PregnancyMONCAPNCT03084627
Evaluation of the Efficiency of Tailored Dietary Advice in Improving the Nutrient Adequacy of the Diet of French Pregnant Women
A study testing Tailored dietary advice in people with Pregnancy, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Tailored dietary advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 20 Sep 2016to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
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
- Being tested
- Tailored dietary advice
- Keywords
- tailored dietary advice, nutrient adequacy, dietary modifications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored dietary adviceBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Generic dietary advice for pregnancy | No intervention | Not described |
| Generic dietary advice for pregnancy + Tailored dietary advice | Experimental | Not described Receives: Behavioral: Tailored dietary advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
The improvement in the PANDiet, a diet quality index which has been adapted to pregnancy.
Measured: Week 2 Week 3 week 11 week 12
Secondary outcomes (1)
frequency of dietary advice applied
Questionnaire
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2017
- Study start20 Sep 2016
- Primary completion8 Nov 2017
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Collaborators
- AgroParisTech, INRA, Université Paris-Saclay
- Responsible party
- Sponsor
- Investigators
- Jean François HUNEAU, Professor, Study director, UMR Physiologie de la Nutrition et du Comportement Alimentaire INRA/AgroParisTechElie AZRIA, MD, Principal investigator, Groupe Hospitalier Paris St JosephClelia BIANCHI, PhD student, Study director, UMR Physiologie de la Nutrition et du Comportement Alimentaire INRA/AgroParisTech
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03084627
- Sponsor's protocol ID
- MONCAP
- Acronym
- MONCAP
- Status last verified
- Apr 2023
- First submitted
- 1 Mar 2017
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficiency of Tailored Dietary Advice in Improving the Nutrient Adequacy of the Diet of French Pregnant Women
- ClinicalTrials.gov ID
- NCT03084627
- Acronym / sponsor ID
- MONCAP / MONCAP
- Conditions
- Pregnancy
- Keywords
- tailored dietary advice, nutrient adequacy, dietary modifications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Collaborators
- AgroParisTech, INRA, Université Paris-Saclay
- Study start
- 20 Sep 2016 (actual)
- Primary completion
- 8 Nov 2017 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 21 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Generic dietary advice for pregnancy | No intervention | – |
| Generic dietary advice for pregnancy + Tailored dietary advice | Experimental | Behavioral: Tailored dietary advice |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Female
- Pregnant (between 10 and 24 amenorrhea weeks)
- Aged from 18 to 40
- BMI between 18.5 and 25 kg/m²
- Singleton pregnancy
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tailored 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. | Behavioural | Generic dietary advice for pregnancy + Tailored dietary advice |
Primary outcome
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
1 secondary outcome
frequency of dietary advice applied
Time frame: week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean François HUNEAU, Professor study director
UMR Physiologie de la Nutrition et du Comportement Alimentaire INRA/AgroParisTech
Elie AZRIA, MD principal investigator
Groupe Hospitalier Paris St Joseph
Clelia BIANCHI, PhD student study director
UMR Physiologie de la Nutrition et du Comportement Alimentaire INRA/AgroParisTech
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored dietary advice in people with Pregnancy, run by Fondation Hôpital Saint-Joseph at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2023.