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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK139225 | U.S. NIH Grant/Contract | View source |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: STRIDE Program | Experimental | 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. |
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| Usual Care | No Intervention | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Diabetes Distress Scale (DDS) | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c at 6 Months | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amy Valdati | Contact | 925-520-1737 | amy.valdati@kp.org |
| Name | Affiliation | Role |
|---|---|---|
| Anjali Gopalan, MD, MS | Kaiser Permanente | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Northern California | Pleasanton | California | 94588 | United States |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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 | 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 | 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 | 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 | 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 |
| D004700 | Endocrine System Diseases |