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OpenTrials
Completed

NCT Number: NCT00886340

A Lifestyle Change Program to Prevent Type 2 Diabetes

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.

Completed

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Key information

Conditions

PreDiabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Enhanced standard care

Behavioral

One appointment with nurse practitioner (20 minutes) One appointment with nutritionist (45 minutes)

Lifestyle Counseling

Behavioral

Enhanced standard care Six appointments with nurse practitioner (20 minutes)

Primary outcomes

  1. Number of Participants Who Met Weight Loss Goal of 5% Weight Loss

    Time frame: 6 months

Secondary outcomes

  1. Diet and Exercise Behavior

    Time frame: 6 months

  2. Lipids

    Time frame: 6 months

  3. Quality of Life

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

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

Nih

Registry information

Important dates

Study start
2005
Primary completion
2007
Study completion
2008
First posted
Apr 22, 2009
Registry last updated
May 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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