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Family-Centered Diabetes Project - Sharing Wisdom

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ClinicalTrials.gov Identifier: NCT00438126
Recruitment Status : Completed
First Posted : February 21, 2007
Last Update Posted : March 2, 2010
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Brief Summary:
This is a randomized trial of an educational intervention to reduce the risk of diabetes among urban American Indian women

Condition or disease Intervention/treatment
Prediabetes Metabolic Syndrome Overweight Obesity Behavioral: A lifestyle educational program

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : January 2002
Estimated Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. decreased dietary fat intake
  2. increased vegetable consumption
  3. increased self-reported leisure physical activity

Secondary Outcome Measures :
  1. fasting glucose
  2. HOMA
  3. serum free insulin
  4. Body Mass Index
  5. waist circumference
  6. decreased dietary intake of total sugar
  7. decreased time watching television
  8. resting blood pressure


Information from the National Library of Medicine

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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

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

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 Posted: February 21, 2007    Key Record Dates
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