Preference, ConsumerPCAFENCT05191147
Prevalence of Dietary Supplement Consumption Among Pregnant Womenweeks of Pregnancy: a Cross-sectional Telephone Interview Survey
An observational study of Preference, Consumer, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Primary endpoint : Prevalence estimation of the dietary supplement consumption among pregnant women during the first 20-25 weeks of pregnancy. Hypothesis of the study : The sale and consumption of dietary supplements in the general population has increased in recent years. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Preference, Consumer
- What is being tested?
- Dietary supplement
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2022to 10 May 2022
- Phase
- Observational
- 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 45 years
- Women only
- Adult
Study population: Pregnant woman who come in the service for an ultrasound
Who may be able to join
- Aged of 18 or older
- Pregnant woman
- Performing a 2nd trimester ultrasound between 20 and 25 ammenorhea week
- Informed consent signed
- Affiliated to social security insurance or beneficiary of social security insurance
Who cannot join
- Subject participating in another study
- Subject under administrative or legal supervision
- Non-speaking french
- Opposing their participation in the research
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital Grenoble
Grenoble
Marie Dubsay, 06 06 44 20 64, marie.dubsay@gmail.com
About this study
Official title: Prevalence of Dietary Supplement Consumption Among Pregnant Women During the First 20-25 Weeks of Pregnancy: a Cross-sectional Telephone Interview Survey
Primary endpoint :
Prevalence estimation of the dietary supplement consumption among pregnant women during the first 20-25 weeks of pregnancy.
Hypothesis of the study :
The sale and consumption of dietary supplements in the general population has increased in recent years. It would be interesting to know if this is also the case for pregnant women or if they are more vigilant about their health during this period. It would also allow to identify factors associated with their consumption if it exists.
The investigators hypothesize that some women may sometimes fail to mention this supplement intake to care givers and they would like to know if these omissions are voluntary or not.
Read the detailed description
Dietary supplement are foodstuffs whose purpose is to supplement the normal diet, by constituting a concentrated source of nutrients or other substances with a nutritional or physiological effect, alone or in combination. There are many dietary supplement, based on plants, vitamins and minerals, or other concentrates of substances with a nutritional and physiological purpose.
Thus, the consumption of dietary supplement in pregnant women is interesting to pursue because no prevalence exists on the general consumption of food supplements in pregnant women in early pregnancy. Only studies on diet and the potential danger of supplements have been carried out. More specific studies on certain types of vitamins have also been carried out but no prevalence on general consumption has been found.
Therefore, the aim of the study is to know the extent of dietary supplementation in early pregnancy, and the associated factors in order to take it into account in the management and follow-up of patients. The investigators would also like to know the intentions and motivations of these women to consume these products.
To proceed, they will give an information sheet that will allow the collection of the telephone number, during an ultrasound (between 20 and 25 weeks of amenorrhea).Then they will call them and during the telephone interview, they will collect informations needed.
Distribution of an information sheet that will allow the collection of the telephone number of each patient coming for their second trimester ultrasound (between 20 and 25 SA). This form will be accompanied by the letter of information and non-objection which will be kept by the patient. The distribution will be done by the health professionals performing the ultrasound at the beginning or at the end of the medical appointment.
So, the primary endpoint is the proportion of women who report taking at least one dietary supplement during the first 20-25 weeks of pregnancy. This information will be collected by a phone interview.
The secondary endpoints are :
- Describe the dietary supplements consumed during the first 20-25 weeks of pregnancy: galenic form, indication, source of information, place of purchase (pharmacy, supermarket etc.)
- Assess whether beliefs about medication are associated with the use of dietary supplements during pregnancy, using BMQ (Belief on Medicine Questionnaire)
- Describe the mean number of dietary supplements taken by patients in early pregnancy
- Describe the frequency of use for each dietary supplement ('(several times a day / once a day /several times a week / once a week / once a month etc...)
- Conditions
- Preference, Consumer
- Being tested
- Dietary supplement
- Medical subject headings
- Consumer Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary supplementDietary supplement
We will study dietary supplement consumption among pregnant women
What is being measured
The primary outcome is the main question the study is designed to answer.
the proportion of women who report taking at least one dietary supplement during the first 20-25 weeks of pregnancy
what is the percentage of pregnant women who take dietary supplement
Measured: 1 month
Secondary outcomes (4)
Describe the dietary supplements consumed during the first 20-25 weeks of pregnancy
Which galenic form, indication, source of information, place of purchase (pharmacy, supermarket etc.)
Measured: 1 month
Assess whether beliefs about medication are associated with the use of dietary supplements during pregnancy
using BMQ (Belief on Medicine Questionnaire)
Measured: 1 month
Describe the mean number of dietary supplements taken by patients in early pregnancy
How many dietary supplement pregnant women take on a daily basis
Measured: 1 month
Describe the frequency of use for each dietary supplement
Several times a day / once a day /several times a week / once a week / once a month etc.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start1 Jan 2022
- Primary completion10 Apr 2022 (estimated)
- Study completion10 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preference, ConsumerStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05191147
- Sponsor's protocol ID
- 38RC21.0368
- Acronym
- PCAFE
- Status last verified
- Mar 2022
- First submitted
- 22 Dec 2021
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Dietary Supplement Consumption Among Pregnant Women During the First 20-25 Weeks of Pregnancy: a Cross-sectional Telephone Interview Survey
- ClinicalTrials.gov ID
- NCT05191147
- Acronym / sponsor ID
- PCAFE / 38RC21.0368
- Conditions
- Preference, Consumer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 10 Apr 2022 (estimated)
- Study completion
- 10 May 2022 (estimated)
- First posted
- 13 Jan 2022 (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.
Primary endpoint :
Prevalence estimation of the dietary supplement consumption among pregnant women during the first 20-25 weeks of pregnancy.
Hypothesis of the study :
The sale and consumption of dietary supplements in the general population has increased in recent years. It would be interesting to know if this is also the case for pregnant women or if they are more vigilant about their health during this period. It would also allow to identify factors associated with their consumption if it exists.
The investigators hypothesize that some women may sometimes fail to mention this supplement intake to care givers and they would like to know if these omissions are voluntary or not.
Detailed description
Dietary supplement are foodstuffs whose purpose is to supplement the normal diet, by constituting a concentrated source of nutrients or other substances with a nutritional or physiological effect, alone or in combination. There are many dietary supplement, based on plants, vitamins and minerals, or other concentrates of substances with a nutritional and physiological purpose.
Thus, the consumption of dietary supplement in pregnant women is interesting to pursue because no prevalence exists on the general consumption of food supplements in pregnant women in early pregnancy. Only studies on diet and the potential danger of supplements have been carried out. More specific studies on certain types of vitamins have also been carried out but no prevalence on general consumption has been found.
Therefore, the aim of the study is to know the extent of dietary supplementation in early pregnancy, and the associated factors in order to take it into account in the management and follow-up of patients. The investigators would also like to know the intentions and motivations of these women to consume these products.
To proceed, they will give an information sheet that will allow the collection of the telephone number, during an ultrasound (between 20 and 25 weeks of amenorrhea).Then they will call them and during the telephone interview, they will collect informations needed.
Distribution of an information sheet that will allow the collection of the telephone number of each patient coming for their second trimester ultrasound (between 20 and 25 SA). This form will be accompanied by the letter of information and non-objection which will be kept by the patient. The distribution will be done by the health professionals performing the ultrasound at the beginning or at the end of the medical appointment.
So, the primary endpoint is the proportion of women who report taking at least one dietary supplement during the first 20-25 weeks of pregnancy. This information will be collected by a phone interview.
The secondary endpoints are :
- Describe the dietary supplements consumed during the first 20-25 weeks of pregnancy: galenic form, indication, source of information, place of purchase (pharmacy, supermarket etc.)
- Assess whether beliefs about medication are associated with the use of dietary supplements during pregnancy, using BMQ (Belief on Medicine Questionnaire)
- Describe the mean number of dietary supplements taken by patients in early pregnancy
- Describe the frequency of use for each dietary supplement ('(several times a day / once a day /several times a week / once a week / once a month etc...)
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Pregnant woman who come in the service for an ultrasound
Key inclusion criteria (5 listed)
- Aged of 18 or older
- Pregnant woman
- Performing a 2nd trimester ultrasound between 20 and 25 ammenorhea week
- Informed consent signed
- Affiliated to social security insurance or beneficiary of social security insurance
Key exclusion criteria (4 listed)
- Subject participating in another study
- Subject under administrative or legal supervision
- Non-speaking french
- Opposing their participation in the research
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 |
|---|---|---|
| Dietary supplementWe will study dietary supplement consumption among pregnant women | Dietary supplement | – |
Primary outcome
the proportion of women who report taking at least one dietary supplement during the first 20-25 weeks of pregnancy
Time frame: 1 month
what is the percentage of pregnant women who take dietary supplement
4 secondary outcomes
Describe the dietary supplements consumed during the first 20-25 weeks of pregnancy
Time frame: 1 month
Assess whether beliefs about medication are associated with the use of dietary supplements during pregnancy
Time frame: 1 month
Describe the mean number of dietary supplements taken by patients in early pregnancy
Time frame: 1 month
Describe the frequency of use for each dietary supplement
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- Individual participant dataSharing planned: No
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Active, not recruitingObservational study
Family Planning Behaviors, Preferences, Needs and Barriers Within Priority Geographies
Intention to Use Modern Contraception
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preference, Consumer, run by University Hospital, Grenoble 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 5 inclusion and 4 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 17 Mar 2022. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the proportion of women who report taking at least one dietary supplement during the first 20-25 weeks of pregnancy (time frame: 1 month). 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 17 Mar 2022.