Childhood ObesityNCT05966259
Management of Childhood Obesity
A study testing Intervention Group- Intensive Multilevel Intervention in people with Childhood Obesity and Pediatric Obesity, run by Adaliene Versiani M. Ferreira at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity, Pediatric Obesity
- What is being tested?
- Intervention Group- Intensive Multilevel Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteBrazil
- Study dates
- 11 Sep 2023to 30 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- child classified as obesity by values equal to or greater than z-score +2 for BMI/age
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, 30130100
About this study
Official title: Management of Childhood Obesity in the Context of Primary Health Care: an Intensive Multi-level Intervention
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
- Being tested
- Intervention Group- Intensive Multilevel Intervention, Control Group
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention Group- Intensive Multilevel InterventionOther
Also called 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 GroupOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consumption of ultra-processed foods
10% reduction in consumption of ultra-processed foods
Measured: After 5 months
Secondary outcomes (1)
BMI Z score by age
Reduce and/or maintain BMI Z score by age
Measured: After completion of the study (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start11 Sep 2023
- Primary completion31 Jan 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adaliene Versiani M. Ferreira
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundacion MAPFRE
- Responsible party
- Sponsor-investigator, Adaliene Versiani M. Ferreira, Federal University of Minas Gerais
- Investigators
- Larissa L Mendes, Doctor, Principal investigator, UFMG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05966259
- Sponsor's protocol ID
- 39508720.6.0000.5149
- Status last verified
- Aug 2024
- First submitted
- 21 Jul 2023
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jardim MZ, Canella DS, do Carmo AS, Rocha LL, Gratao LHA, Cunha DB, Pessoa MC, Mendes LL. Efficacy of an intervention in the nutritional status and consumption of ultra-processed foods in children with obesity treated in primary health care in Brazil. BMC Nutr. 2026 Jan 5;12(1):17. doi: 10.1186/s40795-025-01221-z.
PubMed 41491792
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Childhood Obesity in the Context of Primary Health Care: an Intensive Multi-level Intervention
- ClinicalTrials.gov ID
- NCT05966259
- Acronym / sponsor ID
- 39508720.6.0000.5149
- Conditions
- Childhood Obesity, Pediatric Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Adaliene Versiani M. FerreiraUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundacion MAPFRE
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 28 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group- Intensive Multilevel Intervention | Other | Other: Intervention Group- Intensive Multilevel InterventionIntervention 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. |
| Control Group | Other | Other: Control GroupThe 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. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- child classified as obesity by values equal to or greater than z-score +2 for BMI/age
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention Group- Intensive Multilevel InterventionAlso: Intensive Multilevel Interventionintensive 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 GroupThe 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 |
Primary outcome
Consumption of ultra-processed foods
Time frame: After 5 months
10% reduction in consumption of ultra-processed foods
1 secondary outcome
BMI Z score by age
Time frame: After completion of the study (12 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Derived from this study: PubMed 41491792Jardim MZ, Canella DS, do Carmo AS, Rocha LL, Gratao LHA, Cunha DB, Pessoa MC, Mendes LL. Efficacy of an intervention in the nutritional status and consumption of ultra-processed foods in children with obesity treated in primary health care in Brazil. BMC Nutr. 2026 Jan 5;12(1):17. doi: 10.1186/s40795-025-01221-z.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Larissa L Mendes, Doctor principal investigator
UFMG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group- Intensive Multilevel Intervention in people with Childhood Obesity and Pediatric Obesity, run by Adaliene Versiani M. Ferreira at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consumption of ultra-processed foods (time frame: After 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05966259, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.