Improving Physical, Mental, and Spiritual Health in Faith-Based Settings Through Creating a Healthy Culture in Bronx, NY

The proposed study "Improving Physical, Mental, and Spiritual Health in Faith- Based Settings through Creating a Healthy Culture in Bronx, NY" aims to assess the efficacy of a holistic health intervention that seeks to integrate physical, mental, spiritual, and community engagement processes into faith-based settings, compared to usual care in Bronx, NY. Briefly, the intervention involves a seven-session faith-based small group education program conducted by trained lay educators. A health ministry at each partner religious institution will be developed and sustained

Study Overview

• Status: Completed
• Conditions: Mental Health Issue
• Intervention / Treatment: Behavioral: The Seven Pathways to Healing, Health and Wellness curriculum

Detailed Description

The purpose of this research study is test a holistic health intervention that combines physical, mental, spiritual, and community processes into faith-based settings in Bronx, NY. The program involves a seven-session faith-based small group education sessions to be conducted by lay educators.

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Intervention study participants

Inclusion Criteria:

• Age 18 and over
• Self-identify as a member of the religious institution for at least three months
• Able to read and speak in English, Vietnamese, or Khmer

Exclusion Criteria:

• Any serious health issue that may interfere with the study procedures

Key informants participants

Inclusion Criteria:

• Age 18 and over
• Must be a study implementation partner, a health ministry member, or lay educator

Exclusion Criteria:

• None

Focus group participants

Inclusion Criteria:

• Must be a participant in the intervention
• Attended at least 3 out of the 7 group education sessions as an intervention participant;

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Faith based educational group; A seven-session faith-based small group educational program using the "The Seven Pathways to Healing, Health and Wellness" curriculum will be delivered.

Behavioral: The Seven Pathways to Healing, Health and Wellness curriculum; The curriculum seeks to increase civic engagement by fostering a sense of community and a sense of social and personal responsibility in community. There will be 7 monthly session that will be approximately 1 hour in duration. Session topics include: Education and Information (including mental health awareness, and a one-day certificate program in Mental Health First Aid); Connection with Others; The Body as Temple; Emotional Healing; The Nature of Mind; Life Assessment; The Nature of Spirit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in sociodemographic characteristics of participants	This will be measured by self reported participant survey about the aspects of personal and social responsibility for well-being.	baseline and 6 months visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Facilitators and Barriers in intervention process by Focus Group participants	A Focus group of a subset of participants will assess the facilitators and barriers in receiving the 7 sessions of the intervention. The focus groups at a private location convenient for participants. Interviews will not exceed two hours and will be audio-recorded. The focus group data will elicit facilitators and barriers to receiving the intervention and making change to improve well-being. The focus group will discuss topics such as how the group sessions impacted on the participants' physical or mental health, what was challenging or not useful and what types of tools were gained that were helpful to become more spiritually healthy.	6 months
Facilitators and Barriers in intervention process by Key informants	The key informant interviews will contain questions that assess facilitators and barriers to implementing the intervention. The key informant interviews will be conducted once, immediately after completion of the intervention among intervention participants	6 months

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Sahnah Lim, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Actual): February 1, 2021
• Study Completion (Actual): February 1, 2021

Study Registration Dates

• First Submitted: April 15, 2020
• First Submitted That Met QC Criteria: April 16, 2020
• First Posted (Actual): April 20, 2020

Study Record Updates

• Last Update Posted (Actual): March 18, 2021
• Last Update Submitted That Met QC Criteria: March 17, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 19-01617

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data. Upon reasonable request, Requests should be directed to Sahnah.lim@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

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