Harmony & Health: Feasibility of a Movement Intervention to Improve Psychosocial Wellbeing in Black Adults in Northeast Texas

NCT05761964 | Active Not Recruiting

• 2 other identifiers: 2022-0793NCI-2023-01856
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psychological

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  through study completion; an average of 1 year.

Study Arms (2)

Health and Harmony

EXPERIMENTAL

Participants will take part in a program combining yoga practices and Christian spirituality.

Behavioral: Harmony & Health; Behavioral: Health Education

Health Education (Control)

OTHER

Participants will take part in a series of health education sessions.

Behavioral: Harmony & Health; Behavioral: Health Education

Interventions

Health Education BEHAVIORAL

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.

Health Education (Control); Health and Harmony

Harmony & Health BEHAVIORAL

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 Education (Control); Health and Harmony

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• \<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
• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Duncan Family Institute (DFI) Seed Funding Program: collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Interventions

Health

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Officials

• Scherezade Mama, DRPH

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: March 9, 2023
• Study Start: December 18, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 3, 2026

Record last verified: 2026-02

Locations

US (1)