Food InsecurityFINCT04186689
Relationship Between Food Insecurity and Child Dental Behavior
An observational study of Food Insecurity and Maternal Psychological Distress, run by dina darwish at 1 site in Egypt.
Trial summary
identifying children with dental uncooperative behavior among those who suffered from food insecurity will enable to implement preventive strategies and early intervention. The aim of this study is to examine the relationship between food insecurity, maternal psychological status and child dental behavior. Read more about this study
- Who is it for?
- Ages 36 months to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Insecurity, Maternal Psychological Distress, Child Dental Behavior
- What is being tested?
- Routine Dental Examination
- How many people
- 109 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2021to 1 Feb 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 36 months to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: study populations are healthy children (3-13 years old) having at least one tooth needs dental treatment, accompanied by their mothers on their first dental visit and whose mothers signed an informed consent were eligible to participate in the study. children were enrolled only if they had at least one carious tooth with ICDAS detection code for coronal caries ranging from 3 to 5. Children with mental, communicative or developmental disabilities were excluded.
- Healthy children (3-13 years old) having at least one tooth needs dental treatment
- Accompanied by their mothers on their first dental visit
- whose mothers signed an informed consent children were enrolled only if they had at least one carious tooth with ICDAS for coronal caries ranging from 3 to 5.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship Between Food Insecurity, Maternal Psychological Status, and Child Dental Behavior: A Cross-Sectional Study
identifying children with dental uncooperative behavior among those who suffered from food insecurity will enable to implement preventive strategies and early intervention. The aim of this study is to examine the relationship between food insecurity, maternal psychological status and child dental behavior.
Read the detailed description
A well-trained investigator will collect data on maternal age (in years), the marital status, the educational levels of both parents and their employment status, pregnancy information, as well as family structure (whether children are living with both parents or not), number of siblings (none, one, two, or ≥three). Information on family monthly income and crowding index which is defined as the average number of people per room, excluding both the kitchen and bathrooms will be also obtained.
The level of household food insecurity will be determined using the validated Arabic version of the Household Food Insecurity Access Scale (HFIAS) which categorizes food insecurity into three levels (food secure, marginally food secure and food insecure) where the final score is given according to the sum of affirmative responses to the tool statements and the higher the score the more the level of food insecurity.
The validated Arabic version of the 14-item Perceived Stress Scale will be used to measure the self-reported level of stress among mothers of the enrolled children by assessing their feelings and thoughts during the last month. The level of child's dental behavior will be assessed during the initial oral examination before starting any dental treatment procedures using the six-point Venham behavior rating scale which ranges from total cooperation (0) to no cooperation
- Being tested
- Routine Dental Examination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine Dental ExaminationOther
Routine dental examination for the children Questionnaire for their mothers
| Study group | Role | What they receive |
|---|---|---|
| children in fully food secure households (G1) | preschool children live in a fully food secure household have at least a carious tooth that needs treatment under local anesthesia other than extraction without any previous dental treatment experience. Receives: Other: Routine Dental Examination | |
| children in marginally food secure households (G2) | preschool children live in a marginally food secure household have at least a carious tooth that needs treatment under local anesthesia other than extraction without any previous dental treatment experience. Receives: Other: Routine Dental Examination | |
| children in food insecure households (G3) | preschool children live in a food-insecure household have at least a carious tooth that needs treatment under local anesthesia other than extraction without any previous dental treatment experience. Receives: Other: Routine Dental Examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
A six-point Venham Behavior Rating Scale to evaluate the child behavior during dental examination scale score from(0)the best outcome to (6) worst outcome
which ranges from total cooperation (0) to no cooperation(6)
Measured: 6 months
questionnaire containing 2 scales Household Food Insecurity Access Scale( score food secure better outcome -severely food insecure the worst outcome) and 14-item Perceived Stress Scale (scores from 0 better outcome to 40 worst outcome)
to measure the effect of the predictor variable and the potential mediators which are the household food insecurity and maternal psychological status respectively.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start1 Feb 2021
- Primary completion1 Feb 2022
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food InsecurityStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- dina darwish
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, dina darwish, Ain Shams University
- Investigators
- Dina D Abd-Elmoneam, masters, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04186689
- Sponsor's protocol ID
- 829
- Acronym
- FI
- Status last verified
- Jun 2026
- First submitted
- 26 Nov 2019
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: the exact plan to share individual participant data (IPD) is still not formulated, once it is ready I will share.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Food Insecurity, Maternal Psychological Status, and Child Dental Behavior: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT04186689
- Acronym / sponsor ID
- FI / 829
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- dina darwishUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 5 Dec 2019 (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.
identifying children with dental uncooperative behavior among those who suffered from food insecurity will enable to implement preventive strategies and early intervention. The aim of this study is to examine the relationship between food insecurity, maternal psychological status and child dental behavior.
Detailed description
A well-trained investigator will collect data on maternal age (in years), the marital status, the educational levels of both parents and their employment status, pregnancy information, as well as family structure (whether children are living with both parents or not), number of siblings (none, one, two, or ≥three). Information on family monthly income and crowding index which is defined as the average number of people per room, excluding both the kitchen and bathrooms will be also obtained.
The level of household food insecurity will be determined using the validated Arabic version of the Household Food Insecurity Access Scale (HFIAS) which categorizes food insecurity into three levels (food secure, marginally food secure and food insecure) where the final score is given according to the sum of affirmative responses to the tool statements and the higher the score the more the level of food insecurity.
The validated Arabic version of the 14-item Perceived Stress Scale will be used to measure the self-reported level of stress among mothers of the enrolled children by assessing their feelings and thoughts during the last month. The level of child's dental behavior will be assessed during the initial oral examination before starting any dental treatment procedures using the six-point Venham behavior rating scale which ranges from total cooperation (0) to no cooperation
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| children in fully food secure households (G1) | – | Other: Routine Dental Examinationpreschool children live in a fully food secure household have at least a carious tooth that needs treatment under local anesthesia other than extraction without any previous dental treatment experience. |
| children in marginally food secure households (G2) | – | Other: Routine Dental Examinationpreschool children live in a marginally food secure household have at least a carious tooth that needs treatment under local anesthesia other than extraction without any previous dental treatment experience. |
| children in food insecure households (G3) | – | Other: Routine Dental Examinationpreschool children live in a food-insecure household have at least a carious tooth that needs treatment under local anesthesia other than extraction without any previous dental treatment experience. |
Who may qualify
- Ages
- 36 months to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- study populations are healthy children (3-13 years old) having at least one tooth needs dental treatment, accompanied by their mothers on their first dental visit and whose mothers signed an informed consent were eligible to participate in the study. children were enrolled only if they had at least one carious tooth with ICDAS detection code for coronal caries ranging from 3 to 5. Children with mental, communicative or developmental disabilities were excluded.
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 |
|---|---|---|
| Routine Dental ExaminationRoutine dental examination for the children Questionnaire for their mothers | Other | children in food insecure households (G3), children in fully food secure households (G1), children in marginally food secure households (G2) |
Primary outcome
A six-point Venham Behavior Rating Scale to evaluate the child behavior during dental examination scale score from(0)the best outcome to (6) worst outcome
Time frame: 6 months
which ranges from total cooperation (0) to no cooperation(6)
questionnaire containing 2 scales Household Food Insecurity Access Scale( score food secure better outcome -severely food insecure the worst outcome) and 14-item Perceived Stress Scale (scores from 0 better outcome to 40 worst outcome)
Time frame: 6 months
to measure the effect of the predictor variable and the potential mediators which are the household food insecurity and maternal psychological status respectively.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: Undecided. the exact plan to share individual participant data (IPD) is still not formulated, once it is ready I will share.
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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.
Dina D Abd-Elmoneam, masters principal investigator
Ain Shams University
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 Food Insecurity and Maternal Psychological Distress, run by dina darwish at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 24 Jun 2026. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
A six-point Venham Behavior Rating Scale to evaluate the child behavior during dental examination scale score from(0)the best outcome to (6) worst outcome (time frame: 6 months). The study lists 2 primary outcomes in all. 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 24 Jun 2026.