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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00489502
Enrollment
30
Registered
2007-06-21
Start date
2007-06-30
Completion date
Unknown
Last updated
2007-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Brief summary

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?

Interventions

DEVICEREE Assessment

Sponsors

Microlife
Lead SponsorINDUSTRY

Study design

Observational model
DEFINED_POPULATION
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Countries

United States

Contacts

Primary ContactJENNIFER SLOWSKY
(352) 735-1400

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026