Online Platform for Healthy Weight Loss (POEmaS) (POEmaS)

February 9, 2018 updated by: Antonio Luiz Pinho Ribeiro, Federal University of Minas Gerais

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

270

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30130000
        • Federal University of Minas Gerais

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life change
Time Frame: 24 weeks
Quality of life as measured by SF-36 change between control and intervention groups
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Minas Gerais

Collaborators

Ministry of Science and Technology, Brazil

Investigators

  • Principal Investigator: Alline Maria R Beleigoli, PhD, Federal University of Minas Gerais
  • Principal Investigator: Andre Q Andrade, PhD, University of South Australia
  • Principal Investigator: Antonio L Ribeiro, PhD, Federal University of Minas Gerais
  • Study Director: Maria de Fatima H Diniz, PhD, Federal University of Minas Gerais
  • Study Chair: Roberta S Alvares, MSc, Federal University of Minas Gerais
  • Study Chair: Leonardo Q Andrade, BSc, Cybergia Tecnologia em Saúde
  • Study Chair: Tiago M Sizenando, BSc, Cybergia Tecnologia em Saúde

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 24, 2017

Primary Completion (Anticipated)

April 23, 2018

Study Completion (Anticipated)

April 23, 2018

Study Registration Dates

First Submitted

January 30, 2018

First Submitted That Met QC Criteria

February 9, 2018

First Posted (Actual)

February 19, 2018

Study Record Updates

Last Update Posted (Actual)

February 19, 2018

Last Update Submitted That Met QC Criteria

February 9, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 73545717500005149

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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