Study to Understand Risk Information to Support and Empower

NCT ID: NCT05752292

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-13

Study Completion Date

2026-07-31

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.

Detailed Description

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Conditions

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Diabetes, Gestational Diabetes Mellitus, Type 2

Keywords

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Gestational Diabetes Diabetes Mellitus, Type 2 Prevention Preventive Health Services Health Communication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Condition 1

Standard health message + VA + TRI + MI+ AP

Group Type EXPERIMENTAL

Standard Health Information

Intervention Type BEHAVIORAL

Standard health information about postpartum screening and lifestyle programs for diabetes prevention

Values Affirmation (VA)

Intervention Type BEHAVIORAL

Interactive prompts to reflect on core personal values

Tailored Risk Information (TRI)

Intervention Type BEHAVIORAL

Interactive prompts to provide tailored information on risk factors for type 2 diabetes

Motivational Interviewing-based (MI)

Intervention Type BEHAVIORAL

Interactive prompts based on principles of motivational interviewing

Action planning (AP)

Intervention Type BEHAVIORAL

Interactive prompts to problem solve challenges

Condition 2

Standard health message + VA + TRI + MI

Group Type EXPERIMENTAL

Standard Health Information

Intervention Type BEHAVIORAL

Standard health information about postpartum screening and lifestyle programs for diabetes prevention

Values Affirmation (VA)

Intervention Type BEHAVIORAL

Interactive prompts to reflect on core personal values

Tailored Risk Information (TRI)

Intervention Type BEHAVIORAL

Interactive prompts to provide tailored information on risk factors for type 2 diabetes

Motivational Interviewing-based (MI)

Intervention Type BEHAVIORAL

Interactive prompts based on principles of motivational interviewing

Condition 3

Standard health message + VA + TRI + AP

Group Type EXPERIMENTAL

Standard Health Information

Intervention Type BEHAVIORAL

Standard health information about postpartum screening and lifestyle programs for diabetes prevention

Values Affirmation (VA)

Intervention Type BEHAVIORAL

Interactive prompts to reflect on core personal values

Tailored Risk Information (TRI)

Intervention Type BEHAVIORAL

Interactive prompts to provide tailored information on risk factors for type 2 diabetes

Action planning (AP)

Intervention Type BEHAVIORAL

Interactive prompts to problem solve challenges

Condition 4

Standard health message + VA + TRI

Group Type EXPERIMENTAL

Standard Health Information

Intervention Type BEHAVIORAL

Standard health information about postpartum screening and lifestyle programs for diabetes prevention

Values Affirmation (VA)

Intervention Type BEHAVIORAL

Interactive prompts to reflect on core personal values

Tailored Risk Information (TRI)

Intervention Type BEHAVIORAL

Interactive prompts to provide tailored information on risk factors for type 2 diabetes

Condition 5

Standard health message + VA + MI+ AP

Group Type EXPERIMENTAL

Standard Health Information

Intervention Type BEHAVIORAL

Standard health information about postpartum screening and lifestyle programs for diabetes prevention

Values Affirmation (VA)

Intervention Type BEHAVIORAL

Interactive prompts to reflect on core personal values

Motivational Interviewing-based (MI)

Intervention Type BEHAVIORAL

Interactive prompts based on principles of motivational interviewing

Action planning (AP)

Intervention Type BEHAVIORAL

Interactive prompts to problem solve challenges

Condition 6

Standard health message + VA + MI

Group Type EXPERIMENTAL

Standard Health Information

Intervention Type BEHAVIORAL

Standard health information about postpartum screening and lifestyle programs for diabetes prevention

Values Affirmation (VA)

Intervention Type BEHAVIORAL

Interactive prompts to reflect on core personal values

Motivational Interviewing-based (MI)

Intervention Type BEHAVIORAL

Interactive prompts based on principles of motivational interviewing

Condition 7

Standard health message + VA + AP

Group Type EXPERIMENTAL

Standard Health Information

Intervention Type BEHAVIORAL

Standard health information about postpartum screening and lifestyle programs for diabetes prevention

Values Affirmation (VA)

Intervention Type BEHAVIORAL

Interactive prompts to reflect on core personal values

Action planning (AP)

Intervention Type BEHAVIORAL

Interactive prompts to problem solve challenges

Condition 8

Standard health message + VA

Group Type EXPERIMENTAL

Standard Health Information

Intervention Type BEHAVIORAL

Standard health information about postpartum screening and lifestyle programs for diabetes prevention

Values Affirmation (VA)

Intervention Type BEHAVIORAL

Interactive prompts to reflect on core personal values

Condition 9

Standard health message + TRI + MI+ AP

Group Type EXPERIMENTAL

Standard Health Information

Intervention Type BEHAVIORAL

Standard health information about postpartum screening and lifestyle programs for diabetes prevention

Tailored Risk Information (TRI)

Intervention Type BEHAVIORAL

Interactive prompts to provide tailored information on risk factors for type 2 diabetes

Motivational Interviewing-based (MI)

Intervention Type BEHAVIORAL

Interactive prompts based on principles of motivational interviewing

Action planning (AP)

Intervention Type BEHAVIORAL

Interactive prompts to problem solve challenges

Condition 10

Standard health message + TRI + MI

Group Type EXPERIMENTAL

Standard Health Information

Intervention Type BEHAVIORAL

Standard health information about postpartum screening and lifestyle programs for diabetes prevention

Tailored Risk Information (TRI)

Intervention Type BEHAVIORAL

Interactive prompts to provide tailored information on risk factors for type 2 diabetes

Motivational Interviewing-based (MI)

Intervention Type BEHAVIORAL

Interactive prompts based on principles of motivational interviewing

Condition 11

Standard health message + TRI + AP

Group Type EXPERIMENTAL

Standard Health Information

Intervention Type BEHAVIORAL

Standard health information about postpartum screening and lifestyle programs for diabetes prevention

Tailored Risk Information (TRI)

Intervention Type BEHAVIORAL

Interactive prompts to provide tailored information on risk factors for type 2 diabetes

Action planning (AP)

Intervention Type BEHAVIORAL

Interactive prompts to problem solve challenges

Condition 12

Standard health message + TRI

Group Type EXPERIMENTAL

Standard Health Information

Intervention Type BEHAVIORAL

Standard health information about postpartum screening and lifestyle programs for diabetes prevention

Tailored Risk Information (TRI)

Intervention Type BEHAVIORAL

Interactive prompts to provide tailored information on risk factors for type 2 diabetes

Condition 13

Standard health message + MI+ AP

Group Type EXPERIMENTAL

Standard Health Information

Intervention Type BEHAVIORAL

Standard health information about postpartum screening and lifestyle programs for diabetes prevention

Motivational Interviewing-based (MI)

Intervention Type BEHAVIORAL

Interactive prompts based on principles of motivational interviewing

Action planning (AP)

Intervention Type BEHAVIORAL

Interactive prompts to problem solve challenges

Condition 14

Standard health message + MI

Group Type EXPERIMENTAL

Standard Health Information

Intervention Type BEHAVIORAL

Standard health information about postpartum screening and lifestyle programs for diabetes prevention

Motivational Interviewing-based (MI)

Intervention Type BEHAVIORAL

Interactive prompts based on principles of motivational interviewing

Condition 15

Standard health message + AP

Group Type EXPERIMENTAL

Standard Health Information

Intervention Type BEHAVIORAL

Standard health information about postpartum screening and lifestyle programs for diabetes prevention

Action planning (AP)

Intervention Type BEHAVIORAL

Interactive prompts to problem solve challenges

Condition 16

Standard health message

Group Type EXPERIMENTAL

Standard Health Information

Intervention Type BEHAVIORAL

Standard health information about postpartum screening and lifestyle programs for diabetes prevention

Interventions

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Standard Health Information

Standard health information about postpartum screening and lifestyle programs for diabetes prevention

Intervention Type BEHAVIORAL

Values Affirmation (VA)

Interactive prompts to reflect on core personal values

Intervention Type BEHAVIORAL

Tailored Risk Information (TRI)

Interactive prompts to provide tailored information on risk factors for type 2 diabetes

Intervention Type BEHAVIORAL

Motivational Interviewing-based (MI)

Interactive prompts based on principles of motivational interviewing

Intervention Type BEHAVIORAL

Action planning (AP)

Interactive prompts to problem solve challenges

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kaiser Foundation Research Institute

OTHER

Sponsor Role collaborator

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

NIH

Sponsor Role collaborator

University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Susan D Brown, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

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Kaiser Permanente Northern California

Pleasanton, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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R01DK122087

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1826240

Identifier Type: -

Identifier Source: org_study_id