Remotely Delivered Mindfulness-Based Diabetes Education
ConditionType 2 Diabetes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorUniversity of Alabama at Birmingham
About this trial
Diabetes distress is common affecting over one-third of people with type 2 diabetes, negatively impacting self-management and outcomes, and disproportionately affecting low-income individuals. The proposed project will conduct a pilot randomized controlled trial comparing remotely delivered Mindfulness-Based Diabetes Education plus remote patient monitoring of blood glucose to standard Diabetes Self-Management Education in rural Black adults with type 2 diabetes and elevated diabetes distress who receive care within federally qualified health centers to assess feasibility and acceptability.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
non-English speaker
current pregnancy
diagnosis of a severe psychiatric comorbidity including bipolar disorder, schizophrenia, or a history of psychosis
Trial design
Design model
Parallel
Treatments tested in this trial
Remotely delivered Mindfulness-Based Diabetes Education with remote patient monitoring
BehavioralRemotely delivered Mindfulness-Based Diabetes Education with remote patient monitoring described in study arm
Standard Diabetes Self Management Education
BehavioralStandard Diabetes Self Management Education described in study arm
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Experimental: Remotely delivered Mindfulness-Based Diabetes Education with remote patient monitoringExperimental treatment 1 intervention
Group B: Standard Diabetes Self Management EducationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility: percentage of screened participants who are eligible
Investigators will assess the percentage of screened participants who are eligible to participate in the study. Study staff will track the number of participants who are screened for participation and the number of participants who are eligible to participate.
Time frame
6 months2
Feasibility: percentage of eligible participants who enroll
Investigators will assess the percentage of eligible participants who enroll in the study. Study staff will track the number of participants who are eligible for participation and the number of participants who enroll in the study.
Time frame
6 months3
Feasibility: ability to randomize participants to study arms
Investigators will assess the percentage of eligible participants who are randomized. Study staff will track the number of participants who are enrolled and the number of participants who are randomized.
Time frame
6 months4
Feasibility: distribution of participants by demographics
Investigators will collect demographics of study participants, including age and gender by participant self-report. This information will be obtained during a questionnaire administered to participants in English by a trained interviewer. Investigators will use descriptive statistics to characterize the demographics of the study sample.
Time frame
6 monthsLocations
Sponsors and contacts
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University of Alabama at Birmingham
Lead sponsor
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: