Targeted Approach to Prevent Early Obesity (TAPEObesity)

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 anamnestic/clinical evaluations and molecular profiling (polygenic risk score) made at the child's birth. Participants of the intervention arm at the top tertile (33%) of the COBRISC, will access an intensive follow-up program (four visits/year 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 child's 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 practitioner/paediatrician.

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 1.5 years of age (EY-PAQ questionnaire), responsive feeding (Infant Feeding Styles Questionnaire (IFSQ) at 1.5 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity, Pediatric
• Intervention / Treatment: Behavioral: Nutritional and lifestyle counseling

• Study Type: Interventional
• Enrollment (Estimated): 3000
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• New-borns
• Parent/Guardian's informed consent

Exclusion Criteria:

• Severe prematurity or congenital disease or anomaly or perinatal complication likely to imply long-term consequences on the child possibility to be fed and to grow physiologically (COBRISC is intended to be used to predict childhood obesity in healthy infants and the TAPE-Obesity trial does not provide specific programmes for children with impaired capacity to thrive physiologically)
• Family unavailability to plan a regular follow-up at the local Paediatric Obesity Centre

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm	Behavioral: Nutritional and lifestyle counseling; At risk children Intervention Arm: schedule at least four visits/year with anthropometric monitoring, educate parents on the appropriate diet, active lifestyle from the first year of life, regular self-monitoring of their child's anthropometry and appropriate dietary composition and portion control, provide tailor-made nutritional suggestions. Not-at-risk children Intervention Arm: educational website with interactive tools for growth self-monitoring and diverse lifestyle suggestions.
No Intervention: Comparator Arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall percentage of children growing on an obesity trajectory at three years of age in the intervention compared to the comparator arm	3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	3 years
Physical activity and sedentary behavior at 1.5 years of age (EY-PAQ questionnaire) in the at-risk group of the intervention arm compared to the at-risk group of the comparator arm.	1.5 years
Responsive feeding (Infant Feeding Styles Questionnaire (IFSQ) at 1.5 years of age in the at-risk group of the intervention arm compared to the at-risk group of the comparator arm.	1.5 years
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.	3 years

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera Universitaria Integrata Verona

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: December 11, 2023
• First Submitted That Met QC Criteria: December 11, 2023
• First Posted (Estimated): December 20, 2023

Study Record Updates

• Last Update Posted (Estimated): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Obesity; Pediatric; Nutrition; Prevention
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: TAPE Obesity

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No