Application of Dietary Guidelines for the Brazilian Population by Teleconsultation in Obesity in Primary Care

NCT05171907 | Active Not Recruiting

• 1 other identifier: 2021-0128
• Study Type: interventional
• Target: 578
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Obesity; Chronic Disease; Noncommunicable Diseases; Telemedicine; Diet, Healthy; Primary Health Care; Unified Health System

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Food consumption improvement

  8 and 24 weeks

• Quality of life measured using the Short Form Health Survey 36

  8 and 24 weeks

• Weight change (follow up)

  24 and 48 weeks

Study Arms (2)

Control Group

NO INTERVENTION

Patients into the control group will receive the same assessments as patients in the intervention group, for the same time (in 1th, 8th, 24, and 48 weeks), but they will not receive nutritional teleconsultation.

Intervention Group

OTHER

Teleintervention based on Dietary Guidelines for the Brazilian Population during 8 weeks; two subsequent assessments will also be made, in 24th and 48th weeks, to assess the maintenance of weight loss.

Behavioral: Teleobesity

Interventions

Teleobesity BEHAVIORAL

Teleintervention based on Dietary Guidelines for the Brazilian Population during 8 weeks; two subsequent assessments will also be made, in 24th and 48th weeks, to assess the maintenance of weight loss.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Individuals who do not have access to the WhatsApp multi-platform application (Facebook Inc.).

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

MeSH Terms

Conditions

Obesity; Chronic Disease; Noncommunicable Diseases

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• Marcelo Rodrigues Gonçalves

  Hospital de Clínicas de Porto Alegre

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A pragmatic multicentre randomised controlled trial, open-label, allocation at 1 : 1

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: December 29, 2021
• Study Start: January 1, 2022
• Primary Completion: January 22, 2024
• Study Completion: March 1, 2025
• Last Updated: March 4, 2024

Record last verified: 2024-03

Locations

BR (1)