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

NCT03084627 | Unknown DMC

• 1 other identifier: MONCAP
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy

Keywords

tailored dietary advice; nutrient adequacy; dietary modifications

Outcome Measures

Primary Outcomes (1)

• The improvement in the PANDiet, a diet quality index which has been adapted to pregnancy.

  Week 2 Week 3 week 11 week 12

Secondary Outcomes (1)

• frequency of dietary advice applied

  week 12

Study Arms (2)

Generic dietary advice for pregnancy

NO INTERVENTION

Generic dietary advice for pregnancy + Tailored dietary advice

EXPERIMENTAL

Behavioral: Tailored dietary advice

Interventions

Tailored dietary advice BEHAVIORAL

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.

Generic dietary advice for pregnancy + Tailored dietary advice

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Only female because it's a study about pregnancy
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead
• AgroParisTech, INRA, Université Paris-Saclay: collaborator

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

Study Officials

• Jean François HUNEAU, Professor

  UMR Physiologie de la Nutrition et du Comportement Alimentaire INRA/AgroParisTech

  STUDY DIRECTOR

• Elie AZRIA, MD

  Groupe Hospitalier Paris St Joseph

  PRINCIPAL INVESTIGATOR

• Clelia BIANCHI, PhD student

  UMR Physiologie de la Nutrition et du Comportement Alimentaire INRA/AgroParisTech

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: volunteers (single masking)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2017
• First Posted: March 21, 2017
• Study Start: September 20, 2016
• Primary Completion: November 8, 2017
• Study Completion: December 31, 2023
• Last Updated: April 27, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)