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OpenTrials
Completed

NCT Number: NCT03550066

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente Northern California

Oakland, California, 94612, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Current diabetes
  • Current pregnancy

Treatment and study plan

Values affirmation

Behavioral

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

No affirmation

Behavioral

A health message alone

Primary outcomes

  1. 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

  1. Diabetes Prevention Behavior: Information Seeking

    Time frame: Up to 2 weeks

    Seeking information about prevention

  2. Diabetes Prevention Behavior: Intention

    Time frame: Up to 2 weeks

    Behavioral intention to engage in, or seeking information about preventive health services

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

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

Registry information

Official study title

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

Acronym: PEP

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 8, 2018
Registry last updated
Apr 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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