Pregnancy RelatedNCT05576363
Food Security and Maternal Nutrition Status
An observational study of Pregnancy Related, run by Universiti Malaysia Sabah.
Trial summary
Food insecurity has been climbing slowly for several recent years and affects more than 30% of the world population in 2021. Poor households tend to have poor diet quality in accordance to expensive price of food, thus reduce dietary diversity. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Pregnancy Related
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 28 Jul 2023to 15 Aug 2024
- 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 39 years
- Women only
- Adult
Study population: Pregnant mother at second trimester
Who may be able to join
- In second trimester (13-27 weeks of pregnancy)
- B40 income group (<RM3490) as categorized for population in Kota Kinabalu, Sabah
- Aged 18-39 years old
- Malaysian
- Have no/controlled medical illness
Who cannot join
- Multiple pregnancy
- Uncontrolled medical illness
- Have pregnancy complications
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Food Security Status and Its Association With Maternal Nutrition and Birth Outcomes Among Low Income Mothers in Kota Kinabalu, Sabah
Food insecurity has been climbing slowly for several recent years and affects more than 30% of the world population in 2021. Poor households tend to have poor diet quality in accordance to expensive price of food, thus reduce dietary diversity. They frequently consume low-cost foods that are high in energy density but low in micronutrient content, diets that are poor in fruits, vegetables, milk, and dairy products, and eating habits that are unhealthy. The double burden malnutrition will affect pregnant women who were vulnerable due to increase demand of nutrition during pregnancy and also their infants. Food insecurity has been linked to maternal stress, weight gain, gestational diabetes, low birth weight, birth defects, premature birth, hospitalization of infants aged less than 6 months and cause the long-term consequences for child growth and development. Therefore, this study aimed to examine the level of food security and its association with maternal nutrition and birth outcomes. This prospective cohort study will be conducted among 150 pregnant women (in 2nd trimester) at government health clinic near Kota Kinabalu. The participants will be assessed on sociodemographic data, socio-economic, medical history, anthropometry measurements, food security, dietary intake and stress level at baseline. After 6 months, birth outcomes will be recorded. The expected outcomes will be that there will be high prevalence of food insecurity among pregnant mother. Besides, the food insecure mothers will be associated with poor nutritional status and have negative consequences on birth outcomes (low birth weight and short stature). This study will highlight the level of food insecurity to inform much needed interventions to address important global health challenges of nutrition and could improve the prenatal care.
Read the detailed description
The burden of food insecurity on maternal nutritional status is understudied. This will underestimate the negative consequences on maternal health and infant. Even though the mechanisms by which food security influences pregnancy outcomes remains unclear, the association between food security and maternal nutritional status warrants further exploration. This prospective study will provide a novel data with the potential to inform that there is much needed interventions to address these important global health challenges.
Therefore, the proposed study is to advocate the evidence-based and obtain a more comprehensive picture of the impact of food security on maternal nutrition and birth outcomes. The prevalence of food security and the risks of malnutrition among maternal and neonates will be explored further. Based on the potential for food insecurity and the effects on maternal health and birth outcomes, screening in primary care settings may help providers to identify the needs and to address the issues through referrals to additional resources.
This is a prospective cohort study design will be conducted among pregnant women in the second trimester at government health clinic located at Kota Kinabalu, Sabah.
Study location:
Randomly selected health clinic near Kota Kinabalu Sabah.
Duration of study:
The study will be conducted from September 2022 to September 2024. The data collection will be held in health clinic in between February 2023 and February 2024.
Tools:
- Sociodemographic, Socio-economic, medical history, anthropometry measurements of maternal and infant
- Radimer/Cornell Item Assessment of food security status of pregnant mother.
- 24-hour dietary recall (3 days) Nutritional assessment were recorded to assess the adequacy of nutrient intake by pregnant women.
- Knowledge, Attitude and Practice (KAP) of maternal nutrition Nutritional knowledge among pregnant women may reflect the quality of food intake and also healthy food choices.
- Perceive Stress Scale (PSS-10) questionnaire
- Conditions
- Pregnancy Related
- Keywords
- Food security, Pregnancy, Nutritional status, Infant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Maternal | Second trimester |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of food security level and nutritional status of pregnant mothers in Kota Kinabalu, Sabah.
Assessment food security by using Radimer Cornell Food Insecurity Questionnaire and 3 days diet recall for nutritional status
Measured: January 2023- June 2023
Secondary outcomes (1)
Association between level of food security and nutritional status status.
Assess the association of food security on anthropometry and dietary data using correlation
Measured: January 2023- June 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start28 Jul 2023 (estimated)
- Primary completion28 Jul 2023 (estimated)
- Study completion15 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Malaysia Sabah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Bibi Nabihah Abdul Hakim, Universiti Malaysia Sabah
- Investigators
- DR. BIBI NABIHAH ABDUL HAKIM, PHD, Principal investigator, Universiti Malaysia Sabah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05576363
- Sponsor's protocol ID
- UMalaysiaSabah
- Status last verified
- Oct 2022
- First submitted
- 8 Sep 2022
- Last updated
- 12 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
1. Life Science Research Office Expert Panel, National Research Council. The federation of American societies for experimental biology. In: Wunderlich GS, Norwood JL, editors. Food insecurity and hunger in the United States: an assessment of the measure. Washington, DC: National Academies Press; 1990. pp. 13-54.
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food Security Status and Its Association With Maternal Nutrition and Birth Outcomes Among Low Income Mothers in Kota Kinabalu, Sabah
- ClinicalTrials.gov ID
- NCT05576363
- Acronym / sponsor ID
- UMalaysiaSabah
- Conditions
- Pregnancy Related
- Keywords
- Food security, Pregnancy, Nutritional status, Infant
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Universiti Malaysia SabahUniversity, hospital or other
- Study start
- 28 Jul 2023 (estimated)
- Primary completion
- 28 Jul 2023 (estimated)
- Study completion
- 15 Aug 2024 (estimated)
- First posted
- 12 Oct 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.
Food insecurity has been climbing slowly for several recent years and affects more than 30% of the world population in 2021. Poor households tend to have poor diet quality in accordance to expensive price of food, thus reduce dietary diversity. They frequently consume low-cost foods that are high in energy density but low in micronutrient content, diets that are poor in fruits, vegetables, milk, and dairy products, and eating habits that are unhealthy. The double burden malnutrition will affect pregnant women who were vulnerable due to increase demand of nutrition during pregnancy and also their infants. Food insecurity has been linked to maternal stress, weight gain, gestational diabetes, low birth weight, birth defects, premature birth, hospitalization of infants aged less than 6 months and cause the long-term consequences for child growth and development. Therefore, this study aimed to examine the level of food security and its association with maternal nutrition and birth outcomes. This prospective cohort study will be conducted among 150 pregnant women (in 2nd trimester) at government health clinic near Kota Kinabalu. The participants will be assessed on sociodemographic data, socio-economic, medical history, anthropometry measurements, food security, dietary intake and stress level at baseline. After 6 months, birth outcomes will be recorded. The expected outcomes will be that there will be high prevalence of food insecurity among pregnant mother. Besides, the food insecure mothers will be associated with poor nutritional status and have negative consequences on birth outcomes (low birth weight and short stature). This study will highlight the level of food insecurity to inform much needed interventions to address important global health challenges of nutrition and could improve the prenatal care.
Detailed description
The burden of food insecurity on maternal nutritional status is understudied. This will underestimate the negative consequences on maternal health and infant. Even though the mechanisms by which food security influences pregnancy outcomes remains unclear, the association between food security and maternal nutritional status warrants further exploration. This prospective study will provide a novel data with the potential to inform that there is much needed interventions to address these important global health challenges.
Therefore, the proposed study is to advocate the evidence-based and obtain a more comprehensive picture of the impact of food security on maternal nutrition and birth outcomes. The prevalence of food security and the risks of malnutrition among maternal and neonates will be explored further. Based on the potential for food insecurity and the effects on maternal health and birth outcomes, screening in primary care settings may help providers to identify the needs and to address the issues through referrals to additional resources.
This is a prospective cohort study design will be conducted among pregnant women in the second trimester at government health clinic located at Kota Kinabalu, Sabah.
Study location:
Randomly selected health clinic near Kota Kinabalu Sabah.
Duration of study:
The study will be conducted from September 2022 to September 2024. The data collection will be held in health clinic in between February 2023 and February 2024.
Tools:
- Sociodemographic, Socio-economic, medical history, anthropometry measurements of maternal and infant
- Radimer/Cornell Item Assessment of food security status of pregnant mother.
- 24-hour dietary recall (3 days) Nutritional assessment were recorded to assess the adequacy of nutrient intake by pregnant women.
- Knowledge, Attitude and Practice (KAP) of maternal nutrition Nutritional knowledge among pregnant women may reflect the quality of food intake and also healthy food choices.
- Perceive Stress Scale (PSS-10) questionnaire
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Maternal | – | –Second trimester |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Pregnant mother at second trimester
Key inclusion criteria (5 listed)
- In second trimester (13-27 weeks of pregnancy)
- B40 income group (<RM3490) as categorized for population in Kota Kinabalu, Sabah
- Aged 18-39 years old
- Malaysian
- Have no/controlled medical illness
Key exclusion criteria (3 listed)
- Multiple pregnancy
- Uncontrolled medical illness
- Have pregnancy complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Level of food security level and nutritional status of pregnant mothers in Kota Kinabalu, Sabah.
Time frame: January 2023- June 2023
Assessment food security by using Radimer Cornell Food Insecurity Questionnaire and 3 days diet recall for nutritional status
1 secondary outcome
Association between level of food security and nutritional status status.
Time frame: January 2023- June 2023
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- Background1. Life Science Research Office Expert Panel, National Research Council. The federation of American societies for experimental biology. In: Wunderlich GS, Norwood JL, editors. Food insecurity and hunger in the United States: an assessment of the measure. Washington, DC: National Academies Press; 1990. pp. 13-54.
- 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.
DR. BIBI NABIHAH ABDUL HAKIM, PHD principal investigator
Universiti Malaysia Sabah
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related, run by Universiti Malaysia Sabah.
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 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 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact DR. BIBI NABIHAH ABDUL HAKIM, PHD ((+06)088210900, bibinabihah@ums.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of food security level and nutritional status of pregnant mothers in Kota Kinabalu, Sabah. (time frame: January 2023- June 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05576363, which also lists 1 linked publication.
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 12 Oct 2022.