Family-Centered Diabetes Project - Sharing Wisdom

Obesity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00438126
• Other study ID #: DK47096 (completed)
• 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
• 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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity
• Overweight
• Prediabetes

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