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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Psychosocial; Mind-body
• Intervention / Treatment: Behavioral: Harmony & Health Intervention; Device: Fitbit; Behavioral: Attention Control

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Scherezade Mama, DRPH; Phone Number: (713) 563-7546; Email: skmama@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center
      • Contact: Scherezade Mama, DRPH; Phone Number: 713-563-7546; Email: skmama@mdanderson.org
      • Principal Investigator: Scherezade Mama, DRPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 without assistance
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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Harmony & Health Intervention (Group 1); Participants randomized to the Harmony and Health intervention group will attend group-based in-person intervention sessions at FOP or COGIC. on.	Behavioral: Harmony & Health Intervention; Participants will attend group in person sessions 2 times each week for 8 weeks. The sessions will be 45 minutes long. In each session, there will be an introduction, 30 minutes of gentle yoga-based poses and breathing exercises, and then 10 minutes of guided relaxation and scripture meditation. Participants will be instructed to practice the exercises at home 2 times each week during the entire 6-month period. You will be given instructions and a yoga mat, belt, and block. After your Week 9 assessment, you will attend in-person or Zoom sessions 1 time each month over the final 4 months of the study; Device: Fitbit; Participants will be given a Fitbit and instructions on how to use it. The Fitbit will record your physical activity and report it to the study staff.
Experimental: Attention Control (Group 2); 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).	Device: Fitbit; Participants will be given a Fitbit and instructions on how to use it. The Fitbit will record your physical activity and report it to the study staff.; Behavioral: Attention Control; Participants will attend group in-person health education sessions 2 times each week for 8 weeks. The sessions will be 45 minutes long and will include discussions of disease prevention and other health and well-being topics. After your Week 9 assessment, you will have the ability to attend additional in-person or Zoom health education sessions 1 time each month over the final 4 months of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fidelity of training and implementation across sites	Fidelity will be achieved if there is ≥90% adherence to intervention delivery and receipt.	6 months

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Institutes of Health (NIH); National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Scherezade Mama, DRPH, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• M D Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): January 31, 2026
• Study Completion (Estimated): January 31, 2026

Study Registration Dates

• First Submitted: March 17, 2023
• First Submitted That Met QC Criteria: March 17, 2023
• First Posted (Actual): March 30, 2023

Study Record Updates

• Last Update Posted (Actual): January 16, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2022-1023; NCI-2023-02353 (Other Identifier: NCI-CTRP Clinical Trials Registry); R01AT012375 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No