NCT07544407

Brief Summary

This study will test STRIDE (SupporTing paRents with DiabEtes), a virtually delivered program that helps adults ages 21-44 who were recently diagnosed with type 2 diabetes and are caring for a child ages 2-14 within Kaiser Permanente Northern California. STRIDE focuses on practical skills for everyday life, with sessions on Prioritizing Self-Care, Eating Well Together, and Getting Active as a Family.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus-type-2

Timeline
19mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
Apr 2026Dec 2027

Study Start

First participant enrolled

April 1, 2026

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

April 15, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 22, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

April 29, 2026

Status Verified

February 1, 2026

Enrollment Period

11 months

First QC Date

April 15, 2026

Last Update Submit

April 23, 2026

Conditions

Diabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (2)

  • Diabetes Distress Scale (DDS)

    Diabetes Distress Scale (DDS), a validated 17-item scale covering 4 domains: emotional burden, physician-related distress, regimen-related distress, and interpersonal distress. Each item is rated on a 6-point scale (1 = not a problem to 6 = a very serious problem), with higher scores indicating greater diabetes-related distress (worse outcome).

    Baseline and 4-5 months following enrollment

  • Diabetes Self-Efficacy

    The Diabetes Self-Efficacy Scale is a validated 8-item measure that assesses an individual's confidence in performing diabetes self-care activities. Items are rated on a 10-point scale (1 = not at all confident to 10 = very confident), with higher scores indicating greater self-efficacy.

    Baseline and 4-5 months following enrollment

Secondary Outcomes (6)

  • HbA1c at 6 Months

    6-Months Following Enrollment

  • Completion of HbA1c Monitoring

    6-Months Following Enrollment

  • T2D-related care

    6-Months Following Enrollment

  • Medication Use

    6-Months Following Enrollment

  • Self-Reported T2D Self-Management

    6-Months Following Enrollment

  • +1 more secondary outcomes

Study Arms (2)

Experimental: STRIDE Program

EXPERIMENTAL

Participants enrolled in the STRIDE arm will be invited to attend the live and recorded sessions let by a clinician and receive 24 tailored text messages, in addition to their usual diabetes care.

Behavioral: STRIDE Program

Usual Care

NO INTERVENTION

This arm will continue to receive their usual diabetes care. After completing 6-month outcome assessments, they will be offered an opportunity to participate in the STRIDE program

Interventions

STRIDE ProgramBEHAVIORAL

Participants randomized to the intervention arm will be enrolled in the STRIDE program, a clinician-led virtually delivered program designed specifically for adults with type 2 diabetes who are raising children. Through 3 virtual sessions, the program provides practical, family-centered self-management support. Participants also receive texts to reinforce session content, family wellness kits, and session recordings as needed.

Experimental: STRIDE Program

Eligibility Criteria

Age21 Years - 44 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Kaiser Permanente Northern California members newly diagnosed with T2D (within the past 5 years)
  • Proficient in English
  • Primary caregivers to ≥1 child (ages 2-14 years at time of enrollment)
  • Can receive text messages
  • Able to participate in a virtual session

You may not qualify if:

  • Pregnant women
  • Type 1 Diabetes
  • Unable to receive text messages
  • Unable to participate in a virtual session

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente Northern California

Pleasanton, California, 94588, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Anjali Gopalan, MD, MS

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy Valdati

CONTACT

925-520-1737amy.valdati@kp.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2026

First Posted

April 22, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

April 29, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)