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Sponsored by: |
Kaiser Permanente |
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Information provided by: | Kaiser Permanente |
ClinicalTrials.gov Identifier: | NCT00384488 |
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 |
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Pre-Diabetes |
Behavioral: Interactive Voice Response System (IVR) |
Study Type: | Interventional |
Study Design: | Health Services Research, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
Official Title: | Effectiveness of Automated Telephone Intervention on Behavioral and Weight Outcomes for Patients With Pre-Diabetes. |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Pregnant females
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 |
Study ID Numbers: | CO-04PEsta-02 |
Study First Received: | October 5, 2006 |
Last Updated: | October 5, 2006 |
ClinicalTrials.gov Identifier: | NCT00384488 History of Changes |
Health Authority: | United States: Institutional Review Board |
Diabetes mellitus Weight control Healthy eating Physical Activity |
Body Weight Hyperglycemia Metabolic Diseases Glucose Intolerance Prediabetic State Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Healthy Glucose Metabolism Disorders Metabolic Disorder |
Hyperglycemia Metabolic Diseases Glucose Intolerance Prediabetic State |
Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders |