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

Health Communication Clinical Trial

— PEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03550066
• Other study ID #: CN-14-1871-H
• Secondary ID: K01DK099404P30DK
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: July 3, 2018

Study information

• Verified date: April 2023
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 3, 2018
• Est. primary completion date: July 3, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• History of gestational diabetes

• Body mass index =25 kg/m2

• English or Spanish language

Exclusion Criteria:

• Current diabetes

• Current pregnancy

Related Conditions & MeSH terms

• Diabetes Mellitus
• Health Communication
• Preventive Health Services

Intervention

Behavioral:
• Values affirmation
A health message with a prompt asking participants to reflect on important personal values
• No affirmation
A health message alone

Locations

Country	Name	City	State
United States	Kaiser Permanente Northern California	Oakland	California

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptance of Health Message	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)	Up to 2 weeks
Secondary	Diabetes Prevention Behavior: Information Seeking	Seeking information about prevention	Up to 2 weeks
Secondary	Diabetes Prevention Behavior: Intention	Behavioral intention to engage in, or seeking information about preventive health services	Up to 2 weeks