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OpenTrials
Completed

NCT Number: NCT00438126

Family-Centered Diabetes Project - Sharing Wisdom

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

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Key information

Conditions

PreDiabetes Body Weight Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Prediabetic State Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of New Mexico School of Medicine

Albuquerque, New Mexico, 87110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

A lifestyle educational program

Behavioral

Primary outcomes

  1. decreased dietary fat intake

  2. increased vegetable consumption

  3. increased self-reported leisure physical activity

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Nih

Registry information

Important dates

Study start
2002
Study completion
2006
First posted
Feb 21, 2007
Registry last updated
Mar 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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