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

Not Applicable

Recruiting

• Conditions: Psychosocial
• Interventions: Behavioral: Harmony & Health program

• Registration Number: NCT05922943
• Lead Sponsor: M.D. Anderson Cancer Center

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.

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 Timeline

• Study First Submitted: 2023-06-20
• Study First Submitted QC: 2023-06-20
• Study First Posted: 2023-06-28
• Study Start: 2024-08-14
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-26
• Primary Completion: 2027-06-30
• Study Completion: 2029-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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

8. 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 .150 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 in the last 6 months
7. Previously participated in Harmony & Health
8. Pregnant or planning to become pregnant in the next 6 months
9. Planning to move from the Houston area within the next 6 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Harmony & Health program	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.

Primary Outcome Measures

Name	Time	Method
Quality of life questionnaires	through study completion; an average of 6 months

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States