Management of Childhood Obesity

NCT ID: NCT05966259

Last Updated: 2024-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-11
• Study Completion Date: 2024-07-30

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.

Conditions

Childhood Obesity; Pediatric Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention Group- Intensive Multilevel Intervention

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.

Group Type: OTHER

Intervention Group- Intensive Multilevel Intervention

Intervention Type: OTHER

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.

Control 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.

Group Type: OTHER

Control Group

Intervention Type: OTHER

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.

Interventions

Intervention 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.

Intervention Type: OTHER

Control 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.

Intervention Type: OTHER

Other Intervention Names

Intensive Multilevel Intervention

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role: collaborator

Fundacion MAPFRE

OTHER

Sponsor Role: collaborator

Adaliene Versiani M. Ferreira

OTHER

Sponsor Role: lead

Responsible Party

Adaliene Versiani M. Ferreira

Doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Larissa L Mendes, Doctor

Role: PRINCIPAL_INVESTIGATOR

UFMG

Locations

Universidade Federal de Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

Countries

Brazil

Other Identifiers

39508720.6.0000.5149

Identifier Type: -

Identifier Source: org_study_id