ObesityNCT05171907
Application of Dietary Guidelines for the Brazilian Population by Teleconsultation in Obesity in Primary Care
A study testing Teleobesity in people with Obesity, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
Obesity is a chronic disease that is highly prevalent in Brazil. It is associated with diabetes and hypertension. Obesity may decrease quality of life. Communication tools, such as mobile devices and social media, are helping to control and prevent obesity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Teleobesity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 578 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jan 2022to Mar 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female and male individuals, with BMI ≥30 kg/m²;
- Age over 18 years;
- Internet access by phone or tablet or computer and WhatsApp multi-platform application (Facebook Inc.);
- Weekly time availability (10-20 minutes).
Who cannot join
- Individuals who do not have access to the WhatsApp multi-platform application (Facebook Inc.).
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul
About this study
Official title: Application of Dietary Guidelines for the Brazilian Population by Teleconsultation for Patients With Obesity in Primary Health Care: A Randomized Clinical Trial
Obesity is a chronic disease that is highly prevalent in Brazil. It is associated with diabetes and hypertension. Obesity may decrease quality of life. Communication tools, such as mobile devices and social media, are helping to control and prevent obesity. In this 2-arm randomized clinical trial, the investigators aim to evaluate the efficacy of the Dietary Guidelines for the Brazilian Population through 8 weekly video nutritional monitoring sessions with nutritionists. Both groups will receive guidance from reference professionals from primary health care (physician and nurse). Throughout the intervention program, both groups will be equally evaluated in order to verify at the end of the study effectiveness in weight loss and life quality improvement.
Read the detailed description
Obesity is a multifactorial disease of epidemic proportions worldwide. The use of telecommunication tools has been used in health and nutrition in different contexts, seeking to reduce the burden of non-communicable chronic diseases. Telehealth interventions are effective to increase quality of life and to improve the dietary food intake of participants; this kind of treatment seems feasable, cost-effective and has promising results to induce weight loss in obese individuals. This project will evaluate the impact of a remote nutritional intervention in short (8 weeks) and long term (24 and 48 weeks) on the weight fo obese individuals. The intervention will be based on the Dietary Guidelines for the Brazilian Population. It will focus on primary care patients and will have a multidisciplinary approach. It is an open-label pragmatic multicentre randomized controlled trial, with an 1:1 allocation: (1) intervention group (n = 289): Remote consultation with nutritionists based on the Dietary Guidelines for the Brazilian Population; (2) control group (n = 289): usual follow-up in Primary Health Care (PHC). The primary outcome will be weight change at 8 weeks. Additionally, the investigators will evaluate food consumption and quality of life at 8 and 24 weeks as secondary outcomes.
- Conditions
- Obesity
- Being tested
- Teleobesity
- Keywords
- Obesity, Chronic Disease, Noncommunicable Diseases, Telemedicine, Diet, Healthy, Primary Health Care, Unified Health System
- Medical subject headings
- Obesity, Chronic Disease, Noncommunicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeleobesityBehavioural
Teleintervention based on Dietary Guidelines for the Brazilian Population during 8 weeks; two subsequent assessments will also be made, in 24th and 48th weeks, to assess the maintenance of weight loss.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Patients into the control group will receive the same assessments as patients in the intervention group, for the same time (in 1th, 8th, 24, and 48 weeks), but they will not receive nutritional teleconsultation. |
| Intervention Group | Other | Teleintervention based on Dietary Guidelines for the Brazilian Population during 8 weeks; two subsequent assessments will also be made, in 24th and 48th weeks, to assess the maintenance of weight loss. Receives: Behavioral: Teleobesity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight change
Weight change, measured using a calibrated scale at a Primary Health Care health unit, at the end of 8 weeks.
Measured: 8 weeks
Secondary outcomes (3)
Food consumption improvement
Improvement in food consumption measured through 24-hour dietary recall (R24h), at the end of 8th and 24th week.
Measured: 8 and 24 weeks
Quality of life measured using the Short Form Health Survey 36
Quality of life improvement measured using the Short Form Health Survey 36, SF-36, at the end of 8th and 24th week. The SF-36 presents a final score from 0 to 100, in which zero corresponds to the worst general health status and 100 the best health status.
Measured: 8 and 24 weeks
Weight change (follow up)
Weight change, measured using a calibrated scale at a Primary Health Care health unit, at the end of 24 and 48 weeks of follow up.
Measured: 24 and 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start1 Jan 2022
- Primary completion22 Jan 2024
- Study completionMar 2025 (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.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A pragmatic multicentre randomised controlled trial, open-label, allocation at 1 : 1
- Masking
- None (open label)
- Enrolment
- 578 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marcelo Rodrigues Gonçalves, Study director, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05171907
- Sponsor's protocol ID
- 2021-0128
- Status last verified
- Mar 2024
- First submitted
- 29 Jul 2021
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Dietary Guidelines for the Brazilian Population by Teleconsultation for Patients With Obesity in Primary Health Care: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05171907
- Acronym / sponsor ID
- 2021-0128
- Conditions
- Obesity
- Keywords
- Obesity, Chronic Disease, Noncommunicable Diseases, Telemedicine, Diet, Healthy, Primary Health Care, Unified Health System
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 578 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 22 Jan 2024 (actual)
- Study completion
- Mar 2025 (estimated)
- First posted
- 29 Dec 2021 (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 chronic disease that is highly prevalent in Brazil. It is associated with diabetes and hypertension. Obesity may decrease quality of life. Communication tools, such as mobile devices and social media, are helping to control and prevent obesity. In this 2-arm randomized clinical trial, the investigators aim to evaluate the efficacy of the Dietary Guidelines for the Brazilian Population through 8 weekly video nutritional monitoring sessions with nutritionists. Both groups will receive guidance from reference professionals from primary health care (physician and nurse). Throughout the intervention program, both groups will be equally evaluated in order to verify at the end of the study effectiveness in weight loss and life quality improvement.
Detailed description
Obesity is a multifactorial disease of epidemic proportions worldwide. The use of telecommunication tools has been used in health and nutrition in different contexts, seeking to reduce the burden of non-communicable chronic diseases. Telehealth interventions are effective to increase quality of life and to improve the dietary food intake of participants; this kind of treatment seems feasable, cost-effective and has promising results to induce weight loss in obese individuals. This project will evaluate the impact of a remote nutritional intervention in short (8 weeks) and long term (24 and 48 weeks) on the weight fo obese individuals. The intervention will be based on the Dietary Guidelines for the Brazilian Population. It will focus on primary care patients and will have a multidisciplinary approach. It is an open-label pragmatic multicentre randomized controlled trial, with an 1:1 allocation: (1) intervention group (n = 289): Remote consultation with nutritionists based on the Dietary Guidelines for the Brazilian Population; (2) control group (n = 289): usual follow-up in Primary Health Care (PHC). The primary outcome will be weight change at 8 weeks. Additionally, the investigators will evaluate food consumption and quality of life at 8 and 24 weeks as secondary outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A pragmatic multicentre randomised controlled trial, open-label, allocation at 1 : 1
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Patients into the control group will receive the same assessments as patients in the intervention group, for the same time (in 1th, 8th, 24, and 48 weeks), but they will not receive nutritional teleconsultation. |
| Intervention Group | Other | Behavioral: TeleobesityTeleintervention based on Dietary Guidelines for the Brazilian Population during 8 weeks; two subsequent assessments will also be made, in 24th and 48th weeks, to assess the maintenance of weight loss. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female and male individuals, with BMI ≥30 kg/m²;
- Age over 18 years;
- Internet access by phone or tablet or computer and WhatsApp multi-platform application (Facebook Inc.);
- Weekly time availability (10-20 minutes).
Key exclusion criteria (1 listed)
- Individuals who do not have access to the WhatsApp multi-platform application (Facebook Inc.).
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 |
|---|---|---|
| TeleobesityTeleintervention based on Dietary Guidelines for the Brazilian Population during 8 weeks; two subsequent assessments will also be made, in 24th and 48th weeks, to assess the maintenance of weight loss. | Behavioural | Intervention Group |
Primary outcome
Weight change
Time frame: 8 weeks
Weight change, measured using a calibrated scale at a Primary Health Care health unit, at the end of 8 weeks.
3 secondary outcomes
Food consumption improvement
Time frame: 8 and 24 weeks
Quality of life measured using the Short Form Health Survey 36
Time frame: 8 and 24 weeks
Weight change (follow up)
Time frame: 24 and 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
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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.
Marcelo Rodrigues Gonçalves study director
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teleobesity in people with Obesity, run by Hospital de Clinicas de Porto Alegre 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 1 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 4 Mar 2024. 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?
Weight change (time frame: 8 weeks). 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 4 Mar 2024.