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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kaiser Permanente

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 15, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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