Harmony & Health: Feasibility of a Movement Intervention to Improve Psychosocial Wellbeing in Black Adults in Northeast Texas

Psychological Clinical Trial

Official title: Harmony & Health: Feasibility of a Movement Intervention to Improve Psychosocial Wellbeing in Black Adults in Northeast Texas

Status Recruiting

Clinical Trial Summary

To test the feasibility and acceptability of a program that combines yoga practices and Christian spirituality (called Harmony & Health) amongst insufficiently active Black adults.

Clinical Trial Description

Objectives

Primary Objective:

The primary objective of this 2-arm randomized controlled pilot study is to test the feasibility and acceptability of HH in Black adults residing in rural areas surrounding Tyler in Northeast Texas. Black adults who are insufficiently active will be randomized to the HH intervention or an attention control group. We hypothesize that we will meet our recruitment goal of 50 participants over 5 months, ≥80% of participants will be retained at post-intervention and follow up, and ≥80% will adhere to sessions.

Secondary Objectives:

The secondary objectives of this study are:

2.a. To explore the effects of HH on sitting time and LPA in Black adults who are insufficiently active. Participants will complete assessments at baseline (week 0), post-intervention (week 9), and follow-up (week 24), and changes in measured sitting time and LPA from week 0 to 9 will be assessed.

2.b. To evaluate acceptability of the intervention and assessment protocols via in-depth interviews. After follow-up, we will conduct interviews with community partners (n=2), delivery agents (n=2), and participants (n=16) to assess acceptance and refine training and implementation protocols in preparation for a future large-scale randomized controlled efficacy trial. ;

Related Conditions & MeSH terms

• Psychological

• NCT number: NCT05761964
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Contact: Scherezade Mama, DRPH
• Phone: (713) 563-7546
• Email: skmama@mdanderson.org
• Status: Recruiting
• Phase: N/A
• Start date: December 18, 2023
• Completion date: December 31, 2026