Clinical trial NCT03084627: Evaluation of the Efficiency of Tailored Dietary Advice in Improving the Nutrient Adequacy of the Diet of French Pregnant Women
Official title: Evaluation of the Efficiency of Tailored Dietary Advice in Improving the Nutrient Adequacy of the Diet of French Pregnant Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy
Keywords: tailored dietary advice
nutrient adequacy
dietary modifications
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
Collaborators: name: AgroParisTech, INRA, Université Paris-Saclay
First posted: 2017-03-21
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Pregnancy is associated with an increase in nutrient requirements. During this period, women would be keener on adopting healthier behaviors. Thus, pregnancy represents an opportunity to improve the nutrient adequacy of the diet of mothers-to-be. This study is a randomized controlled trial, which aims at evaluating the efficiency of a tailored dietary advice tool in improving the nutrient adequacy of the diet of pregnant women, as measured by the PANDiet. Eighty pregnant women will be included in the study and randomized either in the "control" group, or in the "intervention" group. The control group will receive generic dietary advice based on a booklet edited by the French Institute for Health Promotion and Health Education (INPES). The intervention group will receive the same generic dietary advice plus tailored dietary advice to improve the nutrient adequacy of their observed diets. Dietary intakes will be evaluated online using a 3 days food record, at baseline and 6 weeks after patients received the booklet and/or the first tailored dietary advice. Thus, the nutrient adequacy of the diet could be evaluated before and after the intervention in both groups.

The dietary follow-up for one patient will last 12 weeks only, but data will be collected at delivery.

"Moreover, after, the 12-week dietary follow-up and before their deliveries, 10 participants (5 by group) will be contacted to participate in a qualitative interview. This interview will aim at understanding barriers and motivators to implement dietary advice (generic and/or tailored) in the diet of pregnant women in the study.


Eligibility criteria: Inclusion Criteria:

* Female
* Pregnant (between 10 and 24 amenorrhea weeks)
* Aged from 18 to 40
* BMI between 18.5 and 25 kg/m²
* Singleton pregnancy
* Fluently speaking, writing and reading of French
* Having a daily internet access, a personal email address and phone number
* Benefiting from the French Health Coverage
* Not suffering from a gestational diabetes during this pregnancy or a previous pregnancy
* Not being on a specific diet for medical purpose
* Not suffering from major food allergies

Exclusion Criteria:

* Diagnosis of a gestational diabetes during the 12 weeks of the study
* Diagnosis of a pathology that would require diet modifications during the 12 weeks of the study.
* Abortion

Primary outcomes:
measure: The improvement in the PANDiet, a diet quality index which has been adapted to pregnancy.
timeFrame: Week 2 Week 3 week 11 week 12
Secondary outcomes:
measure: frequency of dietary advice applied
timeFrame: week 12
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
affiliation: UMR Physiologie de la Nutrition et du Comportement Alimentaire INRA/AgroParisTech
name: Jean François HUNEAU, Professor
role: STUDY_DIRECTOR
affiliation: Groupe Hospitalier Paris St Joseph
name: Elie AZRIA, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UMR Physiologie de la Nutrition et du Comportement Alimentaire INRA/AgroParisTech
name: Clelia BIANCHI, PhD student
role: STUDY_DIRECTOR
References: