Clinical Observation of Implementing the MedGem Into a Medical Specialty Practice

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2007 by Microlife.
Recruitment status was  Recruiting
Information provided by:
Microlife Identifier:
First received: June 20, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted

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.


  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)?


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

Condition Intervention
Behavioral: Brief Counseling
Device: REE Assessment

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both

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
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Please refer to this study by its identifier: NCT00489502

Contact: JENNIFER SLOWSKY (352) 735-1400

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
Study Director: Scott McDoniel, M.Ed. Microlife USA, Inc.
  More Information

No publications provided Identifier: NCT00489502     History of Changes
Other Study ID Numbers: ML002
Study First Received: June 20, 2007
Last Updated: June 20, 2007
Health Authority: United States: Institutional Review Board processed this record on October 09, 2015