Feasibility of a Yoga Intervention in Sedentary African-American Women

NCT04710979 | Completed Results

• 2 other identifiers: STUDY00010979R34AT011036
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Sedentary Behavior

Keywords

Yoga; African-American; Feasibility Study

Outcome Measures

Primary Outcomes (13)

• Number of Participants Recruited (Feasibility)

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

  Baseline

• 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

• 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

• 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

• 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

• Completion of Assessment Measures (Feasibility)

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

  Baseline

• 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)

• Completion of Assessment Measures (Feasibility)

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

  Post-Intervention (within 2 months)

• 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

• Completion of Assessment Measures (Feasibility)

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

  3-month follow-up

• 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)

• 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)

• 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 Outcomes (3)

• Sedentary Behavior

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

• Systolic and Diastolic Blood Pressure

  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)

• Perceived Stress

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

Study Arms (2)

Yoga Intervention Group

EXPERIMENTAL

Behavioral: Yoga Intervention

Control Group

NO INTERVENTION

Control participants will receive no guidance from the research staff to change their behavior.

Interventions

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).

Yoga Intervention Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Limitations and Caveats

Although Specific Aim 4 addressing the feasibility of salivary sample collection was achieved, due to budgetary constraints, the research team was unable to analyze the cortisol levels of the saliva samples.

Results Point of Contact

• Title: Dr. Daheia J. Barr-Anderson
• Organization: University of Minnesota

barra027@umn.edu

240-475-2806

Study Officials

• Daheia J Barr-Anderson, PhD, MSPH

  University of Minnesota

  PRINCIPAL INVESTIGATOR

• Mark A Pereira, PhD, MPH

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: January 15, 2021
• Study Start: May 2, 2022
• Primary Completion: January 6, 2023
• Study Completion: January 19, 2023
• Last Updated: October 26, 2023
• Results First Posted: October 26, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)