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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Preventive Health Services, Health Communication

Intervention / Treatment
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* Behavioral: Values affirmation
* Behavioral: No affirmation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of gestational diabetes Body mass index ≥25 kg/m2 English or Spanish language Exclusion Criteria: Current diabetes Current pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, gestational, Diabetes Mellitus