Harmony & Health: Feasibility of a Movement Intervention to Improve Psychosocial Wellbeing in Black Adults in Northeast Texas
- Conditions
- Psychological
- Interventions
- Behavioral: Harmony & HealthBehavioral: Health Education
- Registration Number
- NCT05761964
- Lead Sponsor
- M.D. Anderson Cancer Center
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 54
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Health and Harmony Harmony & Health Participants will take part in a program combining yoga practices and Christian spirituality. Health and Harmony Health Education Participants will take part in a program combining yoga practices and Christian spirituality. Health Education (Control) Harmony & Health Participants will take part in a series of health education sessions. Health Education (Control) Health Education Participants will take part in a series of health education sessions.
- Primary Outcome Measures
Name Time Method Feasibility and acceptability of the intervention: Program satisfaction through study completion; an average of 1 year. Following the follow-up data collection time point, we will conduct individual interviews with a subsample of participants (\~16 participants). Interview questions will address participants' overall reactions to and satisfaction with the mind-body intervention, perceived impact on social support, motivation, and self-efficacy for increase physical activity and well-being. Positive satisfaction, i.e., successful feasibility, will be achieved when participants consistently and repeatedly, through subsequent interviews, endorse satisfaction with the program through use of positive language when describing their feelings toward the program. Interviews will be conducted by the PI or trained member of the research team.
Feasibility and acceptability of the intervention: Recruitment and retention through study completion; an average of 1 year. Rates of study eligibility, recruitment, and retention will be assessed. We will maintain detailed information during the recruitment process regarding the number of church members interested, eligible, ineligible and reasons for ineligibility, and enrolled. To assess feasibility, we will calculate the rates of study eligibility, recruitment, and retention, along with their 90% confidence intervals (CIs). Participant feedback will be summarized using means and standard deviations along with graphical display (e.g., box plots). Recruitment success, i.e., feasibility will be achieved if ≥50% of eligible participants enrolls in the study. Retention success will be achieved if ≥80% participants complete the post-intervention and follow-up assessments.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
M D Anderson Cancer Center
🇺🇸Houston, Texas, United States