Study to Understand Risk Information to Support and Empower

NCT05752292 | Enrolling By Invitation

• 2 other identifiers: 1826240R01DK122087
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes, Gestational; Diabetes Mellitus, Type 2

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Completion of recommended postpartum diabetes screening.

  Completion of a 75-gram, 2-hour oral glucose tolerance test (OGTT)

  4-12 weeks postpartum

Secondary Outcomes (3)

• Completion of any recommended postpartum diabetes screening test.

  4-52 weeks postpartum

• Completion of any recommended postpartum diabetes screening test.

  4-12 weeks postpartum

• Uptake of a lifestyle program for diabetes prevention.

  4-52 weeks postpartum

Study Arms (16)

Condition 1

EXPERIMENTAL

Standard health message + VA + TRI + MI+ AP

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

Condition 2

EXPERIMENTAL

Standard health message + VA + TRI + MI

Behavioral: Standard Health Information; Behavioral: Values Affirmation (VA); Behavioral: Tailored Risk Information (TRI); Behavioral: Motivational Interviewing-based (MI)

Condition 3

EXPERIMENTAL

Standard health message + VA + TRI + AP

Behavioral: Standard Health Information; Behavioral: Values Affirmation (VA); Behavioral: Tailored Risk Information (TRI); Behavioral: Action planning (AP)

Condition 4

EXPERIMENTAL

Standard health message + VA + TRI

Behavioral: Standard Health Information; Behavioral: Values Affirmation (VA); Behavioral: Tailored Risk Information (TRI)

Condition 5

EXPERIMENTAL

Standard health message + VA + MI+ AP

Behavioral: Standard Health Information; Behavioral: Values Affirmation (VA); Behavioral: Motivational Interviewing-based (MI); Behavioral: Action planning (AP)

Condition 6

EXPERIMENTAL

Standard health message + VA + MI

Behavioral: Standard Health Information; Behavioral: Values Affirmation (VA); Behavioral: Motivational Interviewing-based (MI)

Condition 7

EXPERIMENTAL

Standard health message + VA + AP

Behavioral: Standard Health Information; Behavioral: Values Affirmation (VA); Behavioral: Action planning (AP)

Condition 8

EXPERIMENTAL

Standard health message + VA

Behavioral: Standard Health Information; Behavioral: Values Affirmation (VA)

Condition 9

EXPERIMENTAL

Standard health message + TRI + MI+ AP

Behavioral: Standard Health Information; Behavioral: Tailored Risk Information (TRI); Behavioral: Motivational Interviewing-based (MI); Behavioral: Action planning (AP)

Condition 10

EXPERIMENTAL

Standard health message + TRI + MI

Behavioral: Standard Health Information; Behavioral: Tailored Risk Information (TRI); Behavioral: Motivational Interviewing-based (MI)

Condition 11

EXPERIMENTAL

Standard health message + TRI + AP

Behavioral: Standard Health Information; Behavioral: Tailored Risk Information (TRI); Behavioral: Action planning (AP)

Condition 12

EXPERIMENTAL

Standard health message + TRI

Behavioral: Standard Health Information; Behavioral: Tailored Risk Information (TRI)

Condition 13

EXPERIMENTAL

Standard health message + MI+ AP

Behavioral: Standard Health Information; Behavioral: Motivational Interviewing-based (MI); Behavioral: Action planning (AP)

Condition 14

EXPERIMENTAL

Standard health message + MI

Behavioral: Standard Health Information; Behavioral: Motivational Interviewing-based (MI)

Condition 15

EXPERIMENTAL

Standard health message + AP

Behavioral: Standard Health Information; Behavioral: Action planning (AP)

Condition 16

EXPERIMENTAL

Standard health message

Behavioral: Standard Health Information

Interventions

Standard Health Information BEHAVIORAL

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

Condition 1; Condition 10; Condition 11; Condition 12; Condition 13; Condition 14; Condition 15; Condition 16; Condition 2; Condition 3; Condition 4; Condition 5; Condition 6; Condition 7; Condition 8; Condition 9

Values Affirmation (VA) BEHAVIORAL

Interactive prompts to reflect on core personal values

Condition 1; Condition 2; Condition 3; Condition 4; Condition 5; Condition 6; Condition 7; Condition 8

Tailored Risk Information (TRI) BEHAVIORAL

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

Condition 1; Condition 10; Condition 11; Condition 12; Condition 2; Condition 3; Condition 4; Condition 9

Action planning (AP) BEHAVIORAL

Interactive prompts to problem solve challenges

Condition 1; Condition 11; Condition 13; Condition 15; Condition 3; Condition 5; Condition 7; Condition 9

Motivational Interviewing-based (MI) BEHAVIORAL

Interactive prompts based on principles of motivational interviewing

Condition 1; Condition 10; Condition 13; Condition 14; Condition 2; Condition 5; Condition 6; Condition 9

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Diagnosis of diabetes before pregnancy
• Maternal or infant current hospitalization
• Pregnancy loss
• History of eating disorder
• Previously requested not to receive research invitations

Sponsors & Collaborators

• Kaiser Foundation Research Institute: collaborator
• University of California, Davis: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Kaiser Permanente Northern California

Pleasanton, California, 94588, United States

Location

MeSH Terms

Conditions

Diabetes, Gestational; Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Susan D Brown, PhD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: March 2, 2023
• Study Start: April 13, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 12, 2026

Record last verified: 2026-05

Locations

US (1)