Diabetes Mellitus Type 2
Conditions
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.
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
BEHAVIORALSTRIDE 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.
Sponsors
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 44 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diabetes Distress Scale (DDS) | 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). |
| Diabetes Self-Efficacy | 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
| Measure | Time frame | Description |
|---|---|---|
| HbA1c at 6 Months | 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. |
| Completion of HbA1c Monitoring | 6-Months Following Enrollment | Completion of at least one HbA1c test within 6 months post-enrollment will be assessed using electronic health record data. |
| T2D-related care | 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. |
| Medication Use | 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. |
| Self-Reported T2D Self-Management | 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). |
| Report of Children's Health-Related Behaviors | 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). |
Countries
United States
Contacts
CONTACTAmy Valdati
PRINCIPAL_INVESTIGATORAnjali Gopalan, MD, MS
Kaiser Permanente
Outcome results
None listed