Strategies for Implementing a Postpartum Lifestyle Intervention in WIC Clinics

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorTulane University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

722 Participants
are divided into 2 treatment groups
Group A: In-person health coach strategyActive comparator 1 intervention
Group B: Multifaceted technology-assisted health coach implementation strategyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

1

Fidelity

Percentage of sessions held

Time frame
12 months
2

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
3

Appropriateness

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

Time frame
baseline
4

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

Other outcomes

1

Sustainability (DPP coordinators): comparison of perceived sustainability of the two implementation strategies among WIC staff

Assessed by surveys and interviews

Time frame
18 months
2

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

Time frame
18 months

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