Clinical trial NCT05761964: Harmony & Health: Feasibility of a Movement Intervention to Improve Psychosocial Wellbeing in Black Adults in Northeast Texas
Official title: Harmony & Health: Feasibility of a Movement Intervention to Improve Psychosocial Wellbeing in Black Adults in Northeast Texas
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychological
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: Duncan Family Institute (DFI) Seed Funding Program
First posted: 2023-03-09
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility and acceptability of the intervention: Recruitment and retention
timeFrame: through study completion; an average of 1 year.
measure: Feasibility and acceptability of the intervention: Program satisfaction
timeFrame: through study completion; an average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Scherezade Mama, DRPH
role: PRINCIPAL_INVESTIGATOR
References: