Harmony & Health: Feasibility of a Movement Intervention to Improve Psychosocial Wellbeing in Black Adults in Northeast Texas
NCT ID: NCT05761964
Last Updated: 2026-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
50 participants
INTERVENTIONAL
2023-12-18
2027-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Health Education (Control)
Participants will take part in a series of health education sessions.
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.
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.
Health and Harmony
Participants will take part in a program combining yoga practices and Christian spirituality.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Duncan Family Institute (DFI) Seed Funding Program
UNKNOWN
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Scherezade Mama, DRPH
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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M D Anderson Cancer Center
Other Identifiers
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NCI-2023-01856
Identifier Type: OTHER
Identifier Source: secondary_id
2022-0793
Identifier Type: -
Identifier Source: org_study_id
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