Clinical trial NCT04034472: Interdisciplinary Weight Loss Therapy Associate With the Use of Interactive Digital Technology
Official title: Interdisciplinary Weight Loss Therapy Associate With the Use of Interactive Digital Technology as Adjuvant Tool to the Clinical Practices in Obesity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: obesity
comorbidities
inflammation
digital technology
metabolic alterations
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2019-07-26
Enrollment: 80
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Body weight (kg)
timeFrame: 12 weeks
measure: Body Fat mass (kg)
timeFrame: 12 weeks
measure: Glucose Concentration
timeFrame: 12 weeks
measure: Body Lean mass (kg)
timeFrame: 12 weeks
measure: Basal Metabolic Rate (KJ/day)
timeFrame: 12 weeks
measure: Insulin Concentration
timeFrame: 12 weeks
measure: Human Fibroblast Growth Factor 21
timeFrame: 12 weeks
measure: Adiponectin
timeFrame: 12 weeks
measure: Atrial Natriuretic Peptide
timeFrame: 12 weeks
measure: Leptin
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Universidade Federal de São Paulo
state: SP
Study officials:
References: