NCT05966259

Management of Childhood Obesity

Completed NA Last updated 23 August 2024

What this trial tests

NA trial testing Intervention Group- Intensive Multilevel Intervention in Childhood Obesity in 78 participants. Completed in 30 July 2024.

Timeline

11 September 2023

Primary endpoint
31 January 2024

30 July 2024

Quick facts

Lead sponsor	Adaliene Versiani M. Ferreira
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	78
Start date	11 September 2023
Primary completion	31 January 2024
Estimated completion	30 July 2024
Sites	1 location across Brazil

Drugs / interventions tested

• Intervention Group- Intensive Multilevel Intervention
• Control Group — full drug profile →

Conditions studied

• Childhood Obesity — all drugs for Childhood Obesity →
• Pediatric Obesity — all drugs for Pediatric Obesity →

Sponsor

Adaliene Versiani M. Ferreira

Who can join

Adults 6 to 10, any sex, with Childhood Obesity or Pediatric Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The significant increase in the prevalence of obesity can also be attributed to various social changes, in which the environment (political, economic, social, cultural), and not only the individual and his choices, takes a strategic place in the analysis of the problem and proposed interventions. The food environment can influence the choice and consumption of foods that promote obesity, such as ultra-processed foods (UPA). It is suggested that to intervene to effectively change behavior and eating habits, intensive interventions are needed that consider multiple levels that include the family, school, and community rather than one-off interventions that may not be effective in changing behavior and lifestyle. Regarding the family environment, parents or guardians can assist in the adoption of obesity-related behavioral patterns. It is known that the context of Primary Health Care (PHC) is ideal for actions to prevent diseases and promote children's health, since the PHC professional team is closest to the reality of life of the child, family, and community. We emphasize the importance of this study from the perspective of treatment of childhood obesity, in order to generate scientific evidence and practical subsidies for the implementation of interventions focused not only on the individual, but also in the context of the Unified Health System (SUS). The hypothesis of the study is that there will be a decrease in the consumption of ultra-processed foods (UPA) among children, aged 6 to 10 years, living with obesity and who are treated in primary health care. In addition to encouraging healthy habits such as physical activity and the consumption of in natura and minimally processed foods. The management of childhood obesity is one of the priority topics on the national agenda of SUS's food, nutrition, and health promotion policies.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Efficacy of an intervention in the nutritional status and consumption of ultra-processed foods in children with obesity treated in primary health care in Brazil.
   Jardim MZ, Canella DS, do Carmo AS, Rocha LL, et al · · 2026 · PMID 41491792 · DOI 10.1186/s40795-025-01221-z