Clinical Trial 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 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.
