Diabetes Self-Management Plus Tai Chi Easy

NCT06180655 | Completed

• 1 other identifier: STUDY00003577
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Diabetes; Self-Management; Tai Chi

Outcome Measures

Primary Outcomes (6)

• 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.

  screening pre-intervention

• 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

  pre and post intervention at 6-weeks

• 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.

  post-intervention at 6-weeks

• 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.

  post-intervention at 6-weeks

• 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.

  post-intervention at 6-weeks

• Study Feasibility: Intervention safety

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

  during the 6-week intervention

Secondary Outcomes (16)

• self-reported physical health: Weight

  pre-intervention (self-report)

• self-reported physical health: Height

  pre-intervention (self-report)

• self-reported physical health: Waist Circumference

  pre-intervention (self-report)

• self-reported physical health: Blood Pressure

  pre-intervention (self-report)

• self-reported physical health: Blood Sugar

  pre-intervention (self-report)

Study Arms (1)

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

EXPERIMENTAL

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.

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

Interventions

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.

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

Eligibility Criteria

• Age: 40 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

University of Arizona College of Nursing

Tucson, Arizona, 85721, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Palliative Care; Trichloroethylene

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Hydrocarbons, Chlorinated; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 22, 2023
• Study Start: January 31, 2024
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: December 6, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)