Clinical trial NCT05171907: Application of Dietary Guidelines for the Brazilian Population by Teleconsultation in Obesity in Primary Care
Official title: Application of Dietary Guidelines for the Brazilian Population by Teleconsultation for Patients With Obesity in Primary Health Care: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity
Keywords: Obesity
Chronic Disease
Noncommunicable Diseases
Telemedicine
Diet, Healthy
Primary Health Care
Unified Health System
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2021-12-29
Enrollment: 578
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A pragmatic multicentre randomised controlled trial, open-label, allocation at 1 : 1
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Obesity is a multifactorial disease of epidemic proportions worldwide. The use of telecommunication tools has been used in health and nutrition in different contexts, seeking to reduce the burden of non-communicable chronic diseases. Telehealth interventions are effective to increase quality of life and to improve the dietary food intake of participants; this kind of treatment seems feasable, cost-effective and has promising results to induce weight loss in obese individuals. This project will evaluate the impact of a remote nutritional intervention in short (8 weeks) and long term (24 and 48 weeks) on the weight fo obese individuals. The intervention will be based on the Dietary Guidelines for the Brazilian Population. It will focus on primary care patients and will have a multidisciplinary approach. It is an open-label pragmatic multicentre randomized controlled trial, with an 1:1 allocation: (1) intervention group (n = 289): Remote consultation with nutritionists based on the Dietary Guidelines for the Brazilian Population; (2) control group (n = 289): usual follow-up in Primary Health Care (PHC). The primary outcome will be weight change at 8 weeks. Additionally, the investigators will evaluate food consumption and quality of life at 8 and 24 weeks as secondary outcomes.

Eligibility criteria: 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.).

Primary outcomes:
measure: Weight change
timeFrame: 8 weeks
Secondary outcomes:
measure: Food consumption improvement
timeFrame: 8 and 24 weeks
measure: Quality of life measured using the Short Form Health Survey 36
timeFrame: 8 and 24 weeks
measure: Weight change (follow up)
timeFrame: 24 and 48 weeks
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande Do Sul
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Marcelo Rodrigues Gonçalves
role: STUDY_DIRECTOR
References: