PsychosocialNCT05922943
Harmony & Health: A Culturally Adapted Mindbody Intervention to Reduce Sitting Time and Improve Psychosocial Wellbeing in Black Adults
A study testing Harmony & Health program in people with Psychosocial, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This community-based study will assess the efficacy of a culturally adapted, yoga-based intervention to reduce sitting time, increase physical activity, and improve psychosocial wellbeing among insufficiently active Black adults in the Houston area. Read more about this study
- Who is it for?
- Ages 18 to 18 years
- Conditions the study is for
- Psychosocial
- What is being tested?
- Harmony & Health program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 251 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2024to 30 Jun 2029
- 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 to 18 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults ≥18 years old
- Self-identify as Black or African American
- Self-reports MVPA <150 minutes/week
- Self-reports sedentary time ≥6 hours/ day
- Body mass index [BMI] ≥25.0 kg/m2 based on self-reported height and weight (and verified at baseline)
- Able to pass the modified Physical Activity Readiness Questionnaire (PAR-Q) or provide physician's clearance to participate
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- Willing to be randomized to intervention or control
- Comfortable participating in group-based physical activity
- Able to read, speak, and write in English
- Able to provide written informed consent without assistance
Who cannot join
- < 18 years old
- Self-reports MVPA .150 minutes/week
- Self-reports sedentary time <6 hours/day
- Not classified as overweight or obese (BMI <25.0 kg/m2)
- Absolute contraindications to unassisted physical activity (e.g. acute MI, orthopedic and musculoskeletal limitations)
- Practicing yoga or enrolled in another program targeting physical activity, sedentary behavior, or weight loss in the last 6 months
Show all 9Show fewer
- Previously participated in Harmony \& Health
- Pregnant or planning to become pregnant in the next 6 months
- Planning to move from the Houston area within the next 6 months
Trial locations and contacts
1 site in 1 country.
About this study
This community-based study will assess the efficacy of a culturally adapted, yoga-based intervention to reduce sitting time, increase physical activity, and improve psychosocial wellbeing among insufficiently active Black adults in the Houston area.
Read the detailed description
Primary Objectives:
--The primary aim of the proposed study is to determine the efficacy of HH in reducing sitting time and increasing physical activity in insufficiently active Black adults. Hypothesis: HH participants will spend less time sitting and more time moving at post-intervention (week 9) compared to participants in the attention control group.
Secondary Objectives:
The secondary aims of this proposed study are to:
- Examine the effects of HH on psychosocial wellbeing and the association of psychosocial wellbeing with behavioral outcomes. Hypothesis: HH participants will report improved psychosocial wellbeing, including reduced stress, depressive symptoms, and negative affect and improved quality of life, which will in turn mediate intervention outcomes at post-intervention (week 9) and follow up (week 24).
- Evaluate the long-term benefits of the HH intervention. Hypothesis: HH participants will spend less time sitting and more time moving at follow up (week 24) compared to participants in the attention control group.
An exploratory aim of the proposed study is to identify implementation facilitators and barriers using a mixed-methods approach. Implementation of HH will be evaluated using the Consolidated Framework for Implementation Research (CFIR) and the RE-AIM Framework. In-depth interviews with key informants combined with administrative and questionnaire data will be used to identify critical facilitators and barriers for implementing HH and to evaluate reach, implementation, adoption, and maintenance.
- Conditions
- Psychosocial
- Being tested
- Harmony & Health program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Harmony & Health programBehavioural
Harmony \& Health program may help improve psychosocial wellbeing in participants and if improvements in physical activity and wellbeing can last after the program ends. Yoga combines gentle movements, breathing exercises, relaxation techniques, and meditation all tailored to the participant's needs.
| Study group | Role | What they receive |
|---|---|---|
| Harmony & Health program | Experimental | Participants will take part in the Harmony \& Health program or participants will attend in-person group health education sessions 2 times a week for 8 weeks. Receives: Behavioral: Harmony & Health program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life questionnaires
Measured: through study completion; an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start14 Aug 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosocialStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society (ACS)
- Responsible party
- Sponsor
- Investigators
- Scherezade Mama, DRPH, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05922943
- Sponsor's protocol ID
- 2023-0321
- Other IDs
- NCI-2023-04992
- Status last verified
- May 2026
- First submitted
- 20 Jun 2023
- Last updated
- 22 May 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 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Harmony & Health: A Culturally Adapted Mindbody Intervention to Reduce Sitting Time and Improve Psychosocial Wellbeing in Black Adults
- ClinicalTrials.gov ID
- NCT05922943
- Acronym / sponsor ID
- 2023-0321
- Conditions
- Psychosocial
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 251 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- American Cancer Society (ACS)
- Study start
- 14 Aug 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 28 Jun 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.
This community-based study will assess the efficacy of a culturally adapted, yoga-based intervention to reduce sitting time, increase physical activity, and improve psychosocial wellbeing among insufficiently active Black adults in the Houston area.
Detailed description
Primary Objectives:
--The primary aim of the proposed study is to determine the efficacy of HH in reducing sitting time and increasing physical activity in insufficiently active Black adults. Hypothesis: HH participants will spend less time sitting and more time moving at post-intervention (week 9) compared to participants in the attention control group.
Secondary Objectives:
The secondary aims of this proposed study are to:
- Examine the effects of HH on psychosocial wellbeing and the association of psychosocial wellbeing with behavioral outcomes. Hypothesis: HH participants will report improved psychosocial wellbeing, including reduced stress, depressive symptoms, and negative affect and improved quality of life, which will in turn mediate intervention outcomes at post-intervention (week 9) and follow up (week 24).
- Evaluate the long-term benefits of the HH intervention. Hypothesis: HH participants will spend less time sitting and more time moving at follow up (week 24) compared to participants in the attention control group.
An exploratory aim of the proposed study is to identify implementation facilitators and barriers using a mixed-methods approach. Implementation of HH will be evaluated using the Consolidated Framework for Implementation Research (CFIR) and the RE-AIM Framework. In-depth interviews with key informants combined with administrative and questionnaire data will be used to identify critical facilitators and barriers for implementing HH and to evaluate reach, implementation, adoption, and maintenance.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Harmony & Health program | Experimental | Behavioral: Harmony & Health programParticipants will take part in the Harmony \& Health program or participants will attend in-person group health education sessions 2 times a week for 8 weeks. |
Who may qualify
- Ages
- 18 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Adults ≥18 years old
- Self-identify as Black or African American
- Self-reports MVPA <150 minutes/week
- Self-reports sedentary time ≥6 hours/ day
- Body mass index [BMI] ≥25.0 kg/m2 based on self-reported height and weight (and verified at baseline)
Key exclusion criteria (9 listed)
- < 18 years old
- Self-reports MVPA .150 minutes/week
- Self-reports sedentary time <6 hours/day
- Not classified as overweight or obese (BMI <25.0 kg/m2)
- Absolute contraindications to unassisted physical activity (e.g. acute MI, orthopedic and musculoskeletal limitations)
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 & Health programHarmony \& Health program may help improve psychosocial wellbeing in participants and if improvements in physical activity and wellbeing can last after the program ends. Yoga combines gentle movements, breathing exercises, relaxation techniques, and meditation all tailored to the participant's needs. | Behavioural | Harmony & Health program |
Primary outcome
Quality of life questionnaires
Time frame: through study completion; an average of 6 months
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 22 May 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
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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.
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 program in people with Psychosocial, 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 10 inclusion and 9 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 22 May 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?
Quality of life questionnaires (time frame: through study completion; an average of 6 months). 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 22 May 2026.