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This paper describes the design, methods, baseline characteristics and cost effective measures, of a single-blinded, cluster- randomized trial of a faith-based adaptation of the GLB program, Fit Body and Soul FBAS. The primary outcome is weight change at weeks post intervention. Secondary outcomes include hemoglobin A1C, fasting plasma glucose, waist circumference, blood pressure, physical activity level, quality of life measures, and cost-effectiveness. Reliance on health professionals from within the church for program implementation and the cost analysis are unique aspects of this trial. The design provides a model for faith-based DPPs and holds promise for program sustainability and widespread dissemination.

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This paper describes the design, methods, baseline characteristics and cost effective measures, of a single-blinded, cluster- randomized trial of a faith-based adaptation of the GLB program, Fit Body and Soul FBAS. The primary outcome is weight change at weeks post intervention. Secondary outcomes include hemoglobin A1C, fasting plasma glucose, waist circumference, blood pressure, physical activity level, quality of life measures, and cost-effectiveness.

Reliance on health professionals from within the church for program implementation and the cost analysis are unique aspects of this trial. The design provides a model for faith-based DPPs and holds promise for program sustainability and widespread dissemination. Keywords: African-American, church, cluster, translation research, diabetes prevention, obesity 1. Risk factors include older age, family history of diabetes, previous history of gestational diabetes, and physical inactivity, however weight is the risk factor most associated with incident diabetes [ 2 ].

Multiple DPP lifestyle intervention adaptations, including the Group Lifestyle Balance GLB program, were effective in lowering diabetes risk factors [ 4 , 5 , 6 , 7 , 8 , 9 ]; however, evidence of implementation of such programs in African American AA populations is sparse. Disparities in rates of diabetes are partly attributed to the disproportionately higher prevalence of overweight and obesity among AAs compared to whites While US obesity trends are leveling off in other races, obesity continues to trend upward among AAs [ 11 ].

Despite disparities, much of the current DPP translation evidence originates from samples primarily of pre-diabetic non-Hispanic whites [ 12 ]. The church is an effective setting to gain access to AAs for health promotion research [ 13 , 14 ]. Churches play a major role in AA communities, often providing support for spiritual, financial and social needs. Many AA churches consider health as part of their mission and have well-organized multidisciplinary health ministries [ 15 ].

A church health ministry is a group of health professionals and lay volunteers that integrates faith and health within the congregation and provides health-promoting activities such as health screenings and health education [ 16 ]. Due to their commitment to health promotion within their individual churches, health ministries could play an integral role with DPP translation research conducted within AA churches.

Published AA church-based DPP trials to date have primarily been small non-randomized feasibility trials, ranging from 10 — 40 participants [ 17 , 18 , 19 ]. Although researchers have used lay community health workers to recruit participants and deliver a DPP translation intervention through AA churches [ 21 ], to our knowledge there are no DPP randomized efficacy trials in which researchers have trained the professional health ministry members to deliver the entire intervention.

In addition, investigators have not generated sufficient evidence regarding the cost utility of DPP community-based translation [ 4 , 5 , 6 , 7 , 8 ]. The purpose of this paper is to describe the design, methods, baseline characteristics and cost effective measures of a church-based cluster randomized trial, Fit Body and Soul FBAS.

Members of the CAB, which includes local pastors, nurses, and other community leaders, identified obesity and diabetes as priority health conditions for the local AA community. The pastors on the CAB expressed a desire to have a community-led diabetes prevention program offered through the local churches.

The investigators along with representative community partners sought to develop the project within the framework of community based participatory research [ 22 ]. Our multi-disciplinary academic research team includes a nurse-scientist who is a trusted AA faith- leader. Based on the CAB recommendations, the nurse scientist and other research team members met with other local AA pastors and health ministry members to determine interest, garner additional support and input on a collaborative project.

With high local interest, we formed a project-specific advisory group comprised of the research team, DPP experts from the University of Pittsburgh Diabetes Prevention Support Center [ 24 ]; an expert from another church-based trial Body and Soul [ 25 ]; and a pastor and health ministry members from six local churches, which were identified by CAB members as churches having active health ministries.

The advisory group provided input for all aspects of the planned project, including recommendations to modify the GLB curriculum by adding selected scriptures, socio-cultural preferences, AA graphics, and quotes from famous AAs [ 17 ].

The advisory group also suggested the project name as Fit Body and Soul. With preferences from both the community and investigators to address the multiple layers of influence within the church, we adopted the Socio-ecological Model as the theoretical framework for project implementation [ 26 ]. The advisory group provided input on the best methods for integrating the multiple levels i. Based on these formative assessments, investigators developed and implemented a week feasibility pilot study in one church [ 17 , 27 ].

Results indicated that successful translation of the DPP to a faith-based setting was feasible and potentially effective. We obtained additional funding to test the faith-based translational model in a larger randomized control trial, which is the focus of this paper.

Investigators allocated churches to two arms: the FBAS intervention arm which is a faith-based adaptation of the GLB intervention, and a health education program comparison arm developed from the list of topics provided by the Centers for Disease Control and Prevention CDC Guide to Community Prevention Services [ 28 , 29 ]. We recruited 20 churches located in a Georgia metropolitan area, which includes both urban and rural communities.

We assumed that churches of similar size would share similar resources and church culture; we therefore stratified the churches by membership size and then randomized them in pairs at the church level to receive the FBAS intervention or the comparison intervention. The study began with participant recruitment and training of church health advisors CHAs at the first church in September , followed by baseline data collection in October Investigators completed baseline assessment for all twenty churches in March Final data collection will occur by April Due to the large number of churches in Richmond County, Georgia, we targeted churches that were: 1 known by the nurse scientist or another research team member or, 2 recommended by a member of the CAB.

The nurse-scientist or study coordinator then contacted each church to arrange an appointment with the pastor. With a recruitment goal of 20 churches, we met with the pastors from 28 of 35 churches who had expressed interest. After the pastors agreed to participate, the investigators requested a letter of support.

Church recruitment continued until investigators had obtained signed letters of support from 20 pastors. The pastors of two churches initially agreed, but did not respond to follow-up phone calls; and the pastor of one church stated that the church lacked sufficient members who were willing to participate. All of the included churches were of the Christian faith. Churches entered the study in six cohorts, each cohort including either two or four churches.

A new cohort began every four months. To maximize early participant enrollment, we chose to begin with the larger churches.

Investigators informed the pastors of the overall project timeline and the anticipated start date at their church. To keep the pastors engaged and abreast of the study timeline, we invited them to CAB meetings and periodically sent them study update letters.

Prior to the start of a new cohort, investigators met again with each pastor of the upcoming cohort. During the meeting, the investigators informed the pastor of the results of randomization, confirmed the start date of participant recruitment, intervention start dates, session days and times, and data collection dates.

Additionally, the pastor signed a memorandum of understanding, which described the responsibilities of the church, the CHAs and the research team. The memorandum also described the incentives for the participants, CHAs and church. Inclusion criteria were selected to include AAs who were non-diabetic but at risk for developing T2DM. Exclusion criteria were medical contraindications to physical activity, physical conditions or medications that might affect glucose metabolism, behaviors that may interfere with participation and illnesses that would limit life span.

Investigators consented participants and excluded , which resulted in a final enrollment of participants. Figure 1 shows the number of consented participants by intervention arm and assessed for eligibility, the reasons for exclusion, and the final number enrolled from the 20 churches.

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