About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Serve a large number of WIC postpartum participants
Willing and able to provide space for the study
Age 18 or older
Gave birth in the past 6 weeks to 12 months
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
In-person health coach delivery of the GLB
BehavioralDelivery 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
BehavioralDelivery 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.
Treatment groups
Trial 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.
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
Secondary outcomes
Fidelity
Percentage of sessions held
Acceptability
Acceptability scores for participants, DPP coordinators, DPP coaches, WIC clinic management. Measured by survey; higher score means better outcome.
Appropriateness
Appropriateness scores for participants, DPP coordinators, DPP coaches, WIC clinic management. Measured by survey; higher score means better outcome.
Feasibility (suitability)
Feasibility scores for participants, DPP coordinators, DPP coaches, and WIC clinic management. Measured by survey; higher score means better outcome.
Other outcomes
Sustainability (DPP coordinators): comparison of perceived sustainability of the two implementation strategies among WIC staff
Assessed by surveys and interviews
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
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Tulane University
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Pennington Biomedical Research Center
Collaborator
University of Pennsylvania
Collaborator