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Automated Diabetes Prevention Program

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ClinicalTrials.gov Identifier: NCT00384488
Recruitment Status : Completed
First Posted : October 6, 2006
Last Update Posted : October 6, 2006
Sponsor:
Information provided by:
Kaiser Permanente

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.

Condition or disease Intervention/treatment Phase
Pre-Diabetes Behavioral: Interactive Voice Response System (IVR) Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Effectiveness of Automated Telephone Intervention on Behavioral and Weight Outcomes for Patients With Pre-Diabetes.
Study Start Date : May 2004
Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes




Primary Outcome Measures :
  1. Weight loss

Secondary Outcome Measures :
  1. Increased physical activity
  2. Improved healthy eating habits
  3. Weight maintenance
  4. Reduction in progression to type 2 DM


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00384488


Locations
United States, Colorado
Kaiser-Permanente of Colorado
Aurora, Colorado, United States, 80014
Sponsors and Collaborators
Kaiser Permanente
Investigators
Principal Investigator: Paul A. Estabrooks, PhD Kaiser-Permanente of Colorado Clinical Research Unit

ClinicalTrials.gov Identifier: NCT00384488     History of Changes
Other Study ID Numbers: CO-04PEsta-02
First Posted: October 6, 2006    Key Record Dates
Last Update Posted: October 6, 2006
Last Verified: October 2006

Keywords provided by Kaiser Permanente:
Diabetes mellitus
Weight control
Healthy eating
Physical Activity

Additional relevant MeSH terms:
Diabetes Mellitus
Prediabetic State
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia