Automated Diabetes Prevention Program

Pre-Diabetes Clinical Trial

Official title:

Effectiveness of Automated Telephone Intervention on Behavioral and Weight Outcomes for Patients With Pre-Diabetes.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00384488
• Other study ID #: CO-04PEsta-02
• Status: Completed
• Phase: N/A
• First received: October 5, 2006
• Last updated: October 5, 2006
• Start date: May 2004
• Est. completion date: May 2006

Study information

• Verified date: October 2006
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Glucose Intolerance
• Pre-Diabetes
• Prediabetic State

Intervention

Behavioral:
• Interactive Voice Response System (IVR)

Locations

Country	Name	City	State
United States	Kaiser-Permanente of Colorado	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss
Secondary	Increased physical activity
Secondary	Improved healthy eating habits
Secondary	Weight maintenance
Secondary	Reduction in progression to type 2 DM