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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).
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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.
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:
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Obese patients, with obesity-associated comorbidities, treated with the standardized multidisciplinary weight loss method (PronoKal® Method).
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| Name | Affiliation | Role |
|---|---|---|
| Rosana Cafardo, Ph | Hospital Italiano de Buenos Aires, Argentina | Principal Investigator |
| Lucio Criado, Ph | Centro Médico Mansilla. Buenos Aires. Argentina | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lucio Criado | Buenos Aires | Argentina |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 25, 2017 | Oct 30, 2017 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| 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 | 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 | 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 | 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 | 2 years |
| Body weight loss | Change of body weight from baseline to end of treatment | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. | 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 | 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. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |