A Lifestyle Change Program to Prevent Type 2 Diabetes

April 4, 2012 updated by: Robin Whittemore, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lifestyle counseling
Behavioral: Lifestyle counseling
Enhanced standard care Six appointments with nurse practitioner (20 minutes)
Active Comparator: Enhanced standard care
Behavioral: Enhanced standard care
One appointment with nurse practitioner (20 minutes) One appointment with nutritionist (45 minutes)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants Who Met Weight Loss Goal of 5% Weight Loss
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of Life
Time Frame: 6 months
6 months
Lipids
Time Frame: 6 months
6 months
Diet and Exercise Behavior
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Robin Whittemore, PhD, Yale School of Nursing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

January 22, 2009

First Submitted That Met QC Criteria

March 16, 2009

First Posted (Estimate)

April 22, 2009

Study Record Updates

Last Update Posted (Estimate)

May 7, 2012

Last Update Submitted That Met QC Criteria

April 4, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DK70594 (completed)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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