Obesity Clinical Trial
Official title:
Application of Dietary Guidelines for the Brazilian Population by Teleconsultation for Patients With Obesity in Primary Health Care: A Randomized Clinical Trial
Verified date | March 2024 |
Source | Hospital de Clinicas de Porto Alegre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Obesity is a chronic disease that is highly prevalent in Brazil. It is associated with diabetes and hypertension. Obesity may decrease quality of life. Communication tools, such as mobile devices and social media, are helping to control and prevent obesity. In this 2-arm randomized clinical trial, the investigators aim to evaluate the efficacy of the Dietary Guidelines for the Brazilian Population through 8 weekly video nutritional monitoring sessions with nutritionists. Both groups will receive guidance from reference professionals from primary health care (physician and nurse). Throughout the intervention program, both groups will be equally evaluated in order to verify at the end of the study effectiveness in weight loss and life quality improvement.
Status | Active, not recruiting |
Enrollment | 578 |
Est. completion date | March 2025 |
Est. primary completion date | January 22, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Female and male individuals, with BMI =30 kg/m²; - Age over 18 years; - Internet access by phone or tablet or computer and WhatsApp multi-platform application (Facebook Inc.); - Weekly time availability (10-20 minutes). Exclusion Criteria: - Individuals who do not have access to the WhatsApp multi-platform application (Facebook Inc.). |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital de Clínicas de Porto Alegre | Porto Alegre | Rio Grande Do Sul |
Lead Sponsor | Collaborator |
---|---|
Hospital de Clinicas de Porto Alegre |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Weight change | Weight change, measured using a calibrated scale at a Primary Health Care health unit, at the end of 8 weeks. | 8 weeks | |
Secondary | Food consumption improvement | Improvement in food consumption measured through 24-hour dietary recall (R24h), at the end of 8th and 24th week. | 8 and 24 weeks | |
Secondary | Quality of life measured using the Short Form Health Survey 36 | Quality of life improvement measured using the Short Form Health Survey 36, SF-36, at the end of 8th and 24th week. The SF-36 presents a final score from 0 to 100, in which zero corresponds to the worst general health status and 100 the best health status. | 8 and 24 weeks | |
Secondary | Weight change (follow up) | Weight change, measured using a calibrated scale at a Primary Health Care health unit, at the end of 24 and 48 weeks of follow up. | 24 and 48 weeks |
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