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

• Sponsor: M.D. Anderson Cancer Center (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05761964
• Collaborator: Duncan Family Institute (DFI) Seed Funding Program (Other)
• Enrollment: 54
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 40
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Psychological	Behavioral: Harmony & Health; Behavioral: Health Education	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 54 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Harmony & Health: Feasibility of a Movement Intervention to Improve Psychosocial Wellbeing in Black Adults in Northeast Texas
• Anticipated Study Start Date: Aug 31, 2023
• Anticipated Primary Completion Date: Dec 31, 2024
• Anticipated Study Completion Date: Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Health and Harmony Participants will take part in a program combining yoga practices and Christian spirituality.	Behavioral: Harmony & Health; 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.; Behavioral: Health Education; 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.
Other: Health Education (Control) Participants will take part in a series of health education sessions.	Behavioral: Harmony & Health; 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.; Behavioral: Health Education; 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.

Outcome Measures

Primary Outcome Measures

1. Perceived Stress Scale questionnaires (PSS) [through study completion; an average of 1 year.]

   Perceived Stress Scale questionnaires Score scales (0-4) 0-Never, 1-Almost Never, 2-Sometimes 3-Fairly Often 4-Very Often

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria:

1. Men and women ≥18 years of age

2. Self-identify as Black or African American

3. Able to read, speak, and write in English

4. Primary residence in the Northeast Texas area (Public Health Region 4/5N)

5. Insufficiently active (self-report <75 minutes/week of physical activity)

6. Sedentary (self-report ≥6 hours/day of sitting time)

7. Body mass index [BMI] ≥25 kg/m2

8. Able to pass the Physical Activity Readiness Questionnaire (PARQ) or provide physician's clearance to participate

9. Able to provide written informed consent without assistance

Exclusion criteria:

1. <18 years of age

2. Do not self-identify as Black or African American

3. Unable to read, speak, and write in English

4. Primary residence falls outside of the Northeast Texas area or Public Health Region 4/5N

5. Physically active or self-report doing ≥75 minutes/week of physical activity

6. Not sedentary or self-report <6 hours/day of sitting time

7. BMI <25.0 kg/m2

8. Absolute contraindications to unassisted physical activity based on the PARQ (e.g., acute MI, orthopedic and musculoskeletal limitations)

9. Planning to move from the Northeast Texas during the 6 month study period

10. Pregnant or planning to become pregnant during the 6 month study period

11. Currently participating in another program to increase physical activity, reduce sedentary behavior, or manage weight

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	M D Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Scherezade Mama, DRPH, M.D. Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• M D Anderson Cancer Center

Publications

None provided.

• Responsible Party: M.D. Anderson Cancer Center
• ClinicalTrials.gov Identifier: NCT05761964
• Other Study ID Numbers: 2022-0793; NCI-2023-01856
• First Posted: Mar 9, 2023
• Last Update Posted: Mar 9, 2023
• Last Verified: Feb 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Mar 9, 2023