Application of Dietary Guidelines for the Brazilian Population by Teleconsultation in Obesity in Primary Care
Primary Purpose
Obesity
Status
Active
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Teleobesity
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Obesity, Chronic Disease, Noncommunicable Diseases, Telemedicine, Diet, Healthy, Primary Health Care, Unified Health System
Eligibility Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
- Individuals who do not have access to the WhatsApp multi-platform application (Facebook Inc.).
Sites / Locations
- Hospital de Clínicas de Porto Alegre
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Other
Arm Label
Control Group
Intervention Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Weight change
Weight change, measured using a calibrated scale at a Primary Health Care health unit, at the end of 8 weeks.
Secondary Outcome Measures
Food consumption improvement
Improvement in food consumption measured through 24-hour dietary recall (R24h), at the end of 8th and 24th week.
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.
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.
Full Information
NCT ID
NCT05171907
First Posted
July 29, 2021
Last Updated
March 29, 2022
Sponsor
Hospital de Clinicas de Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT05171907
Brief Title
Application of Dietary Guidelines for the Brazilian Population by Teleconsultation in Obesity in Primary Care
Official Title
Application of Dietary Guidelines for the Brazilian Population by Teleconsultation for Patients With Obesity in Primary Health Care: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Chronic Disease, Noncommunicable Diseases, Telemedicine, Diet, Healthy, Primary Health Care, Unified Health System
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A pragmatic multicentre randomised controlled trial, open-label, allocation at 1 : 1
Masking
None (Open Label)
Allocation
Randomized
Enrollment
578 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Intervention Group
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Teleobesity
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight change
Description
Weight change, measured using a calibrated scale at a Primary Health Care health unit, at the end of 8 weeks.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Food consumption improvement
Description
Improvement in food consumption measured through 24-hour dietary recall (R24h), at the end of 8th and 24th week.
Time Frame
8 and 24 weeks
Title
Quality of life measured using the Short Form Health Survey 36
Description
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.
Time Frame
8 and 24 weeks
Title
Weight change (follow up)
Description
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.
Time Frame
24 and 48 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
Individuals who do not have access to the WhatsApp multi-platform application (Facebook Inc.).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcelo Rodrigues Gonçalves
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Study Director
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Application of Dietary Guidelines for the Brazilian Population by Teleconsultation in Obesity in Primary Care
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