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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
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Lifestyle Change Program to Prevent Type 2 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

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:
  • 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
Active Comparator: Enhanced standard care Behavioral: Enhanced standard care
One appointment with nurse practitioner (20 minutes) One appointment with nutritionist (45 minutes)
Experimental: Lifestyle counseling 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 impaired glucose tolerance (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:

Responsible Party: Robin Whittemore, Associate Professor, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00886340     History of Changes
Other Study ID Numbers: DK70594 (completed)
Study First Received: January 22, 2009
Results First Received: January 22, 2009
Last Updated: April 4, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
diabetes prevention, primary care

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Glucose Intolerance
Prediabetic State
Diabetes Mellitus
 Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia

ClinicalTrials.gov processed this record on May 23, 2013