STRIDE: Supporting Early Diabetes Self-Management for Parents
ConditionDiabetes Mellitus Type 2
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-44
SponsorKaiser Permanente
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Pregnant women
Type 1 Diabetes
Unable to receive text messages
Unable to participate in a virtual session
Trial design
Design model
Parallel
Treatments tested in this trial
STRIDE Program
BehavioralParticipants 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.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Experimental: STRIDE ProgramExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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).
Time frame
Baseline and 4-5 months following enrollment2
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.
Time frame
Baseline and 4-5 months following enrollmentSecondary outcomes
1
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.
Time frame
6-Months Following Enrollment2
Completion of HbA1c Monitoring
Completion of at least one HbA1c test within 6 months post-enrollment will be assessed using electronic health record data.
Time frame
6-Months Following Enrollment3
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.
Time frame
6-Months Following Enrollment4
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.
Time frame
6-Months Following EnrollmentSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: