Not_yet_recruitingNANCT06312553

Remotely Delivered Mindfulness-Based Diabetes Education for Rural Adults With Uncontrolled Diabetes and Elevated Distress

Sponsor: University of Alabama at Birmingham

Trial Details

Condition	Type 2 Diabetes
Intervention	Remotely delivered Mindfulness-Based Diabetes Education with remote patient monitoring; Standard Diabetes Self Management Education
Phase	NA
Status	Not_yet_recruiting
Participants	80
Est. Completion	30 June 2027
Last Updated	7 July 2026

Primary Outcome

Feasibility: percentage of screened participants who are eligible; Feasibility: percentage of eligible participants who enroll; Feasibility: ability to randomize participants to study arms; Feasibility: distribution of participants by demographics; Feasibility: percentage of sessions attended; Feasibility: participant adherence to study tasks include home mindfulness practices, self-monitoring activities.; Feasibility: barriers to participation in intervention sessions or completing study activities at home; Feasibility: reasons for dropping out; Feasibility: overall study retention; Acceptability

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria: * age 19 years or older * diagnosis of type 2 diabetes * Black race (self-report) * receipt of care at one of the study sites with one or more visits to within the prior year * presence of elevated diabetes distress (score ≥2 on Diabetes Distress Scale indicating moderate-severe distress) * uncontrolled diabetes indicated by an elevated hemoglobin A1c (A1C) ≥8% Exclusion Criteria (Presence of any of the following criteria): * non-English speaker * current pregnancy * diagnosis of a severe psychiatric comorbidity including bipolar disorder, schizophrenia, or a history of psychosis

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Related Analysis

Pilot RCT Opens: Remotely Delivered Mindfulness-Based Diabetes Education vs Standard DSME in Rural Black Adults With Uncontrolled T2D and Elevated Distress

A pilot RCT from the University of Alabama at Birmingham is set to test remotely delivered Mindfulness-Based Diabetes Education combined with remote glucose monitoring against standard DSME in rural Black adults with uncontrolled type 2 diabetes and elevated diabetes distress. The 80-participant feasibility study, conducted within Federally Qualified Health Centers, aims to generate the operational evidence needed to design a future fully powered trial addressing one of diabetes care's most persistent equity gaps.

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