Online Platform for Healthy Weight Loss (POEmaS)

Study Overview
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Brief Summary
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Clinical trial to test the efficacy of an online platform based on behavior change principles in promoting weight loss among overweight and obese students and employees of the Federal University of Minas Gerais. The hypothesis is that participants of the group which use the platform with or without a dietitian coaching will lose more weight than those allocated to the group who receives dietary and physical activity orientations by educational videos only.

Official Title
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Use of Web as a Tool to Promote Weight Loss in Overweight and Obese Adults

Conditions
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Obesity, Overweight

Intervention / Treatment
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* Behavioral: Online platform group
* Behavioral: Online dietitian coaching
* Behavioral: Control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index >=25 kg/m2 intention to lose weight by healthy lifestyle habits internet access Exclusion Criteria: pregnancy diabetes heart failure coronary artery disease kidney disease hepatic disease cancer phenylketonuria celiac disease food allergies bariatric surgery history participation in any other weight loss program

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 3 arms: Experimental group 1 receives diet, physical change and behavior change recommendations via an online platform for 24 weeks; Experimental Group 2 receives recommendations via an online platform plus a dietitian coaching via the online platform for 24 weeks; Control groups receives a minimal intervention with access to diet and physical change recommendations videos. After 24 weeks, the control group will gain access to the online platform.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Online platform group<br>Online platform with diet, physical activity and behavior change recommendations for 24 weeks | Behavioral: Online platform group<br>* The online platform has social network, gamification and short-text sessions.<br>|
| Experimental: Online dietitian coaching<br>Diet, physical activity and behavior change recommendations for 24 weeks and online sessions with a dietitian specialist for 12 weeks | Behavioral: Online platform group<br>* The online platform has social network, gamification and short-text sessions.<br>Behavioral: Online dietitian coaching<br>* Dietitian coaching refers to individual online sessions between a dietitian and participants to strengthen dietary recommendations<br>|
| Active Comparator: Control group<br>Videos with diet, physical activity and behavior change recommendations for 24 weeks | Behavioral: Control group<br>* Minimal intervention with four videos with diet, physical activity and behavior change recommendations<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean weight difference | self-reported mean weight difference of 4kg between experimental and control groups | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean body mass index difference | Body mass index difference between experimental and control groups | 24 weeks | 
| Daily fruit and vegetables consumption difference | Number of daily portions of fruit and vegetables intake difference between experimental and control groups | 24 weeks | 
| Sugar-added liquids consumption difference | Mean difference in weekly consumption of sugar-added liquids in mL between experimental and control groups | 24 weeks | 
| Physical activity classification change | Change physical activity level as measured by the International Physical Activity Questionnaire IPAQ | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, overweight, telemedicine, ehealth