Feasibility of a Yoga Intervention in Sedentary African-American Women

• ClinicalTrials.gov Identifier: NCT04710979
• Recruitment Status: Recruiting
• First Posted: January 15, 2021
• Last Update Posted: November 30, 2021
• Sponsor: University of Minnesota
• Collaborator: National Center for Complementary and Integrative Health (NCCIH)
• Information provided by (Responsible Party): University of Minnesota

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Sedentary Behavior	Behavioral: Yoga Intervention	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Feasibility of a Yoga Intervention in Sedentary African-American Women
• Actual Study Start Date: September 30, 2021
• Estimated Primary Completion Date: October 1, 2022
• Estimated Study Completion Date: August 31, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Yoga Intervention Group	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).
No Intervention: Control Group; Control participants will receive no guidance from the research staff to change their behavior.

Outcome Measures

Primary Outcome Measures :

1. Number of Participants Recruited (Feasibility) [ Time Frame: Baseline ]
   200 women recruited and screened; 76 women (60 for pilot intervention) enrolled and consented
2. Rate of Participant Retention and Adherence (Feasibility) [ Time Frame: Post-intervention (within 2 months) ]
   At least 80% of intervention participants attend at least 80% of intervention sessions
3. Fidelity of Intervention Delivery (Feasibility) [ Time Frame: Post-intervention (within 2 months) ]
   At least 90% of each videotaped session is delivered as planned based on training
4. Rate of Delivery of Intervention Materials and Resources (Feasibility) [ Time Frame: Post-intervention (within 2 months) ]
   100% of intervention materials and resources are delivered as planned
5. Rating and Completion of Assessment Measures (Feasibility) [ Time Frame: Baseline ]
   At least 80% intervention and control participants rate the assessments as not too burdensome; at least 90% intervention and control participants will complete baseline assessments
6. Rating and Completion of Assessment Measures (Feasibility) [ Time Frame: Post-intervention (within 2 months) ]
   At least 80% intervention and control participants rate the assessments as not too burdensome; at least 90% intervention and control participants will complete post-intervention assessments
7. Rating and Completion of Assessment Measures (Feasibility) [ Time Frame: 3-month follow-up ]
   At least 80% intervention and control participants rate the assessments as not too burdensome; at least 90% intervention and control participants will complete 3-month follow-up assessments
8. Rating of Intervention Location, in-person classes, instructors, home-based resources (Acceptability) [ Time Frame: Post-intervention (within 2 months) ]
   At least 90% intervention participants rate the various intervention components as acceptable
9. Participant Rating of Yoga Intervention (Acceptability) [ Time Frame: Post-intervention (within 2 months) ]
   At least 90% intervention participants rate intervention acceptable
10. Number of Adverse Events (Safety) [ Time Frame: Post-intervention (within 2 months) ]
    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)

Secondary Outcome Measures :

1. Sedentary behavior [ Time Frame: Seven consecutive days at baseline before intervention, during three randomly selected weeks over the course of the 3-month intervention, for one week at post-intervention, and one week at 3-month follow-up periods ]
   Assessed with activPAL3 micro accelerometer
2. Systolic and Diastolic Blood pressure [ Time Frame: Two blood pressures will be collected and averaged at each data collection time point (baseline, one month post-intervention window, and 3 month follow-up) ]
   Measured using BpTRU BPM-200
3. Salivary Cortisol Levels [ Time Frame: 3 times per day (upon waking, 30 minutes after waking, before going to bed) for 2 days at each data collection timepoint (baseline, one month post-intervention window, and 3 month follow-up) ]
   Biomarkers of physiological stress using cortisol saliva (nmol/L)
4. Perceived Stress [ Time Frame: Questionnaires will be distributed at each data collection timepoint (baseline, one month post-intervention window, and 3 month follow-up) ]
   Measured using the Perceived Stress Scale (higher scores indicate higher perceived stress)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Contacts

Contact: Daheia J Barr-Anderson, PhD; 2404752806; barra027@umn.edu

Contact: Mark A Pereira, PhD; 6126244173; perei004@umn.edu

Locations

United States, Minnesota

University of Minnesota; Recruiting

Minneapolis, Minnesota, United States, 55455

Contact: Daheia Julina Barranderson, PhD, MSPH

Principal Investigator: Daheia Julina Barranderson, PhD, MSPH

Sponsors and Collaborators

University of Minnesota

National Center for Complementary and Integrative Health (NCCIH)

More Information

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT04710979
• Other Study ID Numbers: STUDY00010979; R34AT011036 ( U.S. NIH Grant/Contract )
• First Posted: January 15, 2021
• Last Update Posted: November 30, 2021
• Last Verified: November 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Minnesota:

Yoga; African-American; Feasibility Study