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

NCT03084627 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-04-27

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • AgroParisTech, INRA, Université Paris-Saclay

    collaborator UNKNOWN

  • Fondation Hôpital Saint-Joseph

    lead OTHER

Principal Investigators

  • Jean François HUNEAU, Professor · UMR Physiologie de la Nutrition et du Comportement Alimentaire INRA/AgroParisTech

  • Elie AZRIA, MD · Groupe Hospitalier Paris St Joseph

  • Clelia BIANCHI, PhD student · UMR Physiologie de la Nutrition et du Comportement Alimentaire INRA/AgroParisTech

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-20
Primary Completion
2017-11-08
Completion
2023-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03084627 on ClinicalTrials.gov