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

NCT ID: NCT03550066

Last Updated: 2023-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2018-07-03

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).

Conditions

Preventive Health Services; Health Communication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Values affirmation

In the values affirmation condition, the health outreach message contained a prompt asking participants to reflect on important personal values.

Group Type: EXPERIMENTAL

Values affirmation

Intervention Type: BEHAVIORAL

A health message with a prompt asking participants to reflect on important personal values

No affirmation

In the "no affirmation" condition, the health outreach message appeared alone, with no values affirmation.

Group Type: ACTIVE_COMPARATOR

No affirmation

Intervention Type: BEHAVIORAL

A health message alone

Interventions

Values affirmation

A health message with a prompt asking participants to reflect on important personal values

Intervention Type: BEHAVIORAL

No affirmation

A health message alone

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Current diabetes
• Current pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan D Brown, PhD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Locations

Kaiser Permanente Northern California

Oakland, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

K01DK099404

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P30DK092924

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CN-14-1871-H

Identifier Type: -

Identifier Source: org_study_id