Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ministry of Science and Technology, Brazil | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Online platform group | Experimental | Online platform with diet, physical activity and behavior change recommendations for 24 weeks |
|
| Online dietitian coaching | Experimental | Diet, physical activity and behavior change recommendations for 24 weeks and online sessions with a dietitian specialist for 12 weeks |
|
| Control group | Active Comparator | Videos with diet, physical activity and behavior change recommendations for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Online platform group | Behavioral | The online platform has social network, gamification and short-text sessions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| mean weight difference | self-reported mean weight difference of 4kg between experimental and control groups | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean body mass index difference | Body mass index difference between experimental and control groups | 24 weeks |
| Daily fruit and vegetables consumption difference | Number of daily portions of fruit and vegetables intake difference between experimental and control groups |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life change | Quality of life as measured by SF-36 change between control and intervention groups | 24 weeks |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal University of Minas Gerais | Belo Horizonte | Minas Gerais | 30130000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25369490 | Background | 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. | |
| 22555246 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 9, 2018 | Feb 9, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 9, 2018 | Feb 9, 2018 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
Not provided
Not provided
| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
| Online dietitian coaching | Behavioral | Dietitian coaching refers to individual online sessions between a dietitian and participants to strengthen dietary recommendations |
|
| Control group | Behavioral | Minimal intervention with four videos with diet, physical activity and behavior change recommendations |
|
| 24 weeks |
| Sugar-added liquids consumption difference | Mean difference in weekly consumption of sugar-added liquids in mL between experimental and control groups | 24 weeks |
| Physical activity classification change | Change physical activity level as measured by the International Physical Activity Questionnaire IPAQ | 24 weeks |
| 25753009 | Background | 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. |
| 34081012 | Derived | 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. |
| 33151151 | Derived | 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. |
| 30068393 | Derived | 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. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008722 | Methods |