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
  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:


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
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 April 22, 2014