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Clinical Observation of Implementing the MedGem Into a Medical Specialty Practice

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2007 by Microlife.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00489502
First Posted: June 21, 2007
Last Update Posted: June 21, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Microlife
  Purpose

Due to common CVD diseases associated from obesity, medical providers are in a position to provide assistance. However, less than 10% of all patients receive any weight loss advice from physicians. Perceived barriers to weight loss counseling include lack of self-control of their patients and belief that recommendation is futile, lack of medical training in nutrition, exercise, and obesity management, and lack of insurance reimbursement. Though many barriers are prevalent, research has demonstrated a positive effect with medical advice on the number of obese individuals attempting to lose weight. Analyzing data from the 1996 Behavioral Risk Factor Surveillance System, researchers found, when advised to lose weight by a physician, 78% of overweight patients reported attempting to lose weight. However, if their physician did not discuss weight loss, only 33% of patients within the same BMI category attempted to do so 7. From this information, physicians or allied health staff that provide brief counseling (5-10 minute) along with medical technology that provides basic nutrition assessment might have a positive impact on the number CVD patients that are obese attempting to lose weight.

HYPOTHESIS: Will a medical specialty clinic focused on cardiovascular medicine successfully be able to implement the MedGem device for assessment of basic nutritional needs along with providing “brief” patient education into the medical practice without a house dietitian.

PRIMARY AIMS

  1. Can medical staff and/or support staff provide REE assessments (15-minutes) and brief patient education (5-15 minutes) as part of the clinic’s operations?
  2. Will a third-party payer compensate the Medical Specialty Clinic for the diagnostic procedure CPT Code 94690 for obese patients diagnosed with hypertension (401.1-9, 402.10-11, & 402.90-91), hypercholesterolemia (272.1), and/or hyperlipdemia (272.2)?

SECONDARY AIMS

  1. Does self-efficacy increase from REE assessments?
  2. Do patients adopt healthy eating (Calorie Reduction and Fat Reduction)following REE assessments?

Condition Intervention
Obesity Behavioral: Brief Counseling Device: REE Assessment

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Phase I: Clinical Observation of Implementing the MedGem Into a Medical Specialty (i.e. Cardiology) Practice

Further study details as provided by Microlife:

Estimated Enrollment: 30
Study Start Date: June 2007
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Patients with a BMI (Body Mass Index > 30.0 kg/m2)
  • Patients Diagnosed with any of the following ICD-9 Codes: Hypertension (401.1), Hypercholesterolemia (272.1), and/or Hyperlipdemia (272.2-4)
  • Patients diagnosed with a secondary ICD-9 Code: Obesity (278) or Morbid Obesity (278.01)

Exclusion Criteria:

  • Patients that are pregnant
  • Patients under the age of 18 years
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00489502


Contacts
Contact: JENNIFER SLOWSKY (352) 735-1400

Locations
United States, Florida
Lake Cardiology Recruiting
Mount Dora, Florida, United States, 32757
Contact: JENNIFER SLOWSKY         
Principal Investigator: KEN KRONHAUS, M.D., Ph.D         
Sub-Investigator: SCOTT MCDONIEL, M.ED.         
Sponsors and Collaborators
Microlife
Investigators
Study Director: Scott McDoniel, M.Ed. Microlife USA, Inc.
  More Information

ClinicalTrials.gov Identifier: NCT00489502     History of Changes
Other Study ID Numbers: ML002
First Submitted: June 20, 2007
First Posted: June 21, 2007
Last Update Posted: June 21, 2007
Last Verified: June 2007