Evaluation of the Efficiency of Tailored Dietary Advice in Improving the Nutrient Adequacy of the Diet of French Pregnant Women (MONCAP)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pregnancy
• Intervention / Treatment: Behavioral: Tailored dietary advice

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Ile-de-France
    • Paris, Ile-de-France, France, 75014
      • Groupe hospitalier Paris saint Joseph

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Generic dietary advice for pregnancy
Experimental: Generic dietary advice for pregnancy + Tailored dietary advice	Behavioral: Tailored dietary advice; The nutrient adequacy of the diet of each patient will be evaluated, at baseline, by a diet quality index: the PANDiet. Then, tailored dietary advice aiming at improving the nutrient adequacy of the diet will be generated for each patient in the arm #2. Patients will choose 3 tailored dietary advices among 3 options during three appointments with a research project team member (the first in person and the second and the third by phone). Each appointment will be spaced of 2 weeks. In total, each patient in the arm #2 will choose nine tailored dietary advice. Tailored dietary advices are of two kinds: substitution of a consumed food item by a food item in the same food subgroup or modification of the consumed amount (increase or decrease) of a food item. Tailored dietary advices cannot generate an increase of more than 190 kcal or a decrease as compared to the observed energy intake.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The improvement in the PANDiet, a diet quality index which has been adapted to pregnancy.	Week 2 Week 3 week 11 week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
frequency of dietary advice applied	Questionnaire	week 12

Collaborators and Investigators

• Sponsor: Groupe Hospitalier Paris Saint Joseph
• Collaborators: AgroParisTech, INRA, Université Paris-Saclay
• Investigators: Study Director: Jean François HUNEAU, Professor, UMR Physiologie de la Nutrition et du Comportement Alimentaire INRA/AgroParisTech; Principal Investigator: Elie AZRIA, MD, Groupe Hospitalier Paris St Joseph; Study Director: Clelia BIANCHI, PhD student, UMR Physiologie de la Nutrition et du Comportement Alimentaire INRA/AgroParisTech

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2016
• Primary Completion (Actual): November 8, 2017
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: March 1, 2017
• First Submitted That Met QC Criteria: March 14, 2017
• First Posted (Actual): March 21, 2017

Study Record Updates

• Last Update Posted (Actual): April 27, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: tailored dietary advice; nutrient adequacy; dietary modifications
• Other Study ID Numbers: MONCAP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No