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

Overview

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.

Full Title of Study: “Interdisciplinary Weight Loss Therapy Associate With the Use of Interactive Digital Technology as Adjuvant Tool to the Clinical Practices in Obesity”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 1, 2018

Detailed Description

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.

Interventions

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

Arms, Groups and Cohorts

  • Other: Cardiometabolic risk in women with obesity
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Body weight (kg)
    • Time Frame: 12 weeks
    • Body weight was measured using light clothes and barefoot on a Filizola® scale to 0,1kg and capacity of 180kg.
  • Body Fat mass (kg)
    • Time Frame: 12 weeks
    • Body fat mass was measured by Bio-impedance meter (BIA) by the device BIODYNAMICS 310e (TBW®).
  • Glucose Concentration
    • Time Frame: 12 weeks
    • 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.
  • Body Lean mass (kg)
    • Time Frame: 12 weeks
    • Body lean mass was measured by Bio-impedance meter (BIA) by the device BIODYNAMICS 310e (TBW®).
  • Basal Metabolic Rate (KJ/day)
    • Time Frame: 12 weeks
    • Basal Metabolic Rate was estimated by Bio-impedance meter (BIA) – device BIODYNAMICS 310e (TBW®).
  • Insulin Concentration
    • Time Frame: 12 weeks
    • 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.
  • Human Fibroblast Growth Factor 21
    • Time Frame: 12 weeks
    • 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.
  • Adiponectin
    • Time Frame: 12 weeks
    • 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.
  • Atrial Natriuretic Peptide
    • Time Frame: 12 weeks
    • 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.
  • Leptin
    • Time Frame: 12 weeks
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 20 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Federal University of São Paulo
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ana R. Damaso, Professor – Federal University of São Paulo

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