A Lifestyle Change Program to Prevent Type 2 Diabetes

Prediabetes Clinical Trial

Official title:

A Lifestyle Change Program to Prevent Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00886340
• Other study ID #: DK70594 (completed)
• Status: Completed
• Phase: Phase 2
• First received: January 22, 2009
• Last updated: April 4, 2012
• Start date: September 2005
• Est. completion date: August 2008

Study information

• Verified date: April 2012
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: August 2008
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Prediabetes

Intervention

Behavioral:
• Enhanced standard care
One appointment with nurse practitioner (20 minutes) One appointment with nutritionist (45 minutes)
• Lifestyle counseling
Enhanced standard care Six appointments with nurse practitioner (20 minutes)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Met Weight Loss Goal of 5% Weight Loss		6 months	No
Secondary	Diet and Exercise Behavior		6 months	No
Secondary	Lipids		6 months	No
Secondary	Quality of Life		6 months	No