Clinical trial NCT03435445: Online Platform for Healthy Weight Loss (POEmaS)
Official title: Use of Web as a Tool to Promote Weight Loss in Overweight and Obese Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Overweight
Keywords: obesity
overweight
telemedicine
ehealth
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, Brazil
First posted: 2018-02-19
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: mean weight difference
timeFrame: 24 weeks
Secondary outcomes:
measure: Mean body mass index difference
timeFrame: 24 weeks
measure: Daily fruit and vegetables consumption difference
timeFrame: 24 weeks
measure: Sugar-added liquids consumption difference
timeFrame: 24 weeks
measure: Physical activity classification change
timeFrame: 24 weeks
Other outcomes:
measure: Quality of life change
timeFrame: 24 weeks
Locations:
city: Belo Horizonte
country: Brazil
facility: Federal University of Minas Gerais
state: Minas Gerais
Study officials:
affiliation: Federal University of Minas Gerais
name: Alline Maria R Beleigoli, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of South Australia
name: Andre Q Andrade, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Minas Gerais
name: Antonio L Ribeiro, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Minas Gerais
name: Maria de Fatima H Diniz, PhD
role: STUDY_DIRECTOR
affiliation: Federal University of Minas Gerais
name: Roberta S Alvares, MSc
role: STUDY_CHAIR
affiliation: Cybergia Tecnologia em Saúde
name: Leonardo Q Andrade, BSc
role: STUDY_CHAIR
affiliation: Cybergia Tecnologia em Saúde
name: Tiago M Sizenando, BSc
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.
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.