Multi-site Feasibility and Acceptability of a Faith-based Mind-body Intervention for Black Adults

Psychosocial Clinical Trial

Official title: Multi-site Feasibility and Acceptability of a Faith-based Mind-body Intervention for Black Adults

Status Recruiting

Clinical Trial Summary

To test a program that combines yoga and Christian spirituality (called Harmony & Health) to learn if it can help participants exercise more.

Clinical Trial Description

Primary Objectives:

The primary objective of this multi-site, community-based, two-arm randomized controlled feasibility trial is to evaluate the feasibility of recruitment, retention, and adherence to the HH intervention and attention control conditions and acceptability of assessments across sites. 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 per site (10 participants per month), >80% of participants will be retained at post-intervention and follow-up, and >80% will adhere to sessions. After follow-up, we will conduct interviews with community partners (n=2), delivery agents (n=2), and participants (n=20) at each site (N=44 total) to assess acceptance and refine training and implementation protocols in preparation for a future large-scale multi-site randomized controlled trial to test the efficacy of HH.

Secondary Objectives:

Secondary objectives include assessing changes in sitting time, physical activity, and psychosocial wellbeing from baseline to post-intervention as defined below.

1. Sitting time. Sitting time will be measured using an activPAL, a small and slim thigh-worn device that directly measures postural aspects of sedentary behavior (e.g., sitting, lying down, upright), and provides time spent sitting and bouts. Additionally, self-reported sedentary behavior will be assessed via the Sedentary Behavior Questionnaire.

2. Physical activity. Physical activity will be measured using an activPAL, a small and slim thigh-worn device that directly measures steps and intensity-specific physical activity duration. Additionally, self-reported physical activity will be assessed via the Godin Leisure-Time Exercise Questionnaire.

3. Psychosocial wellbeing. Psychosocial wellbeing, including perceived stress, depressive symptoms, and quality of life, will be assessed using the 10-item Perceived Stress Scale (PSS), Center for Epidemiologic Studies Depression Scale (CES-D), and SF-36 Short Form Health Survey. ;

Related Conditions & MeSH terms

• Psychosocial

• NCT number: NCT05791981
• 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: February 26, 2024
• Completion date: January 31, 2026