Automated Diabetes Prevention Program

NCT ID: NCT00384488

Last Updated: 2006-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2006-05-31

Brief Summary

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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

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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.

Conditions

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Pre-Diabetes

Keywords

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Diabetes mellitus Weight control Healthy eating Physical Activity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Interventions

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Interactive Voice Response System (IVR)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaiser Permanente

OTHER

Sponsor Role lead

Principal Investigators

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Paul A. Estabrooks, PhD

Role: PRINCIPAL_INVESTIGATOR

Kaiser-Permanente of Colorado Clinical Research Unit

Locations

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Kaiser-Permanente of Colorado

Aurora, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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CO-04PEsta-02

Identifier Type: -

Identifier Source: org_study_id