Recruiting

Observational Study

Sponsor:

Microlife

Code:

NCT00489502

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Brief Counseling

REE Assessment

Study Details

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?

Conditions

Obesity

Study ID

NCT00489502

Start date

Jun, 2007

Status verified date

Jun, 2007

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Interventions

Brief Counseling

REE Assessment

Central Contacts and Locations

Central contacts

JENNIFER SLOWSKY

(352) 735-1400

Locations

Lake Cardiology

Recruiting

Mount Dora, Florida, United States, 32757

Principal Investigator:

KEN KRONHAUS, M.D., Ph.D

More Information

Sponsor

Microlife

Last update posted

Jun 21, 2007

Last verified

Jun, 2007

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Microlife on 2007-06-21.