NCT00384488

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2004

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 6, 2006

Completed
Last Updated

October 6, 2006

Status Verified

October 1, 2006

First QC Date

October 5, 2006

Last Update Submit

October 5, 2006

Conditions

Pre-Diabetes

Keywords

Diabetes mellitusWeight controlHealthy eatingPhysical Activity

Outcome Measures

Primary Outcomes (1)

  • Weight loss

Secondary Outcomes (4)

  • Increased physical activity

  • Improved healthy eating habits

  • Weight maintenance

  • Reduction in progression to type 2 DM

Interventions

Interactive Voice Response System (IVR)BEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant females
  • Enrollment in another research study involving diabetes or weight management during the time of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser-Permanente of Colorado

Aurora, Colorado, 80014, United States

Location

MeSH Terms

Conditions

Glucose IntoleranceDiabetes MellitusMotor Activity

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Study Officials

  • Paul A. Estabrooks, PhD

    Kaiser-Permanente of Colorado Clinical Research Unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 5, 2006

First Posted

October 6, 2006

Study Start

May 1, 2004

Study Completion

May 1, 2006

Last Updated

October 6, 2006

Record last verified: 2006-10

Locations

US(1)