Feasibility of a Yoga Intervention in Sedentary African-American Women

Sedentary Behavior Clinical Trial

Official title:

Feasibility of a Yoga Intervention in Sedentary African-American Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04710979
• Other study ID #: STUDY00010979
• Secondary ID: R34AT011036
• Status: Completed
• Phase: N/A
• Start date: May 2, 2022
• Est. completion date: January 19, 2023

Study information

• Verified date: October 2023
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to test the feasibility, acceptability, safety of a 3-month hatha and restorative yoga intervention to decrease sedentary behavior, stress and blood pressure in sedentary African-American women.

Description:

This study aims to assess feasibility of a hatha and restorative yoga intervention compared to a control group. Investigators will examine feasibility of participant recruitment, retention and adherence; fidelity of intervention delivery; and intervention materials. Investigators also aim to evaluate the acceptability and safety of a hatha and restorative yoga intervention compared to a control group. Investigators will examine the acceptability of intervention location and strategies, class format, enjoyment of sessions, and safety of the intervention. Finally, investigators aim to test feasibility and appropriateness of the targeted outcomes for subsequent trials. Expected outcomes will be properly measured, but no comparisons between intervention and control groups will be made.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: January 19, 2023
• Est. primary completion date: January 6, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Self-identified as an African-American woman at least 18 years old

• Engaging in less than 30 minutes/week of moderate-to-vigorous physical activity

• If employed, working in a sedentary occupation that requires primarily seated work; • If unemployed, typical day involves sedentary, primarily seated activities

• Able to exercise for 20 minutes continuously

• No pre-existing condition that limits physical activity

• Access to a computer (or mobile device) and internet service

Exclusion Criteria:

• Diagnosed with heart disease, diabetes, cancer, kidney, liver disease, major depression or bipolar disease

• Take more than two daily medications for lipids or blood pressure

• Current smoker

Related Conditions & MeSH terms

• Sedentary Behavior

Intervention

Behavioral:
• Yoga Intervention
This group will have in-person, 60 minute yoga sessions three times per week for 12 weeks. These sessions will also include a sharing circle to provide group feedback as to how the practice felt and integration into ones' daily life. There will be biweekly themes established for these sessions (i.e. common yoga poses, importance of breath) and biweekly in-person workshops will be offered. These will be specialty classes for participants to experience additional exposure to meditation and breathing. They will be a longer format so participants can delve deeper into yogic philosophy and practice. There will also be a private Facebook group for participants to connect with each other and for the research staff to maintain contact and share information with the participants (eg. weekly reminder for yoga sessions and workshops).

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Recruited (Feasibility)	Goals were for 200 women recruited and screened for eligibility, and 60 enrolled and consented.	Baseline
Primary	Rate of Participant Retention and Adherence (Feasibility)	At least 80% of intervention participants attend at least 80% of intervention sessions	During the 12-week yoga intervention
Primary	Fidelity of Intervention Delivery (Feasibility)	At least 90% (8 of 9 class segments) of each of the 6 videotaped sessions is delivered as planned based on training.	During the 12-week yoga intervention
Primary	Rate of Delivery of Intervention Materials and Resources (Feasibility)	100% of intervention materials and resources are delivered as planned to intervention participants.	During the 12-week yoga intervention
Primary	Rating of Assessment Measures (Feasibility)	At least 80% intervention and control participants rate the assessments as not too burdensome (rated 1 or 2) on a scale from 1 (not burdensome) to 5 (very burdensome).	Baseline
Primary	Completion of Assessment Measures (Feasibility)	At least 90% intervention and control participants will complete baseline assessments.	Baseline
Primary	Rating of Assessment Measures (Feasibility)	At least 80% intervention and control participants rate the assessments as not too burdensome (rated 1 or 2) on a scale from 1 (not burdensome) to 5 (very burdensome).	Post-intervention (within 2 months)
Primary	Completion of Assessment Measures (Feasibility)	At least 90% of intervention and control participants will complete post-intervention assessments.	Post-Intervention (within 2 months)
Primary	Rating of Assessment Measures (Feasibility)	At least 80% intervention and control participants rate the assessments as not too burdensome (rated 1 or 2) on a scale from 1 (not burdensome) to 5 (very burdensome).	3-month follow-up
Primary	Completion of Assessment Measures (Feasibility)	At least 90% of intervention and control participants will complete 3-month follow-up assessments.	3-month follow-up
Primary	Rating of Intervention Components (Acceptability)	At least 90% intervention participants rate the various intervention components (e.g., location, in-person classes, instructors, home-based resources) as acceptable with a rating of 4, 5, or 6 on a scale from 1 (strongly dislike) to 6 (strongly like).	Post-intervention (within 2 months)
Primary	Participant Rating of Yoga Intervention (Acceptability)	At least 90% intervention participants rate intervention acceptable (i.e., rating of 4, 5, or 6 on a scale from 1 (strongly dislike) to 6 (strongly like)) and enjoyable (i.e., rating of 3, 4, or 5 on a scale from 1 (not enjoyed) to 5 (enjoyed very much)).	Post-intervention (within 2 months)
Primary	Number of Adverse Events (Safety)	Zero adverse events (causes major disruption to participants' life, e.g., sprain, broken bone, cardiovascular event, death), zero moderate adverse events (causes minor inconvenience to participant, e.g., fainting spell, sore muscles for more than 3 days) and less than 10% of participants report mild adverse events (no major impact, e.g., headache, sore muscles for 2-3 days)	During the 12-week yoga intervention
Secondary	Sedentary Behavior	Objective sedentary time (i.e., time spent sitting and lying down) assessed with activPAL4 micro accelerometer. Analyze data to report average total hours of sedentary behavior per day.	Seven consecutive days at three time points: baseline before intervention, post-intervention (within 2 months), and 3-month follow-up.
Secondary	Systolic and Diastolic Blood Pressure	Measured using the automated OMRON Hem 907XL blood pressure recorder. Three blood pressures will be collected and averaged at each data collection time point following a two minute period of rest.	Three blood pressures will be collected and averaged at each of the 3 data collection time points (baseline, post-intervention (within 2 months), and 3 month follow-up)
Secondary	Perceived Stress	Measured using the 14-item Perceived Stress Scale. Each item is scored from 1-5, with higher scores indicating higher perceived stress. Estimates represent the mean total score of the 14 items, ranging from 1-5. Scale was included in an online survey that participants completed at the data collection site via an iPad. Survey items asked participants how often they had experienced acute stress within last month.	Surveys will be distributed at each data collection timepoint (baseline, post-intervention (within 2 months), and 3 month follow-up)