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Not yet recruiting NCT07544407

STRIDE: Supporting Early Diabetes Self-Management for Parents

No phase Interventional Diabetes Mellitus Type 2

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: STRIDE Program.
Who it may be relevant to
Registry conditions: Diabetes Mellitus Type 2. Basic parameters: 21 years — 44 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Interventions

  • 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.

Primary outcome measures

  • Diabetes Distress Scale (DDS) [Time frame: Baseline and 4-5 months following enrollment]
  • Diabetes Self-Efficacy [Time frame: Baseline and 4-5 months following enrollment]
Secondary outcome measures (6)
  • HbA1c at 6 Months [Time frame: 6-Months Following Enrollment]
  • Completion of HbA1c Monitoring [Time frame: 6-Months Following Enrollment]
  • T2D-related care [Time frame: 6-Months Following Enrollment]
  • Medication Use [Time frame: 6-Months Following Enrollment]
  • Self-Reported T2D Self-Management [Time frame: 6-Months Following Enrollment]
  • Report of Children's Health-Related Behaviors [Time frame: Baseline and 4-5 months following enrollment]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • Kaiser Permanente Northern California — Pleasanton

Identifiers

NCT: NCT07544407 · 2315563-1 · R01DK139225

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗