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Clinical Trials/NCT03084627
NCT03084627
Active, not recruiting
Not Applicable

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

Fondation Hôpital Saint-Joseph1 site in 1 country80 target enrollmentSeptember 20, 2016
ConditionsPregnancy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnancy
Sponsor
Fondation Hôpital Saint-Joseph
Enrollment
80
Locations
1
Primary Endpoint
The improvement in the PANDiet, a diet quality index which has been adapted to pregnancy.
Status
Active, not recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 20, 2016
End Date
December 31, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.

Outcomes

Primary Outcomes

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

Time Frame: Week 2 Week 3 week 11 week 12

Secondary Outcomes

  • frequency of dietary advice applied(week 12)

Study Sites (1)

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