Clinical Observation of Implementing the MedGem Into a Medical Specialty Practice

Obesity Clinical Trial

Official title:

Phase I: Clinical Observation of Implementing the MedGem Into a Medical Specialty (i.e. Cardiology) Practice

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00489502
• Other study ID #: ML002
• Status: Recruiting
• Phase: N/A
• First received: June 20, 2007
• Last updated: June 20, 2007
• Start date: June 2007

Study information

• Verified date: June 2007
• Source: Microlife
• Contact: JENNIFER SLOWSKY
• Phone: (352) 735-1400
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Brief Counseling

Device:
• REE Assessment

Locations

Country	Name	City	State
United States	Lake Cardiology	Mount Dora	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Microlife

Country where clinical trial is conducted

United States,