The study aims to evaluate the efficacy of a family-based dietary monitoring during pregnancy on gestational weight gain in pregnant women. The study will be conducted as a randomized controlled trial, women will be randomly allocated into two groups: a group receiving family-based dietary monitoring, and a control group receiving individual dietary monitoring per standard recommendation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,374
only the pregnant patient receives dietetic counseling
the pregnant patient and her companion receive dietetic counseling
Hospital of Auch
Auch, France
RECRUITINGClinique Rive Gauche
Toulouse, France
RECRUITINGUniversity Hospital of Toulouse
Toulouse, France
RECRUITINGMaternal weight change
Maternal weight change will be calculated from the difference between the weight at delivery and the pre-pregnancy weight,
Time frame: delivery
evaluation of BMI during pregnancy
from the weight of the patient, the BMI is calculated
Time frame: from day 0 to delivery
Weight of the baby at birth
The weight of the child will be measured at delivery by a baby-scale measured in kilograms on the day of birth. This weight will be adjusted to the gestational age, in accordance with ARS recommendations defining weight standards according to gestational age.
Time frame: delivery
The women's nutritional intake and its distribution
The women's nutritional intake and its distribution will be assessed through a food frequency questionnaire and recall from 24 hours to 16 SA (over a period of 8-16 SA). At the next two appointments during pregnancy and postpartum, a 3-day dietary survey will be conducted at 24 SA (over a period of 21- 24 SA) and 34 SA (over a period of 31-34 SA), as well as at 6 months postpartum
Time frame: 16 weeks of gestation, 24 weeks of gestation, 34 of gestation, 6 months of gestation
Screening for gestational diabetes
by fasting blood glucose or OGTT (orally induced glucose)
Time frame: 16 weeks of gestation, 24 weeks of gestation, 34 weeks of gestation
Maternal weight loss
Maternal weight loss will be calculated by the difference between the weight at delivery and the weight 6 months after delivery
Time frame: 6 months after delivery
Compliance
measured with the Goal Attainment Scaling (GAS)
Time frame: 24 weeks of gestation, 34 weeks of gestation, 6 months after delivery
Physical activity
will be measured with the Pregnancy Physical Activity Questionnaire (PPAQ)
Time frame: 16 weeks of gestation, 24 weeks of gestation, 34 of gestation, 6 months of gestation
The support of the entourage
will be measured by the Sarason Social Support Questionnaire (SSQ6 )
Time frame: 34 weeks of gestation, 6 months after delivery
Women's satisfaction with their follow-up during pregnancy
will be assessed by means of a satisfaction survey adapted to the needs of the study at 34 days' gestation
Time frame: 34 weeks of gestation, 6 months after delivery
Direct medical, non-medical and indirect costs, valued from the French Healthcare insurance
measured with the EQ-5D-5L questionnaire evaluated at 6 months after delivery (for the cost-utility analysis), the number of caesarean sections avoided (for the cost-effectiveness analysis)
Time frame: from day 0 to 6 months after delivery
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