Obesity Clinical Trial
Official title:
Project Diabetes: Prescription for Healthy Living
Verified date | May 2015 |
Source | Vanderbilt University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 13 |
Est. completion date | November 2009 |
Est. primary completion date | November 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary outcome will be assessed by the short version of the International Physical Activity Questionnaire and the 6-minute Walk Test. | Baseline and 6 months | No | |
Secondary | 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. | Baseline and 6 months | No |
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