Automated Diabetes Prevention Program
Primary Purpose
Pre-Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Interactive Voice Response System (IVR)
Sponsored by
About this trial
This is an interventional health services research trial for Pre-Diabetes focused on measuring Diabetes mellitus, Weight control, Healthy eating, Physical Activity
Eligibility Criteria
Inclusion Criteria:
- Male and female Kaiser-Permanente of Colorado members age 18 and above who have been diagnosed with pre-diabetes and who have enrolled in a clinically indicated pre-diabetes class.
- Subjects must be English speaking and have a telephone
Exclusion Criteria:
Pregnant females
- Enrollment in another research study involving diabetes or weight management during the time of the study.
Sites / Locations
- Kaiser-Permanente of Colorado
Outcomes
Primary Outcome Measures
Weight loss
Secondary Outcome Measures
Increased physical activity
Improved healthy eating habits
Weight maintenance
Reduction in progression to type 2 DM
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00384488
Brief Title
Automated Diabetes Prevention Program
Official Title
Effectiveness of Automated Telephone Intervention on Behavioral and Weight Outcomes for Patients With Pre-Diabetes.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2006
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Kaiser Permanente
4. Oversight
5. Study Description
Brief Summary
The objective for this pilot project is to determine the feasibility and effectiveness of the Interactive Voice Response protocol (IVR) on physical activity and eating behaviors in a group men and women who have been identified by their physician as being pre-diabetic. We hypothesize that participants receiving the IVR follow-up will have greater positive changes in their physical activity and eating behaviors when compared to those who receive only the standard-care pre-diabetes class.
Detailed Description
Patients diagnosed with pre-diabetes present a unique opportunity for health care providers to implement preventive practices. Behavioral intervention strategies that target weight reduction or maintenance and increased fitness not only provide exceptional cardiovascular benefits, but also play an important role in delayed development or prevention of type 2 diabetes mellitus (DM). This study was designed to determine the feasibility and effectiveness of automated telephone support calls targeting physical activity and healthful eating as strategies for weight loss for patients with pre-diabetes.
Participants with pre-diabetes who participated in a 90-minute diabetes prevention class were consented to participate in this behavioral study and were then randomly assigned to receive automated telephone support targeting physical activity and nutrition weight loss strategies or to a no-contact control group. Objective physical activity (accelerometer), self-reported dietary intake, and body weight were assessed at baseline and at 3-months follow-up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-Diabetes
Keywords
Diabetes mellitus, Weight control, Healthy eating, Physical Activity
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Interactive Voice Response System (IVR)
Primary Outcome Measure Information:
Title
Weight loss
Secondary Outcome Measure Information:
Title
Increased physical activity
Title
Improved healthy eating habits
Title
Weight maintenance
Title
Reduction in progression to type 2 DM
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female Kaiser-Permanente of Colorado members age 18 and above who have been diagnosed with pre-diabetes and who have enrolled in a clinically indicated pre-diabetes class.
Subjects must be English speaking and have a telephone
Exclusion Criteria:
Pregnant females
Enrollment in another research study involving diabetes or weight management during the time of the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul A. Estabrooks, PhD
Organizational Affiliation
Kaiser-Permanente of Colorado Clinical Research Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser-Permanente of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80014
Country
United States
12. IPD Sharing Statement
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Automated Diabetes Prevention Program
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