A Lifestyle Change Program to Prevent Type 2 Diabetes

NCT ID: NCT00886340

Last Updated: 2012-05-07

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2008-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Prediabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Enhanced standard care

Group Type ACTIVE_COMPARATOR

Enhanced standard care

Intervention Type BEHAVIORAL

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

Lifestyle counseling

Group Type EXPERIMENTAL

Lifestyle counseling

Intervention Type BEHAVIORAL

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

Interventions

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Enhanced standard care

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

Intervention Type BEHAVIORAL

Lifestyle counseling

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role lead

Responsible Party

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Robin Whittemore

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robin Whittemore, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale School of Nursing

References

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Whittemore R, Melkus G, Wagner J, Dziura J, Northrup V, Grey M. Translating the diabetes prevention program to primary care: a pilot study. Nurs Res. 2009 Jan-Feb;58(1):2-12. doi: 10.1097/NNR.0b013e31818fcef3.

Reference Type RESULT
PMID: 19092550 (View on PubMed)

Other Identifiers

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DK70594 (completed)

Identifier Type: -

Identifier Source: org_study_id

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