A Lifestyle Change Program to Prevent Type 2 Diabetes
1 other identifier
interventional
58
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2005
Typical duration for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 22, 2009
CompletedFirst Posted
Study publicly available on registry
April 22, 2009
CompletedResults Posted
Study results publicly available
April 22, 2009
CompletedMay 7, 2012
April 1, 2012
2 years
January 22, 2009
January 22, 2009
April 4, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Who Met Weight Loss Goal of 5% Weight Loss
6 months
Secondary Outcomes (3)
Diet and Exercise Behavior
6 months
Lipids
6 months
Quality of Life
6 months
Study Arms (2)
Enhanced standard care
ACTIVE COMPARATORLifestyle counseling
EXPERIMENTALInterventions
One appointment with nurse practitioner (20 minutes) One appointment with nutritionist (45 minutes)
Enhanced standard care Six appointments with nurse practitioner (20 minutes)
Eligibility Criteria
You may qualify if:
- age 21 or older
- medically stable and safe to exercise
- at high risk for type 2 diabetes
- able to speak English.
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 19092550RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Robin Whittemore, PhD
- Organization
- Yale School of Nursing
Study Officials
- PRINCIPAL INVESTIGATOR
Robin Whittemore, PhD
Yale School of Nursing
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 22, 2009
First Posted
April 22, 2009
Study Start
September 1, 2005
Primary Completion
September 1, 2007
Study Completion
August 1, 2008
Last Updated
May 7, 2012
Results First Posted
April 22, 2009
Record last verified: 2012-04