Dietetics, Pregnancy
Conditions
Keywords
Gestational weight gain, Birth weight, Recommendations, Intervention, Nutrition
Brief summary
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.
Interventions
PROCEDUREindividual dietetic counseling
only the pregnant patient receives dietetic counseling
PROCEDUREfamily-based dietetic conseling
the pregnant patient and her companion receive dietetic counseling
Sponsors
University Hospital, Toulouse
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Multicenter, randomized, open-label clinical study.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adult (+18 years old) Pregnant woman who can be accompanied by a member of the household, adult sharing at least 1 meal per day with her. Affiliated to the social security. French speaking person (read/written and spoken). Single pregnancy between 8 SA and 16 SA. Starting BMI between 18.5 and 35
Exclusion criteria
* Person under legal protection or guardianship * Women suffering from a disease requiring a dietary follow-up: * Type 1 or type 2 diabetes. * Gestational diabetes diagnosed on the basis of fasting blood sugar. * History of bariatric surgery. * Eating disorders. * Metabolic pathologies leading to special diets (phenylketonuria). * Digestive pathologies (with an indication) with special diets * Women who have lost more than 10% of their weight at the beginning of pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maternal weight change | delivery | Maternal weight change will be calculated from the difference between the weight at delivery and the pre-pregnancy weight, |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight of the baby at birth | delivery | 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. |
| The women's nutritional intake and its distribution | 16 weeks of gestation, 24 weeks of gestation, 34 of gestation, 6 months of gestation | 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 |
| Screening for gestational diabetes | 16 weeks of gestation, 24 weeks of gestation, 34 weeks of gestation | by fasting blood glucose or OGTT (orally induced glucose) |
| Maternal weight loss | 6 months after delivery | Maternal weight loss will be calculated by the difference between the weight at delivery and the weight 6 months after delivery |
| evaluation of BMI during pregnancy | from day 0 to delivery | from the weight of the patient, the BMI is calculated |
| Physical activity | 16 weeks of gestation, 24 weeks of gestation, 34 of gestation, 6 months of gestation | will be measured with the Pregnancy Physical Activity Questionnaire (PPAQ) |
| The support of the entourage | 34 weeks of gestation, 6 months after delivery | will be measured by the Sarason Social Support Questionnaire (SSQ6 ) |
| Women's satisfaction with their follow-up during pregnancy | 34 weeks of gestation, 6 months after delivery | will be assessed by means of a satisfaction survey adapted to the needs of the study at 34 days' gestation |
| Direct medical, non-medical and indirect costs, valued from the French Healthcare insurance | from day 0 to 6 months after delivery | 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) |
| Compliance | 24 weeks of gestation, 34 weeks of gestation, 6 months after delivery | measured with the Goal Attainment Scaling (GAS) |
Countries
France
Contacts
Primary ContactNadege ALGANS
Outcome results
None listed