CClinicalTrials.gg
CompletedNCT01564719SpiritedLifeUpdated Sep 30, 2020

Study of a Holistic Health Program for United Methodist Clergy

An interventional study of Holistic health in Obesity, Depression and Diabetes, sponsored by Duke Clergy Health Initiative. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-30.

Sponsored by Duke Clergy Health Initiative · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 5 months after the study started (first participant enrolled Oct 2010, registered Mar 2012).
Phase
Not applicable
Study type
Interventional
Enrollment
1,114
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

Studies are beginning to surface that indicate that clergy suffer from high rates of chronic disease, including obesity (1, 2) and diabetes, arthritis, and hypertension (1). Clergy also experience above average rates of depression (3-5) and anxiety (3, 6). High stress is an additional common problem for clergy. A review of the literature on clergy stress cites the following five stressors as the most salient for clergy: mobility, low financial compensation, inadequate social support, high time demands, and intrusions on family boundaries (7). Health interventions for clergy are needed, and yet, as far as the investigators know, no clergy health interventions have been rigorously tested.

The investigators seek to design and rigorously test a holistic health intervention for United Methodist clergy in North Carolina. Based on the existing epidemiological data, the investigators hope to create a health intervention that will reduce Metabolic Syndrome, which is a set of risk factors that clusters with obesity and is related to cardiovascular disease, diabetes, and death (8, 9). Thus, the investigators seek to reduce rates of hypertension, diabetes, large abdominal circumference, high triglycerides, and low HDL. The investigators additionally seek to decrease stress, depression, and anxiety in clergy.

The investigators developed a 23-month intervention called Spirited Life. This intervention utilizes a combination of: 1) in-person workshops, 2) online videos, 3) contacts with a Wellness Advocate, and 4) small grants. 1) The workshops include the stress management program called Williams LifeSkills, which has a strong evidence base [see, for example, (10)]. The workshops also emphasize theological reasons to take care of one's health. 2) The online videos are the Naturally Slim weight loss and healthy eating program offered by ACAP Health. 3) The Wellness Advocates use Motivational Interviewing to work with clergy to set goals and check on progress. The frequency of Wellness Advocate contact may vary but is intended to be monthly, and generally occurs by phone. 4) The small grants are $500 offered during month 13 of the program and may be broadly used to promote health; participants submit a short application that must be approved by their Wellness Advocate.

The investigators will recruit clergy (Elders, Probationary Elders, Deacons, Interim Supply Pastors, and Local Pastors) serving a local church, as Bishop or as a District Superintendent, or as a campus minister or someone on Conference staff, in either the North Carolina Annual Conference or Western North Carolina Conference, as of July 2010. Additional inclusion criteria are that clergy must be age 18 or higher, and may be full or part-time pastors; student pastors; of any current health status; and non-United Methodist if they are serving a United Methodist Church in one of the North Carolina Conferences. The investigators will exclude extension ministers other than Conference staff and campus ministers, and the investigators will exclude pastors on leave.

This study employs a randomized multiple baseline research design in which all consenting clergy will be randomized to one of three cohorts, which differ in when they will begin receiving the 23-month intervention treatment. Cohort 1 will begin the intervention in January 2011; Cohort 2 in January 2012; and Cohort 3 in January 2013. As is standard in Multiple Baseline research designs, participants in all cohorts will participate in data collection throughout the study period, including prior to their initiation of the intervention treatment.

The investigators will collect both survey and health screening data. The survey data cover the following constructs: depression, anxiety, stress, life satisfaction, relationship satisfaction, hostility, mental and physical health functioning, burnout, spiritual well-being, nutrition, and exercise. The health screening data include height, weight, abdominal circumference, resting blood pressure and heart rate, fasting cholesterol, and hemoglobin A1c.

The data collection schedule varies by cohort, and both survey and health screening data will be sought at each data collection time point. All cohorts will provide baseline survey and health screening data in November 2010. During the 23-month intervention treatment period for each cohort, the investigators will seek data in months 9, 16, and 23. For Cohort 1, the investigators will also seek post-treatment data 6, 12, and 18 months after the end of the intervention period to examine the durability of effects. The investigators will do the same for Cohorts 2 and 3, dependent upon funding.

The investigators' primary analysis will be to compare Cohort 1 at the end of treatment to Cohort 3, which will provide data while waiting for treatment. Thus, embedded in this randomized multiple baseline design is a randomized controlled trial between Cohorts 1 and 3. The investigators therefore will seek data from Cohorts 1 and 3 in September 2011, April 2012, and November 2012. The investigators will also seek data from Cohort 2 in November 2011 to get updated baseline data before Cohort 2 participants start the intervention treatment.

If successful in reducing Metabolic Syndrome, stress, depression, and anxiety, the Spirited Life intervention could have a major impact in reducing health problems and improving the holistic health of clergy.

02

Conditions studied

  • Obesity
  • Depression
  • Diabetes
  • Hypertension
  • Hypercholesterolemia

Keywords

  • clergy
  • weight loss
  • holistic
  • stress
  • spiritual
03

In context

Hypercholesterolemia

1,238 studies on the registry are indexed under Hypercholesterolemia; 109 are open to participants now.

This study's enrollment of 1,114 is above the median of 99 across 991 interventional studies indexed under Hypercholesterolemia.

Browse Hypercholesterolemia studies →

Lead sponsor

This is the only study on the registry with Duke Clergy Health Initiative as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Extension ministers other than Conference staff
  • Pastors on leave
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Single (Outcomes assessor)
Enrollment
1,114 participants (actual)

Study arms

  • 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

  • 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

  • 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

Interventions

  • BehavioralHolistic health

    The investigators 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.

    Also known as: Williams Life Skills, Naturally Slim

06

What researchers measure

Primary outcomes

  1. Metabolic Syndrome

    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.

    Time frame: 2.0 years, 2.5 years, 3.0 years, and 3.5 years

Secondary outcomes

  1. Depression

    Changes in depression scores measured by the Patient Health Questionnaire-9

    Time frame: 2.0 years, 2.5 years, 3.0 years, 3.5 years

  2. Stress

    Changes in stress scores using the Perceived Stress Scale

    Time frame: 2.0 years, 2.5 years, 3.0 years, 3.5 years

07

Study locations

1 site
  • Duke Divinity School
    Durham, North Carolina 27707, United States
08

References and documents

Publications

  • Proeschold-Bell RJ, LeGrand SH. High rates of obesity and chronic disease among United Methodist clergy. Obesity (Silver Spring). 2010 Sep;18(9):1867-70. doi: 10.1038/oby.2010.102. Epub 2010 May 6. PubMed 20448538 ↗
  • Proeschold-Bell RJ, Legrand S, James J, Wallace A, Adams C, Toole D. A theoretical model of the holistic health of United Methodist clergy. J Relig Health. 2011 Sep;50(3):700-20. doi: 10.1007/s10943-009-9250-1. Epub 2009 Apr 10. PubMed 19360471 ↗
  • Mottillo S, Filion KB, Genest J, Joseph L, Pilote L, Poirier P, Rinfret S, Schiffrin EL, Eisenberg MJ. The metabolic syndrome and cardiovascular risk a systematic review and meta-analysis. J Am Coll Cardiol. 2010 Sep 28;56(14):1113-32. doi: 10.1016/j.jacc.2010.05.034. PubMed 20863953 ↗
  • Alberti KG, Zimmet P, Shaw J. Metabolic syndrome--a new world-wide definition. A Consensus Statement from the International Diabetes Federation. Diabet Med. 2006 May;23(5):469-80. doi: 10.1111/j.1464-5491.2006.01858.x. PubMed 16681555 ↗
  • Kirby ED, Williams VP, Hocking MC, Lane JD, Williams RB. Psychosocial benefits of three formats of a standardized behavioral stress management program. Psychosom Med. 2006 Nov-Dec;68(6):816-23. doi: 10.1097/01.psy.0000238452.81926.d3. PubMed 17132834 ↗
  • 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).
  • Proeschold-Bell RJ, Turner EL, Bennett GG, Yao J, Li XF, Eagle DE, Meyer RA, Williams RB, Swift RY, Moore HE, Kolkin MA, Weisner CC, Rugani KM, Hough HJ, Williams VP, Toole DC. A 2-Year Holistic Health and Stress Intervention: Results of an RCT in Clergy. Am J Prev Med. 2017 Sep;53(3):290-299. doi: 10.1016/j.amepre.2017.04.009. Epub 2017 Jun 19. PubMed 28641912 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01564719
Lead sponsor
Duke Clergy Health Initiative
Collaborators
The Duke Endowment
Responsible party
Rae Jean Proeschold-Bell (Associate Research Professor, Duke University) — Principal investigator
First posted
Mar 28, 2012
Start date
Oct 2010
Primary completion
Aug 2016
Completion
Aug 2016
Last update
Sep 30, 2020

Study contacts

David Toole, PhD, MTS
principal investigator · Duke Divinity School
Rae Jean Proeschold-Bell, PhD
study director · Duke University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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