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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05922943
Other study ID # 2023-0321
Secondary ID NCI-2023-04992
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 30, 2024
Est. completion date June 30, 2029

Study information

Verified date June 2024
Source M.D. Anderson Cancer Center
Contact Scherezade Mama, DRPH
Phone (713) 563-7546
Email skmama@mdanderson.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 250
Est. completion date June 30, 2029
Est. primary completion date June 30, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years to 18 Years
Eligibility Inclusion Criteria: 1. Adults =18 years old 2. Self-identify as Black or African American 3. Self-reports MVPA <90 minutes/week 4. Self-reports sedentary time =6 hours/ day 5. Body mass index [BMI] =25.0 kg/m2 based on self-reported height and weight (and verified at baseline) 6. Able to pass the Physical Activity Readiness Questionnaire (PARQ) or provide physician's clearance to participate 7. Willing to be randomized to intervention or control 8. Comfortable participating in group-based physical activity 9. Able to read, speak, and write in English 10. Able to provide written informed consent without assistance Exclusion Criteria: 1. < 18 years old 2. Self-reports MVPA =90 minutes/week 3. Self-reports sedentary time <6 hours/day 4. Not classified as overweight or obese (BMI <25.0 kg/m2) 5. Absolute contraindications to unassisted physical activity (e.g. acute MI, orthopedic and musculoskeletal limitations) 6. Practicing yoga or enrolled in another program targeting physical activity, sedentary behavior, or weight loss 7. Pregnant or planning to become pregnant in the next 6 months 8. Planning to move from the Houston area within the next 6 months

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Harmony & Health program
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.

Locations

Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center American Cancer Society (ACS)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of life questionnaires through study completion; an average of 6 months
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