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Completed

NCT Number: NCT06180655

Diabetes Self-Management Plus 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.

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Key information

Age range

40 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arizona College of Nursing

Tucson, Arizona, 85721, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Behavioral

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.

Primary outcomes

  1. Study Feasibility: Recruitment

    Time frame: screening pre-intervention

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

  2. Study Feasibility: Retention

    Time frame: pre and post intervention at 6-weeks

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

  3. Study Feasibility: Intervention acceptability

    Time frame: post-intervention at 6-weeks

    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.

  4. Study Feasibility: Intervention feasibility

    Time frame: post-intervention at 6-weeks

    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.

  5. Study Feasibility: Intervention appropriateness

    Time frame: post-intervention at 6-weeks

    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.

  6. Study Feasibility: Intervention safety

    Time frame: during the 6-week intervention

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

Secondary outcomes

  1. self-reported physical health: Weight

    Time frame: pre-intervention (self-report)

    body weight in pounds

  2. self-reported physical health: Height

    Time frame: pre-intervention (self-report)

    body height in inches

  3. self-reported physical health: Waist Circumference

    Time frame: pre-intervention (self-report)

    waist circumference in inches

  4. self-reported physical health: Blood Pressure

    Time frame: pre-intervention (self-report)

    blood pressure in millimeters of mercury (mm/Hg)

  5. self-reported physical health: Blood Sugar

    Time frame: pre-intervention (self-report)

    blood sugar in milligrams per deciliter (mg/dL)

  6. self-reported physical health: Hemoglobin A1C

    Time frame: pre-intervention (self-report)

    percentage of hemoglobin in blood that is coated with glucose

  7. perceived psychological health: Diabetes Distress Scale

    Time frame: pre and post-intervention at 6-weeks

    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.

  8. perceived psychological health: Patient Health Questionnaire-9

    Time frame: pre and post-intervention at 6-weeks

    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.

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

    Time frame: pre and post-intervention at 6-weeks

    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.

  10. perceived psychological health: Diabetes Quality of Life Questionnaire

    Time frame: pre and post-intervention at 6-weeks

    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.

  11. perceived psychological health: Perceived Stress Scale

    Time frame: pre and post-intervention at 6-weeks

    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.

  12. health behaviors: Dietary Screener Questionnaire

    Time frame: pre and post-intervention at 6-weeks

    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.

  13. health behaviors: Rapid Assessment of Physical Activity

    Time frame: pre and post-intervention at 6-weeks

    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.

  14. Objective measures using an Oura Ring: Sleep

    Time frame: during the 6-week intervention

    Daily total sleep in hours and minutes

  15. Objective measures using an Oura Ring: Physical Activity

    Time frame: during the 6-week intervention

    Daily total physical activity in number of steps

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

    Time frame: during the 6-week intervention

    Daily average heart rate variability during the night in milliseconds

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 22, 2023
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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