Automated Diabetes Prevention Program

This study has been completed.
Sponsor:
Information provided by:
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT00384488
First received: October 5, 2006
Last updated: NA
Last verified: October 2006
History: No changes posted
  Purpose

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 Intervention
Pre-Diabetes
Behavioral: Interactive Voice Response System (IVR)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Effectiveness of Automated Telephone Intervention on Behavioral and Weight Outcomes for Patients With Pre-Diabetes.

Resource links provided by NLM:


Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • Weight loss

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

Estimated Enrollment: 84
Study Start Date: May 2004
Estimated Study Completion Date: May 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00384488     History of Changes
Other Study ID Numbers: CO-04PEsta-02
Study First Received: October 5, 2006
Last Updated: October 5, 2006
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 28, 2014