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

History of Changes

Tracking Information

First Received Date ^ICMJE

February 20, 2007

Last Updated Date

March 1, 2010

Start Date ^ICMJE

January 2002

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

decreased dietary fat intake
increased vegetable consumption
increased self-reported leisure physical activity

Original Primary Outcome Measures ^ICMJE

HOMA
fasting glucose
Body Mass Index
serum free insulin
waist circumference

Change History

Complete list of historical versions of study NCT00438126 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

fasting glucose
HOMA
serum free insulin
Body Mass Index
waist circumference
decreased dietary intake of total sugar
decreased time watching television
resting blood pressure

Original Secondary Outcome Measures ^ICMJE

fasting lipids
self-reported physical activity
cardiorespiratory fitness (V02 peak)
food frequency for percentage of total energy from fat and vegetable intake

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Family-Centered Diabetes Project - Sharing Wisdom

Official Title ^ICMJE

Not Provided

Brief Summary

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

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 ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Prediabetes
Metabolic Syndrome
Overweight
Obesity

Intervention ^ICMJE

Behavioral: A lifestyle educational program

Study Arm (s)

Not Provided

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
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. 2006 Jul 21; [Epub ahead of print]
Thompson JL, Allen P, Helitzer DL, Qualls C, Whyte AN, Wolfe VK, Herman CJ. Reducing diabetes risk in American Indian women. Am J Prev Med. 2008 Mar;34(3):192-201.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

200

Completion Date

May 2006

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 40 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00438126

Other Study ID Numbers ^ICMJE

DK47096 (completed)

Has Data Monitoring Committee

Yes

Responsible Party

Not Provided

Study Sponsor ^ICMJE

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

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Carla J Herman, MD, MPH

Univeristy of New Mexico

Information Provided By

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

Verification Date

March 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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