Clinical trial NCT06180655: Diabetes Self-Management Plus Tai Chi Easy
Official title: An Integrative Online Diabetes Self-Management Education and Support Intervention Featuring Tai Chi Easy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes
Self-Management
Tai Chi
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2023-12-22
Enrollment: 28
Sex: ALL
Minimum age (years): 40
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this project is to increase access to diabetes care and education for adults aged 40-64 years old who are diagnosed with Type 2 Diabetes Mellitus and are unable to attend education and support classes due to their work situation. This project will use an established, well-known program for Diabetes Self-Management Education and Support (DSMES) and combine it with Tai Chi Easy (TCE)™ to enhance physical health, psychological health, and health behaviors. Participants will be asked to attend 45 minutes of DSMES and 45 min of TCE twice a week for 6 weeks. All classes will be recorded and available online and can viewed at a time when it is most convenient to accommodate working adults. Participants will be asked to complete survey questionnaires online, at the beginning and end of the program; and have a smart phone to connect with a smart ring during the 6-week DSMES+TCE program. After the program is done, participants will be asked to return the smart ring. Upon receipt of the smart ring, they will receive a give a gift card to thank them for their participation in the program.


Eligibility criteria: Inclusion Criteria:

* diagnosed with T2DM
* any sex/gender
* any race/ethnicity
* any socioeconomic group
* has a smartphone
* receives care in a Federally Qualified Healthcare Center in Southern Arizona

Exclusion Criteria:

* Individuals with T1DM
* Individuals with gestational DM
* Individuals with pre-diabetes
* children
* pregnant women
* Individuals unable to provide informed consent
* Individuals with other serious co-occurring health condition (e.g., active cancer treatment)

Primary outcomes:
measure: Study Feasibility: Recruitment
timeFrame: screening pre-intervention
measure: Study Feasibility: Retention
timeFrame: pre and post intervention at 6-weeks
measure: Study Feasibility: Intervention acceptability
timeFrame: post-intervention at 6-weeks
measure: Study Feasibility: Intervention feasibility
timeFrame: post-intervention at 6-weeks
measure: Study Feasibility: Intervention appropriateness
timeFrame: post-intervention at 6-weeks
measure: Study Feasibility: Intervention safety
timeFrame: during the 6-week intervention
Secondary outcomes:
measure: self-reported physical health: Weight
timeFrame: pre-intervention (self-report)
measure: self-reported physical health: Height
timeFrame: pre-intervention (self-report)
measure: self-reported physical health: Waist Circumference
timeFrame: pre-intervention (self-report)
measure: self-reported physical health: Blood Pressure
timeFrame: pre-intervention (self-report)
measure: self-reported physical health: Blood Sugar
timeFrame: pre-intervention (self-report)
measure: self-reported physical health: Hemoglobin A1C
timeFrame: pre-intervention (self-report)
measure: perceived psychological health: Diabetes Distress Scale
timeFrame: pre and post-intervention at 6-weeks
measure: perceived psychological health: Patient Health Questionnaire-9
timeFrame: pre and post-intervention at 6-weeks
measure: perceived psychological health: Posttraumatic Stress Scale-Civilian Version
timeFrame: pre and post-intervention at 6-weeks
measure: perceived psychological health: Diabetes Quality of Life Questionnaire
timeFrame: pre and post-intervention at 6-weeks
measure: perceived psychological health: Perceived Stress Scale
timeFrame: pre and post-intervention at 6-weeks
measure: health behaviors: Dietary Screener Questionnaire
timeFrame: pre and post-intervention at 6-weeks
measure: health behaviors: Rapid Assessment of Physical Activity
timeFrame: pre and post-intervention at 6-weeks
measure: Objective measures using an Oura Ring: Sleep
timeFrame: during the 6-week intervention
measure: Objective measures using an Oura Ring: Physical Activity
timeFrame: during the 6-week intervention
measure: Objective measures using an Oura Ring: Heart Rate Variability
timeFrame: during the 6-week intervention
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona College of Nursing
state: Arizona
Study officials:
References: