Quality Improvement and Implementation Science for Mental and Physical Health in Women Veterans

(EMPOWER Trial)

Overseen By Alison B Hamilton, PhD MPH

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not involve individual patients, so there is no requirement for participants to stop taking their current medications.

What data supports the effectiveness of the treatment DPP, Diabetes Prevention Program, for mental and physical health in women veterans?

Research shows that the Diabetes Prevention Program (DPP) has been effectively adapted for various communities, including African American women and American Indian youth, to help reduce the risk of type 2 diabetes. These adaptations suggest that the DPP can be tailored to meet the specific needs of different groups, potentially benefiting women veterans as well. ^{1 2 3 4 5}

How does the treatment for mental and physical health in women veterans differ from other treatments?

This treatment is unique because it combines multiple evidence-based programs like the Diabetes Prevention Program (DPP) and Reach Out, Stay Strong, Essentials for Mothers of Newborns (ROSE) to address both mental and physical health, focusing on lifestyle changes and behavioral management, which is not commonly integrated in standard treatments for women veterans. ^{2 4 6 7 8}

What is the purpose of this trial?

Women Veterans are the fastest growing segment of VA users. This dramatic growth has created challenges for VA to ensure that appropriate services are available to meet women Veterans' needs, and that they will want and be able to use those services. The EMPOWER QUERI 2.0 Program is a cluster randomized type 3 hybrid implementation-effectiveness trial testing two strategies designed to support implementation and sustainment of evidence-based practices for women Veterans in at least 20 VA facilities from 4 regions.

Research Team

Alison B Hamilton, PhD MPH

Principal Investigator

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Eligibility Criteria

This trial is for VA facilities that serve women veterans. It's not for individual patients. Facilities must have leadership support to participate and are prepared to implement evidence-based practices aimed at improving health outcomes in areas like diabetes, obesity, depression, and cardiovascular disease.

Inclusion Criteria

This study is recruiting VA sites - not individual patients. Prior to randomization, the study team will work with sites to ensure they have met the preconditions necessary to enroll in the study, which includes VISN, regional and/or facility level leadership support for participation.

Exclusion Criteria

N/A

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Randomization of VA sites to REP or EBQI strategies to implement evidence-based practices for preventive services

12 months

Ongoing virtual and in-person meetings

Evaluation

Mixed methods implementation evaluation to compare effectiveness of REP and EBQI strategies

12 months

Follow-up

Participants are monitored for engagement and outcomes in virtual preventive services

6 months

Treatment Details

Interventions

• DPP
• EBQI
• REP
• ROSE
• TLC

Trial Overview The EMPOWER QUERI 2.0 Program is testing two strategies (EBQI and REP) across up to 20 VA facilities to see which better supports the implementation of healthcare practices designed for women veterans' mental and physical health.

Participant Groups

Group I: EBQI Experimental Treatment 1 Intervention

Evidence-Based Quality Improvement (EBQI) is a higher-intensity implementation strategy that entails external facilitation and formal training in quality improvement.

Group II: REP Active Control 1 Intervention

Replicating Effective Practices (REP) is a lower-intensity implementation strategy with explicit process framework for local tailoring

DPP is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Diabetes Prevention Program for:

• Prediabetes prevention
• Type 2 diabetes prevention

Approved in European Union as National Diabetes Prevention Program for:

• Prediabetes prevention
• Type 2 diabetes prevention

Approved in Canada as CDC Diabetes Prevention Program for:

• Prediabetes prevention
• Type 2 diabetes prevention

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

A church-based Diabetes Prevention Program (DPP) effectively reduced fasting glucose levels from 108.1 to 101.7 mg/dL and led to weight loss in African American participants, with these benefits lasting for 12 months after the intervention.

The 6-session DPP was as effective as the 16-session version in lowering glucose and weight, while also being less expensive to implement, suggesting that shorter programs can be a viable option for community health initiatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translation of the National Institutes of Health Diabetes Prevention Program in African American churches. Boltri, JM., Davis-Smith, M., Okosun, IS., et al.[2022]

The study reviewed 28 interventions related to the Diabetes Prevention Program (DPP) and found that various cultural adaptations did not significantly impact weight or BMI reduction outcomes, suggesting the DPP is robust to these modifications.

Programs that included a maintenance component showed significantly greater weight reduction over time, highlighting the importance of ongoing support in reducing the risk of developing type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Program Modification Strategies of the Diabetes Prevention Program: A Systematic Review. Neamah, HH., Sebert Kuhlmann, AK., Tabak, RG.[2022]

Community interventions based on the NIH Diabetes Prevention Program (DPP) curriculum led to significant weight loss in participants, with some studies showing sustained results up to 12 months after the intervention.

The DPP-based programs also demonstrated improvements in physical activity levels and components of metabolic syndrome, indicating their potential effectiveness in preventing type 2 diabetes and promoting overall health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translating the Diabetes Prevention Program into practice: a review of community interventions. Jackson, L.[2022]

A community-based faith-based diabetes prevention program (FDPP) significantly improved weight loss among African American women, with those attending at least 15 sessions losing an average of 6.1 pounds at 4 months and achieving a 5.8% reduction at 10 months.

Both the faith-based and standard diabetes prevention programs led to improvements in health behaviors and biometrics, but the FDPP met the CDC's weight loss recommendations for diabetes prevention, highlighting its effectiveness in this demographic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Better Me Within Randomized Trial: Faith-Based Diabetes Prevention Program for Weight Loss in African American Women. Kitzman, H., Mamun, A., Dodgen, L., et al.[2023]

The study involved 31 community members from two Montana Indian reservations who provided insights on adapting the Diabetes Prevention Program (DPP) to be culturally relevant for American Indian youth.

Key strategies identified for effective translation of the DPP included incorporating cultural practices like berry picking and dancing, enhancing access to healthy foods, and using interactive learning methods led by tribal members and elders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translating the diabetes prevention program for Northern Plains Indian youth through community-based participatory research methods. Brown, BD., Harris, KJ., Harris, JL., et al.[2022]

A pharmacist-led diabetes prevention service successfully integrated A1C screening into a wellness program for university employees, identifying 9.3% of participants as having prediabetes.

Despite the identification of at-risk individuals, participation in the National Diabetes Prevention Program (NDPP) was low, with only 12 out of 69 participants engaging, highlighting the need to address barriers to improve program effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Description of a pharmacist-led diabetes prevention service within an employer-based wellness program. Gamston, CE., Kirby, AN., Hansen, RA., et al.[2022]

The National Diabetes Prevention Program (National DPP) is effective in preventing or delaying diabetes in at-risk patients, but its implementation in primary care settings faces significant challenges, including limited awareness and lack of standard referral processes among clinic personnel.

Using the Implementation Mapping framework, researchers identified barriers to the National DPP's adoption and developed tailored strategies, such as provider education and optimizing electronic health records, to enhance program implementation in four participating clinics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of implementation mapping to develop strategies for integrating the National Diabetes Prevention Program into primary care clinics. Perkison, WB., Rodriguez, SA., Velasco-Huerta, F., et al.[2023]

The Diabetes Prevention Program (DPP) has been adapted for ethnic minority communities in the U.S. to address the higher risk of type 2 diabetes, with only 6 studies specifically focusing on these translations identified in a review of 89 papers.

Successful translation strategies included group-based delivery and bilingual personnel, which enhanced the acceptability of the DPP among diverse ethnic groups, suggesting these methods should be prioritized in future implementations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translation of the Diabetes Prevention Program to Ethnic Communities in the United States. Hall, DL., Lattie, EG., McCalla, JR., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Translation of the National Institutes of Health Diabetes Prevention Program in African American churches. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of Program Modification Strategies of the Diabetes Prevention Program: A Systematic Review. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Translating the Diabetes Prevention Program into practice: a review of community interventions. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Better Me Within Randomized Trial: Faith-Based Diabetes Prevention Program for Weight Loss in African American Women. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Translating the diabetes prevention program for Northern Plains Indian youth through community-based participatory research methods. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Description of a pharmacist-led diabetes prevention service within an employer-based wellness program. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Application of implementation mapping to develop strategies for integrating the National Diabetes Prevention Program into primary care clinics. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Translation of the Diabetes Prevention Program to Ethnic Communities in the United States. [2022]