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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
The Duke Endowment
Information provided by (Responsible Party):
Rae Jean Proeschold-Bell, Duke Clergy Health Initiative
ClinicalTrials.gov Identifier:
NCT01564719
First received: March 14, 2012
Last updated: June 19, 2014
Last verified: June 2014
  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 Phase
Obesity
Depression
Diabetes
Hypertension
Hypercholesterolemia
Behavioral: Holistic health
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Changes in stress scores using the Perceived Stress Scale


Estimated Enrollment: 1167
Study Start Date: October 2010
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
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
Genders Eligible for Study:   Both
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 Global Health Institute
  More Information

Publications:
Responsible Party: Rae Jean Proeschold-Bell, Assistant Research Professor, Duke Clergy Health Initiative
ClinicalTrials.gov Identifier: NCT01564719     History of Changes
Other Study ID Numbers: ORC-1447SP
Study First Received: March 14, 2012
Last Updated: June 19, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Depression
Depressive Disorder
Hypercholesterolemia
Hypertension
Obesity
Behavioral Symptoms
Mood Disorders
Mental Disorders
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Cardiovascular Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014