Management of Childhood Obesity

NCT05966259 | Completed

• 1 other identifier: 39508720.6.0000.5149
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Consumption of ultra-processed foods

  10% reduction in consumption of ultra-processed foods

  After 5 months

Secondary Outcomes (1)

• BMI Z score by age

  After completion of the study (12 months)

Study Arms (2)

Intervention Group- Intensive Multilevel Intervention

OTHER

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.

Other: Intervention Group- Intensive Multilevel Intervention

Control Group

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.

Other: Control Group

Interventions

Intervention Group- Intensive Multilevel Intervention 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.

Also known as: Intensive Multilevel Intervention

Intervention Group- Intensive Multilevel Intervention

Control Group 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.

Control Group

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Adaliene Versiani M. Ferreira: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator
• Fundacion MAPFRE: collaborator

Study Sites (1)

Universidade Federal de Minas Gerais

Belo Horizonte, Minas Gerais, 30130100, Brazil

Location

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Larissa L Mendes, Doctor

  UFMG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Model Details: 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.

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: July 28, 2023
• Study Start: September 11, 2023
• Primary Completion: January 31, 2024
• Study Completion: July 30, 2024
• Last Updated: August 23, 2024

Record last verified: 2024-08

Locations

BR (1)