Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06177756
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-20
First Post:
2023-12-11
Brief Title:
Targeted Approach to Prevent Early Obesity
Sponsor:
Azienda Ospedaliera Universitaria Integrata Verona
Organization:
Azienda Ospedaliera Universitaria Integrata Verona
Study Overview
Official Title:
Targeted Approach to Prevent Early Obesity
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TAPEObesity
Brief Summary:
Lead UNIVR Partners involved UNIME CHU Lille INSERM-Lille
This is a multi-center UNIVR UNIME CHU Lille randomized controlled trial aiming at evaluating the effect of a selective intervention directed to parents of newborns 1500 subjects will be recruited in both arms and evaluated with the Childhood Obesity Risk Score COBRISC thanks to anamnesticclinical evaluations and molecular profiling polygenic risk score made at the childs birth Participants of the intervention arm at the top tertile 33 of the COBRISC will access an intensive follow-up program four visitsyear on average with anthropometric monitoring at the local Obesity Tertiary Center This will include educating parents on the appropriate diet active lifestyle from the first year of life regular self-monitoring of their childs anthropometry appropriate dietary composition and portion control as well as tailor-made nutritional suggestions To ensure a patient-centred approach the parents participating in the intensive follow-up program will annually give their feedback and suggestions by an anonymous online survey whose results will be used to adapt interventions according to parents requests as possible and appropriate The children of the intervention arm classified as not-at-risk will benefit from a soft intervention consisting in the access to an educational website specially implemented with interactive tools for growth self-monitoring and diverse lifestyle suggestions The children of the whole comparator arm will benefit from routine well visits from their general practitionerpaediatrician
This is based on the following rationale that i targeted approaches imply higher motivation and commitment for parents more intense care for families and more effectiveness and cost-effectiveness compared to traditional population-based interventions and ii early preventive trials have not demonstrated durable effects after the end of the intervention no cascade effect while uninterrupted intervention and follow-up from infancy to late childhood have proved long lasting results
The following end-points will be evaluated Primary overall percentage of children growing on an obesity trajectory at three years of age in the intervention compared to the comparator arm Secondary percentage of children growing on an obesity trajectory at three years of age in the at-risk group of the intervention arm compared to the at-risk group of the comparator arm physical activity and sedentary behavior at 15 years of age EY-PAQ questionnaire responsive feeding Infant Feeding Styles Questionnaire IFSQ at 15 years of age and dietary composition at three years of age dietary diary and food frequency questionnaire in the at-risk group of the intervention arm compared to the at-risk group of the comparator arm All the children will be measured at the tertiary centre at one two and three years of age and afterwards at six and ten years of age
All the intervention components will comply with the ESPGHAN Guidelines about infant feeding and complementary feeding the Italian Consensus on Prevention and Treatment of Childhood Obesity the Italian Reference Levels of Assumption of Nutrients and Energy and the French Ministerial Recommendations about Nutrition and Physical Activity for infants and children
Who does what UNIVR will be in charge of the study protocol writing UNIVR will also provide Italian and French centers with educational and monitoring materials including the web-based tool for parents UNIVR will provide monitoring to all centers and will be in charge of deliverables data analyses and results publication INSERM-Lille will perform DNA microarrays and risk assessments in all recruited newborns
This is a multi-center UNIVR UNIME CHU Lille randomized controlled trial aiming at evaluating the effect of a selective intervention directed to parents of newborns 1500 subjects will be recruited in both arms and evaluated with the Childhood Obesity Risk Score COBRISC thanks to anamnesticclinical evaluations and molecular profiling polygenic risk score made at the childs birth Participants of the intervention arm at the top tertile 33 of the COBRISC will access an intensive follow-up program four visitsyear on average with anthropometric monitoring at the local Obesity Tertiary Center This will include educating parents on the appropriate diet active lifestyle from the first year of life regular self-monitoring of their childs anthropometry appropriate dietary composition and portion control as well as tailor-made nutritional suggestions To ensure a patient-centred approach the parents participating in the intensive follow-up program will annually give their feedback and suggestions by an anonymous online survey whose results will be used to adapt interventions according to parents requests as possible and appropriate The children of the intervention arm classified as not-at-risk will benefit from a soft intervention consisting in the access to an educational website specially implemented with interactive tools for growth self-monitoring and diverse lifestyle suggestions The children of the whole comparator arm will benefit from routine well visits from their general practitionerpaediatrician
This is based on the following rationale that i targeted approaches imply higher motivation and commitment for parents more intense care for families and more effectiveness and cost-effectiveness compared to traditional population-based interventions and ii early preventive trials have not demonstrated durable effects after the end of the intervention no cascade effect while uninterrupted intervention and follow-up from infancy to late childhood have proved long lasting results
The following end-points will be evaluated Primary overall percentage of children growing on an obesity trajectory at three years of age in the intervention compared to the comparator arm Secondary percentage of children growing on an obesity trajectory at three years of age in the at-risk group of the intervention arm compared to the at-risk group of the comparator arm physical activity and sedentary behavior at 15 years of age EY-PAQ questionnaire responsive feeding Infant Feeding Styles Questionnaire IFSQ at 15 years of age and dietary composition at three years of age dietary diary and food frequency questionnaire in the at-risk group of the intervention arm compared to the at-risk group of the comparator arm All the children will be measured at the tertiary centre at one two and three years of age and afterwards at six and ten years of age
All the intervention components will comply with the ESPGHAN Guidelines about infant feeding and complementary feeding the Italian Consensus on Prevention and Treatment of Childhood Obesity the Italian Reference Levels of Assumption of Nutrients and Energy and the French Ministerial Recommendations about Nutrition and Physical Activity for infants and children
Who does what UNIVR will be in charge of the study protocol writing UNIVR will also provide Italian and French centers with educational and monitoring materials including the web-based tool for parents UNIVR will provide monitoring to all centers and will be in charge of deliverables data analyses and results publication INSERM-Lille will perform DNA microarrays and risk assessments in all recruited newborns
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None