Obesity Clinical Trial
Official title:
Project Diabetes: Prescription for Healthy Living
Health disparities related to obesity, pre-diabetes and Type 2 diabetes in the United States
represent public health concerns. Given the benefit of exercise in disease prevention and
management, evidence-based, cost-effective, brief interventions are needed to improve
patient outcomes related to Type 2 diabetes and associated conditions. This novel behavioral
intervention study connects individuals with resources within their community to affect
change in their health and wellness. The aim is to connect disparate individuals to health
and wellness resources to prevent the onset of diabetes. This will be accomplished through a
collaborative effort with Vanderbilt Diabetes Center, Nashville Metro Parks and Recreation,
and the Metro Public Health Department.
A time series design will be used to assess the efficacy of physical activity counseling
delivered by a health care professional, plus continued contact intervention delivered via a
proactive and reactive health promotion counseling hotline that will leverage our
partnership with Metro Parks versus counseling advice alone. In order to refine this
intervention (Phase II) before it is executed, focus groups will first be conducted in Phase
I with members of the target population in order to obtain feedback on the proposed
intervention activities and materials. Qualitative findings and feasibility testing will be
the basis for modifying the intervention.
Lifestyle changes, such as moderate physical activity (e.g. brisk walking) have been shown
to delay or prevent the development of Type 2 diabetes in patients with obesity and
pre-diabetes. Given the clear benefit of exercise in disease prevention and management,
evidence-based cost-effective brief interventions are needed to improve patient outcomes
related to Type 2 diabetes and associated health disparities.
In America over the last two decades, adult obesity rates have doubled from 15% to 30%. In
1990, no state had an obesity rate over 14%. In 2003, thirty-five states posted obesity
rates of over 20%. Tennessee currently ranks fifth in the U.S. for highest rate of adult
obesity. In 2003, direct medical costs associated with obesity totaled an estimated $1.84
billion in Tennessee. Medicare ($433 million) and Medicaid ($488 million) absorbed
approximately 50% of these medical costs. Obesity is closely linked with such diseases as
heart disease, stroke, diabetes, and certain cancers. In both East and South Nashville,
cancer, heart disease, and stroke are listed as three of the top five causes of death with
significant racial, educational, and economic disparities.
Reducing socioeconomic and racial/ethnic disparities in Type 2 diabetes among adults will
require multiple interventions society-wide in order to provide cumulative and synergistic
effects that can result in sustained health practices and improved patient outcomes. One
step in this approach is to encourage health care providers to deliver health promotion
advice and counseling to their patients during routine office visits. Another is to link
advice with readily available resources wherein an individual might be able to implement
counsel. Therefore, the specific aim of this proposal is to evaluate the relative
contribution of a multi-component, behavioral counseling intervention delivered by health
care professionals versus the same behavioral counseling intervention when augmented by an
interactive health promotion "telephone helpline" that will, among other things offer
guidance on the availability of physical activity resources at Metro Parks facilities. In
order to refine this intervention (Phase II) before it is executed, focus groups will first
be conducted in Phase I with members of the target population in order to obtain feedback on
the proposed intervention activities and materials. Qualitative findings and feasibility
testing will be the basis for modifying the intervention.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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