Project Diabetes: Prescription for Healthy Living

NCT ID: NCT00775216

Last Updated: 2015-05-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2009-11-30

Brief Summary

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.

Detailed Description

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.

Conditions

Type 2 Diabetes Mellitus; Exercise; Obesity; Behavioral Research

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Standard care

Standard behavioral counseling

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

Behavioral counseling intervention augmented with an interactive health promotion "telephone helpline"

Group Type: EXPERIMENTAL

Behavioral counseling plus "telephone helpline"

Intervention Type: BEHAVIORAL

A trained behavioral counselor will place phone calls to Phase 2 intervention participants. These calls will be used to provide tailored physical activity advice and to extend our partnership with the Metro Nashville Parks and Recreation Department, directing participants to community centers close to their homes or workplaces where they can access a variety of physical activities (e.g., indoor pools, walking tracks, fitness centers, greenways, etc) using a newly developed electronic database. Following an orientation to the Metro Parks services which will be held at either Hadley Regional Park or Coleman Regional Park, participants will be directed to the Metro Parks facility most convenient to them.

Interventions

Behavioral counseling plus "telephone helpline"

A trained behavioral counselor will place phone calls to Phase 2 intervention participants. These calls will be used to provide tailored physical activity advice and to extend our partnership with the Metro Nashville Parks and Recreation Department, directing participants to community centers close to their homes or workplaces where they can access a variety of physical activities (e.g., indoor pools, walking tracks, fitness centers, greenways, etc) using a newly developed electronic database. Following an orientation to the Metro Parks services which will be held at either Hadley Regional Park or Coleman Regional Park, participants will be directed to the Metro Parks facility most convenient to them.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Aged 18-75 years old
• Overweight (BMI greater than or equal to 25)
• Sedentary (self-report less than 30 minutes of moderate physical activity most days of the week)
• Has a family member (parent, grandparent, or sibling) with diabetes or pre-diabetes

Exclusion Criteria

• Participants unable to engage in physical activity (oxygen dependent, wheel chair bound, amputations, Class 3 or 4 NY Heart Association classification for Congestive Heart Failure)
• Non-English speaking

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

Vanderbilt University

Principal Investigators

Bettina M. Beech, DrPH, MPH

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

080811

Identifier Type: -

Identifier Source: org_study_id