Interdisciplinary Weight Loss Therapy Associate With the Use of Interactive Digital Technology
Primary Purpose
Obesity
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Interdisciplinary intervention in obesity
Sponsored by
About this trial
This is an interventional health services research trial for Obesity focused on measuring obesity, comorbidities, inflammation, digital technology, metabolic alterations
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
Sites / Locations
- Universidade Federal de São Paulo
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Cardiometabolic risk in women with obesity
Arm Description
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.
Outcomes
Primary Outcome Measures
Body weight (kg)
Body weight was measured using light clothes and barefoot on a Filizola® scale to 0,1kg and capacity of 180kg.
Body Fat mass (kg)
Body fat mass was measured by Bio-impedance meter (BIA) by the device BIODYNAMICS 310e (TBW®).
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.
Body Lean mass (kg)
Body lean mass was measured by Bio-impedance meter (BIA) by the device BIODYNAMICS 310e (TBW®).
Basal Metabolic Rate (KJ/day)
Basal Metabolic Rate was estimated by Bio-impedance meter (BIA) - device BIODYNAMICS 310e (TBW®).
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04034472
First Posted
March 15, 2019
Last Updated
July 24, 2019
Sponsor
Federal University of São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT04034472
Brief Title
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
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
March 1, 2018 (Actual)
Study Completion Date
December 10, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
obesity, comorbidities, inflammation, digital technology, metabolic alterations
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cardiometabolic risk in women with obesity
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Interdisciplinary intervention in obesity
Intervention Description
Interdisciplinary weight loss intervention associate to the use of digital technology to treat obesity and related disorders
Primary Outcome Measure Information:
Title
Body weight (kg)
Description
Body weight was measured using light clothes and barefoot on a Filizola® scale to 0,1kg and capacity of 180kg.
Time Frame
12 weeks
Title
Body Fat mass (kg)
Description
Body fat mass was measured by Bio-impedance meter (BIA) by the device BIODYNAMICS 310e (TBW®).
Time Frame
12 weeks
Title
Glucose Concentration
Description
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.
Time Frame
12 weeks
Title
Body Lean mass (kg)
Description
Body lean mass was measured by Bio-impedance meter (BIA) by the device BIODYNAMICS 310e (TBW®).
Time Frame
12 weeks
Title
Basal Metabolic Rate (KJ/day)
Description
Basal Metabolic Rate was estimated by Bio-impedance meter (BIA) - device BIODYNAMICS 310e (TBW®).
Time Frame
12 weeks
Title
Insulin Concentration
Description
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.
Time Frame
12 weeks
Title
Human Fibroblast Growth Factor 21
Description
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.
Time Frame
12 weeks
Title
Adiponectin
Description
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.
Time Frame
12 weeks
Title
Atrial Natriuretic Peptide
Description
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.
Time Frame
12 weeks
Title
Leptin
Description
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.
Time Frame
12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Universidade Federal de São Paulo
City
São Paulo
State/Province
SP
ZIP/Postal Code
04023-900
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
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Interdisciplinary Weight Loss Therapy Associate With the Use of Interactive Digital Technology
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