Project Diabetes: Prescription for Healthy Living

NCT00775216 | Terminated

• 1 other identifier: 080811
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus; Exercise; Obesity; Behavioral Research

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Study Arms (2)

Standard care

NO INTERVENTION

Standard behavioral counseling

Intervention

EXPERIMENTAL

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

Behavioral: Behavioral counseling plus "telephone helpline"

Interventions

Behavioral counseling plus "telephone helpline" 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.

Intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Motor Activity; Obesity

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Bettina M. Beech, DrPH, MPH

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 7, 2008
• First Posted: October 20, 2008
• Study Start: October 1, 2008
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: May 25, 2015

Record last verified: 2015-05

Locations

US (1)