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Management of Childhood Obesity

Management of Childhood Obesity in the Context of Primary Health Care: an Intensive Multi-level Intervention

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05966259
Enrollment
78
Registered
2023-07-28
Start date
2023-09-11
Completion date
2024-07-30
Last updated
2024-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood Obesity, Pediatric Obesity

Brief summary

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.

Interventions

OTHERIntervention Group- Intensive Multilevel Intervention

intensive multilevel intervention, with a minimum of 26 contact hours, for a period of 5 months. The children will be re-evaluated in the eighth month (three months after intervention) and in the eleventh month (six months after intervention). The monthly activities were composed of four weekly contacts: Individual Attendance, Food and Nutrition Education (at home), Group Food and Nutrition Education in the basic health unit and Telephone monitoring. There will be five monthly themes: food, physical activity, sedentary behavior, sleep, and mental health.

OTHERControl Group

The children in the Control Group were followed in a similar way, observing the activities so that they did not exceed 26 hours of contact, during the 5 months.

Sponsors

Conselho Nacional de Desenvolvimento Científico e Tecnológico
CollaboratorOTHER_GOV
Fundacion MAPFRE
CollaboratorOTHER
Adaliene Versiani M. Ferreira
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention model description

Intervention Group: intensive multilevel intervention, with a minimum of 26 contact hours, for a period of 5 months. The children will be re-evaluated in the eighth month (three months after intervention) and in the eleventh month (six months after intervention). The monthly activities were composed of four weekly contacts: Individual Attendance, Food and Nutrition Education (at home), Group Food and Nutrition Education in the basic health unit and Telephone monitoring. There will be five monthly themes: food, physical activity, sedentary behavior, sleep, and mental health. The children in the Control Group were followed in a similar way, observing the activities so that they did not exceed 26 hours of contact, during the 5 months.

Eligibility

Sex/Gender
ALL
Age
6 Years to 10 Years
Healthy volunteers
Yes

Inclusion criteria

* child classified as obesity by values equal to or greater than z-score +2 for BMI/age

Exclusion criteria

* children with severe mental disorders * children on weight loss medication and with comorbidities associated with obesity * children participating in any diet and physical activity program for weight loss/maintenance * parents/guardians who do not agree to participate and do not sign the informed consent form

Design outcomes

Primary

MeasureTime frameDescription
Consumption of ultra-processed foodsAfter 5 months10% reduction in consumption of ultra-processed foods

Secondary

MeasureTime frameDescription
BMI Z score by ageAfter completion of the study (12 months)Reduce and/or maintain BMI Z score by age

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026