Clinical Trials Directory

Trials / Unknown

UnknownNCT03084627

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
80 (actual)
Sponsor
Fondation Hôpital Saint-Joseph · Academic / Other
Sex
Female
Age
18 Years – 40 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
BEHAVIORALTailored dietary adviceThe 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.

Timeline

Start date
2016-09-20
Primary completion
2017-11-08
Completion
2023-12-31
First posted
2017-03-21
Last updated
2023-04-27

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03084627. Inclusion in this directory is not an endorsement.