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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00438126
Other study ID # DK47096 (completed)
Secondary ID
Status Completed
Phase N/A
First received February 20, 2007
Last updated March 1, 2010
Start date January 2002
Est. completion date May 2006

Study information

Verified date March 2010
Source National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date May 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

Behavioral:
A lifestyle educational program


Locations

Country Name City State
United States University of New Mexico School of Medicine Albuquerque New Mexico

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Helitzer D, Peterson AB, Thompson J, Fluder S. Development of a planning and evaluation methodology for assessing the contribution of theory to a diabetes prevention lifestyle intervention. Health Promot Pract. 2008 Oct;9(4):404-14. Epub 2006 Jul 21. — View Citation

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

Outcome

Type Measure Description Time frame Safety issue
Primary decreased dietary fat intake
Primary increased vegetable consumption
Primary increased self-reported leisure physical activity
Secondary fasting glucose
Secondary HOMA
Secondary serum free insulin
Secondary Body Mass Index
Secondary waist circumference
Secondary decreased dietary intake of total sugar
Secondary decreased time watching television
Secondary resting blood pressure
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