Strategies for Implementing a Postpartum Lifestyle Intervention in WIC Clinics

Obesity Clinical Trial

— STRIVE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06116149
• Other study ID #: 2022-1294
• Secondary ID: OT2HL158287
• Status: Recruiting
• Phase: N/A
• Start date: December 12, 2023
• Est. completion date: April 2027

Study information

• Verified date: September 2023
• Source: Tulane University
• Contact: Tara Dobson, BA
• Phone: 504.988.9922
• Email: tdobson[@]tulane.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: April 2027
• Est. primary completion date: October 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Tulane University School of Public Health and Tropical Medicine	New Orleans	Louisiana

Sponsors (4)

Lead Sponsor	Collaborator
Tulane University	National Heart, Lung, and Blood Institute (NHLBI), Pennington Biomedical Research Center, University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sustainability (DPP coordinators): comparison of perceived sustainability of the two implementation strategies among WIC staff	Assessed by surveys and interviews	18 months
Other	Sustainability (Participants): comparison of the proportion of participants maintaining DPP goals at six months after their participation in the DPP has ended	Assessed by validated questionnaires, 24-hour dietary recalls, and weight measurements	18 months
Primary	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
Primary	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	Fidelity	Percentage of sessions held	12 months
Secondary	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
Secondary	Appropriateness	Appropriateness scores for participants, DPP coordinators, DPP coaches, WIC clinic management. Measured by survey; higher score means better outcome.	baseline
Secondary	Feasibility (suitability)	Feasibility scores for participants, DPP coordinators, DPP coaches, and WIC clinic management. Measured by survey; higher score means better outcome.	Baseline
Secondary	Adoption (WIC clinics)	Percentage of invited WIC clinics adopting the DPP program. Measured by study administrative data.	Baseline
Secondary	Adoption (WIC nutritionists)	Percentage of invited WIC nutritionists being trained. Measured by study administrative data.	Baseline
Secondary	Adoption (WIC health educators)	Percentage of invited WIC health educators being trained. Measured by study administrative data.	Baseline
Secondary	Penetrance (participants)	Percentage of enrolled participants receiving assigned intervention. Measured by study administrative data.	12 months
Secondary	Penetrance (WIC DPP coordinators)	Percentage of percentage of trained WIC DPP coordinators supporting health coaches. Measured by study administrative data.	12 months
Secondary	Penetrance (WIC health coaches)	Percentage of percentage of trained WIC DPP health coaches delivering the intervention. Measured by study administrative data.	12 months
Secondary	Percentage of participants who were either eligible, screened, or contacted who were enrolled.	Reach	Baseline
Secondary	Cost-effectiveness	Incremental direct costs (intervention) per additional percentage of individuals reaching weight loss goal at 12 months	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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