Efficacy of an Intervention Based on the Dietary Guidelines for the Brazilian Population in the Treatment of Overweight and Obesity: A Randomized Clinical Trial
Phase: NA
Conditions: Obesity & Overweight, Overweight (BMI > 25)
Sponsor: Federal University of Health Science of Porto Alegre

 
 
FEDERAL UNIVERSITY OF HEALTH SCIENCES OF PORTO ALEGRE 
PROGRAM OF POSTGRADUATE STUDIES IN NUTRITIONAL SCIENCES 
 
 
 
 
 
 
 
 
 
 
Performance of an intervention based on the Brazilian Dietary Guidelines in the 
treatment of overweight and obese individuals: a randomized clinical trial. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Porto Alegre- RS, Brazil 
April 08, 2025 

 
 
2 
 
SUMMARY 
 
 
 
 
 
1.  
INTRODUCTION ....................................................................................................... 5 
3.  
JUSTIFICATION  ....................................................................................................... 7 
4.  
HYPOTHESIS ............................................................................................................. 7 
5.  
OBJECTIVES  ............................................................................................................. 7 
5.1  
General objectives: ........................................................................................................ 7 
5.2  
Specific objectives:  ....................................................................................................... 7 
6.  
Ethical Aspects  ............................................................................................................ 8 
7.  
METHODOLOGY  ..................................................................................................... 8 
7.1  
Study design  .................................................................................................................. 8 
7.2  
Characterization of the study population and sampling  ................................................ 8 
7.2.1  Sample size calculation  ............................................................................................... 8 
7.2.2  Sampling  ...................................................................................................................... 9 
7.2.3  Randomization and concealment of the allocation list  ............................................ 9 
7.3  
Outcomes  ...................................................................................................................... 9 
7.3.1  Primary outcomes  ....................................................................................................... 9 
7.3.2  Secondary outcomes .................................................................................................. 10 
7.4  
Study Procedures  ........................................................................................................ 10 
7.4.1  Control group procedures  ........................................................................................ 11 
7.4.2  Intervention group procedures  ................................................................................ 12 
7.5  
Sociodemographic ....................................................................................................... 14 
7.6  
Anthropometric  ........................................................................................................... 14 
7.7  
Behavioral and Lifestyle  ............................................................................................. 16 
7.8  
Assessment of food consumption  ............................................................................... 17 
7.9  
Evaluation of biochemical tests  .................................................................................. 17 
8.  
STATISTICAL ANALYSIS  .................................................................................... 17 
9.  
SCHEDULE ............................................................................................................... 18 
10.  
BUDGET  .................................................................................................................... 19 
REFERENCES  ...................................................................................................................... 20 
APPENDIX A  ........................................................................................................................ 23 
 
 

 
 
3 
 
SUMMARY 
Introduction: The global increase in obesity implies the need to develop and evaluate 
treatment strategies aligned with national food and nutrition guidelines. The causes are 
multifactorial and require integrated health actions. Food and Nutrition Education aims to 
promote the autonomous and voluntary practice of healthy eating habits, which can directly 
impact diet quality and health profile. The Dietary Guidelines for the Brazilian Population are 
one of the main instruments guiding FNE actions in the country. 
Objective: To evaluate the effect of a Dietary Guidelines for the Brazilian Population -based 
intervention on diet quality and clinical parameters in overweight and obese individuals. 
Methodology: A Randomized clinical trial to compare the effect of a GAPB-based 
intervention (intervention group - IG) vs. standard individual nutritional follow-up (control 
group - CG). The control group (CG) will receive individual nutritional counseling, and the 
intervention group (IG) will receive guidance in group activities based on the recommendations 
of the Dietary Guidelines for the Brazilian Population. The study will include adult individuals 
of both sexes diagnosed with overweight and obesity, as defined by Body Mass Index. 
Participants will be assessed before and after the interventions using food consumption 
questionnaires and the eating practices scale, along with anthropometric, sociodemographic, 
and lifestyle data. 
 
Keywords: Food and nutrition education; overweight; obesity; Hospital Outpatient Clinic. 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
4 
 
LIST OF ABBREVIATIONS 
CT  
 
Total Cholesterol 
GC  
 
Control Group 
GI  
 
Intervention Group 
HDL   
High-density lipoproteins High-density lipoprotein 
BMI   
Body Mass Index 
IPAQ   
International Physical Activity Questionnaire 
LDL   
Low-density lipoproteins 
CRP   
C-reactive protein 
SISVAN  
Food and Nutritional Surveillance System 
SUS   
Unified Health System 
TG  
 
Triglycerides 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
5 
 
1. INTRODUCTION 
Obesity is a growing public health problem, affecting more than one billion people 
worldwide. In Brazil, the percentage of overweight and obese people is 57.7%, encompassing 
more than half of the population (1). The southern region of Brazil also shows a significant 
increase, with the percentage of overweight people rising from 19.83% to 27.6% from 2019 to 
2023. The city of Porto Alegre, capital of Rio Grande do Sul, is the second-largest city in Brazil, 
with the highest percentage of overweight adults, at approximately 62.2% (2–4). Given these 
rising epidemiological data, it is estimated that by 2035, more than 4 billion people will be 
overweight and obese globally (5). 
Another relevant aspect concerns the economic impact of chronic non-communicable 
diseases on the Brazilian Unified Health System (SUS), where approximately $ 654 million is 
spent annually, representing 22% of all direct health costs in Brazil. This is attributable to high 
Body Mass Index (BMI), demonstrating the urgent need for effective public policies to control 
overweight and obesity (6). 
Overweight and obesity are characterized by the abnormal or excessive accumulation 
of adipose tissue, which poses a greater risk of health complications (7). Recognized as a 
multifactorial condition, obesity presents important behavioral risk factors, evidenced by 
inadequate habits (8). Thus, a major influence on this health condition is the modern lifestyle, 
which is mostly based on unfavorable behaviors such as a sedentary lifestyle, stress, inadequate 
eating habits, alcohol, and smoking (9). 
It is also observed that dietary practices in this current lifestyle have undergone a 
transition from the use of unprocessed and minimally processed foods to the incorporation of 
ultra-processed foods, a practice common in countries with both higher and lower 
socioeconomic development (10). This behavior can be observed according to reports from 
SISVAN Web, which show that the prevalence of ultra-processed food consumption in Brazil 
was 70% among adults in 2024 (11). Several studies have pointed to the health risks associated 
with the consumption of ultra-processed foods, with a high level of evidence linking them to 
being overweight and obesity, in addition to evidence from experimental studies (12,13). 
Primary treatments for obesity include dietary modifications, increased physical 
activity, behavioral changes, and, when necessary, medication and surgical interventions. 
(14)From a nutritional standpoint, it is evident that a diverse, balanced, and healthy diet is 
essential for the prevention and control of chronic non-communicable diseases. Therefore, it is 
essential to include food and nutrition education initiatives to promote healthy eating, support 

 
 
6 
 
regional habits, reduce food waste, and foster sustainability (15).   
The inclusion of Nutrition Education as part of the treatment for overweight and obesity 
is an important tool for promoting autonomy in both the development of culinary skills and 
food choices. It also encourages self-care and dialogue between the individual and healthcare 
professionals, in a continuous and prolonged manner (Brazil, 2018), to provide an environment 
of mutual support, with greater exchange of knowledge, optimization of working time, and 
ample opportunities for use in community spaces and... better health education (16). 
Based on the information presented, it is evident how important it is to develop nutrition 
education actions for overweight and obese individuals, aiming to promote knowledge about 
healthy eating and improve the quality of life of this population. Therefore, the objective of 
this research is to evaluate the effects of an intervention based on the Dietary Guidelines for 
the Brazilian Population in overweight and obese patients treated in a hospital outpatient clinic. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
7 
 
2. JUSTIFICATION 
 
Evidence in the literature has indicated a growing and consistent relationship between 
the consumption of ultra-processed foods and overweight and obesity. In this sense, there is a 
perceived need to evaluate the performance of methods for treating overweight and obesity that 
are aligned with the Dietary Guidelines for the Brazilian Population and, consequently, with 
contemporary national guidelines. 
 
Based on this, this research is justified by the need to investigate nutritional monitoring 
methods to deepen understanding of how effective collective actions can improve food 
consumption, clinical parameters, and adherence to treatment, with the aim of enhancing the 
nutritional treatment of overweight and obese individuals. 
 
3. HYPOTHESIS 
 
Overweight and obese individuals seen in outpatient settings who participate in a group-
based intervention can achieve the same benefits in improved food consumption and clinical 
and anthropometric parameters as those in standard individual follow-up. 
 
4. OBJECTIVES 
4.1 General objectives: 
To evaluate the performance of an intervention based on the Dietary Guidelines for the 
Brazilian Population regarding food consumption and clinical parameters in overweight and 
obese individuals. 
4.2 Specific objectives: 
 To characterize the studied population according to sociodemographic, behavioral, and 
lifestyle data, such as sex, gender, age group, average family income, education level, 
physical activity, smoking, alcohol consumption, medications used, and associated 
comorbidities, among other data relevant to the research, through a specific questionnaire. 
 To assess and compare patients' food consumption according to the NOVA food 
classification before and after the interventions. 
 Analyze and compare dietary practices according to the Dietary Guidelines for the 
Brazilian Population using the dietary practices scale before and after the interventions. 

 
 
8 
 
 Analyze and compare laboratory tests, such as fasting blood glucose, glycated hemoglobin, 
uric acid, triglycerides, total cholesterol, LDL cholesterol, HDL cholesterol, and C-reactive 
protein, before and after the interventions. 
 To evaluate individuals' anthropometric data according to weight, BMI, and waist 
circumference before and after the interventions. 
 To identify and evaluate participation in treatment based on participant attendance and 
changes in nutritional (anthropometric) parameters, and diet quality. 
 To analyze the participants' level of motivation toward the outcome of weight loss using 
the transtheoretical model of change, before and after the interventions. 
5. ETHICAL ASPECTS 
The study will be submitted to the Research Ethics Committee of the Santa Casa de 
Misericordia de Porto Alegre (ISCMPA) and the Federal University of Health Sciences of 
Porto Alegre (UFCSPA) for review through the Plataforma Brazil platform and can only begin 
after obtaining written approval of the protocol and the Informed Consent Form (ICF). 
The study will be conducted according to the recommendations of the International Good 
Clinical Practice guidelines (17), the updated version of the Declaration of Helsinki (WMA, 
2024), and in accordance with Brazilian Resolution RDC 466/2012 and all its complementary 
regulations (19). 
 
6. METHODOLOGY  
6.1 Study design  
This is a randomized, parallel-group, open-label clinical trial with a 1:1 allocation, designed 
according to the Standard Protocol Items: Recommendations for Interventional Trials (20)and 
will be reported in accordance with the guidelines of the Consolidated Standards of Reporting 
Trials (21), and will be registered in the Brazilian Registry of Clinical Trials (ReBEC), through 
the website http://www.ensaiosclinicos.gov.br.  
 
6.2 Characterization of the study population and sampling.  
6.2.1 Sample calculation 

 
 
9 
 
The sample size calculation was performed using G*Power 3.1.9.7. The sample size 
was calculated to estimate an effect size of f=0.2 (corresponding to Cohen's d=0.4), as 
suggested by Brysbaert. A significant level of 0.05 and 80% power will be adopted, requiring 
52 participants (26 per group). An additional 15% will be added to account for potential loss 
to follow-up. Therefore, the sample will consist of 60 participants, with 30 participants per 
group (22). 
 
6.2.2 Sampling 
The sampling will be non-probabilistic, non-purposive, and convenience based. It will 
consist of adult individuals under follow-up at the Endocrinology Service of the Santa Casa de 
Misericordia de Porto Alegre. Individuals will be invited to participate in the study and answer 
the questionnaires. 
 
6.2.3 Randomization and concealment of the allocation list 
The randomization list will be generated electronically by validated software, with a 
1:1 allocation ratio. The researchers responsible for including individuals will access the study 
website and complete a simple clinical form to generate that patient's randomization. The 
randomization performed by the system developed for this study will be characterized as 
central randomization, which ensures the confidentiality of the randomization list, so that the 
researchers do not know which group the patient will be allocated to. 
 
6.3 OUTCOMES 
6.3.1 Primary outcomes 
6.3.1.1 Food consumption according to the NOVA food classification 
Dietary intake will be assessed using the 24-hour dietary recall available on the Quest Nova 
platform. This instrument consists of 58 items featuring common foods in the Brazilian diet; 
participants indicate whether they consume each item using dichotomous (yes/no) responses. 
The estimated completion time for the questionnaire is 15 minutes. This tool enables the 
identification of both quantitative and qualitative aspects of the participants' dietary habits. To 
ensure a representative average intake, the assessment will be administered twice within the 
same week, once at baseline (pre-intervention) and once post-intervention. 

 
 
10 
 
6.3.1.2 Dietary practices in accordance with the GAPB. 
Adherence to healthy eating practices will be measured using the Dietary Practice Scale based 
on the Dietary Guidelines for the Brazilian Population. This validated, self-administered 
instrument consists of 24 statements regarding healthy dietary habits as recommended by the 
guidelines. For each statement, participants indicate their level of adherence using a 4-point 
Likert scale ranging from "Strongly Agree" to "Strongly Disagree." The scale is a robust tool 
designed to quantify compliance with national dietary recommendations and to evaluate the 
overall quality of food-related behaviors. 
 
6.3.2 Secondary outcomes 
6.3.2.1 Anthropometric measurements: 
Anthropometric measurements will be taken before and after the application of the group 
intervention and individualized care, to allow comparative analyses. Body weight will be 
measured using a standardized scale, and Body Mass Index (BMI) will be calculated by 
dividing weight in kilograms by height in meters squared to determine nutritional status. Waist 
circumference will be measured with a tape measure at established anatomical reference points 
and recorded in centimeters. Waist circumference will help classify metabolic risk, with cutoff 
points of 102 cm for men and 88 cm for women. These measurements provide essential data 
for assessing changes in body composition and associated health risks. 
 
6.3.2.2 Biochemical tests: 
Data on laboratory tests, including fasting blood glucose, glycated hemoglobin, total 
cholesterol, HDL cholesterol, LDL cholesterol, uric acid, triglycerides (TG), and C-reactive 
protein (CRP), will be obtained from participants' medical records. 
 
6.3.2.3 Transtheoretical model of change: 
The Transtheoretical Model, based on the Prochaska Scale, will be used, comprising five stages 
of individual motivation: pre-contemplation, contemplation, preparation, action, and 
maintenance.(23)  
 
6.4 Study procedures 
This study aims to evaluate the performance of an intervention based on the Dietary 
Guidelines for the Brazilian Population, in improving food consumption and clinical 

 
 
11 
 
parameters in overweight individuals. To this end, it will consist of two groups: a control 
group (CG) and an intervention group (IG). Patients will be invited to participate in the study 
during their scheduled appointment at the Metabolic Nutrition Clinic. They will be invited to 
participate after the consultation is completed. Data collection will be carried out through 
interviews by the principal investigator and a trained team. Patients in the control group will 
continue to be monitored at the clinic. The interventions for the control group will be 
conducted in the rooms of UFCSPA. 
The GC will receive standard, individualized outpatient nutritional counseling at the 
Metabolic Nutrition Clinic of the Endocrinology Service of the Irmandade Santa Casa de 
Misericordia de Porto Alegre, comprising four individual monthly consultations. The GI 
group will participate in four group sessions on Food and Nutrition Education, held at the 
Federal University of Health Sciences of Porto Alegre (UFCSPA) campus. These sessions 
will be based on the Dietary Guidelines for the Brazilian Population and the first booklet of 
the series of Protocols for the Use of the Dietary Guidelines for the Brazilian Population. 
There will be no additional costs for participating in these meetings. 
In addition, both groups will receive phone calls or text messages after the start of the 
consultations/collective actions, as well as brochures (educational material) about healthy 
eating. This contract aims to clarify any doubts, reinforce the guidelines, and remind 
participants to attend the meetings. 
6.4.1 Control group 
The control group will receive individualized nutritional care consisting of 4 monthly in-person 
consultations, held at the Metabolic Nutrition Clinic of the Endocrinology Service of the 
Irmandade Santa Casa de Misericordia de Porto Alegre and conducted by a qualified 
nutritionist. Each consultation will last 50 to 60 minutes. 
Individual nutritional care provided in the outpatient clinic follows the principles of 
person-centered care, considering the individual's current health status, lifestyle, cultural 
preferences, adequacy of energy and nutrient intake, and individual circumstances. Realistic 
treatment goals will be defined, such as a 5% to 10% reduction in body weight, with a focus 
on weight-loss maintenance, preservation of lean mass, clinical improvement, and quality of 
life. Therefore, each appointment aims to assess food consumption, identify areas for 
improvement through active listening, propose gradual and realistic changes in diet through 

 
 
12 
 
nutritional guidance, and establish jointly constructed goals for the month leading up to the 
next appointment (8,24).   
During the consultations, topics related to healthy eating will be addressed, as 
recommended by the Dietary Guidelines for the Brazilian Population, aiming to improve the 
quality of food through the NOVA food classification system and recommendations for 
healthy eating practices, respecting the reality of each participant, encouraging autonomy and 
empowerment through information for healthier food choices (25).  
As an informative tool to reinforce the guidelines, participants will receive materials 
with practical recommendations based on the food guide. Furthermore, when the nutritionist 
determines that the dietary prescription will facilitate adherence to the dietary 
recommendations and ensure adequate quantities consumed for weight loss, an individualized 
meal plan will be prescribed, emphasizing the importance of food quality by encouraging the 
consumption of unprocessed and minimally processed foods, respecting the participant's 
socioeconomic conditions, cultural preferences, and appropriate level of readiness for change. 
Therefore, a dietary plan is recommended that involves a reduction of 500 to 1000 
kcal/day, combined with encouragement of higher-quality food. It is worth highlighting that 
care will be provided ethically and without stigmatization, with an understanding of excess 
weight as a multifactorial, complex condition. Therefore, the service is based on a welcoming 
approach through empathetic communication aimed at promoting adherence to treatment and 
the participant's autonomy (8,26).  
 
6.4.2 Intervention group 
Participants in the Intervention Group (GI) will attend four monthly group sessions on Food 
and Nutrition Education (FNE), lasting up to 1 hour for the first three sessions and 2 hours for 
the last. These sessions will be held in person and conducted by the research nutritionist, using 
educational materials and active, interactive teaching-learning methodologies with accessible, 
inclusive, and stigma-free language, aiming to promote participant empowerment in their own 
dietary care. The objective of the sessions is to promote autonomy and empowerment in 
decision-making about food choices, as well as to promote person-centered care by considering 
the participants' social, family, and cultural contexts. It also aims to strengthen the bond 
between professionals and users, and to provide encouragement and support in the process of 
changing habits (27). 

 
 
13 
 
The activities will be based on the guidelines of the Dietary Guidelines for the 
Brazilian Population, which values food as a social and cultural practice and recognizes food 
in its nature and degree of processing as central to healthy choices (25). Therefore, the actions 
will be developed as follows: 
- The first session will last up to one hour and will consist of a roundtable discussion 
for participants to introduce themselves. The goal is to create an environment of listening, 
belonging, and interaction, and to foster bonding among group participants while addressing 
important concepts of proper and healthy eating. This will include a conversation about the 
meanings and importance of healthy eating, and, at the end, a dynamic activity to demystify 
common myths surrounding it. 
- The second session will last up to one hour and will cover the NOVA classification 
of foods according to the Dietary Guidelines for the Brazilian Population, with emphasis on 
the differentiation between unprocessed, minimally processed, processed, and ultra-processed 
foods. The practical activity will involve examples of everyday foods and the identification 
of their corresponding food groups according to the NOVA classification. In addition, the 
recommended proportions for a healthy meal, according to the principles of the Food Guide, 
will be addressed. 
- The third nutritional education session will address food nutritional labeling and 
guidelines for purchasing commercially available foods. Printed examples of food products 
will be used to critically analyze labels and identify the main nutrients associated with health 
risks, such as sodium, sugar, and saturated fat. Real examples of printed food packaging will 
be used for analysis. Furthermore, the discussion will include practical guidance on healthier 
choices in the shopping environment, reinforcing participants' active role in building healthier, 
more conscious eating habits. 
- The fourth session will be a culinary workshop held in the UFCSPA food laboratory, 
lasting up to 2 hours. In this session, healthy, practical, and low-cost recipes will be prepared, 
prioritizing local and culturally appropriate ingredients. The culinary workshop aims to 
promote the development of culinary skills, the revival of homemade recipes, and the 
appreciation of food as a social and pleasurable act. It is expected that the intervention will 
contribute to expanding the dietary repertoire, reducing the consumption of ultra-processed 
foods, and improving the health status of overweight and obese participants. To ensure equal 
benefit for both subgroups, all relevant questions or comments arising from the collective 
actions of one subgroup will be clarified and passed on to the other. 
 

 
 
14 
 
6.5 Sociodemographic data 
will be collected from participants using a questionnaire developed by the researchers 
containing: name, age, date of birth, full address, race (white, black, brown, yellow, and 
indigenous), marital status, education level, occupation, email, and telephone number. This 
data will then be classified according to these criteria: 
Age range: The age will be calculated based on the date of birth provided by the respondent. 
Sex: will be provided by the interviewee and categorized as male and female. 
Gender: will be provided by the respondent and categorized as male, female, non-binary, other 
(with the option to specify) or with the option "prefer not to answer". 
Marital status: will be provided by the interviewee and stratified into single, married/living 
with a partner, divorced, and widowed. 
Family income: the family's financial support will be expressed in absolute terms and 
categorized into tertiles: low, medium, or high. 
Education level: This will be determined by the level of education, such as incomplete 
elementary school, complete elementary school, incomplete high school, complete high 
school, incomplete higher education, or complete higher education. 
 
Occupation: The interviewee will indicate whether they perform any paid productive activity, 
and the work activity will be classified into two categories: works / does not work/retired / 
unemployed / INSS beneficiary/housewife/student or other. 
Health issues: you will be asked about any chronic illnesses or current health conditions. 
6.6 Anthropometric data 
Weight: Will be measured before and after the procedure for comparison purposes, using a 
Welmy Digital Scale with a capacity of 300kg and an accuracy of 100g. The person being 
evaluated should stand barefoot, wearing minimal clothing and accessories, with their arms at 
their sides and their gaze fixed on a point in front of them. The measurement will be recorded 
in kilograms, with two decimal places, on the data collection form. (Brazil, 2011). 

 
 
15 
 
Height: This will be measured using a Tonelli-brand stadiometer. Height will be quantified 
only once before the interventions. The stadiometer will be positioned at A wall without a 
baseboard, forming a right angle with the floor. The person being evaluated should be barefoot 
, with feet together , in an upright position , arms extended along the body, the back of the head, 
shoulders, buttocks, calves, and heels against the wall , and if this is not possible, at least three 
of these factors should be positioned, and the head should be positioned in the Frankfurt 
horizontal plane. The movable part of the equipment will be lowered, fixing it against the head 
with sufficient pressure to compress the hair. Remove the individual when you are certain that 
the person has not moved. The reading will be carried out. without releasing the moving part 
of the equipment, and the measurement will be made in centimeters (28). 
BMI (Body Mass Index): Body mass index (BMI) will be calculated by dividing body weight 
(kg) by height (m) squared and will serve to classify nutritional status (Table 1). The BMI 
values found will be classified according to WHO (2000)... 
BMI 
Classification 
<18.5 
Underweight 
18.5-24.9 
Eutrophic 
25-29.9 
Overweight 
30-34.9 
Grade I Obesity 
35-39.9 
Grade II Obesity 
>40 
Grade III Obesity 
Table 1. Classification of nutritional status (29). 
Waist circumference: This will be measured using the Cescorf brand measuring tape, 
provided by the researchers. Waist circumference will be measured three times. The patient 
should stand upright, with a relaxed abdomen, arms extended along the body, and legs parallel 
and slightly apart. Clothing should be removed to expose the waist area. The researcher will 
make a small mark with a pen at the midpoint between the lower edge of the last rib and the 
hip bone (iliac crest), viewed from the front of the person, on the right or left side. It should be 
verified that the tape measure is at the same level around the waist; it should be neither loose 
nor tight. At the end of a normal exhalation, with an inelastic anthropometric tape measure 
encircling the abdominal region at the midpoint between the lower edge of the last rib and the 
iliac crest, the measurements will be recorded in centimeters on the data collection form. The 

 
 
16 
 
average will be used for metabolic risk classification, with the cutoff point for risk being 102 
cm for men and 88 cm for women (NIH, 1998). 
6.7 Behavioral and lifestyle data 
Some lifestyle data will be collected individually before and after the interventions using a 
questionnaire developed by the researchers to determine whether participants' self-perceptions 
and lifestyle habits have changed. The questionnaires will be produced by the researchers and 
will contain the following topics: 
Smoking: whether the participant is a smoker (smoker / ex-smoker / non-smoker); 
Perception of health status: based on the following question added to the questionnaire 
developed by the researchers: "In general, how do you think your health is?" with answers 
categorized as ' excellent ', ' good ', ' fair ', ' poor '; this question is simple and widely used in 
research for self-assessment of current health status. (IBGE, 2020).The results will be presented 
as percentages. 
 
Treatment attendance: This will be assessed through appointment registration (attendance at 
75% of appointments required). 
Transtheoretical model of change: To better understand how much the participant is 
progressing towards healthier behaviors, the transtheoretical model will be used, based on the 
Prochaska Scale, which is composed of five stages of individual motivation: pre-
contemplation; contemplation; preparation; action; and maintenance (Prochaska; DiClemente; 
Norcross, 1992). At each stage, participants will be asked about the aspect of weight, 
characterized as follows: Pre-contemplation: does not intend to lose weight in the next 6 
months; Contemplation: intends to lose weight in the next 6 months, but without concrete plans 
for the next month; Preparation or Decision: intends to lose weight in the next 30 days; Action: 
has adopted behavioral changes aimed at a healthy weight, but only recently (< 6 months); 
Maintenance: has already adopted behavioral changes aimed at a healthy weight for 6 months 
or more. The scale will be applied to both groups, before and after the study. 
 
Physical activity: Patients will also be asked about their physical activity. For this, the 
International Physical Activity Questionnaire (IPAQ - short version) will be used to determine 
how many times a week participants walk continuously for 10 minutes, how many times a week 

 
 
17 
 
they do light, moderate, and vigorous exercise (stages determined by physical exertion and 
changes in heart rate), and how long they usually spend sitting in a day (32). 
 
Medications used: Participants will be asked about the medications they are using. 
6.8 Assessment of food consumption 
To assess food consumption and eating habits, the R24-Nova and the eating habits scale will 
be used (33,34). 
R24-Nova: The 24-hour dietary recall from the Quest Nova platform will be applied. This 
questionnaire presents 58 questions covering a range of foods commonly found on Brazilian 
tables – participants must indicate whether they consumed each food (yes or no). The estimated 
time to complete the questionnaire is 15 minutes. This tool will enable the identification of both 
quantitative and qualitative aspects of participants' eating habits. It will be applied twice in the 
same week, before and after the interventions, to obtain an average of the results. 
Food Practices Scale of the Dietary Guidelines for the Brazilian Population: The scale will 
be administered. This scale presents 24 statements about healthy eating according to the GAPB. 
For each statement, respondents must indicate whether they incorporate that practice, using a 
4-point Likert scale: "strongly agree"; "agree"; "disagree"; "strongly disagree".  
The Dietary Guidelines for the Brazilian Population Practices Scale is an instrument that 
measures adherence to a healthy diet. This scale of dietary practices, composed of 24 
statements, is a self-administered, validated, and useful tool for evaluating adherence to dietary 
practices according to the GAPB recommendations (35). This scale is used by the Ministry of 
Health to compose the brochure "How is your diet?", a material that assesses the level of 
adherence to healthy dietary practices (34). 
 
6.9 Evaluation of biochemical tests 
Data regarding laboratory tests, including fasting blood glucose, glycated hemoglobin, total 
cholesterol, HDL cholesterol, LDL cholesterol, uric acid, TG (triglycerides), and CRP (C-
reactive protein), will be found in the medical records. 
STATISTICAL ANALYSIS 

 
 
18 
 
The results for qualitative variables will be presented as frequencies and percentages, 
symmetrical quantitative variables as means and standard deviations, and asymmetrical 
quantitative variables as medians and interquartile ranges [P25-P75]. 
Normality will be verified using the Shapiro-Wilk test. Groups will be compared using the Chi-
square test, Fisher's exact test, Mann-Whitney test, and Student's t-test, according to the nature 
and distribution of the data. To evaluate the effects of the interventions, a repeated measures 
mixed ANOVA will be applied, or, in case of absence of normality and/or losses, GEE 
(Generalized Estimating Equations) models will be used to evaluate the main effects of group 
and time point assessed, and the group*time interaction, with Sidak's test for multiple 
comparisons. Results will be presented as mean and confidence interval. 95%. 
The analyses will be performed using SPSS (IBM SPSS Statistics for Windows, Version 25.0; 
Armonk, NY: IBM Corp.). The significance level adopted will be 0.05, and comparisons will 
be considered significant when p < 0.05. 
For statistical calculation of treatment adherence, attendance will be considered using the 
following formula: number of appointments held / total number of appointments scheduled X 
100. 
The data collected will be stored in a database, with any information that could identify omitted 
participants. 
7. TIMELINE 
Period : January 2025 to December 2026 
 
  
J F M A M J J A S O N D J F M A M J J A S O N D
Literature Review 
 
 
 
 
 
Project development 
x
 
 
 
 
 
Submission to the Ethics 
Committee
x x x
 
 
 
 
 
Recruitment of participants
 
 
 x x x
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data collection 
x x x x x x x x x x x x x x x x x x
 
 
 
Development of actions in 
the GC and GI
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 x x x x
 
 
 
 
Data tabulation 
x x x x x x x x x x x x x x x x x
 
 
 
Statistical analysis 
 
 x x
 

 
 
19 
 
Article Writing 
 
 
 x
 
Revision 
 
 
 
 x
Presentation 
 
 
 
 x 
Announcement of results 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 x
 
8. BUDGET 
Item 
Amount
Justification 
Unit Price 
Total 
value 
A4 sheets 
1500 
Printouts of informed consent 
forms and questionnaires. 
13.90 (500 
units) 
41.70 
Ballpoint pen 
5 
Used for completing 
questionnaires and informed 
consent forms.
0.80 
4.00 
Black ink cartridge 
2 
Printouts of informed consent 
forms and questionnaires. 
21.90 
43.80 
Measuring tape 
1 
Used for anthropometry. 
52.00 
52.00 
Ingredients for 
culinary activity 
1 
Activity in the intervention 
group 
500.00 
500.00 
Expenses for 
transporting 
participants 
300 
Reimbursement for the 30 
patients of 
The intervention group 
attended 4 group activity 
sessions in 
UFCSPA
5.00 
3000 
Total: R$ 1841.50 
Note: The researcher will be responsible for the costs. 
 
 
 
 
 
 

 
 
20 
 
REFERENCES 
1. 
Brasil. Cenário da obesidade no Brasil. Vol. 54. 2024. Report. 
2. 
Pan American Health Organization. One in eight people are now living with obesity. 
2024. 
3. 
Phelps NH, Singleton RK, Zhou B, Heap RA, Mishra A, Bennett JE, et al. Worldwide 
trends in underweight and obesity from 1990 to 2022: a pooled analysis of 3663 
population-representative studies with 222 million children, adolescents, and adults. The 
Lancet. 2024 Mar 16;403(10431):1027–50. doi:10.1016/S0140-6736(23)02750-2 
PubMed PMID: 38432237. 
4. 
Brasil. Ministério da Saúde. Vigitel Brasil 2021: vigilância de fatores de risco e proteção 
para doenças crônicas por inquérito telefônico: estimativas sobre frequência e 
distribuição sociodemográfica de fatores de risco e proteção para doenças crônicas nas 
capitais dos 26 estados brasileiros e no Distrito Federal em 2021. Brasília: Ministério da 
Saúde, 2021. 2022. p. 131. 
5. 
World Obesity Federation. World Obesity Atlas 2023 [Internet]. 2023. Report. 
Available from: www.johnclarksondesign.co.uk 
6. 
Giannichi B, Nilson E, Ferrari G, Rezende LFM. The projected economic burden of non-
communicable diseases attributable to overweight in Brazil by 2030. Public Health. 
2024 May 1;230:216–22. doi:10.1016/j.puhe.2024.02.029 PubMed PMID: 38579649. 
7. 
World Health Organization. Obesity and overweight [Internet]. 2024 [cited 2024 Dec 
6]. Available from: https://www.who.int/news-room/fact-sheets/detail/obesity-and-
overweight 
8. 
ABESO. POSICIONAMENTO SOBRE O TRATAMENTO NUTRICIONAL DO 
SOBREPESO E DA OBESIDADE DEPARTAMENTO DE NUTRIÇÃO DA 
ASSOCIAÇÃO BRASILEIRA PARA O ESTUDO DA OBESIDADE E DA 
SÍNDROME METABÓLICA. 2022. 
9. 
Balwan WK, Kour S. Lifestyle Diseases: The Link between Modern Lifestyle and 
Threat to Public Health. Saudi Journal of Medical and Pharmaceutical Sciences. 2021 
Apr 6;7(4):179–84. doi:10.36348/sjmps.2021.v07i04.003 
10. 
Baker P, Machado P, Santos T, Sievert K, Backholer K, Hadjikakou M, et al. Ultra-
processed foods and the nutrition transition: Global, regional and national trends, food 
systems transformations and political economy drivers. Obesity Reviews. Blackwell 
Publishing Ltd; 2020. doi:10.1111/obr.13126 PubMed PMID: 32761763. 
11. 
SISVAN. Relatório do Consumo Alimentar dos indivíduos acompanhados por período, 
fase do ciclo da vida e índice [Internet]. 2024 [cited 2024 Dec 11]. Available from: 
https://sisaps.saude.gov.br/sisvan/relatoriopublico/index 
12. 
Lane MM, Gamage E, Du S, Ashtree DN, McGuinness AJ, Gauci S, et al. Ultra-
processed food exposure and adverse health outcomes: umbrella review of 
epidemiological meta-analyses. BMJ. 2024 Feb 28;e077310. doi:10.1136/bmj-2023-
077310 
13. 
Hall KD, Ayuketah A, Brychta R, Cai H, Cassimatis T, Chen KY, et al. Ultra-Processed 
Diets Cause Excess Calorie Intake and Weight Gain: An Inpatient Randomized 

 
 
21 
 
Controlled Trial of Ad Libitum Food Intake. Cell Metab. 2019 Jul;30(1):67-77.e3. 
doi:10.1016/j.cmet.2019.05.008 
14. 
Shauna M. Levy, Michelle Nessen. 2023 [Internet]. 2023 [cited 2024 Dec 14]. 
Obesidade. 
Available 
from: 
https://www.msdmanuals.com/pt/profissional/dist%C3%BArbios-
nutricionais/obesidade-e-s%C3%ADndrome-metab%C3%B3lica/obesidade 
15. 
Brasil. 
MARCO 
DE 
REFERÊNCIA 
DE 
EDUCAÇÃO 
ALIMENTAR 
E 
NUTRICIONAL PARA AS POLÍTICAS PÚBLICAS [Internet]. Ministério do 
Desenvolvimento Social e Combate à Fome, Secretaria Nacional de Segurança 
Alimentar e Nutricional, editors. 2012 [cited 2024 Dec 12]. Available from: 
https://www.cfn.org.br/wp-content/uploads/2017/03/marco_EAN.pdf 
16. 
Brasil.INSTRUTIVO DE ABORDAGEM COLETIVA PARA MANEJO DA 
OBESIDADE NO SUS [Internet]. 2021 [cited 2024 Dec 21]. Available from: 
http://189.28.128.100/dab/docs/portaldab/publicacoes/instrutivo_abordagem_coletiva.
pdf 
17. 
Organiação Mundial de Saúde. Boas Práticas Clínicas: Documento das Américas 
República Dominicana 2-4 de Março de 2005. 2005. Report. 
18. 
World Medical Association. WMA Declaration of Helsinki - Ethical Principles for 
Medical Research Involving Human Participants. 2024. Report. 
19. 
Conselho Nacional de Saúde. RESOLUÇÃO No 466, DE 12 DE DEZEMBRO DE 2012. 
2012. 
20. 
Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 
2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 
Jan 9;346(jan08 15):e7586–e7586. doi:10.1136/bmj.e7586 
21. 
Schulz KF, Altman DG, Moher D. CONSORT 2010 Statement: updated guidelines for 
reporting parallel group randomised trials. BMC Med. 2010 Dec 24;8(1):18. 
doi:10.1186/1741-7015-8-18 
22. 
Brysbaert M. How Many Participants Do We Have to Include in Properly Powered 
Experiments? A Tutorial of Power Analysis with Reference Tables. J Cogn. 2019 Jul 
19;2(1). doi:10.5334/joc.72 
23. 
Prochaska JO, Diclemente CC, Norcross JC. In Search of How People Change 
Applications to Addictive Behaviors. 1992. Report. 
24. 
Brasil. Instrutivo de Abordagem Individual para Manejo da Obesidade no SUS 
[Internet]. 2024. Available from: https://aps.saude.gov.br/ 
25. 
Ministério da Saúde. Guia Alimentar para a População Brasileira [Internet]. 2014. 
Available from: www.saude.gov.br/bvs 
26. 
Brasil. Portaria SCTIE/MS no 53, de 11 de novembro de 2020. Aprova o Protocolo 
Clínico e Diretrizes Terapêuticas de Sobrepeso e Obesidade em Adultos. [Internet]. 2020 
Nov. Report. Available from: http://conitec.gov.br/. 
27. 
Ministério da Saúde. Manual de atenção às pessoas com sobrepeso e obesidade no 
âmbito da atenção primária (APS) do Sistema Único de Saúde [Internet]. 2022. 
Available from: http://bvsms.saude.gov.br/bvs/publicacoes/manual_atencao_pessoas_ 
28. 
Brasil. Orientações para a coleta e análise de dados antropométricos em serviços de 
saúde 
[Internet]. 
2011 
[cited 
2025 
Jan 
13]. 
Available 
from: 

 
 
22 
 
https://bvsms.saude.gov.br/bvs/publicacoes/orientacoes_coleta_analise_dados_antropo
metricos.pdf 
29. 
WHO. WHO Technical Report Series OBESITY: PREVENTING AND MANAGING 
THE GLOBAL EPIDEMIC. 2000. 
30. 
National Institutes of Health. Clinical Guidelines on the Identification, Evaluation, and 
Treatment of Overweight and Obesity in Adults: Executive Summary. Am J Clin Nutr. 
1998 Oct;68(4):899–917. doi:10.1093/ajcn/68.4.899 
31. 
IBGE. Pesquisa Nacional de Saúde 2019. 2020. 
32. 
Matsudo S, Araujo T, Matsudo V, Andrade D. QUESTIONARIO INTERNACIONAL 
DE 
ATIVI 
DADE 
FISICA 
(I 
PAQ): 
ESTUDO 
DE 
VAll 
DADE 
E 
REPRODUTIBILIDADE NO BRASIL INTERNATIONAL PHYSICAL ACTIVITY 
QUESTIONNAIRE (lPAQ): STUDY OF VALIDITY AND RELIABILITY IN 
BRAZIL. 2001. Report. 
33. 
Louzada ML da C, Souza TN, Frade E, Gabe KT, Patricio GA. QuestNova: inovação na 
avaliação do consumo alimentar segundo o processamento industrial. Rev Saude 
Publica. 2024 Nov 21;58(1):38. doi:10.11606/s1518-8787.2024058006307 
34. 
Brasil. COMO ESTÁ A SUA ALIMENTAÇÃO? [Internet]. 2018 [cited 2025 Jan 20]. 
Report. 
Available 
from: 
http://189.28.128.100/dab/docs/portaldab/publicacoes/guiadebolso_folder.pdf 
35. 
Gabe KT, Jaime PC. Development and testing of a scale to evaluate diet according to 
the recommendations of the Dietary Guidelines for the Brazilian Population. Public 
Health Nutr. 2019 Apr 1;22(5):785–96. doi:10.1017/S1368980018004123 PubMed 
PMID: 30744711. 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
23 
 
1. APPENDIX A 
FREE AND INFORMED CONSENT FORM (TCLE) 
Study title: “Performance of a dietary guide-based intervention for the Brazilian population in the 
treatment of overweight and obese individuals: a randomized clinical trial” 
You are invited to participate in the study " Performance of an intervention based on the dietary 
guidelines for the Brazilian population in the treatment of overweight and obese individuals: a 
randomized clinical trial". 
Before agreeing to participate, it is important that you understand the objectives of this research 
and clarify any doubts you may have. Participation in this study is entirely voluntary, and if you 
agree to participate, you will receive a signed copy of this document, which contains all the 
explanations. Please read the information carefully and feel free to ask any questions that come to 
mind. You may discuss this study with the rest of your family, friends, or your doctor before giving 
your consent. You have the full right to refuse to participate. If you choose to withdraw your consent 
to the study after agreeing to participate, you have the right to do so at any time. If you decide to 
leave the study, please inform the study team. A final consultation with the researchers may be 
scheduled to answer your questions and conclude your participation in the study. 
In this study, we aim to evaluate the effect of a form of dietary counseling on the nutritional 
treatment of overweight and obese individuals. In this way, we can foster healthy eating habits, 
improving the health and quality of life for these people. 
1) How many participants are in the study, and how long will my participation last? We 
expect to include 60 individuals in this study. Your participation will last 5 months. 
2) What are the study interventions? You will be randomly assigned to one of the two study 
groups. Neither you nor the attending professional will be able to choose which group you are 
assigned to. 
 If you are selected for group 1: You will receive monthly individual consultations based 
on established guidelines and recommendations from the Dietary Guidelines for the 
Brazilian Population, conducted in an outpatient setting. You will then be required to 
follow the nutritionist's recommendations for 4 months. 
 If you are selected for group 2: You will participate in group sessions developed by a 
nutritionist based on the recommendations of the Dietary Guidelines for the Brazilian 
Population, held on the UFCSPA campus (Federal University of Health Sciences of 
Porto Alegre). You will then be invited to follow the proposed recommendations for 4 
months. 
 During the 5 months of the study, you may receive phone calls, text messages, or emails 
from the research team, who will be able to answer questions, remind you to follow 
recommendations, and remind you to attend your scheduled appointment. 

 
 
24 
 
What are the study procedures? By agreeing to participate in this study, you will be asked to 
complete two data collection periods: one before and one after the intervention. Therefore, during 
the first and last consultations, we would like to ask for your authorization to collect the following 
data: 
 Weight, height, and waist circumference. 
 Two questionnaires to assess your food consumption and eating habits. 
 Application of questions regarding your level of motivation for weight loss. 
 A questionnaire to characterize the frequency and intensity level of physical activity 
performed. 
 Data from your medical record regarding blood tests (fasting blood glucose, glycated 
hemoglobin, uric acid, triglycerides, total cholesterol, LDL cholesterol, HDL cholesterol, 
and C-reactive protein). 
 
The data listed above will be collected to compile the analyses necessary for the study. Therefore, 
throughout these procedures, your data will be completely private. If any questions during this 
collection cause you any embarrassment or discomfort, you do not need to answer them. 
Furthermore, throughout the study you will receive phone calls or messages after the start of the 
group consultations/actions. This contract aims to clarify any doubts, reinforce the guidelines, and 
remind you to attend the meetings. 
3) Who will have access to my information? All information collected in this research or obtained 
through medical records will be confidential, and only the study team will have access. At no time 
will your name or any information about your health be provided to anyone who is not a member 
of the study team. The information will be confidential and used only for the purposes of this 
research. The study results will be released for academic and scientific purposes without identifying 
any data that could reveal the participants' identities. 
4) What are my responsibilities? Over the next 5 months, you will attend the study site once for 
initial data collection, then every 30 days for 4 months for consultations/group sessions, and once 
at the end of the study for data collection. Each time you attend, you will need to sign the attendance 
list; this information will also be important for the study. 
5) It is important that you attend all appointments/group sessions so that the study team can check 
your health and collect the data needed for this study. 
6) What are the possible risks of participating in this study? You will be subject to minimal risks. 
If you do not feel comfortable answering any questions or performing the measurements, you do 
not need to do so. 
7) At any time, you can contact the researchers of this study by telephone. The person responsible for 
the research is Fernanda Michielin Busnello, and she can be contacted at (51) 3303-8867. 
If you experience any symptoms, especially weakness or a feeling of faintness, you will be referred 
for treatment at the Porto Alegre Emergency Hospital, under the researchers' responsibility. 

 
 
25 
 
8) What are the potential benefits? Your participation in this research will help evaluate the effects 
of two nutritional monitoring methods. We hope that your data, collected during this study, will 
provide valuable insights into science and may benefit overweight and obese individuals in the 
future. 
9) Will I be paid or reimbursed for participating in the study? Individuals participating in the 
group activities, which will be held in the classrooms of the Federal University of Health Sciences 
of Porto Alegre (UFCSPA), will receive a reimbursement of 10 reais for transportation expenses 
per meeting (5 reais for the trip there and 5 reais for the return trip). This amount will be paid on 
meeting days via Pix transfer, TED (Electronic Transfer Available), or in cash, at the participant's 
preference. 
10) viduals participating in the group activities, which will be held in the classrooms of the Federal 
University of Health Sciences of Porto Alegre (UFCSPA), will receive a reimbursement of 10 reais 
for transportation expenses per meeting (5 reais for the trip there and 5 reais for the return trip). 
This amount will be paid on the meeting days via Pix transfer, TED (Electronic Transfer Available), 
or in cash, according to the participant's preference. 
11) Will I be compensated for damages related to the study? You will be guaranteed the necessary 
assistance throughout your participation in the study, and all your rights will be maintained, 
including guarantees of compensation for any damage arising from the research, during your 
participation and until the conclusion of this project. 
12) Contact in case of questions or emergencies: This study was approved by the Ethics and Research 
Committee of the Santa Casa de Misericórdia de Porto Alegre (ISCMPA) and the Federal 
University of Health Sciences of Porto Alegre (UFCSPA). The Ethics Committee is a group that 
conducts the ethical review of the study to maintain your safety and protect your rights. The study 
team is available to provide any clarifications before, during, and after the study. 
Contact information: 
- Research Ethics Committee of the Santa Casa de Misericordia de Porto Alegre (ISCMPA). Av. 
Osvaldo Aranha, 80, Room 17. Historic Center neighborhood. Postal Code: 90035-190 - Porto 
Alegre/RS. Telephone: 51 3214-8571. Email: cep@santacasa.tche.br. Public service hours: 09:00 
to 12:00 hours - 13:30 to 17:00 hours. 
- Research Ethics Committee of the Federal University of Health Sciences of Porto Alegre. Rua 
Sarmento Leite, 245, Building 3, Room 605. Postal Code: 90050-170 - Porto Alegre/RS. Tel 51 
3303-8804. Email: cep@ufcspa.edu.br. Public. Service Hours: 8:00 AM to 12:00 PM / 1:00 PM to 
5:00 PM. 
Principal Investigator: Fernanda Michielin Busnello, e-mail: fernandab@ufcspa.edu.br, Telephone: 
(51) 33038867. Address: Rua Sarmento Leite, 245, Building 3, room 507. Postal Code: 90050-170 
- Porto Alegre/RS 
You will be provided with any information that is discovered during the study that may influence 
your decision to continue participating. 

 
 
26 
 
YOUR AGREEMENT TO PARTICIPATE IN THE SURVEY 
This Informed Consent Form is prepared in duplicate. All pages must be initialed and signed (at the 
end) by the person invited to participate in the research or by their legal representative/guardian, 
and by the responsible researcher or by a person delegated by them. 
Based on the information in this document, I voluntarily agree to participate in this research 
because: 
I received a full explanation of the research. 
I have read and understood this document. 
All my doubts have been clarified. 
I grant access to my medical records, and the researcher has assured me that the information will 
be treated confidentially, securely, and anonymously. 
I voluntarily agree to participate in this research as described and understand that I may withdraw 
my consent at any time during the research without prejudice. 
I received a signed copy of this document. 
 
Therefore, in agreement, I have initialized all pages and signed this document, with one copy 
remaining in my possession. 
 
 
Porto Alegre, _____/_____/_____ (Location, day, month and year) 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
27 
 
______________________________________________________________________ 
Name of the research participant in block letters. 
 
 
 
__________________________________________  
 
 
______/_____/_____   
Participant's signature  
 
 
 
 
 
 
Date 
 
 
Researcher 
I, Fernanda Michielin Busnello (principal investigator), explained the study objectives, procedures, 
and potential risks and benefits to the research participant indicated above, answered all questions 
asked, and obtained their voluntary consent to participate. I confirm that I will comply with all 
requirements set forth in CNS Resolution No. 466 of 2012, items IV.3 and IV.4, during the process 
of obtaining the participant's voluntary consent for this research and during the conduct of the study. 
 
Porto Alegre, _____/_____/_____ (Location, day, month and year) 
 
 
 
______________________________________________________________________ 
Researcher's name 
 
 
 
__________________________________________  
 
 
______/_____/_____  
Researcher's signature  
 
 
 
 
 
 
Date