STRIDE: Supporting Early Diabetes Self-Management for Parents (STRIDE)

April 23, 2026 updated by: Kaiser Permanente

A Pilot Trial of an Intervention to Support Initial Type 2 Diabetes Self-management Among Younger Adults With Children (STRIDE)

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

To date, most tailored programs have focused only on cultural tailoring (based on race and ethnicity) and not on a patient's life stage. To address this gap, we developed a self-management support program, STRIDE (SupporTing paRents with DiabEtes), designed for adults with type 2 diabetes who are raising children.

This study will evaluate the STRIDE program in a randomized pilot design to understand how well it meets the needs of younger adults with type 2 diabetes who are raising children. The study will examine whether STRIDE helps participants build early self management skills and reduces challenges that can interfere with diabetes care. Findings from this pilot will provide information needed to refine the program and guide future implementation.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Pleasanton, California, United States, 94588
        • Kaiser Permanente Northern California
        • Contact:
        • Principal Investigator:
          • Anjali Gopalan, MD, MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: STRIDE Program
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

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.
No Intervention: Usual Care
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diabetes Distress Scale (DDS)
Time Frame: Baseline and 4-5 months following enrollment
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
Time Frame: Baseline and 4-5 months following enrollment
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c at 6 Months
Time Frame: 6-Months Following Enrollment
HbA1c will be obtained from the electronic health record using values collected through routine clinical care. The HbA1c value closest to 6 months post-enrollment will be used.
6-Months Following Enrollment
Completion of HbA1c Monitoring
Time Frame: 6-Months Following Enrollment
Completion of at least one HbA1c test within 6 months post-enrollment will be assessed using electronic health record data.
6-Months Following Enrollment
T2D-related care
Time Frame: 6-Months Following Enrollment
Healthcare utilization related to T2D management will be abstracted from the electronic health record, including primary care visits, telemedicine contacts, T2D care manager visits, dietitian visits, wellness coaching contacts, and participation in health education classes during the 6-month study period.
6-Months Following Enrollment
Medication Use
Time Frame: 6-Months Following Enrollment
T2D medication initiation (filling of a first T2D-related prescription) and adherence (refill of an existing T2D medication prescription) will be assessed using KPNC pharmacy records.
6-Months Following Enrollment
Self-Reported T2D Self-Management
Time Frame: 6-Months Following Enrollment
Self-reported T2D self-management will be assessed using the Summary of Diabetes Self-Care Activities (SDSCA), a validated measure of diabetes self-care behaviors over the prior 7 days. Domains assessed include general diet, specific diet (fat intake), physical activity, blood glucose monitoring, and medication taking. Assessed at baseline and follow-up (4-5 months post-enrollment).
6-Months Following Enrollment
Report of Children's Health-Related Behaviors
Time Frame: Baseline and 4-5 months following enrollment
Parent-reported child health behaviors (youngest child ages 2-14) will be assessed using a combination of questions from KPNC pediatric clinical care and study-developed items. KPNC-derived items assess fruit and vegetable intake, sugar-sweetened beverage consumption, screen time, and physical activity. Study-developed items assess shared parent-child physical activity and child involvement in food preparation and grocery shopping. Items are analyzed individually; response options vary by item (yes/no, frequency, or number of days).
Baseline and 4-5 months following enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaiser Permanente

Investigators

  • Principal Investigator: Anjali Gopalan, MD, MS, Kaiser Permanente

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

April 15, 2026

First Submitted That Met QC Criteria

April 15, 2026

First Posted (Actual)

April 22, 2026

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2315563-1
  • R01DK139225 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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