Clinical trial NCT05833464: Cost-effectiveness Study of a Multidisciplinary Weight Loss Method to Improve the Health Condition of Obese Patients
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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Obesity
Obese
Keywords: comorbidities
PronoKal® Method
Cost-Benefit Analysis
loss weight
obesity
Lead sponsor: Protein Supplies SL
Sponsor class: OTHER
First posted: 2023-04-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obese patients, with obesity-associated comorbidities, treated with the standardized multidisciplinary weight loss method (PronoKal® Method).

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, dietitians/nutritionists, 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 his/her 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.

Eligibility criteria: Inclusion Criteria:

* Patients of both sexes 18 years of age or older
* Patients with overweight or obesity (BMI\> 30 kg/m2) with at least one or more of the following comorbidities associated with obesity (type 2 diabetes mellitus, arterial hypertension, dyslipidemia, hyperuricemia) those who are under pharmacological treatment with two or more drugs (oral antidiabetic and/or lipid-lowering agents and/or antihypertensive and/or hypouricemic agents)
* Patients who agree to attend the follow-up visits at the Pronokal centre, in Buenos Aires.
* Patients who agree to participate and provide a signed informed consent

Exclusion Criteria:

* Patients who do not sign the informed consent
* Pregnant or breastfeeding patients.
* Patients with severe eating disorders, alcoholism, or substance abuse.
* Patients with severe psychological disorders (e.g., schizophrenia, bipolar disorder).
* Patients with liver failure.
* Patients with kidney failure.
* Patients with type 1 DM or insulin-dependent, or currently under insulin treatment, or candidates for insulin treatment in a short period of time.
* Patients with obesity caused by other endocrine diseases (except type 2 DM).
* Patients with blood disorders.
* Patients with cancer.
* Patients with cardiovascular or cerebrovascular disease (heart rhythm disorders, recent infarction \[\<6m\], unstable angina, decompensated heart failure, recent stroke \[\<6m\]).
* Patients with renal lithiasis.
* Patients with cholelithiasis.

Primary outcomes:
measure: Healthcare expenditure for one year
timeFrame: 1 year
Secondary outcomes:
measure: Healthcare expenditure the second year
timeFrame: 2 years
measure: Monthly costs of pharmacological treatment of obesity comorbidities (after one year)
timeFrame: 1 year
measure: Monthly costs of pharmacological treatment of obesity comorbidities (after 2 years)
timeFrame: 2 years
measure: Work absenteeism for 1 year
timeFrame: 1 year
measure: Work absenteeism the second year
timeFrame: 2 years
measure: Body weight loss
timeFrame: from baseline through treatment completion, an average of 6 months in patients with an initial body mass index of 30 to 35 kg/m2 and an average of 9 months for those patients with initial body mass index higher than 35 kg/m2.
measure: Waist circumference reduction
timeFrame: from baseline through treatment completion, an average of 6 months in patients with an initial body mass index of 30 to 35 kg/m2 and an average of 9 months for those patients with initial body mass index higher than 35 kg/m2.
measure: Blood glucose reduction
timeFrame: from baseline through treatment completion, an average of 6 months in patients with an initial body mass index of 30 to 35 kg/m2 and an average of 9 months for those patients with initial body mass index higher than 35 kg/m2.
measure: Glycosylated hemoglobin reduction
timeFrame: from baseline through treatment completion, an average of 6 months in patients with an initial body mass index of 30 to 35 kg/m2 and an average of 9 months for those patients with initial body mass index higher than 35 kg/m2.
measure: Total cholesterol reduction
timeFrame: from baseline through treatment completion, an average of 6 months in patients with an initial body mass index of 30 to 35 kg/m2 and an average of 9 months for those patients with initial body mass index higher than 35 kg/m2.
measure: LDL-cholesterol reduction
timeFrame: from baseline through treatment completion, an average of 6 months in patients with an initial body mass index of 30 to 35 kg/m2 and an average of 9 months for those patients with initial body mass index higher than 35 kg/m2.
measure: HDL-cholesterol increase
timeFrame: from baseline through treatment completion, an average of 6 months in patients with an initial body mass index of 30 to 35 kg/m2 and an average of 9 months for those patients with initial body mass index higher than 35 kg/m2.
measure: Triglycerides reduction
timeFrame: from baseline through treatment completion, an average of 6 months in patients with an initial body mass index of 30 to 35 kg/m2 and an average of 9 months for those patients with initial body mass index higher than 35 kg/m2.
measure: Serum uric acid reduction
timeFrame: from baseline through treatment completion, an average of 6 months in patients with an initial body mass index of 30 to 35 kg/m2 and an average of 9 months for those patients with initial body mass index higher than 35 kg/m2.
measure: Systolic blood pressure reduction
timeFrame: from baseline through treatment completion, an average of 6 months in patients with an initial body mass index of 30 to 35 kg/m2 and an average of 9 months for those patients with initial body mass index higher than 35 kg/m2.
measure: Diastolic blood pressure reduction
timeFrame: from baseline through treatment completion, an average of 6 months in patients with an initial body mass index of 30 to 35 kg/m2 and an average of 9 months for those patients with initial body mass index higher than 35 kg/m2.
measure: Quality of life (score)
timeFrame: from baseline through treatment completion, an average of 6 months in patients with an initial body mass index of 30 to 35 kg/m2 and an average of 9 months for those patients with initial body mass index higher than 35 kg/m2.
measure: Number of Participants With Adverse Events
timeFrame: from baseline through treatment completion, an average of 6 months in patients with an initial body mass index of 30 to 35 kg/m2 and an average of 9 months for those patients with initial body mass index higher than 35 kg/m2.
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Lucio Criado
Study officials:
affiliation: Hospital Italiano de Buenos Aires, Argentina
name: Rosana Cafardo, Ph
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro Médico Mansilla. Buenos Aires. Argentina
name: Lucio Criado, Ph
role: STUDY_DIRECTOR
References: