Clinical trial NCT05791981: Multi-site Feasibility and Acceptability of a Faith-based Mind-body Intervention for Black Adults
Official title: Multi-site Feasibility and Acceptability of a Faith-based Mind-body Intervention for Black Adults
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Psychosocial
Mind-body
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2023-03-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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. Self-report doing \<90 minutes/week of physical activity
5. Self-report sitting ≥6 hours/day
6. Body mass index \[BMI\] ≥25.0 kg/m2 based on self-reported height and weight
7. Able to provide informed consent
8. Able to pass the Physical Activity Readiness Questionnaire (PARQ) or provide physician's clearance to participate

Exclusion Criteria:

1. \<18 years of age
2. Does not identify as Black or African American
3. Unable or uncomfortable participating in English
4. Self-reports doing ≥90 minutes/week of physical activity
5. Self-reports sitting for \<6 hours/day
6. BMI \<25.0 kg/m2
7. Absolute contraindications to unassisted physical activity based on the PARQ (e.g., acute MI, orthopedic and musculoskeletal limitations)
8. Practicing yoga or enrolled in another program targeting physical activity, sitting time, or weight loss
9. Pregnant or planning to become pregnant during the 6 month study period
10. Planning to move from the Houston or Northeast Texas areas during the 6 month study period

Primary outcomes:
measure: Fidelity of training and implementation across sites
timeFrame: 6 months
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: