Back to resultsFamily-Centered Diabetes Project - Sharing Wisdom
Primary Purpose
Prediabetes, Metabolic Syndrome, Overweight
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
A lifestyle educational program
Sponsored by
About this trial
This is an interventional prevention trial for Prediabetes focused on measuring diabetes, Prevention, American Indian
Eligibility Criteria
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
Sites / Locations
- University of New Mexico School of Medicine
Outcomes
Primary Outcome Measures
decreased dietary fat intake
increased vegetable consumption
increased self-reported leisure physical activity
Secondary Outcome Measures
fasting glucose
HOMA
serum free insulin
Body Mass Index
waist circumference
decreased dietary intake of total sugar
decreased time watching television
resting blood pressure
Full Information
NCT ID
NCT00438126
First Posted
February 20, 2007
Last Updated
March 1, 2010
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT00438126
Brief Title
Family-Centered Diabetes Project - Sharing Wisdom
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetes, Metabolic Syndrome, Overweight, Obesity
Keywords
diabetes, Prevention, American Indian
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
A lifestyle educational program
Primary Outcome Measure Information:
Title
decreased dietary fat intake
Title
increased vegetable consumption
Title
increased self-reported leisure physical activity
Secondary Outcome Measure Information:
Title
fasting glucose
Title
HOMA
Title
serum free insulin
Title
Body Mass Index
Title
waist circumference
Title
decreased dietary intake of total sugar
Title
decreased time watching television
Title
resting blood pressure
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carla J Herman, MD, MPH
Organizational Affiliation
Univeristy of New Mexico
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of New Mexico School of Medicine
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87110
Country
United States
12. IPD Sharing Statement
Citations:
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
Results Reference
background
PubMed Identifier
16861598
Citation
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.
Results Reference
background
PubMed Identifier
18312806
Citation
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.
Results Reference
derived
Learn more about this trial
Family-Centered Diabetes Project - Sharing Wisdom
We'll reach out to this number within 24 hrs