Harmony & Health: A Culturally Adapted Mindbody Intervention to Reduce Sitting Time and Improve Psychosocial Wellbeing in Black Adults
2 other identifiers
interventional
250
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 20, 2023
CompletedFirst Posted
Study publicly available on registry
June 28, 2023
CompletedStudy Start
First participant enrolled
August 14, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2029
October 23, 2025
October 1, 2025
2.9 years
June 20, 2023
October 21, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Quality of life questionnaires
through study completion; an average of 6 months
Study Arms (1)
Harmony & Health program
EXPERIMENTALParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- \< 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- American Cancer Society (ACS)collaborator
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Scherezade Mama, DRPH
M.D. Anderson Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2023
First Posted
June 28, 2023
Study Start
August 14, 2024
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 30, 2029
Last Updated
October 23, 2025
Record last verified: 2025-10