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

Not Applicable

Completed

• Conditions: Preventive Health Services; Health Communication
• Interventions: Behavioral: No affirmation; Behavioral: Values affirmation

• 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

Arm && Interventions

Group	Intervention	Description
No affirmation	No affirmation	In the "no affirmation" condition, the health outreach message appeared alone, with no values affirmation.
Values affirmation	Values affirmation	In the values affirmation condition, the health outreach message contained a prompt asking participants to reflect on important personal values.

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