Study to Understand Risk Information to Support and Empower

Study Overview
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Brief Summary
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The aim of this trial is to test components of a digital health outreach intervention to promote uptake of postpartum screening and lifestyle programs for diabetes prevention among patients with gestational diabetes (GDM). The outreach intervention, designed to be interactive and delivered online, includes standard health information plus up to four theory-based components, targeting motivational and logistical barriers to engaging in diabetes preventive care during the postpartum period. The trial leverages the Multiphase Optimization Strategy (MOST) using a randomized factorial study design.

Official Title
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Optimizing a Scalable Intervention to Maximize Guideline-recommended Diabetes Testing After GDM

Conditions
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Diabetes, Gestational, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: Standard Health Information
* Behavioral: Values Affirmation (VA)
* Behavioral: Tailored Risk Information (TRI)
* Behavioral: Motivational Interviewing-based (MI)
* Behavioral: Action planning (AP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Current pregnancy complicated by gestational diabetes mellitus (GDM) Age: 18 years and older Contact with the Kaiser Permanente Northern California (KPNC) Regional Perinatal Service Center Able to communicate in English Exclusion Criteria: Diagnosis of diabetes before pregnancy Maternal or infant current hospitalization Pregnancy loss History of eating disorder Previously requested not to receive research invitations

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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No

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: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Condition 1<br>Standard health message + VA + TRI + MI+ AP | Behavioral: Standard Health Information<br>* Standard health information about postpartum screening and lifestyle programs for diabetes prevention<br>Behavioral: Values Affirmation (VA)<br>* Interactive prompts to reflect on core personal values<br>Behavioral: Tailored Risk Information (TRI)<br>* Interactive prompts to provide tailored information on risk factors for type 2 diabetes<br>Behavioral: Motivational Interviewing-based (MI)<br>* Interactive prompts based on principles of motivational interviewing<br>Behavioral: Action planning (AP)<br>* Interactive prompts to problem solve challenges<br>|
| Experimental: Condition 2<br>Standard health message + VA + TRI + MI | Behavioral: Standard Health Information<br>* Standard health information about postpartum screening and lifestyle programs for diabetes prevention<br>Behavioral: Values Affirmation (VA)<br>* Interactive prompts to reflect on core personal values<br>Behavioral: Tailored Risk Information (TRI)<br>* Interactive prompts to provide tailored information on risk factors for type 2 diabetes<br>Behavioral: Motivational Interviewing-based (MI)<br>* Interactive prompts based on principles of motivational interviewing<br>|
| Experimental: Condition 3<br>Standard health message + VA + TRI + AP | Behavioral: Standard Health Information<br>* Standard health information about postpartum screening and lifestyle programs for diabetes prevention<br>Behavioral: Values Affirmation (VA)<br>* Interactive prompts to reflect on core personal values<br>Behavioral: Tailored Risk Information (TRI)<br>* Interactive prompts to provide tailored information on risk factors for type 2 diabetes<br>Behavioral: Action planning (AP)<br>* Interactive prompts to problem solve challenges<br>|
| Experimental: Condition 4<br>Standard health message + VA + TRI | Behavioral: Standard Health Information<br>* Standard health information about postpartum screening and lifestyle programs for diabetes prevention<br>Behavioral: Values Affirmation (VA)<br>* Interactive prompts to reflect on core personal values<br>Behavioral: Tailored Risk Information (TRI)<br>* Interactive prompts to provide tailored information on risk factors for type 2 diabetes<br>|
| Experimental: Condition 5<br>Standard health message + VA + MI+ AP | Behavioral: Standard Health Information<br>* Standard health information about postpartum screening and lifestyle programs for diabetes prevention<br>Behavioral: Values Affirmation (VA)<br>* Interactive prompts to reflect on core personal values<br>Behavioral: Motivational Interviewing-based (MI)<br>* Interactive prompts based on principles of motivational interviewing<br>Behavioral: Action planning (AP)<br>* Interactive prompts to problem solve challenges<br>|
| Experimental: Condition 6<br>Standard health message + VA + MI | Behavioral: Standard Health Information<br>* Standard health information about postpartum screening and lifestyle programs for diabetes prevention<br>Behavioral: Values Affirmation (VA)<br>* Interactive prompts to reflect on core personal values<br>Behavioral: Motivational Interviewing-based (MI)<br>* Interactive prompts based on principles of motivational interviewing<br>|
| Experimental: Condition 7<br>Standard health message + VA + AP | Behavioral: Standard Health Information<br>* Standard health information about postpartum screening and lifestyle programs for diabetes prevention<br>Behavioral: Values Affirmation (VA)<br>* Interactive prompts to reflect on core personal values<br>Behavioral: Action planning (AP)<br>* Interactive prompts to problem solve challenges<br>|
| Experimental: Condition 8<br>Standard health message + VA | Behavioral: Standard Health Information<br>* Standard health information about postpartum screening and lifestyle programs for diabetes prevention<br>Behavioral: Values Affirmation (VA)<br>* Interactive prompts to reflect on core personal values<br>|
| Experimental: Condition 9<br>Standard health message + TRI + MI+ AP | Behavioral: Standard Health Information<br>* Standard health information about postpartum screening and lifestyle programs for diabetes prevention<br>Behavioral: Tailored Risk Information (TRI)<br>* Interactive prompts to provide tailored information on risk factors for type 2 diabetes<br>Behavioral: Motivational Interviewing-based (MI)<br>* Interactive prompts based on principles of motivational interviewing<br>Behavioral: Action planning (AP)<br>* Interactive prompts to problem solve challenges<br>|
| Experimental: Condition 10<br>Standard health message + TRI + MI | Behavioral: Standard Health Information<br>* Standard health information about postpartum screening and lifestyle programs for diabetes prevention<br>Behavioral: Tailored Risk Information (TRI)<br>* Interactive prompts to provide tailored information on risk factors for type 2 diabetes<br>Behavioral: Motivational Interviewing-based (MI)<br>* Interactive prompts based on principles of motivational interviewing<br>|
| Experimental: Condition 11<br>Standard health message + TRI + AP | Behavioral: Standard Health Information<br>* Standard health information about postpartum screening and lifestyle programs for diabetes prevention<br>Behavioral: Tailored Risk Information (TRI)<br>* Interactive prompts to provide tailored information on risk factors for type 2 diabetes<br>Behavioral: Action planning (AP)<br>* Interactive prompts to problem solve challenges<br>|
| Experimental: Condition 12<br>Standard health message + TRI | Behavioral: Standard Health Information<br>* Standard health information about postpartum screening and lifestyle programs for diabetes prevention<br>Behavioral: Tailored Risk Information (TRI)<br>* Interactive prompts to provide tailored information on risk factors for type 2 diabetes<br>|
| Experimental: Condition 13<br>Standard health message + MI+ AP | Behavioral: Standard Health Information<br>* Standard health information about postpartum screening and lifestyle programs for diabetes prevention<br>Behavioral: Motivational Interviewing-based (MI)<br>* Interactive prompts based on principles of motivational interviewing<br>Behavioral: Action planning (AP)<br>* Interactive prompts to problem solve challenges<br>|
| Experimental: Condition 14<br>Standard health message + MI | Behavioral: Standard Health Information<br>* Standard health information about postpartum screening and lifestyle programs for diabetes prevention<br>Behavioral: Motivational Interviewing-based (MI)<br>* Interactive prompts based on principles of motivational interviewing<br>|
| Experimental: Condition 15<br>Standard health message + AP | Behavioral: Standard Health Information<br>* Standard health information about postpartum screening and lifestyle programs for diabetes prevention<br>Behavioral: Action planning (AP)<br>* Interactive prompts to problem solve challenges<br>|
| Experimental: Condition 16<br>Standard health message | Behavioral: Standard Health Information<br>* Standard health information about postpartum screening and lifestyle programs for diabetes prevention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion of recommended postpartum diabetes screening. | Completion of a 75-gram, 2-hour oral glucose tolerance test (OGTT) | 4-12 weeks postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion of any recommended postpartum diabetes screening test. | Completion of any screening test (OGTT, fasting plasma glucose, or HbA1c) | 4-52 weeks postpartum | 
| Uptake of a lifestyle program for diabetes prevention. | Enrollment in a lifestyle program for diabetes prevention among women without type 2 diabetes mellitus according to any screening result | 4-52 weeks postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gestational Diabetes, Diabetes Mellitus, Type 2 Prevention, Preventive Health Services, Health Communication