Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2026-04-11 @ 9:02 PM
Study NCT ID:
NCT00489502
Status:
UNKNOWN
Last Update Posted:
2007-06-21
First Post:
2007-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Observation of Implementing the MedGem Into a Medical Specialty Practice
Sponsor:
Microlife
Organization:
Study Overview
Official Title:
Phase I: Clinical Observation of Implementing the MedGem Into a Medical Specialty (i.e. Cardiology) Practice
Status:
UNKNOWN
Status Verified Date:
2007-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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?
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?
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: