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

Study Overview
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Brief Summary
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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.

Detailed Description
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This study consists in a 12-week clinical interdisciplinary weight loss therapy, with endocrinologist, nutritionist, psychologist and exercise physiologist to evaluate the effects of clinical interdisciplinary therapy associated to use the eletronic means on inflammatory biomarkers and metabolic alterations in women with obesity. The present study was composed by a sample of obese women (20 to 45 years old), recruited through advertisements in the media (newspapers, magazines, radio, television and social media - Twitter®, Facebook® and Instagram®). The volunteers lived in the city of São Paulo or nearby, so they could attend monthly the University on the days of the clinical, nutritional, psychological and exercise evaluations, counseling, educational sessions and motivational strategies supporting adherence. To complete the Education Behaviors Program the volunteers follow weekly the instructions found in the Platform #12Semanas®. All participants met the inclusion criteria for the obesity profile according to the World Health Organization (WHO), presenting Body Mass Index (BMI) values above 30 kg/m². Patients with any pathology that could compromise the results of the study (heart disease, musculoskeletal deformities, diseases related to the immune system, genetic, metabolic or endocrine diseases, identified by the physician) were not included in the study. Anthropometric measures, body composition by bio-impedance and bood samples were collected to serum analysis.

Official Title
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Interdisciplinary Weight Loss Therapy Associate With the Use of Interactive Digital Technology as Adjuvant Tool to the Clinical Practices in Obesity

Conditions
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Obesity

Intervention / Treatment
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* Other: Interdisciplinary intervention in obesity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: obesity diagnosis; body mass index (BMI) values above 30 kg/m² adult aged 20-45 years Exclusion Criteria: presence of heart diseases musculoskeletal deformities diseases related to the immune system

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cardiometabolic risk in women with obesity<br>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<br>* Interdisciplinary weight loss intervention associate to the use of digital technology to treat obesity and related disorders<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, comorbidities, inflammation, digital technology, metabolic alterations