PsychologicalNCT05761964
Harmony & Health: Feasibility of a Movement Intervention to Improve Psychosocial Wellbeing in Black Adults in Northeast Texas
A study testing Harmony & Health and Health Education in people with Psychological, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To test the feasibility and acceptability of a program that combines yoga practices and Christian spirituality (called Harmony \& Health) amongst insufficiently active Black adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychological
- What is being tested?
- Harmony & Health and Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2023to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women ≥18 years of age
- Self-identify as Black or African American
- Able to read, speak, and write in English
- Primary residence in the Northeast Texas area (Public Health Region 4/5N)
- Insufficiently active (self-report <75 minutes/week of physical activity)
- Sedentary (self-report ≥6 hours/day of sitting time)
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- Body mass index [BMI] ≥25 kg/m2
- Able to pass the Physical Activity Readiness Questionnaire (PARQ) or provide physician's clearance to participate
- Able to provide written informed consent without assistance
Who cannot join
- <18 years of age
- Do not self-identify as Black or African American
- Unable to read, speak, and write in English
- Primary residence falls outside of the Northeast Texas area or Public Health Region 4/5N
- Physically active or self-report doing ≥75 minutes/week of physical activity
- Not sedentary or self-report <6 hours/day of sitting time
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- BMI <25.0 kg/m2
- Absolute contraindications to unassisted physical activity based on the PARQ (e.g., acute MI, orthopedic and musculoskeletal limitations)
- Planning to move from the Northeast Texas during the 6 month study period
- Pregnant or planning to become pregnant during the 6 month study period
- Currently participating in another program to increase physical activity, reduce sedentary behavior, or manage weight
Trial locations and contacts
1 site in 1 country.
About this study
To test the feasibility and acceptability of a program that combines yoga practices and Christian spirituality (called Harmony \& Health) amongst insufficiently active Black adults.
Read the detailed description
Objectives
Primary Objective:
The primary objective of this 2-arm randomized controlled pilot study is to test the feasibility and acceptability of HH in Black adults residing in rural areas surrounding Tyler in Northeast Texas. Black adults who are insufficiently active will be randomized to the HH intervention or an attention control group. We hypothesize that we will meet our recruitment goal of 50 participants over 5 months, ≥80% of participants will be retained at post-intervention and follow up, and ≥80% will adhere to sessions.
Secondary Objectives:
The secondary objectives of this study are:
2.a. To explore the effects of HH on sitting time and LPA in Black adults who are insufficiently active. Participants will complete assessments at baseline (week 0), post-intervention (week 9), and follow-up (week 24), and changes in measured sitting time and LPA from week 0 to 9 will be assessed.
2.b. To evaluate acceptability of the intervention and assessment protocols via in-depth interviews. After follow-up, we will conduct interviews with community partners (n=2), delivery agents (n=2), and participants (n=16) to assess acceptance and refine training and implementation protocols in preparation for a future large-scale randomized controlled efficacy trial.
- Conditions
- Psychological
- Being tested
- Harmony & Health, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Harmony & HealthBehavioural
Participants will attend group in-person sessions 2 times each week for 8 weeks. The session will be 45 minutes long. In each session, there will be an introduction, 30 minutes of gentle yoga-based poses and breathing exercises, and then 10 minutes of guided relaxation and scripture meditation. Participants will be asked to complete at-home stretching practices 2 times each week for the 8 week intervention period. Participants will also be asked to complete weekly logs to self-monitor their physical activity.
Health EducationBehavioural
Participants will attend group in-person health education sessions 2 times each week for 8 weeks. The sessions will be 45 minutes long and will include discussions of disease prevention and other health and wellbeing topics.
| Study group | Role | What they receive |
|---|---|---|
| Health and Harmony | Experimental | Participants will take part in a program combining yoga practices and Christian spirituality. Receives: Behavioral: Harmony & Health; Behavioral: Health Education |
| Health Education (Control) | Other | Participants will take part in a series of health education sessions. Receives: Behavioral: Harmony & Health; Behavioral: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and acceptability of the intervention: Recruitment and retention
Rates of study eligibility, recruitment, and retention will be assessed. We will maintain detailed information during the recruitment process regarding the number of church members interested, eligible, ineligible and reasons for ineligibility, and enrolled. To assess feasibility, we will calculate the rates of study eligibility, recruitment, and retention, along with their 90% confidence intervals (CIs). Participant feedback will be summarized using means and standard deviations along with graphical display (e.g., box plots). Recruitment success, i.e., feasibility will be achieved if ≥50% of eligible participants enrolls in the study. Retention success will be achieved if ≥80% participants complete the post-intervention and follow-up assessments.
Measured: through study completion; an average of 1 year.
Feasibility and acceptability of the intervention: Program satisfaction
Following the follow-up data collection time point, we will conduct individual interviews with a subsample of participants (~16 participants). Interview questions will address participants' overall reactions to and satisfaction with the mind-body intervention, perceived impact on social support, motivation, and self-efficacy for increase physical activity and well-being. Positive satisfaction, i.e., successful feasibility, will be achieved when participants consistently and repeatedly, through subsequent interviews, endorse satisfaction with the program through use of positive language when describing their feelings toward the program. Interviews will be conducted by the PI or trained member of the research team.
Measured: through study completion; an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start18 Dec 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychologicalStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Duncan Family Institute (DFI) Seed Funding Program
- Responsible party
- Sponsor
- Investigators
- Scherezade Mama, DRPH, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05761964
- Sponsor's protocol ID
- 2022-0793
- Other IDs
- NCI-2023-01856
- Status last verified
- Jul 2026
- First submitted
- 23 Feb 2023
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Harmony & Health: Feasibility of a Movement Intervention to Improve Psychosocial Wellbeing in Black Adults in Northeast Texas
- ClinicalTrials.gov ID
- NCT05761964
- Acronym / sponsor ID
- 2022-0793
- Conditions
- Psychological
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Duncan Family Institute (DFI) Seed Funding Program
- Study start
- 18 Dec 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To test the feasibility and acceptability of a program that combines yoga practices and Christian spirituality (called Harmony \& Health) amongst insufficiently active Black adults.
Detailed description
Objectives
Primary Objective:
The primary objective of this 2-arm randomized controlled pilot study is to test the feasibility and acceptability of HH in Black adults residing in rural areas surrounding Tyler in Northeast Texas. Black adults who are insufficiently active will be randomized to the HH intervention or an attention control group. We hypothesize that we will meet our recruitment goal of 50 participants over 5 months, ≥80% of participants will be retained at post-intervention and follow up, and ≥80% will adhere to sessions.
Secondary Objectives:
The secondary objectives of this study are:
2.a. To explore the effects of HH on sitting time and LPA in Black adults who are insufficiently active. Participants will complete assessments at baseline (week 0), post-intervention (week 9), and follow-up (week 24), and changes in measured sitting time and LPA from week 0 to 9 will be assessed.
2.b. To evaluate acceptability of the intervention and assessment protocols via in-depth interviews. After follow-up, we will conduct interviews with community partners (n=2), delivery agents (n=2), and participants (n=16) to assess acceptance and refine training and implementation protocols in preparation for a future large-scale randomized controlled efficacy trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health and Harmony | Experimental | Behavioral: Harmony & Health, Behavioral: Health EducationParticipants will take part in a program combining yoga practices and Christian spirituality. |
| Health Education (Control) | Other | Behavioral: Harmony & Health, Behavioral: Health EducationParticipants will take part in a series of health education sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Men and women ≥18 years of age
- Self-identify as Black or African American
- Able to read, speak, and write in English
- Primary residence in the Northeast Texas area (Public Health Region 4/5N)
- Insufficiently active (self-report <75 minutes/week of physical activity)
Key exclusion criteria (11 listed)
- <18 years of age
- Do not self-identify as Black or African American
- Unable to read, speak, and write in English
- Primary residence falls outside of the Northeast Texas area or Public Health Region 4/5N
- Physically active or self-report doing ≥75 minutes/week of physical activity
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 |
|---|---|---|
| Harmony & HealthParticipants will attend group in-person sessions 2 times each week for 8 weeks. The session will be 45 minutes long. In each session, there will be an introduction, 30 minutes of gentle yoga-based poses and breathing exercises, and then 10 minutes of guided relaxation and scripture meditation. Participants will be asked to complete at-home stretching practices 2 times each week for the 8 week intervention period. Participants will also be asked to complete weekly logs to self-monitor their physical activity. | Behavioural | Health Education (Control), Health and Harmony |
| Health EducationParticipants will attend group in-person health education sessions 2 times each week for 8 weeks. The sessions will be 45 minutes long and will include discussions of disease prevention and other health and wellbeing topics. | Behavioural | Health Education (Control), Health and Harmony |
Primary outcome
Feasibility and acceptability of the intervention: Recruitment and retention
Time frame: through study completion; an average of 1 year.
Rates of study eligibility, recruitment, and retention will be assessed. We will maintain detailed information during the recruitment process regarding the number of church members interested, eligible, ineligible and reasons for ineligibility, and enrolled. To assess feasibility, we will calculate the rates of study eligibility, recruitment, and retention, along with their 90% confidence intervals (CIs). Participant feedback will be summarized using means and standard deviations along with graphical display (e.g., box plots). Recruitment success, i.e., feasibility will be achieved if ≥50% of eligible participants enrolls in the study. Retention success will be achieved if ≥80% participants complete the post-intervention and follow-up assessments.
Feasibility and acceptability of the intervention: Program satisfaction
Time frame: through study completion; an average of 1 year.
Following the follow-up data collection time point, we will conduct individual interviews with a subsample of participants (~16 participants). Interview questions will address participants' overall reactions to and satisfaction with the mind-body intervention, perceived impact on social support, motivation, and self-efficacy for increase physical activity and well-being. Positive satisfaction, i.e., successful feasibility, will be achieved when participants consistently and repeatedly, through subsequent interviews, endorse satisfaction with the program through use of positive language when describing their feelings toward the program. Interviews will be conducted by the PI or trained member of the research team.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
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Healthy Adult Participants
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.
Scherezade Mama, DRPH principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Harmony & Health and Health Education in people with Psychological, run by M.D. Anderson Cancer Center 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 9 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Feasibility and acceptability of the intervention: Recruitment and retention (time frame: through study completion; an average of 1 year.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jul 2026.