NCT01564719

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,114

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Oct 2010

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 28, 2012

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

September 30, 2020

Status Verified

September 1, 2020

Enrollment Period

5.8 years

First QC Date

March 14, 2012

Last Update Submit

September 28, 2020

Conditions

ObesityDepressionDiabetesHypertensionHypercholesterolemia

Keywords

clergyweight lossholisticstressspiritual

Outcome Measures

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.

    2.0 years, 2.5 years, 3.0 years, and 3.5 years

Secondary Outcomes (2)

  • Depression

    2.0 years, 2.5 years, 3.0 years, 3.5 years

  • Stress

    2.0 years, 2.5 years, 3.0 years, 3.5 years

Study Arms (3)

Immediate-intervention arm

EXPERIMENTAL

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

One-year waitlist arm

EXPERIMENTAL

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

Two-year waitlist arm

EXPERIMENTAL

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

Holistic healthBEHAVIORAL

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
Immediate-intervention armOne-year waitlist armTwo-year waitlist arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Extension ministers other than Conference staff
  • Pastors on leave

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke Divinity School

Durham, North Carolina, 27707, United States

Location

Related Publications (12)

  • 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.

    PMID: 20448538BACKGROUND

  • 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.

    PMID: 19360471BACKGROUND

  • 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.

    PMID: 20863953BACKGROUND

  • 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.

    PMID: 16681555BACKGROUND

  • 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.

    PMID: 17132834BACKGROUND

  • Morris ML, Blanton PW. The influence of work-related stressors on clergy husbands and their wives. Family Relations. 1994;43(2):189-95.

    BACKGROUND

  • 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.

    BACKGROUND

  • Halaas GW. Ministerial health and wellness, 2002, Evangelical Lutheran Church in America. Chicago, IL; 2002.

    BACKGROUND

  • Knox S, Virginia SG, Lombardo J. Depression and anxiety in Roman Catholic secular clergy. Pastoral Psychology. 2002;50:345-58.

    BACKGROUND

  • Knox S, Virginia SG, Smith J. Pilot study of psychopathology among Roman Catholic secular clergy. Pastoral Psychology. 2007;55(297-306).

    BACKGROUND

  • 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).

    BACKGROUND

  • 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.

    PMID: 28641912DERIVED

MeSH Terms

Conditions

ObesityDepressionDiabetes MellitusHypertensionHypercholesterolemiaWeight Loss

Interventions

Holistic Health

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular DiseasesHyperlipidemiasDyslipidemiasLipid Metabolism DisordersBody Weight Changes

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsHealthPopulation Characteristics

Study Officials

  • David Toole, PhD, MTS

    Duke Divinity School

    PRINCIPAL INVESTIGATOR

  • Rae Jean Proeschold-Bell, PhD

    Duke University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Assessors of metabolic syndrome indicators did not know participants' treatment group.
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: The investigators 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Research Professor

Study Record Dates

First Submitted

March 14, 2012

First Posted

March 28, 2012

Study Start

October 1, 2010

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

September 30, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)