Use of Web as a Tool to Promote Weight Loss in Overweight and Obese Adults
Phase: NA
Conditions: Obesity, Overweight
Sponsor: Federal University of Minas Gerais

 
 
 
 
 
 
Online Platform for Healthy Weight Loss (POEmaS) 
 
 
 
 
 
 
 
 
 
 
 
February 9th, 2018 
 

 
STUDY PROTOCOL 
Design  
This is a three-arm parallel randomized controlled trial which recruited adults (18-60 
years) participants classified as overweight or obese (body mass index – BMI >=25 
kg/m2)  and who had the intention to lose weight.  
Participants and recruitment 
Students (current and past) and staff of the Federal University of Minas Gerais 
(UFMG), Belo Horizonte, in the southern Brazil, were recruited by physical and online 
advertising (flyers, University website, UFMG mailing list) for one month from the 25th 
September to 24th October, 2017. They were invited to access the project website 
www.poemasufmg.com.br, where they can watch a video with details of the project. 
Interested participants can join the project online and create an account profile after 
checking for the inclusion and exclusion criteria (Table 1) and signing the informed 
consent form. Participants excluded from the study can reference colleagues by entering 
their email. 
Table 1- Inclusion and exclusion criteria for recruitment into “POEmaS (Online 
Platform for healthy weight loss)” Randomized Clinical Trial 
Inclusion criteria 
Exclusion criteria 
Age between 18 and 60 years  
 
Pregnancy 
BMI* >=25 kg/m2 
Self-report of comorbidities that demand 
specific dietary or physical activity 
recommendations- diabetes, heart failure, 
coronary artery disease, kidney disease, 
hepatic disease, cancer, phenylketonuria, 
celiac disease, food allergies, bariatric 
surgery history 
Intention to lose weight by changes in Participation in any other weight loss 

lifestyle habits 
program 
Internet access  
 
* BMI: Body mass index 
 
Randomization and allocation 
Once informed consent was obtained, participants were randomly allocated to one of the 
three groups using a stratified randomized block design. Participants were stratified by 
gender and category of body mass index (25 to <30 or ≥30 kg/m2) using blocks of 
variable length (either 3 or 6).  
Participants were initially allocated to one of three groups: 
(1) Group 1, control group which is submitted to an initial minimal intervention for 24 
weeks and subsequently will have access to all the platform functionalities; 
(2) Group 2 will follow a standard weight loss program delivered by the website 
platform for 24 weeks; 
(3) Group 3 followed the standard weight loss program enhanced by personalized 
feedback by a nutritionist based on lifestyle habits reported in the platform for 12 weeks 
and the standard weight loss program for the following 12 weeks. 
Subsequently, subjects received an automatic email with detailed information on the 
groups they were allocated to.  Researchers were blinded to participants´ allocation. 
Outcome measures 
All outcomes will be assessed at baseline, 12 and 24 weeks afterwards. Weight and 
BMI change are the primary outcomes of the study and will be self-reported by the 
participants. Secondary outcomes will be changes in dietary habits, food-related 
behaviors, physical activity habits, sedentary behaviors, quality of life, health 
perception, online activity and users´ satisfaction, as detailed in Table 2. Outcome 
assessors will be blinded to group allocation. 
 
Sample size 

Based on a 90% power to detect a significant difference of 4kg weight loss between 
groups, assuming the SD of weight is 6.0 and using a two-sided significance level of 
0.05, and a 40% attrition rate, a sample size of 90 participants was calculated for each 
group.  
Interventions 
The interventions will be delivered online for 24 weeks, with new program content 
distributed to the user weekly for Groups 2 and 3. The content of dietary and physical 
activity recommendations was based on Brazilian and international evidence-based 
guidelines. Dietary recommendations focused on particular Brazilian habits. Physical 
activity recommendations focused on increasing time of leisure exercise and decreasing 
sitting time. 
In group 1, subjects have access to four videos with information on health consequences 
of excessive weight, dietary and physical activity weight loss recommendations, as well 
as strategies to behavior change. They also received an e-book with lifestyle habits and 
behavioral recommendations to lose weight.  Access to the study website will be limited 
for the first 24 weeks and they have been asked not to undertake any other weight-loss 
program during this time. They will be invited to report their weight, dietary and 
physical activity habits at 12 and 24 weeks after baseline by email. Afterwards, they 
will gain access to the standard online platform.  
Group 2 has access to the study website program for 24 weeks. The platform used in 
this study was adapted from a commercial product (Cybergia® Inc.), which runs various 
Internet-based health programs in Brazil (www.cybergia.com). The platform is cloud- 
based progressive, web-app developed and can be accessed in desktop and smartphone 
environments. It has three areas: 1) Main area, presenting weekly updated tasks such as 
content (video, articles), suggested dietary and physical activities and questionnaires; 2) 
Self-monitoring area, containing a food diary, functionalities for activity self-report and 
charts; 3) Social area, containing a private social network where users can share and 
react to photos and posts. Connecting these areas, the platform presents gamification 
mechanics, such as weekly points (connected to completing tasks and interacting with 
other participants) and social challenges, which invite users to complete one-time 

specific tasks and share their accomplishments. Interaction with the project’s team was 
restricted to public posts and selected comments on the social network. 
Group 3 has access to this online program plus weekly individual chat in the platform 
with a dietitian. At these times, they have the opportunity to discuss and manage 
individual issues. 
Quality Control 
Several procedures will be employed to optimize the quality of the study and maximize 
internal validity and reliability of the program delivery and outcome assessments. 
Assessors of the main outcome measures are blinded to the participants’ group 
allocation. Assessment protocols and orientations to participants were standardized in 
written documents. Validation of self-reported weight and height will be performed by 
correlation to measurements for a random sample of 10% of the study population.  
Personnel will be trained on anthropometry procedures prior to the assessment. Regular 
team meetings between the clinical and information technology teams, in order to align 
strategies, are planned. 
Measurements and instruments 
Demographic Data 
Data on gender, education, civil status and place of work will be collected at baseline.  
Questionnaires to obtain current medical conditions and medications will be completed 
at baseline and 24 weeks.  
Anthropometry 
Weight and height will be self-reported by the participants and BMI will be calculated 
by the formula weight in kg/ (height*height) in m2. For the random 10% sample 
selected for additional measurements, weight will measured in light clothing, without 
shoes on a Welmy ® analogic scale with stadiometer. For this sample, waist 
circumference will be measured at the mid-level between the last rib and the iliac crest 
using an inelastic tape and body composition will be measured by electrical 
bioimpedance using Sanny ® Bioimpedance.  

Dietary intake and food-related behavior 
For groups 2 and 3, calculation of the total daily caloric intake and dietary nutrients will 
be performed by an automatic dietary calculator which was based on food nutrition 
composition tables for the Brazilian population  (http://www.unicamp.br/nepa/taco/).  
Questions about the total number of daily serves of fruit and vegetables, and whole 
carbohydrates sources, as well as weekly serves of sweetened beverages and snack 
foods will be applied. Moreover, food-related behaviors, including number of days 
taking breakfast, number of daily meals, frequency of take-away food consumption and 
eating while watching television will be assessed by questionnaires. 
Eating behavior 
The random sample selected to anthropometry will have cognitive and behavioral 
components of eating assessed across three scales of cognitive restraint, uncontrolled 
eating and emotional eating by the Brazilian version of the Three Factor Eating 
Questionnaire-R21, (TFEQ-R21). 
Physical activity and sedentary behavior 
 The short-form of the International Physical Activity Questionnaire (IPAQ) will 
be used to estimate total MET-minutes/week and to classify participants into 
either high, medium or low physical activity categories according to the IPAQ 
Scoring Protocol [18]. 
 The daily screen-time (i.e., in front of TV, computers, video games, 
smartphones) and the daily sitting time will be used to assess sedentary 
behavior. 
 Pedometers: the number of steps will be measured by XXX pedometer in the 
sample randomly selected to anthropometry.   
Health perception 
The Brazilian version of the 12-item Short-Form Health Survey – Version 2, 
(QualityMetric Incorporated, Lincoln, RI, USA) which is a self-reported measure of 
health-related quality of life (HRQoL) designed to investigate multidimensional aspects 

of physical and mental health for the general population and those with chronic 
diseases, will be applied to all participants.  
Self-rated health will be assessed by one question derived from the Short-Form-36(SF-
36)-  "In general, you say your health is…” with "excellent", "very good", "good", 
"regular" or "bad" as alternative answers.  
Body image perception and satisfaction will be assessed by a scale in which the 
participant can choose his current and ideal silhouette from 15 options, according to 
gender. 
Online activity and satisfaction with the weight loss program 
 Self-monitoring entries, posts and comments in forums and chats will be collected and 
stored in the platform database and exported as CSV files. For Group 3, we also 
analyzed the number of interactions with the nutrition specialist. To assess users´ 
satisfaction with the weight loss program and with the web-based platform we will 
develop and apply a specific questionnaire.