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

History of Changes

Tracking Information

First Received Date ^ICMJE

January 22, 2009

Last Updated Date

April 4, 2012

Start Date ^ICMJE

September 2005

Primary Completion Date

September 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number of Participants Who Met Weight Loss Goal of 5% Weight Loss [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00886340 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Lifestyle Change Program to Prevent Type 2 Diabetes

Official Title ^ICMJE

A Lifestyle Change Program to Prevent Type 2 Diabetes

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Prediabetes

Intervention ^ICMJE

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)

Study Arm (s)

Active Comparator: Enhanced standard care
Intervention: Behavioral: Enhanced standard care
Experimental: Lifestyle counseling
Intervention: Behavioral: Lifestyle counseling

Publications *

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.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2008

Primary Completion Date

September 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

21 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00886340

Other Study ID Numbers ^ICMJE

DK70594 (completed)

Has Data Monitoring Committee

Yes

Responsible Party

Robin Whittemore, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Sponsor ^ICMJE

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Robin Whittemore, PhD

Yale School of Nursing

Information Provided By

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Verification Date

April 2012

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

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