NCT05791981

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Psychosocial
• Mind-body

Interventions

Type	Name	Description
BEHAVIORAL	Harmony & Health Intervention	Participants will attend group in person sessions 2 times each week for 8 weeks. The sessions will be 45 minutes long. In each session, there will be an introduction, 30 minutes of gentle yoga-based poses and breathing exercises, and then 10 minutes of guided relaxation and scripture meditation. Participants will be instructed to practice the exercises at home 2 times each week during the entire 6-month period. You will be given instructions and a yoga mat, belt, and block. After your Week 9 assessment, you will attend in-person or Zoom sessions 1 time each month over the final 4 months of the study
BEHAVIORAL	Attention Control	Participants will attend group in-person health education sessions 2 times each week for 8 weeks. The sessions will be 45 minutes long and will include discussions of disease prevention and other health and well-being topics. After your Week 9 assessment, you will have the ability to attend additional in-person or Zoom health education sessions 1 time each month over the final 4 months of the study.
DEVICE	Fitbit	Participants will be given a Fitbit and instructions on how to use it. The Fitbit will record your physical activity and report it to the study staff.

Timeline

• Start date: 2024-03-26
• Primary completion: 2026-01-31
• Completion: 2026-01-31
• First posted: 2023-03-30
• Last updated: 2025-11-14

Locations

1 site across 1 country: United States