Sedentary BehaviorNCT04710979

Feasibility of a Yoga Intervention in Sedentary African-American Women

A study testing Yoga Intervention in people with Sedentary Behavior, run by University of Minnesota at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for: Sedentary Behavior
What is being tested?: Yoga Intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 69 participants
Where: 1 siteUnited States
Study dates: 2 May 2022to 19 Jan 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Minnesota
Minneapolis, Minnesota, 55455

Other trials in United States

About this study

Read the 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.

Conditions: Sedentary Behavior
Being tested: Yoga Intervention
Keywords: Yoga, African-American, Feasibility Study
Medical subject headings: Sedentary Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Yoga InterventionBehavioural
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).

Study groups in NCT04710979
Study group	Role	What they receive
Yoga Intervention Group	Experimental	Not described Receives: Behavioral: Yoga Intervention
Control Group	No intervention	Control participants will receive no guidance from the research staff to change their behavior.

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Recruited (Feasibility)
Goals were for 200 women recruited and screened for eligibility, and 60 enrolled and consented.
Measured: Baseline
Rate of Participant Retention and Adherence (Feasibility)
At least 80% of intervention participants attend at least 80% of intervention sessions
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline
Completion of Assessment Measures (Feasibility)
At least 90% intervention and control participants will complete baseline assessments.
Measured: 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).
Measured: Post-intervention (within 2 months)
Completion of Assessment Measures (Feasibility)
At least 90% of intervention and control participants will complete post-intervention assessments.
Measured: 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).
Measured: 3-month follow-up
Completion of Assessment Measures (Feasibility)
At least 90% of intervention and control participants will complete 3-month follow-up assessments.
Measured: 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).
Measured: 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)).
Measured: 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)
Measured: During the 12-week yoga intervention

Secondary outcomes (3)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 May 202219 Jan 2023

First posted15 Jan 2021
Study start2 May 2022
Primary completion6 Jan 2023
Study completion19 Jan 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Sedentary BehaviorStudies of the same condition, open and under way.
More trials run by University of MinnesotaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 69 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04710979
Sponsor's protocol ID: STUDY00010979
Other IDs: R34AT011036
Status last verified: Oct 2023
First submitted: 11 Dec 2020
Last updated: 26 Oct 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
Recruiting
Yoga vs. Stretching-Strengthening: Physical Fitness in Sedentary Young Adults
Sedentary Lifestlye, Exercise
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Recruiting
Scalable TELeheaLth Cancer CARe: The STELLAR Program to Treat Cancer Risk Behaviors
Obesity, Smoking Cessation
Not yet recruiting
Be Well at Work-Plus: A Depression and Physical Activity Intervention for Hospital Service Workers (Aim 3)
Depression, Physical Inactivity

All Sedentary Behavior trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Feasibility of a Yoga Intervention in Sedentary African-American Women
ClinicalTrials.gov ID: NCT04710979
Acronym / sponsor ID: STUDY00010979
Conditions: Sedentary Behavior
Keywords: Yoga, African-American, Feasibility Study
Study type: Interventional
Recruitment status: Completed
Enrolment: 69 participants (actual)
Lead sponsor: University of MinnesotaUniversity, hospital or other
Collaborators: National Center for Complementary and Integrative Health (NCCIH)
Study start: 2 May 2022 (actual)
Primary completion: 6 Jan 2023 (actual)
Study completion: 19 Jan 2023 (actual)
First posted: 15 Jan 2021 (actual)
Results: Posted 26 Oct 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
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.

Who may qualify

Ages: 18 to 65 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Yoga InterventionThis 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).	Behavioural	Yoga Intervention Group

Primary outcome

Number of Participants Recruited (Feasibility)
Time frame: Baseline
Goals were for 200 women recruited and screened for eligibility, and 60 enrolled and consented.
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
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.
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.
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).
Completion of Assessment Measures (Feasibility)
Time frame: Baseline
At least 90% intervention and control participants will complete baseline assessments.
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).
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.
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).
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.
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).
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)).
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)

3 secondary outcomes

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

Results and safety

Results posted to the registry on 26 Oct 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Yoga Intervention Group	34	31
Control Group	34	30

Primary outcome: Number of Participants Recruited (Feasibility)

Time frame: Baseline. Count of participants. Unit: Participants

Measure	Total Recruitment Sample, Pre-Assignment n = 319
Number of Participants Recruited and Screened	319
Number of Participants Enrolled and Consented	69

Population analysed: Total number of participants who were recruited and screened via an online interest/pre-screening survey. For this outcome measure analysis, we will report the number of recruited participants who then enrolled and consented in the study. This pre-assignment sample size differs from the number of participants who started the 12-week intervention period because 2 participants withdrew from the study before the 12-week intervention period began.

Primary outcome: Rate of Participant Retention and Adherence (Feasibility)

Time frame: During the 12-week yoga intervention. Count of participants. Unit: Participants

Measure	Yoga Intervention Group n = 33
Value	8

Population analysed: The number of participants analyzed was 33 because this outcome was measured during the 12-week yoga intervention and prior to the post-intervention data collection milestone. There were originally 34 participants randomized to the yoga intervention, but 1 intervention participant officially withdrew from the study prior to the start of the intervention. Thus, we calculated attendance rates for 33 intervention participants.

Primary outcome: Fidelity of Intervention Delivery (Feasibility)

Time frame: During the 12-week yoga intervention. Count of units. Unit: yoga segments

Measure	Yoga Segments n = NA
Session 1	8
Session 2	7
Session 3	9
Session 4	9
Session 5	8
Session 6	8

Population analysed: Please note that no participants were analyzed for this outcome measure. Six video recordings of yoga intervention sessions were analyzed to enumerate the number of yoga segments (e.g., planned specific yoga components) that were completed as a percentage of the total (n = 9 yoga segments per session).

Primary outcome: Rate of Delivery of Intervention Materials and Resources (Feasibility)

Time frame: During the 12-week yoga intervention. Count of participants. Unit: Participants

Measure	Yoga Intervention Group n = 33
Yoga Equipment	31
Resource Guide	33
Pose Book	33
Facebook Group Invitation	25
Workshop Pamphlet	28
Workshop Book	27

Population analysed: Compute the percentage of intervention participants who receive the materials and resources throughout the intervention. The number of participants analyzed was 33 because this outcome was measured during the 12-week yoga intervention and prior to the post-intervention data collection milestone. There were originally 34 participants randomized to the yoga intervention, but 1 intervention participant officially withdrew from the study prior to the start of the intervention.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Yoga Intervention Group	0 of 33 (0%)	1 of 33 (3%)	0 of 33

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Sedentary Behavior

Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
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Recruiting
Yoga vs. Stretching-Strengthening: Physical Fitness in Sedentary Young Adults
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Active, not recruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Daheia J Barr-Anderson, PhD, MSPH principal investigator

University of Minnesota

Mark A Pereira, PhD, MPH principal investigator

University of Minnesota

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Yoga Intervention in people with Sedentary Behavior, run by University of Minnesota at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Recruited (Feasibility) (time frame: Baseline). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04710979.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2023.