Project Diabetes: Prescription for Healthy Living

This study has been terminated.
(grant funding ended and lack of sufficient participants to complete trial)
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00775216
First received: October 7, 2008
Last updated: November 18, 2009
Last verified: November 2009
  Purpose

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.


Condition Intervention
Type 2 Diabetes Mellitus
Exercise
Obesity
Behavioral Research
Behavioral: Behavioral counseling plus "telephone helpline"

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Project Diabetes: Prescription for Healthy Living

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • The primary outcome will be assessed by the short version of the International Physical Activity Questionnaire and the 6-minute Walk Test. [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Questions regarding readiness to change, self-efficacy, knowledge of and access to physical activity centers, basic demographics, height/weight, and blood pressure will be assessed. [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: October 2008
Study Completion Date: November 2009
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard care
Standard behavioral counseling
Experimental: Intervention
Behavioral counseling intervention augmented with an interactive health promotion "telephone helpline"
Behavioral: 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00775216

Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Bettina M. Beech, DrPH, MPH Vanderbilt University
  More Information

No publications provided

Responsible Party: Bettina M. Beech, DrPH, MPH, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00775216     History of Changes
Other Study ID Numbers: 080811
Study First Received: October 7, 2008
Last Updated: November 18, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 20, 2014