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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03435445
Other study ID # 73545717500005149
Secondary ID
Status Active, not recruiting
Phase N/A
First received January 30, 2018
Last updated February 9, 2018
Start date September 24, 2017
Est. completion date April 23, 2018

Study information

Verified date February 2018
Source Federal University of Minas Gerais
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 270
Est. completion date April 23, 2018
Est. primary completion date April 23, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Online platform group
The online platform has social network, gamification and short-text sessions.
Online dietitian coaching
Dietitian coaching refers to individual online sessions between a dietitian and participants to strengthen dietary recommendations
Control group
Minimal intervention with four videos with diet, physical activity and behavior change recommendations

Locations

Country Name City State
Brazil Federal University of Minas Gerais Belo Horizonte Minas Gerais

Sponsors (2)

Lead Sponsor Collaborator
Federal University of Minas Gerais Ministry of Science and Technology, Brazil

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

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. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Quality of life change Quality of life as measured by SF-36 change between control and intervention groups 24 weeks
Primary mean weight difference self-reported mean weight difference of 4kg between experimental and control groups 24 weeks
Secondary Mean body mass index difference Body mass index difference between experimental and control groups 24 weeks
Secondary Daily fruit and vegetables consumption difference Number of daily portions of fruit and vegetables intake difference between experimental and control groups 24 weeks
Secondary Sugar-added liquids consumption difference Mean difference in weekly consumption of sugar-added liquids in mL between experimental and control groups 24 weeks
Secondary Physical activity classification change Change physical activity level as measured by the International Physical Activity Questionnaire IPAQ 24 weeks
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