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

July 24, 2019 updated by: Ana R. Damaso, Federal University of São Paulo

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 04023-900
        • Universidade Federal de Sao Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: Interdisciplinary intervention in obesity
Interdisciplinary weight loss intervention associate to the use of digital technology to treat obesity and related disorders

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks
Body Fat mass (kg)
Time Frame: 12 weeks
Body fat mass was measured by Bio-impedance meter (BIA) by the device BIODYNAMICS 310e (TBW®).
12 weeks
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.
12 weeks
Body Lean mass (kg)
Time Frame: 12 weeks
Body lean mass was measured by Bio-impedance meter (BIA) by the device BIODYNAMICS 310e (TBW®).
12 weeks
Basal Metabolic Rate (KJ/day)
Time Frame: 12 weeks
Basal Metabolic Rate was estimated by Bio-impedance meter (BIA) - device BIODYNAMICS 310e (TBW®).
12 weeks
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.
12 weeks
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.
12 weeks
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.
12 weeks
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.
12 weeks
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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Actual)

March 1, 2018

Study Completion (Anticipated)

December 10, 2019

Study Registration Dates

First Submitted

March 15, 2019

First Submitted That Met QC Criteria

July 24, 2019

First Posted (Actual)

July 26, 2019

Study Record Updates

Last Update Posted (Actual)

July 26, 2019

Last Update Submitted That Met QC Criteria

July 24, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UNIFESP - GEO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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