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NCT Number: NCT06116149

Strategies for Implementing a Postpartum Lifestyle Intervention in WIC Clinics

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.

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Key information

Conditions

Obesity Body Weight Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Gestational Diabetes Glucose Intolerance During Pregnancy Glucose Metabolism Disorders Hyperglycemia Lifestyle, Healthy Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms PreDiabetes Prediabetic State Pregnancy Complications Signs and Symptoms Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Difference in uptake (primary implementation outcome)

    Time frame: Measured from baseline to 12 months

    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.

  2. Difference in mean 12-month weight reduction (primary health-related outcome)

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

    The primary health-related outcome will be difference in mean weight reduction from baseline to 12 months between study arms

Secondary outcomes

  1. Fidelity

    Time frame: 12 months

    Percentage of sessions held

  2. Acceptability

    Time frame: Measured at baseline, 6, and 12 months

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

  3. Appropriateness

    Time frame: baseline

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

  4. Feasibility (suitability)

    Time frame: Baseline

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

  5. Adoption (WIC clinics)

    Time frame: Baseline

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

  6. Adoption (WIC nutritionists)

    Time frame: Baseline

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

  7. Adoption (WIC health educators)

    Time frame: Baseline

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

  8. Penetrance (participants)

    Time frame: 12 months

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

  9. Penetrance (WIC DPP coordinators)

    Time frame: 12 months

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

  10. Penetrance (WIC health coaches)

    Time frame: 12 months

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

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

    Time frame: Baseline

    Reach

  12. Cost-effectiveness

    Time frame: 12 months

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

  13. Difference in mean 12-month change in percent weight reduction

    Time frame: Measured from baseline to 12 months

    Difference in mean percent weight reduction from baseline to 12 months between study arms

  14. Difference in mean 12-month change in physical activity

    Time frame: Measured from baseline to 12 months

    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)

  15. Difference in mean 12-month change in healthy eating index

    Time frame: Measured from baseline to 12 months

    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)

  16. Difference in mean 12-month change in waist circumference

    Time frame: Measured from baseline to 12 months

    Difference in mean change in waist circumference from baseline to 12 months between study arms

  17. Difference in mean 12-month change in hemoglobin A1c

    Time frame: Measured from baseline to 12 months

    Difference in mean change in hemoglobin A1c from baseline to 12 months between study arms

  18. Difference in mean 12-month change in systolic blood pressure

    Time frame: Measured from baseline to 12 months

    Difference in mean change in systolic blood pressure from baseline to 12 months between study arms

  19. Difference in mean 12-month change in diastolic blood pressure

    Time frame: Measured from baseline to 12 months

    Difference in mean change in diastolic blood pressure from baseline to 12 months between study arms

  20. Difference in mean 12-month change in health-related quality of life (HRQoL)

    Time frame: Measured from baseline to 12 months

    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)

  21. Difference in proportion of participants meeting intervention goals at 12 months

    Time frame: Measured from baseline to 12 months

    Assessed by validated questionnaires, 24-hour dietary recalls, and weight measurements

Other outcomes

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

    Time frame: 18 months

    Assessed by surveys and interviews

  2. Sustainability (Participants): comparison of the proportion of participants maintaining DPP goals at six months after their participation in the DPP has ended

    Time frame: 18 months

    Assessed by validated questionnaires, 24-hour dietary recalls, and weight measurements

Study contacts

Contact information is provided by the study sponsor or research team.

Kirsten Dorans, ScD

CONTACT

[email protected]

504.988.0883

Tara Dobson, BA

CONTACT

[email protected]

504.988.9922

Sponsors and collaborators

Lead sponsor

Tulane University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • Pennington Biomedical Research Center
  • University of Pennsylvania

Registry information

Official study title

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

Acronym: STRIVE

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Nov 3, 2023
Registry last updated
Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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