Clinical trial NCT04710979: Feasibility of a Yoga Intervention in Sedentary African-American Women
Official title: Feasibility of a Yoga Intervention in Sedentary African-American Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Behavior
Keywords: Yoga
African-American
Feasibility Study
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2021-01-15
Enrollment: 69
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Number of Participants Recruited (Feasibility)
timeFrame: Baseline
measure: Rate of Participant Retention and Adherence (Feasibility)
timeFrame: During the 12-week yoga intervention
measure: Fidelity of Intervention Delivery (Feasibility)
timeFrame: During the 12-week yoga intervention
measure: Rate of Delivery of Intervention Materials and Resources (Feasibility)
timeFrame: During the 12-week yoga intervention
measure: Rating of Assessment Measures (Feasibility)
timeFrame: Baseline
measure: Completion of Assessment Measures (Feasibility)
timeFrame: Baseline
measure: Rating of Assessment Measures (Feasibility)
timeFrame: Post-intervention (within 2 months)
measure: Completion of Assessment Measures (Feasibility)
timeFrame: Post-Intervention (within 2 months)
measure: Rating of Assessment Measures (Feasibility)
timeFrame: 3-month follow-up
measure: Completion of Assessment Measures (Feasibility)
timeFrame: 3-month follow-up
measure: Rating of Intervention Components (Acceptability)
timeFrame: Post-intervention (within 2 months)
measure: Participant Rating of Yoga Intervention (Acceptability)
timeFrame: Post-intervention (within 2 months)
measure: Number of Adverse Events (Safety)
timeFrame: During the 12-week yoga intervention
Secondary outcomes:
measure: Sedentary Behavior
timeFrame: Seven consecutive days at three time points: baseline before intervention, post-intervention (within 2 months), and 3-month follow-up.
measure: Systolic and Diastolic Blood Pressure
timeFrame: 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)
measure: Perceived Stress
timeFrame: Surveys will be distributed at each data collection timepoint (baseline, post-intervention (within 2 months), and 3 month follow-up)
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Daheia J Barr-Anderson, PhD, MSPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: Mark A Pereira, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: