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

September 28, 2020 updated by: Rae Jean Proeschold-Bell, Duke Clergy Health Initiative

A Randomized Multiple Baseline Intervention Study of Metabolic Syndrome, Mental Health, and Spiritual Well-Being of United Methodist Clergy in North Carolina

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1114

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27707
        • Duke Divinity School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.
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
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.
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
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.
Other Names:
  • Williams Life Skills
  • Naturally Slim

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2.0 years, 2.5 years, 3.0 years, and 3.5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2.0 years, 2.5 years, 3.0 years, 3.5 years
Stress
Time Frame: 2.0 years, 2.5 years, 3.0 years, 3.5 years
Changes in stress scores using the Perceived Stress Scale
2.0 years, 2.5 years, 3.0 years, 3.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke Clergy Health Initiative

Collaborators

The Duke Endowment

Investigators

  • Principal Investigator: David Toole, PhD, MTS, Duke Divinity School
  • Study Director: Rae Jean Proeschold-Bell, PhD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2010

Primary Completion (ACTUAL)

August 1, 2016

Study Completion (ACTUAL)

August 1, 2016

Study Registration Dates

First Submitted

March 14, 2012

First Submitted That Met QC Criteria

March 27, 2012

First Posted (ESTIMATE)

March 28, 2012

Study Record Updates

Last Update Posted (ACTUAL)

September 30, 2020

Last Update Submitted That Met QC Criteria

September 28, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORC-1447SP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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