Patients Engaged in Prevention: Enhancing Outreach to Increase Patient Engagement in Diabetes Prevention

Not Applicable

Completed

• Conditions: Preventive Health Services; Health Communication

• Registration Number: NCT03550066
• Lead Sponsor: Kaiser Permanente

Brief Summary

This study examines whether a health message that includes a self-affirmation intervention (where people reflect on values that are important to them) increases acceptance of the message and encourages people to take steps to prevent diabetes, as compared to a health message without the self affirmation intervention.

Detailed Description

Background: Despite availability of evidence-based programs for diabetes prevention, few strategies exist to promote patients' interest in them. Strategies should be developed for racial/ethnic minority women with a history of gestational diabetes (GDM), who face exceptionally high risk for chronic diabetes. We previously found that a theory-based outreach message containing a streamlined values affirmation-two sentences prompting individuals to reflect on core personal values-increased women's likelihood of demonstrating interest in a preventive program. Extending this work, this pilot trial tests whether the values affirmation outreach message is as acceptable as (non-inferior to) a standard outreach message among African-American and Latina women.

Methods: Two-arm, parallel-group, randomized trial among English- and Spanish-speaking minority women with prior GDM and overweight/obesity in a healthcare system. Within an online survey, participants are randomized to read an outreach message promoting an existing preventive program. The message contains either a values affirmation (intervention condition) or no affirmation (control condition).

Study Timeline

• Study First Submitted: 2018-05-14
• Study Start: 2018-06-01
• Study First Submitted QC: 2018-06-04
• Study First Posted: 2018-06-08
• Primary Completion: 2018-07-03
• Study Completion: 2018-07-03
• Results First Submitted: 2019-07-01
• Results First Submitted QC: 2019-07-30
• Results First Posted: 2019-08-20
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-25
• Last Update Posted: 2023-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

• History of gestational diabetes
• Body mass index ≥25 kg/m2
• English or Spanish language

Exclusion Criteria

• Current diabetes
• Current pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Acceptance of Health Message	Up to 2 weeks	Index of message acceptance: Persuasiveness (rated on a 7-point scale from not at all (1) to very (7), with higher mean scores corresponding to greater persuasiveness)

Secondary Outcome Measures

Name	Time	Method
Diabetes Prevention Behavior: Information Seeking	Up to 2 weeks	Seeking information about prevention
Diabetes Prevention Behavior: Intention	Up to 2 weeks	Behavioral intention to engage in, or seeking information about preventive health services

Trial Locations

Locations (1)

Kaiser Permanente Northern California; 🇺🇸 Oakland, California, United States