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

M.D. Anderson Cancer Center

Status: Enrolling

Conditions: Psychological

Treatments: Behavioral: Health Education; Behavioral: Harmony & Health

Study type: Interventional

Funder types: Other

Identifiers

NCT05761964

NCI-2023-01856 (Other Identifier)

2022-0793

Details and patient eligibility

About

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

Full 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.

Enrollment: 54 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Men and women ≥18 years of age
2. Self-identify as Black or African American
3. Able to read, speak, and write in English
4. Primary residence in the Northeast Texas area (Public Health Region 4/5N)
5. Insufficiently active (self-report <75 minutes/week of physical activity)
6. Sedentary (self-report ≥6 hours/day of sitting time)
7. Body mass index [BMI] ≥25 kg/m2
8. Able to pass the Physical Activity Readiness Questionnaire (PARQ) or provide physician's clearance to participate
9. Able to provide written informed consent without assistance

Exclusion criteria

1. <18 years of age
2. Do not self-identify as Black or African American
3. Unable to read, speak, and write in English
4. Primary residence falls outside of the Northeast Texas area or Public Health Region 4/5N
5. Physically active or self-report doing ≥75 minutes/week of physical activity
6. Not sedentary or self-report <6 hours/day of sitting time
7. BMI <25.0 kg/m2
8. Absolute contraindications to unassisted physical activity based on the PARQ (e.g., acute MI, orthopedic and musculoskeletal limitations)
9. Planning to move from the Northeast Texas during the 6 month study period
10. Pregnant or planning to become pregnant during the 6 month study period
11. Currently participating in another program to increase physical activity, reduce sedentary behavior, or manage weight

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

Health and Harmony

Experimental group

Description:

Participants will take part in a program combining yoga practices and Christian spirituality.

Treatment:

Behavioral: Health Education

Behavioral: Harmony & Health

Health Education (Control)

Other group

Description:

Participants will take part in a series of health education sessions.

Treatment:

Behavioral: Health Education

Behavioral: Harmony & Health