- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05576363
Food Security and Maternal Nutrition Status
Food Security Status and Its Association With Maternal Nutrition and Birth Outcomes Among Low Income Mothers in Kota Kinabalu, Sabah
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: DR. BIBI NABIHAH ABDUL HAKIM, PHD
- Phone Number: (+06)088210900
- Email: bibinabihah@ums.edu.my
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Multiple pregnancy
- Uncontrolled medical illness
- Have pregnancy complications
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
Maternal
Second trimester
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
January 2023- June 2023
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Association between level of food security and nutritional status status.
Time Frame: January 2023- June 2023
|
Assess the association of food security on anthropometry and dietary data using correlation
|
January 2023- June 2023
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Association between maternal nutritional status and birth outcomes outcomes.
Time Frame: January 2024- April 2024
|
Assess association between maternal nutritional status and birth outcome (anthropometry of infant)
|
January 2024- April 2024
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: DR. BIBI NABIHAH ABDUL HAKIM, PHD, Universiti Malaysia Sabah
Publications and helpful links
General 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 record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- UMalaysiaSabah
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pregnancy Related
-
4YouandMeCambridge Cognition Ltd; Sema4; Evidation Health; Vector Institute of Artificial... and other collaboratorsCompletedPregnancy Related | Wearables | Pregnancy EarlyUnited States
-
Helen Keller InternationalEleanor Crook FoundationNot yet recruitingPregnancy Related | Supplementation | Postnatal Related
-
The University of Texas Health Science Center,...CompletedPregnancy Related | Pregnancy, High RiskUnited States
-
Peking Union Medical College HospitalPeking Union Medical CollegeUnknownPregnancy | Pregnancy Related | Infant | Pregnancy Disease | Risk FactorChina
-
Shaare Zedek Medical CenterUnknownPregnancy Related | Pregnancy, High Risk | Anesthesia
-
University of CopenhagenStanford UniversityNot yet recruiting
-
European Vaccine InitiativeKintampo Health Research Centre, Ghana; Groupe de Recherche Action en Sante; Fondation... and other collaboratorsRecruitingPregnancy RelatedBenin, Burkina Faso, Ghana, Malawi
-
Kahramanmaras Sutcu Imam UniversityNot yet recruitingPregnancy RelatedTurkey
-
Fondation Hôpital Saint-JosephRecruiting
-
German Institute of Human NutritionRecruiting