NCT00717158

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
147

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started May 2001

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2001

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2003

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

July 14, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 16, 2008

Completed
Last Updated

July 16, 2008

Status Verified

August 1, 2007

Enrollment Period

1.8 years

First QC Date

July 14, 2008

Last Update Submit

July 14, 2008

Conditions

Diabetes Mellitus, Type 2Obesity

Keywords

Health BehaviorLifestylehealth care costsquality of life

Outcome Measures

Primary Outcomes (1)

  • Health Care utilization and costs using claims data

    one year

Secondary Outcomes (5)

  • Weight change

    one year

  • Change in hemoglobin A1c

    One Year

  • Work days lost

    One year

  • Disability Days

    One year

  • Change in quality of life

    one year

Study Arms (2)

I

NO INTERVENTION

Usual medical care. They received written healthy lifestyle information

Behavioral: Usual medical care

2

ACTIVE COMPARATOR

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

Behavioral: Lifestyle Case management

Interventions

Usual medical careBEHAVIORAL
I
Lifestyle Case managementBEHAVIORAL

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

2

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Depression, BDI score \> 20
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia School of Medicine

Charlottesville, Virginia, 22908, United States

Location

Related Publications (2)

  • 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.

    PMID: 15220230RESULT

  • 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.

    PMID: 17659904RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2ObesityHealth Behavior

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Anne M Wolf, MS, RD

    University of Virginia School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 14, 2008

First Posted

July 16, 2008

Study Start

May 1, 2001

Primary Completion

February 1, 2003

Study Completion

February 1, 2003

Last Updated

July 16, 2008

Record last verified: 2007-08

Locations

US(1)