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CompletedNCT00438126Updated Mar 2, 2010

Family-Centered Diabetes Project - Sharing Wisdom

An interventional study of A lifestyle educational program in Prediabetes, Metabolic Syndrome and Overweight, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Completed at 1 site in United States. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-03-02.

Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Prediabetes
  • Metabolic Syndrome
  • Overweight
  • Obesity

Keywords

  • diabetes
  • Prevention
  • American Indian
03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.

This study's enrollment of 200 is above the median of 73 across 3,175 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is the lead sponsor of 529 studies on the registry; 54 are open to participants now.

Of its 79 completed or terminated interventional studies of FDA-regulated products, 50 (63%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
200 participants

Interventions

  • BehavioralA lifestyle educational program
06

What researchers measure

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

07

Study locations

1 site
  • University of New Mexico School of Medicine
    Albuquerque, New Mexico 87110, United States
08

References and documents

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. 2008 Oct;9(4):404-14. doi: 10.1177/1524839906289076. Epub 2006 Jul 21. PubMed 16861598 ↗
  • 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. PubMed 18312806 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 2, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00438126
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted
Feb 21, 2007
Start date
Jan 2002
Completion
May 2006
Last update
Mar 2, 2010

Study contacts

Carla J Herman, MD, MPH
principal investigator · Univeristy of New Mexico

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.

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