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Family-Centered Diabetes Project - Sharing Wisdom

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00438126
First received: February 20, 2007
Last updated: March 1, 2010
Last verified: March 2010
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional 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)
Study First Received: February 20, 2007
Last Updated: March 1, 2010
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on June 17, 2013