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Second, the study did not include a control group, and third dietetic control was not taken into consideration.
Patients were subdivided according to the presence of diabetes, defined as current treatment with insulin or oral hypoglycemic medication or dietetic control of blood glucose levels in patients having elevated fasting blood glucose levels or an abnormal glucose tolerance test based on the World Health Organization criteria (11).
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The PASAPAS study is an interventional, controlled, randomised, single-centre, open-label, parallel-group study with two arms: an intervention (or 'APA') group where patients are invited to a 6-month exercise programme in supervised groups in addition to the usual and personalised dietetic care; a control group receiving the usual dietetic care and PA national guidelines.
The first step includes hygieno-dietetic recommendations (weight control, diet, and exercise).
There is no standard or quality control for dietetic review because local diets and habits require a specific structured interview, which is related to the quality of the diet.
They could be controlled by dietetic adjustments (raw corn starch at bedtime in 16 children) and medical treatments (in 15 patients: diazoxide in 10, octreotide in 6, oral steroids in 11, and nifedipine in 2 and diazoxide-octreotide, diazoxide-steroids, octreotide-steroids, or diazoxide-nifedipine in 2 3 patients each).
All participants (intervention as well as control arms) benefit from dietetic and PA support, according to the recommendations of the second French National Health and Nutrition Program Plan National Nutrition Santéé 2, PNNS2).
Moreover, we acknowledge as a limitation of the present study the lack of inclusion of a patients control group staying on the waiting-list not undergoing the dietetic intervention in order to control for effects of repeated measurements at the neurophysiological level and for unpredictable spontaneous clinical improvement.
18 26 In the absence of a control group it is not possible to show superiority of one dietetic therapeutic intervention over another; however, the goal of this study was to demonstrate the efficacy of a dietary intervention with a new therapeutic formula in infants with proven CMPA.
Third, it has been noted that attention and related executive functions such as planning and organizational skills are important for a successful adhesion to dietetic regimen and regular physical exercise [ 18], both of which underpin effective and sustained weight control.
First, it is possible that impulsivity and deficient neurocognitive inhibitory control foster impulsive and dysregulated eating behaviors, which, in turn, would hamper the success of dietetic regimen.
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