Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| individual dietetic follw-up | Experimental | the patient receives individual counseling (as usual clinical practice if the pregnant woman is followed by a dietetician during her pregancy). |
|
| family-based dietary counseling follw-up | Active Comparator | the woman and the person who shares meals with her receive family-based counseling by a dietetician during her pregancy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| individual dietetic counseling | Procedure | only the pregnant patient receives dietetic counseling |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maternal weight change | Maternal weight change will be calculated from the difference between the weight at delivery and the pre-pregnancy weight, | delivery |
| Measure | Description | Time Frame |
|---|---|---|
| evaluation of BMI during pregnancy | from the weight of the patient, the BMI is calculated | 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. |
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nadege ALGANS | Contact | 0561777204 | algans.n@chu-toulouse.fr |
| Name | Affiliation | Role |
|---|---|---|
| Clemence ROUBLIN | University Hospital of Toulouse | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of Auch | Recruiting | Auch | France |
Not provided
Multicenter, randomized, open-label clinical study.
Not provided
Not provided
Not provided
Not provided
| family-based dietetic conseling | Procedure | the pregnant patient and her companion receive dietetic counseling |
|
| 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 | 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) | 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 | 6 months after delivery |
| Compliance | measured with the Goal Attainment Scaling (GAS) | 24 weeks of gestation, 34 weeks of gestation, 6 months after delivery |
| Physical activity | will be measured with the Pregnancy Physical Activity Questionnaire (PPAQ) | 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 ) | 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 | 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) | from day 0 to 6 months after delivery |
| Clinique Rive Gauche | Recruiting | Toulouse | 31300 | France |
|
| University Hospital of Toulouse | Recruiting | Toulouse | France |
|
| ID | Term |
|---|---|
| D000078064 | Gestational Weight Gain |
| D001724 | Birth Weight |
| ID | Term |
|---|---|
| D015430 | Weight Gain |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided