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

M.D. Anderson Cancer Center

Status: Active, not recruiting

Conditions: Psychosocial; Mind-body

Treatments: Behavioral: Attention Control; Device: Fitbit; Behavioral: Harmony & Health Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05791981

NCI-2023-02353 (Other Identifier)

2022-1023

R01AT012375 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 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. 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Harmony & Health Intervention (Group 1)

Experimental group

Description:

Participants randomized to the Harmony and Health intervention group will attend group-based in-person intervention sessions at FOP or COGIC. on.

Treatment:

Behavioral: Harmony & Health Intervention

Device: Fitbit

Attention Control (Group 2)

Experimental group

Description:

Participants randomized to the attention control condition will participate in in-person group-based health education sessions twice a week for 8 weeks with a trained interventionist and will receive 4 monthly newsletters (20 total contacts).

Treatment:

Device: Fitbit

Behavioral: Attention Control