Online Platform for Healthy Weight Loss (POEmaS)

NCT ID: NCT03435445

Last Updated: 2025-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1276 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-24

Study Completion Date

2018-04-23

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.

Detailed Description

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Conditions

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Obesity Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Online platform group

Online platform with diet, physical activity and behavior change recommendations for 24 weeks

Group Type EXPERIMENTAL

Online platform group

Intervention Type BEHAVIORAL

The online platform has social network, gamification and short-text sessions.

Online dietitian coaching

Diet, physical activity and behavior change recommendations for 24 weeks and online sessions with a dietitian specialist for 12 weeks

Group Type EXPERIMENTAL

Online platform group

Intervention Type BEHAVIORAL

The online platform has social network, gamification and short-text sessions.

Online dietitian coaching

Intervention Type BEHAVIORAL

Dietitian coaching refers to individual online sessions between a dietitian and participants to strengthen dietary recommendations

Control group

Videos with diet, physical activity and behavior change recommendations for 24 weeks

Group Type ACTIVE_COMPARATOR

Control group

Intervention Type BEHAVIORAL

Minimal intervention with four videos with diet, physical activity and behavior change recommendations

Interventions

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Online platform group

The online platform has social network, gamification and short-text sessions.

Intervention Type BEHAVIORAL

Online dietitian coaching

Dietitian coaching refers to individual online sessions between a dietitian and participants to strengthen dietary recommendations

Intervention Type BEHAVIORAL

Control group

Minimal intervention with four videos with diet, physical activity and behavior change recommendations

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Science and Technology, Brazil

OTHER

Sponsor Role collaborator

Federal University of Minas Gerais

OTHER

Sponsor Role lead

Responsible Party

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Antonio Luiz Pinho Ribeiro

Full Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alline Maria R Beleigoli, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Minas Gerais

Andre Q Andrade, PhD

Role: PRINCIPAL_INVESTIGATOR

University of South Australia

Antonio L Ribeiro, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Minas Gerais

Maria de Fatima H Diniz, PhD

Role: STUDY_DIRECTOR

Federal University of Minas Gerais

Roberta S Alvares, MSc

Role: STUDY_CHAIR

Federal University of Minas Gerais

Leonardo Q Andrade, BSc

Role: STUDY_CHAIR

Cybergia Tecnologia em Saúde

Tiago M Sizenando, BSc

Role: STUDY_CHAIR

Cybergia Tecnologia em Saúde

Locations

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Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

Site Status

Countries

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Brazil

References

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Wadden TA, Butryn ML, Hong PS, Tsai AG. Behavioral treatment of obesity in patients encountered in primary care settings: a systematic review. JAMA. 2014 Nov 5;312(17):1779-91. doi: 10.1001/jama.2014.14173.

Reference Type BACKGROUND
PMID: 25369490 (View on PubMed)

Collins CE, Morgan PJ, Jones P, Fletcher K, Martin J, Aguiar EJ, Lucas A, Neve MJ, Callister R. A 12-week commercial web-based weight-loss program for overweight and obese adults: randomized controlled trial comparing basic versus enhanced features. J Med Internet Res. 2012 Apr 25;14(2):e57. doi: 10.2196/jmir.1980.

Reference Type BACKGROUND
PMID: 22555246 (View on PubMed)

Hutchesson MJ, Rollo ME, Krukowski R, Ells L, Harvey J, Morgan PJ, Callister R, Plotnikoff R, Collins CE. eHealth interventions for the prevention and treatment of overweight and obesity in adults: a systematic review with meta-analysis. Obes Rev. 2015 May;16(5):376-92. doi: 10.1111/obr.12268. Epub 2015 Mar 5.

Reference Type BACKGROUND
PMID: 25753009 (View on PubMed)

Andrade AQ, Beleigoli A, Diniz MF, Ribeiro AL. Influence of Baseline User Characteristics and Early Use Patterns (24-Hour) on Long-Term Adherence and Effectiveness of a Web-Based Weight Loss Randomized Controlled Trial: Latent Profile Analysis. J Med Internet Res. 2021 Jun 3;23(6):e26421. doi: 10.2196/26421.

Reference Type DERIVED
PMID: 34081012 (View on PubMed)

Beleigoli A, Andrade AQ, Diniz MF, Ribeiro AL. Personalized Web-Based Weight Loss Behavior Change Program With and Without Dietitian Online Coaching for Adults With Overweight and Obesity: Randomized Controlled Trial. J Med Internet Res. 2020 Nov 5;22(11):e17494. doi: 10.2196/17494.

Reference Type DERIVED
PMID: 33151151 (View on PubMed)

Beleigoli AM, Queiroz de Andrade A, Haueisen Diniz MF, Alvares RS, Ribeiro AL. Online platform for healthy weight loss in adults with overweight and obesity - the "POEmaS" project: a randomized controlled trial. BMC Public Health. 2018 Aug 1;18(1):945. doi: 10.1186/s12889-018-5882-y.

Reference Type DERIVED
PMID: 30068393 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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73545717500005149

Identifier Type: -

Identifier Source: org_study_id

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