Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2024-03-25
2025-11-30
Brief Summary
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Detailed Description
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The specific aims for this study are to:
Aim 1: Assess feasibility of the culturally tailored intervention T1DES by measuring intervention acceptability, demand (retention, completed \> 80% of sessions), practicality, and implementation fidelity through participant surveys and key informant interviews with participants and the health care delivery team.
Aim 2: Evaluate the effect of the T1DES intervention on diabetes outcomes in a pilot randomized clinical trial among N=40 Black young adults age 18-30 years with T1D and elevated HbA1c (\>7.5%) by comparing changes in HbA1c, diabetes distress, and self-management from baseline to 6-months postbaseline among participants randomized to T1DES compared to the diabetes education-only control condition.
The goal of this study is to provide diabetes education and emotion regulation support tailored for Black young adults' experiences that will result in sustained glycemic control and can be incorporated into adult endocrinology practices.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Diabetes Education
Participants in this arm will receive traditional diabetes education following a baseline assessment. During months 1-3, participants will attend 5 sessions. Follow up will be conducted at 3-months and 6-months.
Diabetes Education
Participants in this arm will receive traditional diabetes education over 5 sessions in the first 3 months of participation and be followed for 6 months.
T1DES
Participants in this arm will receive a emotion regulation intervention called T1DES following a baseline assessment. During months 1-3, participants will attend 5 sessions. Follow-up will be conducted at 3-months and 6-months.
T1DES
Participants in this arm will receive the T1DES behavioral interventions over 5 sessions in the first 3 months of participation and be followed for 6 months.
Interventions
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Diabetes Education
Participants in this arm will receive traditional diabetes education over 5 sessions in the first 3 months of participation and be followed for 6 months.
T1DES
Participants in this arm will receive the T1DES behavioral interventions over 5 sessions in the first 3 months of participation and be followed for 6 months.
Eligibility Criteria
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Inclusion Criteria
* Aged 18 - 30 years
* Confirmed diagnosis of Type 1 diabetes
* Hemoglobin A1c \> 7.5 at time of enrollment
* a cell phone able to send/receive text messages
* Self-reported race of Black or African American
* Ability to read in English and provide informed consent
Exclusion Criteria
* Subjects with visual impairment or have severe hearing or other physical disabilities that would be a barrier for participating in-group or web sessions
* Diabetes complications that would preclude participation in the study
18 Years
30 Years
ALL
Yes
Sponsors
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The Leona M. and Harry B. Helmsley Charitable Trust
OTHER
Emory University
OTHER
Grady Memorial Hospital
OTHER
Kaiser Permanente
OTHER
Responsible Party
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Principal Investigators
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Teaniese L Davis, PhD
Role: PRINCIPAL_INVESTIGATOR
Kaiser Permanente Georgia
Locations
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Grady Health System
Atlanta, Georgia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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R-2310-06383
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
RNG212536
Identifier Type: -
Identifier Source: org_study_id
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