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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
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 August 28, 2014