Ignite Creation Date:
2024-05-06 @ 6:56 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05833464
Status:
WITHDRAWN
Last Update Posted:
2023-04-27
First Post:
2018-05-08
Brief Title:
Cost-effectiveness Study of a Multidisciplinary Weight Loss Method to Improve the Health Condition of Obese Patients
Sponsor:
Protein Supplies SL
Organization:
Protein Supplies SL
Study Overview
Official Title:
Cost-effectiveness Pharmacoeconomic Study of a Standardized Multidisciplinary Weight Loss Method PronoKal Method to Improve the Health Condition of Obese Patients With Associated Comorbidities
Status:
WITHDRAWN
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was not started and no patients were recruited because the weight loss program was no longer prescribed in Argentina the country where the study was to be carried out
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRONOCOST
Brief Summary:
Prospective observational multicenter study based on a registry of patients with obesity and associated comorbidities undergoing a standardized multidisciplinary weight loss method with a 2-year follow-up
Detailed Description:
The investigators will include obese patients with BMI higher than 30 kg m2 and one or more comorbidities associated with obesity who are following a standardized multidisciplinary weight-loss program PronoKal Method which consists of a very-low-calorie diet into which natural foods are gradually reintroduced accompanied by physical exercise and emotional support
The aim of this study is to assess the cost-effectiveness to improve the health condition of obese patients with comorbidities and thereby reduce healthcare expenditure pharmacological treatment incidence of complications use of health resources and work absenteeism
Patients will be monitored for 2 years The registry of patient data for this study will be made by the doctor and dietitians nutritionists who will regularly see the patient in the face-to-face visits at the Pronokal center
The study will begin with the baseline visit day 0 in which the inclusion and exclusion criteria will be confirmed the signing of informed consent will be obtained and the multidisciplinary treatment will be prescribed followed by 6 control visits 2 visits during the ketogenic stage 1-month after the start and at the end of ketosis 2 visits during the physiological adaptation phase at 4 or 5 months and at the end of stage 2 and 2 follow-up visits during the maintenance up to the 2-year completion
Likewise dietitiansnutritionists according to the methodology of the program will carry out a face-to-face follow-up of the patient which will be fortnightly during the ketogenic diet monthly during the physiological adaptation of stage 2 and quarterly or semi-annual during the maintenance stage
The information about the endpoints will be collected
Costs of weight loss treatment products and dietary supplements number of control visits number of laboratory tests performed
Healthcare expenditure pharmacological treatment of associated comorbidities incidence of complications visits to hisher primary care physician a specialist or emergency department for acute complications treatment of acute complications number of hospital admission days antibiotic treatment consumption of health resources visits to the general practitioner visits to specialists laboratory tests
Work absenteeism number of work leave days hours of work absenteeism due to health problems or medical visits
The aim of this study is to assess the cost-effectiveness to improve the health condition of obese patients with comorbidities and thereby reduce healthcare expenditure pharmacological treatment incidence of complications use of health resources and work absenteeism
Patients will be monitored for 2 years The registry of patient data for this study will be made by the doctor and dietitians nutritionists who will regularly see the patient in the face-to-face visits at the Pronokal center
The study will begin with the baseline visit day 0 in which the inclusion and exclusion criteria will be confirmed the signing of informed consent will be obtained and the multidisciplinary treatment will be prescribed followed by 6 control visits 2 visits during the ketogenic stage 1-month after the start and at the end of ketosis 2 visits during the physiological adaptation phase at 4 or 5 months and at the end of stage 2 and 2 follow-up visits during the maintenance up to the 2-year completion
Likewise dietitiansnutritionists according to the methodology of the program will carry out a face-to-face follow-up of the patient which will be fortnightly during the ketogenic diet monthly during the physiological adaptation of stage 2 and quarterly or semi-annual during the maintenance stage
The information about the endpoints will be collected
Costs of weight loss treatment products and dietary supplements number of control visits number of laboratory tests performed
Healthcare expenditure pharmacological treatment of associated comorbidities incidence of complications visits to hisher primary care physician a specialist or emergency department for acute complications treatment of acute complications number of hospital admission days antibiotic treatment consumption of health resources visits to the general practitioner visits to specialists laboratory tests
Work absenteeism number of work leave days hours of work absenteeism due to health problems or medical visits
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None