Cost-effectiveness Study of a Multidisciplinary Weight Loss Method to Improve the Health Condition of Obese Patients

NCT05833464 | Withdrawn

• 1 other identifier: PRO-COST-2016-02
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Obese

Keywords

comorbidities; PronoKal® Method; Cost-Benefit Analysis; loss weight; obesity

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (18)

• Healthcare expenditure the second year

  2 years

• Monthly costs of pharmacological treatment of obesity comorbidities (after one year)

  1 year

• Monthly costs of pharmacological treatment of obesity comorbidities (after 2 years)

  2 years

• Work absenteeism for 1 year

  1 year

• Work absenteeism the second year

  2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Obese patients, with obesity-associated comorbidities, treated with the standardized multidisciplinary weight loss method (PronoKal® Method).

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Protein Supplies SL: lead

Study Sites (1)

Lucio Criado

Buenos Aires, Argentina

Location

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Rosana Cafardo, Ph

  Hospital Italiano de Buenos Aires, Argentina

  PRINCIPAL INVESTIGATOR

• Lucio Criado, Ph

  Centro Médico Mansilla. Buenos Aires. Argentina

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2018
• First Posted: April 27, 2023
• Study Start: May 1, 2018
• Primary Completion: July 1, 2021
• Study Completion: September 1, 2021
• Last Updated: April 27, 2023

Record last verified: 2023-04

Locations

AR (1)