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

NCT04353427 | Completed DMC

• 1 other identifier: 19-01617
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mental Health Issue

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Facilitators and Barriers in intervention process by Focus Group participants

  6 months

• Facilitators and Barriers in intervention process by Key informants

  6 months

Study Arms (1)

Faith based educational group

EXPERIMENTAL

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

Interventions

The Seven Pathways to Healing, Health and Wellness curriculum BEHAVIORAL

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: 1. Education and Information (including mental health awareness, and a one-day certificate program in Mental Health First Aid) 2. Connection with Others 3. The Body as Temple 4. Emotional Healing 5. The Nature of Mind 6. Life Assessment 7. The Nature of Spirit

Faith based educational group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Any serious health issue that may interfere with the study procedures
• Key informants participants
• Age 18 and over
• Must be a study implementation partner, a health ministry member, or lay educator
• None
• Focus group participants
• Must be a participant in the intervention
• Attended at least 3 out of the 7 group education sessions as an intervention participant;
• None

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone

New York, New York, 10016, United States

Location

MeSH Terms

Interventions

Health

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Officials

• Sahnah Lim, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: April 20, 2020
• Study Start: May 1, 2020
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: March 18, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

US (1)