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Management of Childhood Obesity

Primary Purpose

Childhood Obesity, Pediatric Obesity

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Intervention Group- Intensive Multilevel Intervention
Control Group
Sponsored by
Adaliene Versiani M. Ferreira
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Childhood Obesity

Eligibility Criteria

6 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Universidade Federal de Minas GeraisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Intervention Group- Intensive Multilevel Intervention

Control Group

Arm 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.

Outcomes

Primary Outcome Measures

Consumption of ultra-processed foods
10% reduction in consumption of ultra-processed foods

Secondary Outcome Measures

BMI Z score by age
Reduce and/or maintain BMI Z score by age

Full Information

First Posted
July 21, 2023
Last Updated
September 11, 2023
Sponsor
Adaliene Versiani M. Ferreira
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundacion MAPFRE
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1. Study Identification

Unique Protocol Identification Number
NCT05966259
Brief Title
Management of Childhood Obesity
Official Title
Management of Childhood Obesity in the Context of Primary Health Care: an Intensive Multi-level Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 11, 2023 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
July 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Adaliene Versiani M. Ferreira
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundacion MAPFRE

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity, Pediatric Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Participant
Allocation
Randomized
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group- Intensive Multilevel Intervention
Arm Type
Other
Arm 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.
Arm Title
Control Group
Arm Type
Other
Arm Description
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
Intervention Name(s)
Intervention Group- Intensive Multilevel Intervention
Other Intervention Name(s)
Intensive Multilevel Intervention
Intervention Description
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
Intervention Name(s)
Control Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Consumption of ultra-processed foods
Description
10% reduction in consumption of ultra-processed foods
Time Frame
After 5 months
Secondary Outcome Measure Information:
Title
BMI Z score by age
Description
Reduce and/or maintain BMI Z score by age
Time Frame
After completion of the study (12 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Larissa L Mendes, Doctor
Phone
+55 31 9687-7827
Email
larissa.mendesloures@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Larissa L Mendes, Doctor
Organizational Affiliation
UFMG
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Federal de Minas Gerais
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30130100
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Larissa L Mendes, Doctor
Phone
+55 31 9687-7827
Email
larissa.mendesloures@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Management of Childhood Obesity

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