrolled participants receiving assigned intervention. Measured by study administrative data.

Time frame: 12 months

Penetrance (WIC DPP coordinators)

Percentage of percentage of trained WIC DPP coordinators supporting health coaches. Measured by study administrative data.

Time frame: 12 months

Penetrance (WIC health coaches)

Percentage of percentage of trained WIC DPP health coaches delivering the intervention. Measured by study administrative data.

Time frame: 12 months

Percentage of participants who were either eligible, screened, or contacted who were enrolled.

Reach

Time frame: Baseline

Cost-effectiveness

Incremental direct costs (intervention) per additional percentage of individuals reaching weight loss goal at 12 months

Time frame: 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

Time frame: 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)

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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)

Time frame: 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

Time frame: Measured from baseline to 12 months

Strategies for Implementing a Postpartum Lifestyle Intervention in WIC Clinics

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts