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Family-Centered Diabetes Project - Sharing Wisdom

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00438126
First Posted: February 21, 2007
Last Update Posted: March 2, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  Purpose
This is a randomized trial of an educational intervention to reduce the risk of diabetes among urban American Indian women

Condition Intervention
Prediabetes Metabolic Syndrome Overweight Obesity Behavioral: A lifestyle educational program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • decreased dietary fat intake
  • increased vegetable consumption
  • increased self-reported leisure physical activity

Secondary Outcome Measures:
  • fasting glucose
  • HOMA
  • serum free insulin
  • Body Mass Index
  • waist circumference
  • decreased dietary intake of total sugar
  • decreased time watching television
  • resting blood pressure

Estimated Enrollment: 200
Study Start Date: January 2002
Estimated Study Completion Date: May 2006
Detailed Description:
Two hundred American Indian women aged 18 to 40 years were recruited from a large Southwest city to participate in a type 2 diabetes prevention intervention. Half of the women were randomized to participated in the educational intervention and half were assigned to a delayed intervention. Measures were obtained at baseline, 6-months,12-months and 18-months.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • American Indian women
  • Aged 18-40 years
  • Living in Albuquerque area
  • Not having diabetes

Exclusion Criteria:

  • Pregnancy
  • Planning to become pregnant within 2 years
  • Diagnosed with diabetes fasting blood glucose > 126 planning to move out of town in next 2 years
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00438126


Locations
United States, New Mexico
University of New Mexico School of Medicine
Albuquerque, New Mexico, United States, 87110
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Carla J Herman, MD, MPH Univeristy of New Mexico
  More Information

Publications:
Willging CE, Helitzer D, Thompson, J 'Sharing Wisdom': Lessons learned during the development of a diabetes prevention intervention for urban American Indian women Evaluation and Program Planning 29 (2006) 130-140

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00438126     History of Changes
Other Study ID Numbers: DK47096 (completed)
First Submitted: February 20, 2007
First Posted: February 21, 2007
Last Update Posted: March 2, 2010
Last Verified: March 2010

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
diabetes
Prevention
American Indian

Additional relevant MeSH terms:
Overweight
Metabolic Syndrome X
Prediabetic State
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases