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
Sponsor:
Information provided by:
Microlife
ClinicalTrials.gov Identifier:
NCT00489502
First received: June 20, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted

June 20, 2007
June 20, 2007
June 2007
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No Changes Posted
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Clinical Observation of Implementing the MedGem Into a Medical Specialty Practice
Phase I: Clinical Observation of Implementing the MedGem Into a Medical Specialty (i.e. Cardiology) Practice

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?
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Observational
Observational Model: Defined Population
Time Perspective: Longitudinal
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Obesity
  • Behavioral: Brief Counseling
  • Device: REE Assessment
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
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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
Both
18 Years and older
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Contact: JENNIFER SLOWSKY (352) 735-1400
United States
 
NCT00489502
ML002
No
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Microlife
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Study Director: Scott McDoniel, M.Ed. Microlife USA, Inc.
Microlife
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP