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Completed

NCT Number: NCT00717158

Lifestyle Intervention's Impact on Health Care Costs

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Behavior Body Weight Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Health Behavior Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Virginia School of Medicine

Charlottesville, Virginia, 22908, United States

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Usual medical care

Behavioral

Lifestyle Case management

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

Primary outcomes

  1. Health Care utilization and costs using claims data

    Time frame: one year

Secondary outcomes

  1. Weight change

    Time frame: one year

  2. Change in hemoglobin A1c

    Time frame: One Year

  3. Work days lost

    Time frame: One year

  4. Disability Days

    Time frame: One year

  5. Change in quality of life

    Time frame: one year

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

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

Registry information

Official study title

Evaluating Healthcare Utilization, Costs and Health-Related Outcomes of a Medical Nutrition Therapy Intervention on Obese Patients With Type 2 Diabetes - A Pilot Study

Acronym: ICAN

Important dates

Study start
2001
Primary completion
2003
Study completion
2003
First posted
Jul 16, 2008
Registry last updated
Jul 16, 2008

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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