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

April 25, 2023 updated by: Kaiser Permanente

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Oakland, California, United States, 94612
        • Kaiser Permanente Northern California

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Current diabetes
  • Current pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Values affirmation
In the values affirmation condition, the health outreach message contained a prompt asking participants to reflect on important personal values.
Behavioral: Values affirmation
A health message with a prompt asking participants to reflect on important personal values
Active Comparator: No affirmation
In the "no affirmation" condition, the health outreach message appeared alone, with no values affirmation.
Behavioral: No affirmation
A health message alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Up to 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diabetes Prevention Behavior: Information Seeking
Time Frame: Up to 2 weeks
Seeking information about prevention
Up to 2 weeks
Diabetes Prevention Behavior: Intention
Time Frame: Up to 2 weeks
Behavioral intention to engage in, or seeking information about preventive health services
Up to 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaiser Permanente

Collaborators

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

Investigators

  • Principal Investigator: Susan D Brown, PhD, Kaiser Permanente

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Actual)

July 3, 2018

Study Completion (Actual)

July 3, 2018

Study Registration Dates

First Submitted

May 14, 2018

First Submitted That Met QC Criteria

June 4, 2018

First Posted (Actual)

June 8, 2018

Study Record Updates

Last Update Posted (Actual)

April 27, 2023

Last Update Submitted That Met QC Criteria

April 25, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CN-14-1871-H
  • K01DK099404 (U.S. NIH Grant/Contract)
  • P30DK092924 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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