Harmony & Health: A Culturally Adapted Mindbody Intervention to Reduce Sitting Time and Improve Psychosocial Wellbeing in Black Adults

Psychosocial Clinical Trial

Official title:

Harmony & Health: A Culturally Adapted Mindbody Intervention to Reduce Sitting Time and Improve Psychosocial Wellbeing in Black Adults

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
• 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
• 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

Related Conditions & MeSH terms

• Psychosocial

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

External Links

•   M D Anderson Cancer Center