Automated Diabetes Prevention Program
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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. |
- Weight loss
- 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 |
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 |
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| United States, Colorado | |
| Kaiser-Permanente of Colorado | |
| Aurora, Colorado, United States, 80014 | |
| 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 June 18, 2013