Online Platform for Healthy Weight Loss (POEmaS)

• Sponsor: Federal University of Minas Gerais (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03435445
• Collaborator: Ministry of Science and Technology, Brazil (Other)
• Enrollment: 270
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 6.9
• Patients Per Site Per Month: 38.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity; Overweight	Behavioral: Online platform group; Behavioral: Online dietitian coaching; Behavioral: Control group	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 270 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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.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 (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Use of Web as a Tool to Promote Weight Loss in Overweight and Obese Adults
• Actual Study Start Date: Sep 24, 2017
• Anticipated Primary Completion Date: Apr 23, 2018
• Anticipated Study Completion Date: Apr 23, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. mean weight difference [24 weeks]

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

Secondary Outcome Measures

1. Mean body mass index difference [24 weeks]

   Body mass index difference between experimental and control groups

2. Daily fruit and vegetables consumption difference [24 weeks]

   Number of daily portions of fruit and vegetables intake difference between experimental and control groups

3. Sugar-added liquids consumption difference [24 weeks]

   Mean difference in weekly consumption of sugar-added liquids in mL between experimental and control groups

4. Physical activity classification change [24 weeks]

   Change physical activity level as measured by the International Physical Activity Questionnaire IPAQ

Other Outcome Measures

1. Quality of life change [24 weeks]

   Quality of life as measured by SF-36 change between control and intervention groups

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Federal University of Minas Gerais	Belo Horizonte	Minas Gerais	Brazil	30130000

Sponsors and Collaborators

• Federal University of Minas Gerais
• 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

Study Documents (Full-Text)

• Study Protocol - Feb 9, 2018
• Statistical Analysis Plan - Feb 9, 2018

More Information

Publications

• 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.
• 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. Review.
• 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. Review.

• Responsible Party: Antonio Luiz Pinho Ribeiro, Full Professor, Federal University of Minas Gerais
• ClinicalTrials.gov Identifier: NCT03435445
• Other Study ID Numbers: 73545717500005149
• First Posted: Feb 19, 2018
• Last Update Posted: Feb 19, 2018
• Last Verified: Feb 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Antonio Luiz Pinho Ribeiro, Full Professor, Federal University of Minas Gerais: obesity; overweight; telemedicine; ehealth
• Additional relevant MeSH terms: Overweight; Weight Loss

Study Results

No Results Posted as of Feb 19, 2018