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

• Sponsor: M.D. Anderson Cancer Center (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05922943
• Collaborator: American Cancer Society (ACS) (Other)
• Enrollment: 250
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 66
• Patients Per Site Per Month: 3.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Psychosocial	Behavioral: Harmony & Health program	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 250 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Harmony & Health: A Culturally Adapted Mindbody Intervention to Reduce Sitting Time and Improve Psychosocial Wellbeing in Black Adults
• Anticipated Study Start Date: Dec 30, 2023
• Anticipated Primary Completion Date: Jun 30, 2027
• Anticipated Study Completion Date: Jun 30, 2029

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Harmony & Health program Participants will take part in the Harmony & Health program or participants will attend in-person group health education sessions 2 times a week for 8 weeks.	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.

Outcome Measures

Primary Outcome Measures

1. Quality of life questionnaires [through study completion; an average of 6 months]

Eligibility Criteria

Criteria

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

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

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
• American Cancer Society (ACS)

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: NCT05922943
• Other Study ID Numbers: 2023-0321; NCI-2023-04992
• First Posted: Jun 28, 2023
• Last Update Posted: Jun 28, 2023
• Last Verified: Jun 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Study Results

No Results Posted as of Jun 28, 2023