Interdisciplinary Weight Loss Therapy Associate With the Use of Interactive Digital Technology

NCT04034472 | Unknown

• 1 other identifier: UNIFESP - GEO
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Obesity is a complex disease associate to metabolic alterations, which may lead to cardiometabolic risk in women with obesity. The use of interactive digital technology as adjuvante tool to the clinical practices in weight loss therapy emerges as an innovative strategy. However, it was note fully investigated if this kind of approach can contribute to improve inflammatory state and metabolic alterations in obese population.

Conditions

Obesity

Keywords

obesity; comorbidities; inflammation; digital technology; metabolic alterations

Outcome Measures

Primary Outcomes (10)

• Body weight (kg)

  Body weight was measured using light clothes and barefoot on a Filizola® scale to 0,1kg and capacity of 180kg.

  12 weeks

• Body Fat mass (kg)

  Body fat mass was measured by Bio-impedance meter (BIA) by the device BIODYNAMICS 310e (TBW®).

  12 weeks

• Glucose Concentration

  Blood samples were collected at the outpatient clinic at approximately 8:00 A.M. after an overnight fast (12h). Glucose concentration were available by commercial kits.

  12 weeks

• Body Lean mass (kg)

  Body lean mass was measured by Bio-impedance meter (BIA) by the device BIODYNAMICS 310e (TBW®).

  12 weeks

• Basal Metabolic Rate (KJ/day)

  Basal Metabolic Rate was estimated by Bio-impedance meter (BIA) - device BIODYNAMICS 310e (TBW®).

  12 weeks

• Insulin Concentration

  Blood samples were collected at the outpatient clinic at approximately 8:00 A.M. after an overnight fast (12h). Insulin concentration were available by commercial kits. Insulin resistance was assessed using the homeostasis model assessment-insulin resistance (HOMA-IR). The cutoff value determined for Brazilian population is HOMA-IR\>2.71 for classifying the subjects with insulin resistance.

  12 weeks

• Human Fibroblast Growth Factor 21

  Blood samples were collected at the outpatient clinic at approximately 8:00 A.M. after an overnight fast (12h). The assays of Human Fibroblast Growth Factor 21 (FGF-21) concentration were determined by ELISA.

  12 weeks

• Adiponectin

  Blood samples were collected at the outpatient clinic at approximately 8:00 A.M. after an overnight fast (12h). The assays of adiponectin concentration were determined by ELISA.

  12 weeks

• Atrial Natriuretic Peptide

  Blood samples were collected at the outpatient clinic at approximately 8:00 A.M. after an overnight fast (12h). The assays of atrial natriuretic peptide (ANP) concentration were determined by ELISA.

  12 weeks

• Leptin

  Blood samples were collected at the outpatient clinic at approximately 8:00 A.M. after an overnight fast (12h). The assays of leptin concentration were determined by ELISA.

  12 weeks

Study Arms (1)

Cardiometabolic risk in women with obesity

OTHER

The use of interactive digital technology as adjuvant tool to the clinical practices in weight loss therapy emerges as an innovative strategy. However. it was note fully investigated if this can contribute to decrease inflammatory markers in obese women. In the present investigate it was amied to evaluate the effects of clinical approach associated to use of electronic means on inflammatory markers in women with obesity.

Other: Interdisciplinary intervention in obesity

Interventions

Interdisciplinary intervention in obesity OTHER

Interdisciplinary weight loss intervention associate to the use of digital technology to treat obesity and related disorders

Cardiometabolic risk in women with obesity

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• obesity diagnosis;
• body mass index (BMI) values above 30 kg/m²
• adult
• aged 20-45 years

You may not qualify if:

• presence of heart diseases
• musculoskeletal deformities
• diseases related to the immune system

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Universidade Federal de São Paulo

São Paulo, São Paulo, 04023-900, Brazil

Location

MeSH Terms

Conditions

Obesity; Inflammation

Interventions

Adiposity

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Body Fat Distribution; Body Weights and Measures; Body Constitution; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Body Composition; Biochemical Phenomena; Chemical Phenomena; Metabolism; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 15, 2019
• First Posted: July 26, 2019
• Study Start: March 1, 2017
• Primary Completion: March 1, 2018
• Study Completion: December 10, 2019
• Last Updated: July 26, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)