Clinical trial NCT06445413: Tai Chi as a Novel Strategy to Increase Physical Activity Among Adults Pursuing Metabolic and Bariatric Surgery
Official title: Tai Chi as a Novel Strategy to Increase Physical Activity Among Adults Pursuing Metabolic and Bariatric Surgery: A Feasibility and Acceptability Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Lead sponsor: Hartford Hospital
Sponsor class: OTHER
First posted: 2024-06-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Attendance
timeFrame: Attendance will be taken at each class (up to 10 weeks)
measure: Video view frequency
timeFrame: Measured once weekly for up to 10 weeks
measure: Video view duration
timeFrame: Measured once weekly (up to 10 weeks)
measure: Home practice frequency
timeFrame: Measured once weekly (up to 10 weeks)
measure: Home practice duration
timeFrame: Measured once weekly (up to 10 weeks)
measure: Acceptability of Tai Chi
timeFrame: Measured once at the end of Tai Chi class or when participant drops out
Secondary outcomes:
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
Study officials:
References: