A Lifestyle Change Program to Prevent Type 2 Diabetes

This study has been completed.

First Received: January 22, 2009 Last Updated: March 16, 2009 History of Changes

Sponsored by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00886340

Purpose

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.

Condition	Intervention	Phase
Prediabetes	Behavioral: Enhanced standard care Behavioral: Lifestyle counseling	Phase II

MedlinePlus related topics: Diabetes Weight Control

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Lifestyle Change Program to Prevent Type 2 Diabetes

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Enrollment:	58
Study Start Date:	September 2005
Study Completion Date:	August 2008
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Enhanced standard care (one appointment with nurse practitioner and one appointment with nutritionist)	Behavioral: Enhanced standard care One appointment with nurse practitioner (20 minutes) One appointment with nutritionist (45 minutes)
2: Experimental Lifestyle counseling (enhanced standard care and 6 appointments with nurse practitioner)	Behavioral: Lifestyle counseling Enhanced standard care Six appointments with nurse practitioner (20 minutes)

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 IGT with metformin
Currently taking any glucocorticoid or beta-blocker
Recently prescribed or changed dose of a statin (within 2 months)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00886340

Sponsors and Collaborators

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

Investigators

Principal Investigator:

Robin Whittemore, PhD

Yale School of Nursing

More Information

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.

Responsible Party:	Yale University ( Robin Whittemore PhD, APRN )
Study ID Numbers:	DK70594
Study First Received:	January 22, 2009
Results First Received:	January 22, 2009
Last Updated:	March 16, 2009
ClinicalTrials.gov Identifier:	NCT00886340 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

diabetes prevention, primary care

Study placed in the following topic categories:

Hyperglycemia
Metabolic Diseases
Glucose Intolerance
Diabetes Mellitus, Type 2
Prediabetic State

Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Hyperglycemia
Metabolic Diseases
Glucose Intolerance
Diabetes Mellitus, Type 2

Diabetes Mellitus
Prediabetic State
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 06, 2009