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Type 2 Diabetes MellitusNCT06180655

Diabetes Self-Management Plus Tai Chi Easy

A study testing Diabetes Self-Management Education and Support (DSMES) plus Tai Chi Easy (TCE)™ in people with Type 2 Diabetes Mellitus, run by University of Arizona at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 64 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Diabetes Self-Management Education and Support (DSMES) plus Tai Chi Easy (TCE)™
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteUnited States
Study dates
31 Jan 2024to 30 Nov 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Arizona College of Nursing

    Tucson, Arizona, 85721

Other trials in United States

About this study

Official title: An Integrative Online Diabetes Self-Management Education and Support Intervention Featuring Tai Chi Easy

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.

Being tested
Diabetes Self-Management Education and Support (DSMES) plus Tai Chi Easy (TCE)™
Keywords
Diabetes, Self-Management, Tai Chi
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diabetes Self-Management Education and Support (DSMES) plus Tai Chi Easy (TCE)™Behavioural

    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.

Study groups in NCT06180655
Study groupRoleWhat they receive
Diabetes Self-Management Education and Support (DSMES) plus Tai Chi Easy (TCE)™ExperimentalParticipants 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.
Receives: Behavioral: Diabetes Self-Management Education and Support (DSMES) plus Tai Chi Easy (TCE)™

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Study Feasibility: Recruitment

    the proportion of respondents who remained interested in the study after information and screening. Goal: recruit 10 participants per month for 3 months.

    Measured: screening pre-intervention

  2. Study Feasibility: Retention

    number of participants that completed all aspects of the study (data collection pre-post intervention and study intervention) Goal: 80% study retention

    Measured: pre and post intervention at 6-weeks

  3. Study Feasibility: Intervention acceptability

    The Acceptability of Intervention Measure (AIM) is brief and contains 4-items using a 5-point Likert scale (possible scores 4-20), with higher scores indicating greater acceptability of the intervention. Adequate reliability and validity have been reported. Benchmark: at least 75% intervention acceptability, across sites.

    Measured: post-intervention at 6-weeks

  4. Study Feasibility: Intervention feasibility

    The Feasibility of Intervention Measure (FIM) is brief and contains 4-items using a 5-point Likert scale (possible scores 4-20), with higher scores indicating greater feasibility of the intervention. Adequate reliability and validity have been reported. Benchmark: at least 75% intervention feasibility, across sites.

    Measured: post-intervention at 6-weeks

  5. Study Feasibility: Intervention appropriateness

    The Intervention Appropriateness Measure (IAM) is brief and contains 4-items using a 5-point Likert scale (possible scores 4-20), with higher scores indicating greater appropriateness of the intervention. Adequate reliability and validity have been reported. Benchmark: at least 75% intervention appropriateness, across sites.

    Measured: post-intervention at 6-weeks

  6. Study Feasibility: Intervention safety

    number of adverse events during the intervention. Goal: no safety issues or adverse events

    Measured: during the 6-week intervention

Secondary outcomes (16)

  1. self-reported physical health: Weight

    body weight in pounds

    Measured: pre-intervention (self-report)

  2. self-reported physical health: Height

    body height in inches

    Measured: pre-intervention (self-report)

  3. self-reported physical health: Waist Circumference

    waist circumference in inches

    Measured: pre-intervention (self-report)

  4. self-reported physical health: Blood Pressure

    blood pressure in millimeters of mercury (mm/Hg)

    Measured: pre-intervention (self-report)

  5. self-reported physical health: Blood Sugar

    blood sugar in milligrams per deciliter (mg/dL)

    Measured: pre-intervention (self-report)

  6. self-reported physical health: Hemoglobin A1C

    percentage of hemoglobin in blood that is coated with glucose

    Measured: pre-intervention (self-report)

  7. perceived psychological health: Diabetes Distress Scale

    The Diabetes Distress Scale (DSS-17) is a widely used, self-administered scale. The DDS-17 contains 17 items and asks a person about living with diabetes, using a six-point Likert format (1=not a problem, 6=a very serious problem). The DDS-17 contains questions related to emotional burden, physician distress, regimen distress and interpersonal distress. Possible scores range from 17 to 102, with higher scores indicating greater diabetes distress.

    Measured: pre and post-intervention at 6-weeks

  8. perceived psychological health: Patient Health Questionnaire-9

    The Patient Health Questionnaire-9 (PHQ-9) is a widely used, self-administered scale to screen for depressive symptoms. The PHQ-9 contains 9 items that ask a person about problems that have been bothering them during the past 2 weeks, using a four-point Likert format (0=not at all, 3=nearly every day). Possible scores range from 0 to 27, with higher scores indicating greater severity of depressive symptoms.

    Measured: pre and post-intervention at 6-weeks

  9. perceived psychological health: Posttraumatic Stress Scale-Civilian Version

    The Posttraumatic Stress Scale-Civilian Version (PCL-C) is a self-administered scale that asks a person about problems or stressful life experiences during the past month. The PCL-C contains 17 items using a five-point Likert format (1=not at all, 5=extremely). Possible scores range from 17 to 85, with higher scores indicating greater symptoms associated with posttraumatic stress.

    Measured: pre and post-intervention at 6-weeks

  10. perceived psychological health: Diabetes Quality of Life Questionnaire

    The Diabetes Quality of Life Questionnaire (DQOL) is a self-administered scale that asks a person about their diabetes-related satisfaction, impact and worry. The DQOL contains 64 items using a using a five-point Likert format (satisfaction 1=very satisfied, 5=very dissatisfied; impact 1= no impact, 5=always impacted; worry 1=never worried, 5=always worried). Possible scores range from 64 to 320, with higher scores indicating worse quality of life.

    Measured: pre and post-intervention at 6-weeks

  11. perceived psychological health: Perceived Stress Scale

    The Perceived Stress Scale (PSS-10) is a widely used, self-administered scale. The PSS-10 contains 10 items and asks a person about situations they may have experienced in the past month as being unpredictable, uncontrollable, and overloaded using a five-point Likert format (0=never, 4=very often). Possible scores range from 0 to 40, with higher scores indicating greater perceived stress.

    Measured: pre and post-intervention at 6-weeks

  12. health behaviors: Dietary Screener Questionnaire

    The Dietary Screener Questionnaire (DSQ) is a 26-item self-administered scale that asks about the frequency of consumption of selected foods and drinks in the past month. The DSQ captures intakes of fruits and vegetables, dairy/calcium, added sugars, whole grains/fiber, red meat, and processed meat. The DSQ uses a scoring algorithm to convert responses to estimates of dietary intake for fruits and vegetables (cup equivalents), dairy (cup equivalents), added sugars (tsp), whole grains (ounce equivalents), fiber (g), and calcium (mg). Responses to the red meat and processed meat questions are as qualitative indicators of intake frequency, but no scoring algorithms were developed for those particular dietary factors.

    Measured: pre and post-intervention at 6-weeks

  13. health behaviors: Rapid Assessment of Physical Activity

    The Rapid Assessment of Physical Activity (RAPA) questionnaire is a widely used, self-administered scale to assess a person's engagement in physical activity during the week. The RAPA contains 9 yes/no questions. The first 7 questions assess weekly physical activity during free time (RAPA 1). Affirmative responses are reviewed to determine the person's level of physical activity during the week (1=sedentary, 7=active). Possible scores range from 1 to 7, with higher scores indicating greater the level and intensity of the physical activity. The last two questions include strength training and flexibility items (RAPA 2), which are scored separately (0=none, 1=strength training, 2=flexibility, 3=both). Possible scores range from 0 to 3, which indicate if the person is engaging in strength and flexibility exercise during the week.

    Measured: pre and post-intervention at 6-weeks

  14. Objective measures using an Oura Ring: Sleep

    Daily total sleep in hours and minutes

    Measured: during the 6-week intervention

  15. Objective measures using an Oura Ring: Physical Activity

    Daily total physical activity in number of steps

    Measured: during the 6-week intervention

  16. Objective measures using an Oura Ring: Heart Rate Variability

    Daily average heart rate variability during the night in milliseconds

    Measured: during the 6-week intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2023
  2. Study start31 Jan 2024
  3. Primary completion30 Nov 2024
  4. Study completion30 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06180655
Sponsor's protocol ID
STUDY00003577
Status last verified
Nov 2023
First submitted
28 Nov 2023
Last updated
6 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: this is a feasibility study

Publications

  • Taylor-Piliae RE, Skiba MB, Felion CM, Dando E, Aras S, Hsu CP, Loya J. The Feasibility of an Integrative Online Tai Chi Easy Intervention Plus a Diabetes Self-Management Education and Support Program. Sci Diabetes Self Manag Care. 2026 Apr;52(2):124-137. doi: 10.1177/26350106261426277. Epub 2026 Feb 26.

    PubMed 41742807

Questions about this trial

What is this clinical trial studying?

A study testing Diabetes Self-Management Education and Support (DSMES) plus Tai Chi Easy (TCE)™ in people with Type 2 Diabetes Mellitus, run by University of Arizona at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Study Feasibility: Recruitment (time frame: screening pre-intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06180655, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.

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