ObesityNCT04034472
Interdisciplinary Weight Loss Therapy Associate With the Use of Interactive Digital Technology
A study testing Interdisciplinary intervention in obesity in people with Obesity, run by Federal University of São Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Obesity
- What is being tested?
- Interdisciplinary intervention in obesity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2017to 10 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- obesity diagnosis;
- body mass index (BMI) values above 30 kg/m²
- adult
- aged 20-45 years
Who cannot join
- presence of heart diseases
- musculoskeletal deformities
- diseases related to the immune system
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Interdisciplinary intervention in obesity
- Keywords
- obesity, comorbidities, inflammation, digital technology, metabolic alterations
- Medical subject headings
- Obesity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interdisciplinary intervention in obesityOther
Interdisciplinary weight loss intervention associate to the use of digital technology to treat obesity and related disorders
| Study group | Role | What they receive |
|---|---|---|
| Cardiometabolic risk in women with obesity | Other | 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. Receives: Other: Interdisciplinary intervention in obesity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight (kg)
Body weight was measured using light clothes and barefoot on a Filizola® scale to 0,1kg and capacity of 180kg.
Measured: 12 weeks
Body Fat mass (kg)
Body fat mass was measured by Bio-impedance meter (BIA) by the device BIODYNAMICS 310e (TBW®).
Measured: 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.
Measured: 12 weeks
Body Lean mass (kg)
Body lean mass was measured by Bio-impedance meter (BIA) by the device BIODYNAMICS 310e (TBW®).
Measured: 12 weeks
Basal Metabolic Rate (KJ/day)
Basal Metabolic Rate was estimated by Bio-impedance meter (BIA) - device BIODYNAMICS 310e (TBW®).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start1 Mar 2017
- Primary completion1 Mar 2018
- Study completion10 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana R. Damaso, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04034472
- Sponsor's protocol ID
- UNIFESP - GEO
- Status last verified
- Jul 2019
- First submitted
- 15 Mar 2019
- Last updated
- 26 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interdisciplinary Weight Loss Therapy Associate With the Use of Interactive Digital Technology as Adjuvant Tool to the Clinical Practices in Obesity
- ClinicalTrials.gov ID
- NCT04034472
- Acronym / sponsor ID
- UNIFESP - GEO
- Conditions
- Obesity
- Keywords
- obesity, comorbidities, inflammation, digital technology, metabolic alterations
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 10 Dec 2019 (estimated)
- First posted
- 26 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiometabolic risk in women with obesity | Other | Other: Interdisciplinary intervention in obesityThe 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. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- obesity diagnosis;
- body mass index (BMI) values above 30 kg/m²
- adult
- aged 20-45 years
Key exclusion criteria (3 listed)
- presence of heart diseases
- musculoskeletal deformities
- diseases related to the immune system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interdisciplinary intervention in obesityInterdisciplinary weight loss intervention associate to the use of digital technology to treat obesity and related disorders | Other | Cardiometabolic risk in women with obesity |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interdisciplinary intervention in obesity in people with Obesity, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (kg) (time frame: 12 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2019.