Lifestyle Intervention's Impact on Health Care Costs

NCT ID: NCT00717158

Last Updated: 2008-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

147 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-05-31

Study Completion Date

2003-02-28

Brief Summary

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The ICAN Pilot project aims to evaluate the differences in economic, clinical and quality of life outcomes of a nutrition intervention involving lifestyle case management and medical nutrition therapy by a registered dietitian compared to usual medical care in obese persons with type 2 diabetes. The intervention is aimed at moderate weight loss (\> 5-10%), improvement in diet quality and an increase in physical activity.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2 Obesity

Keywords

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Health Behavior Lifestyle health care costs quality of life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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I

Usual medical care. They received written healthy lifestyle information

Group Type NO_INTERVENTION

Usual medical care

Intervention Type BEHAVIORAL

2

Intervention participants were assigned to one registered dietitian who they met with over a one year period for 6 session (four hours) of individual care, 6- one-hour group classes, and had monthly email contact for follow up and checking in

Group Type ACTIVE_COMPARATOR

Lifestyle Case management

Intervention Type BEHAVIORAL

Intervention participants were assigned to one registered dietitian who they met with over a one year period for 6 session (four hours) of individual care, 6- one-hour group classes, and had monthly email contact for follow up and checking in

Interventions

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Usual medical care

Intervention Type BEHAVIORAL

Lifestyle Case management

Intervention participants were assigned to one registered dietitian who they met with over a one year period for 6 session (four hours) of individual care, 6- one-hour group classes, and had monthly email contact for follow up and checking in

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* BMI \> 30 kg/m2, calculated from measured weight and height.
* Type 2 diabetics on medication for their diabetes.
* Age 20 -60 years of age.
* Have phone.
* Fluency in reading, writing and comprehension of English
* Have Qualchoice as their primary health insurer.

Exclusion Criteria

* Depression, BDI score \> 20
* Pregnancy
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

NIH

Sponsor Role collaborator

University of Virginia

OTHER

Sponsor Role lead

Responsible Party

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University of Virginia School of Medicine

Principal Investigators

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Anne M Wolf, MS, RD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia School of Medicine

Locations

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University of Virginia School of Medicine

Charlottesville, Virginia, United States

Site Status

Countries

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United States

References

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Wolf AM, Conaway MR, Crowther JQ, Hazen KY, L Nadler J, Oneida B, Bovbjerg VE; Improving Control with Activity and Nutrition (ICAN) Study. Translating lifestyle intervention to practice in obese patients with type 2 diabetes: Improving Control with Activity and Nutrition (ICAN) study. Diabetes Care. 2004 Jul;27(7):1570-6. doi: 10.2337/diacare.27.7.1570.

Reference Type RESULT
PMID: 15220230 (View on PubMed)

Wolf AM, Siadaty M, Yaeger B, Conaway MR, Crowther JQ, Nadler JL, Bovbjerg VE. Effects of lifestyle intervention on health care costs: Improving Control with Activity and Nutrition (ICAN). J Am Diet Assoc. 2007 Aug;107(8):1365-73. doi: 10.1016/j.jada.2007.05.015.

Reference Type RESULT
PMID: 17659904 (View on PubMed)

Other Identifiers

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Am Dietetic Assoc 9336

Identifier Type: -

Identifier Source: secondary_id

8742

Identifier Type: -

Identifier Source: org_study_id