Management of Childhood Obesity

Sponsor
Adaliene Versiani M. Ferreira (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05966259
Collaborator
Conselho Nacional de Desenvolvimento Científico e Tecnológico (Other), Fundacion MAPFRE (Other)
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: IG
  • Other: CG
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
78 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Management of Childhood Obesity in the Context of Primary Health Care: an Intensive Multi-level Intervention
Anticipated Study Start Date :
Aug 31, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jul 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Other: Intervention Group

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: IG
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 Names:
  • Intensive Multilevel Intervention
  • Other: CG

    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: CG
    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 Names:
  • Control Group
  • Outcome Measures

    Primary Outcome Measures

    1. Consumption of ultra-processed foods [After 5 months]

      10% reduction in consumption of ultra-processed foods

    Secondary Outcome Measures

    1. BMI Z score by age [After completion of the study (12 months)]

      Reduce and/or maintain BMI Z score by age

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 10 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Universidade Federal de Minas Gerais Belo Horizonte Minas Gerais Brazil 30130100

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Larissa L Mendes, Doctor, UFMG

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Adaliene Versiani M. Ferreira, Doctor, Federal University of Minas Gerais
    ClinicalTrials.gov Identifier:
    NCT05966259
    Other Study ID Numbers:
    • 39508720.6.0000.5149
    First Posted:
    Jul 28, 2023
    Last Update Posted:
    Jul 28, 2023
    Last Verified:
    Jul 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 28, 2023