Management of Childhood Obesity

Childhood Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05966259
• Other study ID #: 39508720.6.0000.5149
• Status: Recruiting
• Phase: N/A
• Start date: September 11, 2023
• Est. completion date: July 30, 2024

Study information

• Verified date: February 2024
• Source: Federal University of Minas Gerais
• Contact: Larissa L Mendes, Doctor
• Phone: +55 31 9687-7827
• Email: larissa.mendesloures[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: July 30, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Childhood Obesity
• Obesity
• Pediatric Obesity

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Brazil	Universidade Federal de Minas Gerais	Belo Horizonte	Minas Gerais

Sponsors (3)

Lead Sponsor	Collaborator
Adaliene Versiani M. Ferreira	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundacion MAPFRE

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Consumption of ultra-processed foods	10% reduction in consumption of ultra-processed foods	After 5 months
Secondary	BMI Z score by age	Reduce and/or maintain BMI Z score by age	After completion of the study (12 months)