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Completed

NCT Number: NCT04353427

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

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Key information

Conditions

Mental Health Issue

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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:

  • 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

Primary outcomes

  1. Changes in sociodemographic characteristics of participants

    Time frame: baseline and 6 months visit

    This will be measured by self reported participant survey about the aspects of personal and social responsibility for well-being.

Secondary outcomes

  1. Facilitators and Barriers in intervention process by Focus Group participants

    Time frame: 6 months

    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.

  2. Facilitators and Barriers in intervention process by Key informants

    Time frame: 6 months

    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

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 20, 2020
Registry last updated
Mar 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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