NCT00438126

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 21, 2007

Completed
Last Updated

March 2, 2010

Status Verified

March 1, 2010

First QC Date

February 20, 2007

Last Update Submit

March 1, 2010

Conditions

PrediabetesMetabolic SyndromeOverweightObesity

Keywords

diabetesPreventionAmerican Indian

Outcome Measures

Primary Outcomes (3)

  • decreased dietary fat intake

  • increased vegetable consumption

  • increased self-reported leisure physical activity

Secondary Outcomes (8)

  • fasting glucose

  • HOMA

  • serum free insulin

  • Body Mass Index

  • waist circumference

  • +3 more secondary outcomes

Interventions

A lifestyle educational programBEHAVIORAL

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • American Indian women
  • Aged 18-40 years
  • Living in Albuquerque area
  • Not having diabetes

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of New Mexico School of Medicine

Albuquerque, New Mexico, 87110, United States

Location

Related Publications (3)

  • 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

    BACKGROUND

  • 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. doi: 10.1177/1524839906289076. Epub 2006 Jul 21.

    PMID: 16861598BACKGROUND

  • 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. doi: 10.1016/j.amepre.2007.11.014.

    PMID: 18312806DERIVED

MeSH Terms

Conditions

Prediabetic StateMetabolic SyndromeOverweightObesityDiabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesInsulin ResistanceHyperinsulinismOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Carla J Herman, MD, MPH

    Univeristy of New Mexico

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

February 20, 2007

First Posted

February 21, 2007

Study Start

January 1, 2002

Study Completion

May 1, 2006

Last Updated

March 2, 2010

Record last verified: 2010-03

Locations

US(1)