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Clinical Trials/NCT03550066
NCT03550066
Completed
Not Applicable

A Self-Affirmation Intervention to Enhance Patient Outreach for Health System-based Lifestyle Programs for Diabetes Prevention

Kaiser Permanente1 site in 1 country90 target enrollmentJune 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Preventive Health Services
Sponsor
Kaiser Permanente
Enrollment
90
Locations
1
Primary Endpoint
Acceptance of Health Message
Status
Completed
Last Updated
3 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
June 1, 2018
End Date
July 3, 2018
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Current diabetes
  • Current pregnancy

Outcomes

Primary Outcomes

Acceptance of Health Message

Time Frame: 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 Outcomes

  • Diabetes Prevention Behavior: Information Seeking(Up to 2 weeks)
  • Diabetes Prevention Behavior: Intention(Up to 2 weeks)

Study Sites (1)

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