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Study of a Holistic Health Program for United Methodist Clergy (SpiritedLife)

This study has been completed.
Sponsor:
Collaborator:
The Duke Endowment
Information provided by (Responsible Party):
Rae Jean Proeschold-Bell, Duke University
ClinicalTrials.gov Identifier:
NCT01564719
First received: March 14, 2012
Last updated: February 9, 2017
Last verified: February 2017
  Purpose
This study seeks to test a two-year intervention designed for United Methodist clergy. The intervention consists of: the stress reduction program Williams LifeSkills, adapted for clergy; the 10-session online weight loss program Naturally Slim Foundations plus its 7-session online booster program, Naturally Slim Advanced; monthly phone conversations with Wellness Advocates who function as health coaches; and three in-person workshops that cover the theology of the body and incarnation and provide the religious rationale for caring for the mind and body. Participants were randomly assigned to one of three cohorts, all of which will eventually receive the intervention but which differ by intervention timing, thereby building in a randomized waitlist control group. The investigators hypothesize that intervention participants will achieve reductions in metabolic syndrome, depression, and stress, and achieve improvements in quality of life and spiritual well-being, compared to the waiting control group participants.

Condition Intervention
Obesity
Depression
Diabetes
Hypertension
Hypercholesterolemia
Behavioral: Holistic health

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
We used a randomized, multiple baseline design in which 3 cohorts were randomly assigned to start date, thereby creating 2 waiting cohorts. Cohort 1 immediately received the intervention; Cohort 2 waited one year and then received the intervention. Cohort 3 waited two years and then received the intervention. Data were collected from Cohorts 2 and 3 while waiting.
Masking: Outcomes Assessor
Masking Description:
Assessors of metabolic syndrome indicators did not know participants' treatment group.
Primary Purpose: Treatment
Official Title: A Randomized Multiple Baseline Intervention Study of Metabolic Syndrome, Mental Health, and Spiritual Well-Being of United Methodist Clergy in North Carolina

Resource links provided by NLM:


Further study details as provided by Duke Clergy Health Initiative:

Primary Outcome Measures:
  • Metabolic Syndrome [ Time Frame: 2.0 years, 2.5 years, 3.0 years, and 3.5 years ]
    Changes in abdominal circumference, blood pressure, HbA1c, triglycerides, and HDL. Metabolic Syndrome is defined as having a large abdominal circumference plus two of more of these indicators. We seek to improve each of the five indicators and decrease overall rates of Metabolic Syndrome.


Secondary Outcome Measures:
  • Depression [ Time Frame: 2.0 years, 2.5 years, 3.0 years, 3.5 years ]
    Changes in depression scores measured by the Patient Health Questionnaire-9

  • Stress [ Time Frame: 2.0 years, 2.5 years, 3.0 years, 3.5 years ]
    Changes in stress scores using the Perceived Stress Scale


Enrollment: 1114
Actual Study Start Date: October 2010
Study Completion Date: August 2016
Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Immediate-intervention arm
This is a holistic health intervention. .The stress reduction program Williams LifeSkills, adapted for clergy; the 10-session online weight loss program Naturally Slim Foundations plus its 7-session online booster program, Naturally Slim Advanced; monthly phone conversations with Wellness Advocates who function as health coaches; and three in-person workshops that cover the theology of the body and incarnation and provide the religious rationale for caring for the mind and body.
Behavioral: Holistic health
We conceptualize this as a holistic health intervention because it has components involving the mind, body, and spirit. The stress reduction program Williams LifeSkills, adapted for clergy; the 10-session online weight loss program Naturally Slim Foundations plus its 7-session online booster program, Naturally Slim Advanced; monthly phone conversations with Wellness Advocates who function as health coaches; $500 small grants to use to promote health; and three in-person workshops that cover the theology of the body and incarnation and provide the religious rationale for caring for the mind and body.
Other Names:
  • Williams Life Skills
  • Naturally Slim
Experimental: One-year waitlist arm
This holistic health intervention arm for Cohort 2 was the same as Cohort 1's, only the intervention delivery was smoother (e.g., Naturally Slim offered at more start times). Cohort 2 waited for one year before beginning the intervention.
Behavioral: Holistic health
We conceptualize this as a holistic health intervention because it has components involving the mind, body, and spirit. The stress reduction program Williams LifeSkills, adapted for clergy; the 10-session online weight loss program Naturally Slim Foundations plus its 7-session online booster program, Naturally Slim Advanced; monthly phone conversations with Wellness Advocates who function as health coaches; $500 small grants to use to promote health; and three in-person workshops that cover the theology of the body and incarnation and provide the religious rationale for caring for the mind and body.
Other Names:
  • Williams Life Skills
  • Naturally Slim
Experimental: Two-year waitlist arm
This holistic health intervention arm for Cohort 3 was the same as Cohort 2's, only Cohort 3 waited for two years and received the stress management program meQuilibrium rather than Williams LifeSkills.
Behavioral: Holistic health
We conceptualize this as a holistic health intervention because it has components involving the mind, body, and spirit. The stress reduction program Williams LifeSkills, adapted for clergy; the 10-session online weight loss program Naturally Slim Foundations plus its 7-session online booster program, Naturally Slim Advanced; monthly phone conversations with Wellness Advocates who function as health coaches; $500 small grants to use to promote health; and three in-person workshops that cover the theology of the body and incarnation and provide the religious rationale for caring for the mind and body.
Other Names:
  • Williams Life Skills
  • Naturally Slim

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • United Methodist Church pastors (Elders, Probationary Elders, Deacons, Interim Supply Pastors, and Local Pastors) serving a local church, as Bishop, as a District Superintendent, or on Conference staff, in either the North Carolina Annual Conference or Western North Carolina Conference as of July 2010
  • age 18 or above

Exclusion Criteria:

  • Extension ministers other than Conference staff
  • Pastors on leave
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01564719

Locations
United States, North Carolina
Duke Divinity School
Durham, North Carolina, United States, 27707
Sponsors and Collaborators
Duke Clergy Health Initiative
The Duke Endowment
Investigators
Principal Investigator: David Toole, PhD, MTS Duke Divinity School
Study Director: Rae Jean Proeschold-Bell, PhD Duke University
  More Information

Publications:
Morris ML, Blanton PW. The influence of work-related stressors on clergy husbands and their wives. Family Relations. 1994;43(2):189-95.
Jones SH, Francis LJ, Jackson C. The relationship between religion and anxiety: a study among Anglican clergymen and clergywomen. Journal of Psychology & Theology. 2004;32(2):137-42.
Halaas GW. Ministerial health and wellness, 2002, Evangelical Lutheran Church in America. Chicago, IL; 2002.
Knox S, Virginia SG, Lombardo J. Depression and anxiety in Roman Catholic secular clergy. Pastoral Psychology. 2002;50:345-58.
Knox S, Virginia SG, Smith J. Pilot study of psychopathology among Roman Catholic secular clergy. Pastoral Psychology. 2007;55(297-306).
Knox S, Virginia SG, Thull J, Lombardo JP. Depression and contributors to vocational satisfaction in Roman Catholic secular clergy. Pastoral Psychology. 2005;54(139-153).

Responsible Party: Rae Jean Proeschold-Bell, Associate Research Professor, Duke University
ClinicalTrials.gov Identifier: NCT01564719     History of Changes
Other Study ID Numbers: ORC-1447SP
Study First Received: March 14, 2012
Last Updated: February 9, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Duke Clergy Health Initiative:
clergy
weight loss
holistic
stress
spiritual

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on March 29, 2017