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临床试验/NCT01564719
NCT01564719已完成不适用

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

Duke Clergy Health Initiative1 个研究点 分布在 1 个国家目标入组 1,114 人开始时间: 2010年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,114
试验地点
1
主要终点
Metabolic Syndrome

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Assessors of metabolic syndrome indicators did not know participants' treatment group.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

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

研究组 & 干预措施

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.

干预措施: Holistic health (Behavioral)

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.

干预措施: Holistic health (Behavioral)

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.

干预措施: Holistic health (Behavioral)

结局指标

主要结局

Metabolic Syndrome

时间窗: 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.

次要结局

  • 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)

研究者

发起方
Duke Clergy Health Initiative
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rae Jean Proeschold-Bell

Associate Research Professor

Duke University

研究点 (1)

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