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

Primary Purpose

Obesity, Overweight

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Online platform group
Online dietitian coaching
Control group
Sponsored by
Federal University of Minas Gerais
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring obesity, overweight, telemedicine, ehealth

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Federal University of Minas Gerais

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Online platform group

Online dietitian coaching

Control group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 30, 2018
Last Updated
February 9, 2018
Sponsor
Federal University of Minas Gerais
Collaborators
Ministry of Science and Technology, Brazil
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1. Study Identification

Unique Protocol Identification Number
NCT03435445
Brief Title
Online Platform for Healthy Weight Loss (POEmaS)
Acronym
POEmaS
Official Title
Use of Web as a Tool to Promote Weight Loss in Overweight and Obese Adults
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 24, 2017 (Actual)
Primary Completion Date
April 23, 2018 (Anticipated)
Study Completion Date
April 23, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Minas Gerais
Collaborators
Ministry of Science and Technology, Brazil

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight
Keywords
obesity, overweight, telemedicine, ehealth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Allocation
Randomized
Enrollment
270 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Online platform group
Arm Type
Experimental
Arm Description
Online platform with diet, physical activity and behavior change recommendations for 24 weeks
Arm Title
Online dietitian coaching
Arm Type
Experimental
Arm Description
Diet, physical activity and behavior change recommendations for 24 weeks and online sessions with a dietitian specialist for 12 weeks
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Videos with diet, physical activity and behavior change recommendations for 24 weeks
Intervention Type
Behavioral
Intervention Name(s)
Online platform group
Intervention Description
The online platform has social network, gamification and short-text sessions.
Intervention Type
Behavioral
Intervention Name(s)
Online dietitian coaching
Intervention Description
Dietitian coaching refers to individual online sessions between a dietitian and participants to strengthen dietary recommendations
Intervention Type
Behavioral
Intervention Name(s)
Control group
Intervention Description
Minimal intervention with four videos with diet, physical activity and behavior change recommendations
Primary Outcome Measure Information:
Title
mean weight difference
Description
self-reported mean weight difference of 4kg between experimental and control groups
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Mean body mass index difference
Description
Body mass index difference between experimental and control groups
Time Frame
24 weeks
Title
Daily fruit and vegetables consumption difference
Description
Number of daily portions of fruit and vegetables intake difference between experimental and control groups
Time Frame
24 weeks
Title
Sugar-added liquids consumption difference
Description
Mean difference in weekly consumption of sugar-added liquids in mL between experimental and control groups
Time Frame
24 weeks
Title
Physical activity classification change
Description
Change physical activity level as measured by the International Physical Activity Questionnaire IPAQ
Time Frame
24 weeks
Other Pre-specified Outcome Measures:
Title
Quality of life change
Description
Quality of life as measured by SF-36 change between control and intervention groups
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alline Maria R Beleigoli, PhD
Organizational Affiliation
Federal University of Minas Gerais
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andre Q Andrade, PhD
Organizational Affiliation
University of South Australia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antonio L Ribeiro, PhD
Organizational Affiliation
Federal University of Minas Gerais
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maria de Fatima H Diniz, PhD
Organizational Affiliation
Federal University of Minas Gerais
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Roberta S Alvares, MSc
Organizational Affiliation
Federal University of Minas Gerais
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Leonardo Q Andrade, BSc
Organizational Affiliation
Cybergia Tecnologia em Saúde
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Tiago M Sizenando, BSc
Organizational Affiliation
Cybergia Tecnologia em Saúde
Official's Role
Study Chair
Facility Information:
Facility Name
Federal University of Minas Gerais
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30130000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25369490
Citation
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.
Results Reference
background
PubMed Identifier
22555246
Citation
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.
Results Reference
background
PubMed Identifier
25753009
Citation
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.
Results Reference
background
PubMed Identifier
34081012
Citation
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.
Results Reference
derived
PubMed Identifier
33151151
Citation
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.
Results Reference
derived
PubMed Identifier
30068393
Citation
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.
Results Reference
derived

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Online Platform for Healthy Weight Loss (POEmaS)

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