A Lifestyle Change Program to Prevent Type 2 Diabetes

National Institutes of Health (NIH)

Status and phase: Completed; Phase 2

Conditions: Prediabetes

Treatments: Behavioral: Lifestyle counseling; Behavioral: Enhanced standard care

Study type: Interventional

Funder types: NIH

Identifiers

NCT00886340

DK70594 (completed)

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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58 participants in 2 patient groups

Enhanced standard care

Active Comparator group

Treatment:

Behavioral: Enhanced standard care

Lifestyle counseling

Experimental group

Treatment:

Behavioral: Lifestyle counseling