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NCT Number: NCT07544407

STRIDE: Supporting Early Diabetes Self-Management for Parents

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.

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Key information

Age range

21 year–44 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente Northern California

Pleasanton, California, 94588, United States

Location contact

Anjali Gopalan, MD, MS

PRINCIPAL_INVESTIGATOR

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

STRIDE Program

Behavioral

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.

Primary outcomes

  1. 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).

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Amy Valdati

CONTACT

[email protected]

925-520-1737

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Registry information

Official study title

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

Acronym: STRIDE

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 22, 2026
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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