NCT03435445

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,276

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 24, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 19, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2018

Completed
Last Updated

August 22, 2025

Status Verified

August 1, 2025

Enrollment Period

7 months

First QC Date

January 30, 2018

Last Update Submit

August 21, 2025

Conditions

ObesityOverweight

Keywords

obesityoverweighttelemedicineehealth

Outcome Measures

Primary Outcomes (1)

  • mean weight difference

    self-reported mean weight difference of 4kg between experimental and control groups

    24 weeks

Secondary Outcomes (4)

  • Mean body mass index difference

    24 weeks

  • Daily fruit and vegetables consumption difference

    24 weeks

  • Sugar-added liquids consumption difference

    24 weeks

  • Physical activity classification change

    24 weeks

Other Outcomes (1)

  • Quality of life change

    24 weeks

Study Arms (3)

Online platform group

EXPERIMENTAL

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

Behavioral: Online platform group

Online dietitian coaching

EXPERIMENTAL

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

Behavioral: Online platform groupBehavioral: Online dietitian coaching

Control group

ACTIVE COMPARATOR

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

Behavioral: Control group

Interventions

Online platform groupBEHAVIORAL

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

Online dietitian coachingOnline platform group
Online dietitian coachingBEHAVIORAL

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

Online dietitian coaching
Control groupBEHAVIORAL

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

Control group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index \>=25 kg/m2
  • intention to lose weight by healthy lifestyle habits
  • internet access

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, 30130000, Brazil

Location

Related Publications (6)

  • 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.

    PMID: 25369490BACKGROUND

  • 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.

    PMID: 22555246BACKGROUND

  • 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.

    PMID: 25753009BACKGROUND

  • 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.

    PMID: 34081012DERIVED

  • 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.

    PMID: 33151151DERIVED

  • 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.

    PMID: 30068393DERIVED

MeSH Terms

Conditions

ObesityOverweight

Interventions

Control Groups

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

  • Maria de Fatima H Diniz, PhD

    Federal University of Minas Gerais

    STUDY DIRECTOR

  • 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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

January 30, 2018

First Posted

February 19, 2018

Study Start

September 24, 2017

Primary Completion

April 23, 2018

Study Completion

April 23, 2018

Last Updated

August 22, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)