ObesityPRONOCOSTNCT05833464
Cost-effectiveness Study of a Multidisciplinary Weight Loss Method to Improve the Health Condition of Obese Patients
An observational study of Obesity and Obese, run by Protein Supplies SL at 1 site in Argentina.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 0 participants
- Where
- 1 siteArgentina
- Study dates
- May 2018to Sep 2021
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Obese patients, with obesity-associated comorbidities, treated with the standardized multidisciplinary weight loss method (PronoKal® Method).
Who may be able to join
- 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
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Keywords
- comorbidities, PronoKal® Method, Cost-Benefit Analysis, loss weight, obesity
- Medical subject headings
- Obesity, Weight Loss
What is being measured
The primary outcome is the main question the study is designed to answer.
Healthcare expenditure for one year
Sum of the following costs: pharmacological treatment of associated comorbidities + visits to primary care physician + visits to specialist + visits to emergency department for acute complications +treatment for acute complications +number of hospital admission days + antibiotic treatment +laboratory tests, for one year (from baseline to 1 year)
Measured: 1 year
Secondary outcomes (18)
Healthcare expenditure the second year
Sum of the following costs: pharmacological treatment of associated comorbidities + visits to primary care physician + visits to specialist + visits to emergency department for acute complications +treatment for acute complications +number of hospital admission days + antibiotic treatment +laboratory tests, from 1 to 2 years
Measured: 2 years
Monthly costs of pharmacological treatment of obesity comorbidities (after one year)
Sum of the pharmacological treatment of associated comorbidities (Antidiabetics + Antihypertensives + Statins / lipid-lowering + treatment of hyperuricemia+ Other treatments of obesity comorbidities
Measured: 1 year
Monthly costs of pharmacological treatment of obesity comorbidities (after 2 years)
Sum of the pharmacological treatment of associated comorbidities (Antidiabetics + Antihypertensives + Statins / lipid-lowering + treatment of hyperuricemia+ Other treatments of obesity comorbidities after 2 years
Measured: 2 years
Work absenteeism for 1 year
Number of absences from work (days and hours) due to health problems or medical visits, from baseline from baseline to 1 year
Measured: 1 year
Work absenteeism the second year
Number of absences from work (days and hours) due to health problems or medical visits, from baseline from 1 to 2 years
Measured: 2 years
Body weight loss
Change of body weight from baseline to end of treatment
Measured: 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.
Waist circumference reduction
Change of Waist circumference from baseline to end of treatment
Measured: 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.
Blood glucose reduction
Change in levels of blood glucose from baseline to the end of treatment
Measured: 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.
Glycosylated hemoglobin reduction
Change in percentage of glycosylated hemoglobin from baseline to the end of treatment
Measured: 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.
Total cholesterol reduction
Change in levels of total cholesterol from baseline to the end of treatment
Measured: 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.
LDL-cholesterol reduction
Change in levels of LDL-cholesterol from baseline to the end of treatment
Measured: 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.
HDL-cholesterol increase
Change in levels of HDL-cholesterol from baseline at the end of treatment
Measured: 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.
Triglycerides reduction
Change in levels of triglycerides from baseline at the end of treatment
Measured: 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.
Serum uric acid reduction
Change in levels of serum uric acid from baseline at the end of treatment
Measured: 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.
Systolic blood pressure reduction
Change in systolic blood pressure from baseline at the end of treatment
Measured: 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.
Diastolic blood pressure reduction
Change in diastolic blood pressure from baseline at the end of treatment
Measured: 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.
Quality of life (score)
Change in score in the Short-Form General Health Survey (SF-12) questionnaire from baseline to end of treatment. Raw scores will be calculated as the sum of (re-coded) scale items and transformed to a 0 (negative response) to 100 (positive response) scale. A higher score indicates a better QoL; a positive change (increase in score) in score indicates improvements in QoL while negative change (decrease in score) indicates deterioration.
Measured: 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.
Number of Participants With Adverse Events
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study startMay 2018 (estimated)
- Primary completionJul 2021 (estimated)
- Study completionSep 2021 (estimated)
Why it stopped: 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).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Protein Supplies SL
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rosana Cafardo, Ph, Principal investigator, Hospital Italiano de Buenos Aires, ArgentinaLucio Criado, Ph, Study director, Centro Médico Mansilla. Buenos Aires. Argentina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05833464
- Sponsor's protocol ID
- PRO-COST-2016-02
- Acronym
- PRONOCOST
- Status last verified
- Apr 2023
- First submitted
- 8 May 2018
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05833464
- Acronym / sponsor ID
- PRONOCOST / PRO-COST-2016-02
- Keywords
- comorbidities, PronoKal® Method, Cost-Benefit Analysis, loss weight, obesity
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: 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).
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Protein Supplies SLUniversity, hospital or other
- Study start
- May 2018 (estimated)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 27 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Obese patients, with obesity-associated comorbidities, treated with the standardized multidisciplinary weight loss method (PronoKal® Method).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Healthcare expenditure for one year
Time frame: 1 year
Sum of the following costs: pharmacological treatment of associated comorbidities + visits to primary care physician + visits to specialist + visits to emergency department for acute complications +treatment for acute complications +number of hospital admission days + antibiotic treatment +laboratory tests, for one year (from baseline to 1 year)
18 secondary outcomes
Healthcare expenditure the second year
Time frame: 2 years
Monthly costs of pharmacological treatment of obesity comorbidities (after one year)
Time frame: 1 year
Monthly costs of pharmacological treatment of obesity comorbidities (after 2 years)
Time frame: 2 years
Work absenteeism for 1 year
Time frame: 1 year
Work absenteeism the second year
Time frame: 2 years
Body weight loss
Time frame: 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.
Waist circumference reduction
Time frame: 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.
Blood glucose reduction
Time frame: 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.
Glycosylated hemoglobin reduction
Time frame: 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.
Total cholesterol reduction
Time frame: 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.
LDL-cholesterol reduction
Time frame: 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.
HDL-cholesterol increase
Time frame: 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.
Triglycerides reduction
Time frame: 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.
Serum uric acid reduction
Time frame: 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.
Systolic blood pressure reduction
Time frame: 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.
Diastolic blood pressure reduction
Time frame: 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.
Quality of life (score)
Time frame: 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.
Number of Participants With Adverse Events
Time frame: 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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosana Cafardo, Ph principal investigator
Hospital Italiano de Buenos Aires, Argentina
Lucio Criado, Ph study director
Centro Médico Mansilla. Buenos Aires. Argentina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Obese, run by Protein Supplies SL at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healthcare expenditure for one year (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2023.