Back to resultsA Lifestyle Change Program to Prevent Type 2 Diabetes
Primary Purpose
Prediabetes
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Enhanced standard care
Lifestyle counseling
Sponsored by
About this trial
This is an interventional prevention trial for Prediabetes focused on measuring diabetes prevention, primary care
Eligibility Criteria
Inclusion Criteria
- age 21 or older
- medically stable and safe to exercise
- at high risk for type 2 diabetes
- able to speak English.
Exclusion Criteria
- Type 2 diabetes
- Cardiovascular disease
- Cancer requiring treatment in the past 5 years
- Anemia
- Hepatitis
- Renal disease
- Gastrointestinal disease
- Recent or significant abdominal surgery
- Pulmonary disease with dependence on oxygen or daily use of bronchodilators
- Chronic infection (ie., HIV, active tuberculosis)
- Unable to walk 0.25 miles in 10 minutes
- Participation in commercial diet program
- Currently pregnant or within 3 months postpartum
- Currently nursing or within 6 weeks of having completed nursing
- Treatment of impaired glucose tolerance (IGT) with metformin
- Currently taking any glucocorticoid or beta-blocker
- Recently prescribed or changed dose of a statin (within 2 months)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Enhanced standard care
Lifestyle counseling
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants Who Met Weight Loss Goal of 5% Weight Loss
Secondary Outcome Measures
Diet and Exercise Behavior
Lipids
Quality of Life
Full Information
NCT ID
NCT00886340
First Posted
January 22, 2009
Last Updated
April 4, 2012
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT00886340
Brief Title
A Lifestyle Change Program to Prevent Type 2 Diabetes
Official Title
A Lifestyle Change Program to Prevent Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
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
The purpose of this study was to evaluate the effect of a diabetes prevention program provided by nurse practitioners in primary care to adults at risk for diabetes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetes
Keywords
diabetes prevention, primary care
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Enhanced standard care
Arm Type
Active Comparator
Arm Title
Lifestyle counseling
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Enhanced standard care
Intervention Description
One appointment with nurse practitioner (20 minutes) One appointment with nutritionist (45 minutes)
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle counseling
Intervention Description
Enhanced standard care Six appointments with nurse practitioner (20 minutes)
Primary Outcome Measure Information:
Title
Number of Participants Who Met Weight Loss Goal of 5% Weight Loss
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Diet and Exercise Behavior
Time Frame
6 months
Title
Lipids
Time Frame
6 months
Title
Quality of Life
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
age 21 or older
medically stable and safe to exercise
at high risk for type 2 diabetes
able to speak English.
Exclusion Criteria
Type 2 diabetes
Cardiovascular disease
Cancer requiring treatment in the past 5 years
Anemia
Hepatitis
Renal disease
Gastrointestinal disease
Recent or significant abdominal surgery
Pulmonary disease with dependence on oxygen or daily use of bronchodilators
Chronic infection (ie., HIV, active tuberculosis)
Unable to walk 0.25 miles in 10 minutes
Participation in commercial diet program
Currently pregnant or within 3 months postpartum
Currently nursing or within 6 weeks of having completed nursing
Treatment of impaired glucose tolerance (IGT) with metformin
Currently taking any glucocorticoid or beta-blocker
Recently prescribed or changed dose of a statin (within 2 months)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robin Whittemore, PhD
Organizational Affiliation
Yale School of Nursing
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
19092550
Citation
Whittemore R, Melkus G, Wagner J, Dziura J, Northrup V, Grey M. Translating the diabetes prevention program to primary care: a pilot study. Nurs Res. 2009 Jan-Feb;58(1):2-12. doi: 10.1097/NNR.0b013e31818fcef3.
Results Reference
result
Learn more about this trial
A Lifestyle Change Program to Prevent Type 2 Diabetes
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