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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity
• Intervention / Treatment: Other: Tai Chi

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yin Wu, PhD; Phone Number: 860-972-5750; Email: yin.wu@hhchealth.org

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Recruiting
      • Hartford Hospital
      • Contact: Dale Bond, PhD; Phone Number: 860-972-4318; Email: dale.bond@hhchealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tai Chi class; Participation in ten weekly group in-person Tai Chi classes	Other: Tai Chi; Ten weekly 60-minute Tai Chi classes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attendance	Percentage of Tai Chi classes attended over 10 week program	Attendance will be taken at each class (up to 10 weeks)
Video view frequency	Number of times the weekly Tai Chi video is viewed	Measured once weekly for up to 10 weeks
Video view duration	Number of minutes the weekly Tai Chi video was played	Measured once weekly (up to 10 weeks)
Home practice frequency	Number of times participant practices Tai Chi at home	Measured once weekly (up to 10 weeks)
Home practice duration	Number of minutes spent practicing Tai Chi at home	Measured once weekly (up to 10 weeks)
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

Collaborators and Investigators

• Sponsor: Hartford Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2024
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: February 26, 2024
• First Submitted That Met QC Criteria: June 4, 2024
• First Posted (Actual): June 6, 2024

Study Record Updates

• Last Update Posted (Actual): June 6, 2024
• Last Update Submitted That Met QC Criteria: June 4, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: R-HHC-2023-0177

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No