Clinical trial NCT06646965: Efficacy of Family-based Dietary Counseling During Pregnancy on Gestational Weight Gain in Pregnant Women in a Randomized Controlled Trial
Official title: Efficacy of Family-based Dietary Counseling During Pregnancy on Gestational Weight Gain in Pregnant Women
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pregnancy
Dietetics
Keywords: Gestational weight gain
Birth weight
Recommendations
Intervention
Nutrition
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2024-10-17
Enrollment: 1374
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter, randomized, open-label clinical study.
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Maternal weight change
timeFrame: delivery
Secondary outcomes:
measure: evaluation of BMI during pregnancy
timeFrame: from day 0 to delivery
measure: Weight of the baby at birth
timeFrame: delivery
measure: The women's nutritional intake and its distribution
timeFrame: 16 weeks of gestation, 24 weeks of gestation, 34 of gestation, 6 months of gestation
measure: Screening for gestational diabetes
timeFrame: 16 weeks of gestation, 24 weeks of gestation, 34 weeks of gestation
measure: Maternal weight loss
timeFrame: 6 months after delivery
measure: Compliance
timeFrame: 24 weeks of gestation, 34 weeks of gestation, 6 months after delivery
measure: Physical activity
timeFrame: 16 weeks of gestation, 24 weeks of gestation, 34 of gestation, 6 months of gestation
measure: The support of the entourage
timeFrame: 34 weeks of gestation, 6 months after delivery
measure: Women's satisfaction with their follow-up during pregnancy
timeFrame: 34 weeks of gestation, 6 months after delivery
measure: Direct medical, non-medical and indirect costs, valued from the French Healthcare insurance
timeFrame: from day 0 to 6 months after delivery
Other outcomes:
Locations:
city: Auch
country: France
facility: Hospital of Auch
city: Toulouse
country: France
facility: Clinique Rive Gauche
city: Toulouse
country: France
facility: University Hospital of Toulouse
Study officials:
affiliation: University Hospital of Toulouse
name: Clemence ROUBLIN
role: STUDY_DIRECTOR
References: