NCT05922943

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Psychosocial

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-08-14
• Primary completion: 2027-06-30
• Completion: 2029-06-30
• First posted: 2023-06-28
• Last updated: 2025-10-23

Locations

1 site across 1 country: United States