Tai Chi as a Novel Strategy to Increase Physical Activity Among Adults Pursuing Metabolic and Bariatric Surgery

Obesity Clinical Trial

— ACHIEVE  

Official title:

Tai Chi as a Novel Strategy to Increase Physical Activity Among Adults Pursuing Metabolic and Bariatric Surgery: A Feasibility and Acceptability Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06445413
• Other study ID #: R-HHC-2023-0177
• Status: Recruiting
• Phase: N/A
• Start date: January 22, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: June 2024
• Source: Hartford Hospital
• Contact: Yin Wu, PhD
• Phone: 860-972-5750
• Email: yin.wu[@]hhchealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to evaluate the feasibility and acceptability of a 10-wk hybrid Tai Chi (TC) program with in-person classes and online TC videos among 24 physically inactive adults who are seeking metabolic and bariatric surgery (MBS) in a single-arm trial.

The aims are:

Aim 1: Feasibility: To evaluate whether TC is feasible, defined as a mean attendance rate of ≥70% in-person TC classes attended.

Aim 2: Acceptability: To evaluate whether TC is acceptable, defined as a mean rating of ≥4 across 4 acceptability questionnaire items measured on a 5-point Likert scale (e.g., rate "Tai Chi practice is appealing to me" on a scale from 1 [completely disagree] to 5 [completely agree]).

Participants will complete four individual in-person visits where they will complete study assessments and ten weekly group in-person Tai Chi classes where they will practice Tai Chi with up to 5 other study participants. Additionally, they will be asked to practice Tai Chi at home with the aid of instructional online videos and log their practice.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: June 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Seeking to undergo MBS at HHC.

2. Be able to give valid informed consent in English. Attending the live, in-person, group TC classes each week is the main component of the intervention. During the classes, the TC instructor will be giving instructions and communicating with the participants in English. It is not practical to having an interpreter during the live classes. Therefore, participation is limited to those who are English speakers.

3. Be 18-70 years of age.

4. Have BMI=35 kg/m2

5. Absence of cognitive impairment since participants will need to learn and memorize the TC forms. Must score =24 Mini-Mental State Examination.

6. Be physically inactive defined as performing <150 min/wk of moderate to vigorous intensity PA based on self-report.

7. Be able to ambulate independently without use of an assistive device.

8. Be able to complete questionnaires and view TC instructional videos via REDCap.

9. Be able to commute to one of the HH Medical and Surgical Weight Loss Center clinics to participate in testing sessions and in-person TC classes.

Exclusion Criteria:

1. Having severe psychological or physical conditions that may impair their ability to adhere to the study protocol such as uncontrolled mental health issues, and severe arthritis.

2. Pregnant women.

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• Tai Chi
Ten weekly 60-minute Tai Chi classes

Locations

Country	Name	City	State
United States	Hartford Hospital	Hartford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Hartford Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attendance	Percentage of Tai Chi classes attended over 10 week program	Attendance will be taken at each class (up to 10 weeks)
Primary	Video view frequency	Number of times the weekly Tai Chi video is viewed	Measured once weekly for up to 10 weeks
Primary	Video view duration	Number of minutes the weekly Tai Chi video was played	Measured once weekly (up to 10 weeks)
Primary	Home practice frequency	Number of times participant practices Tai Chi at home	Measured once weekly (up to 10 weeks)
Primary	Home practice duration	Number of minutes spent practicing Tai Chi at home	Measured once weekly (up to 10 weeks)
Primary	Acceptability of Tai Chi	This is a validated tool to assess the acceptability of interventions with four 5-point Likert scale questions that will be rated from completely disagree to completely agree. Acceptability is defined as a mean rating of =4 across 4 acceptability questionnaire items measured on a 5-point Likert scale (e.g., rate "Tai Chi practice is appealing to me" on a scale from 1 [completely disagree] to 5 [completely agree]).	Measured once at the end of Tai Chi class or when participant drops out