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Completed

NCT Number: NCT04710979

Feasibility of a Yoga Intervention in Sedentary African-American Women

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.

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Key information

Conditions

Sedentary Behavior Behavior

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Yoga intervention

Behavioral

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).

Primary outcomes

  1. Number of Participants Recruited (Feasibility)

    Time frame: Baseline

    Goals were for 200 women recruited and screened for eligibility, and 60 enrolled and consented.

  2. Rate of Participant Retention and Adherence (Feasibility)

    Time frame: During the 12-week yoga intervention

    At least 80% of intervention participants attend at least 80% of intervention sessions

  3. Fidelity of Intervention Delivery (Feasibility)

    Time frame: During the 12-week yoga intervention

    At least 90% (8 of 9 class segments) of each of the 6 videotaped sessions is delivered as planned based on training.

  4. Rate of Delivery of Intervention Materials and Resources (Feasibility)

    Time frame: During the 12-week yoga intervention

    100% of intervention materials and resources are delivered as planned to intervention participants.

  5. Rating of Assessment Measures (Feasibility)

    Time frame: Baseline

    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).

  6. Completion of Assessment Measures (Feasibility)

    Time frame: Baseline

    At least 90% intervention and control participants will complete baseline assessments.

  7. Rating 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 (rated 1 or 2) on a scale from 1 (not burdensome) to 5 (very burdensome).

  8. Completion of Assessment Measures (Feasibility)

    Time frame: Post-Intervention (within 2 months)

    At least 90% of intervention and control participants will complete post-intervention assessments.

  9. Rating of Assessment Measures (Feasibility)

    Time frame: 3-month follow-up

    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).

  10. Completion of Assessment Measures (Feasibility)

    Time frame: 3-month follow-up

    At least 90% of intervention and control participants will complete 3-month follow-up assessments.

  11. Rating of Intervention Components (Acceptability)

    Time frame: Post-intervention (within 2 months)

    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).

  12. Participant Rating of Yoga Intervention (Acceptability)

    Time frame: Post-intervention (within 2 months)

    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)).

  13. Number of Adverse Events (Safety)

    Time frame: During the 12-week yoga intervention

    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 outcomes

  1. Sedentary Behavior

    Time frame: Seven consecutive days at three time points: baseline before intervention, post-intervention (within 2 months), and 3-month follow-up.

    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.

  2. Systolic and Diastolic Blood Pressure

    Time frame: 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)

    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.

  3. Perceived Stress

    Time frame: Surveys will be distributed at each data collection timepoint (baseline, post-intervention (within 2 months), and 3 month follow-up)

    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.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 15, 2021
Registry last updated
Oct 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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