A Lifestyle Change Program to Prevent Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Robin Whittemore, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00886340
First received: January 22, 2009
Last updated: April 4, 2012
Last verified: April 2012

January 22, 2009
April 4, 2012
September 2005
September 2007   (final data collection date for primary outcome measure)
Number of Participants Who Met Weight Loss Goal of 5% Weight Loss [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00886340 on ClinicalTrials.gov Archive Site
  • Diet and Exercise Behavior [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Lipids [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Insulin Resistance [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Diet and Exercise Behavior [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Lipids [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Lifestyle Change Program to Prevent Type 2 Diabetes
A Lifestyle Change Program to Prevent Type 2 Diabetes

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Prediabetes
  • Behavioral: Enhanced standard care
    One appointment with nurse practitioner (20 minutes) One appointment with nutritionist (45 minutes)
  • Behavioral: Lifestyle counseling
    Enhanced standard care Six appointments with nurse practitioner (20 minutes)
  • Active Comparator: Enhanced standard care
    Intervention: Behavioral: Enhanced standard care
  • Experimental: Lifestyle counseling
    Intervention: Behavioral: Lifestyle counseling
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
August 2008
September 2007   (final data collection date for primary outcome measure)

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)
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00886340
DK70594 (completed)
Yes
Robin Whittemore, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Not Provided
Principal Investigator: Robin Whittemore, PhD Yale School of Nursing
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP