Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05576363
Other study ID # UMalaysiaSabah
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 28, 2023
Est. completion date August 15, 2024

Study information

Verified date October 2022
Source Universiti Malaysia Sabah
Contact DR. BIBI NABIHAH ABDUL HAKIM, PHD
Phone (+06)088210900
Email bibinabihah@ums.edu.my
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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: 1. Sociodemographic, Socio-economic, medical history, anthropometry measurements of maternal and infant 2. Radimer/Cornell Item Assessment of food security status of pregnant mother. 3. 24-hour dietary recall (3 days) Nutritional assessment were recorded to assess the adequacy of nutrient intake by pregnant women. 4. 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. 5. Perceive Stress Scale (PSS-10) questionnaire


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 150
Est. completion date August 15, 2024
Est. primary completion date July 28, 2023
Accepts healthy volunteers
Gender Female
Age group 18 Years to 39 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Universiti Malaysia Sabah

References & Publications (1)

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.

Outcome

Type Measure Description Time frame Safety issue
Other Association between maternal nutritional status and birth outcomes outcomes. Assess association between maternal nutritional status and birth outcome (anthropometry of infant) January 2024- April 2024
Primary 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 January 2023- June 2023
Secondary Association between level of food security and nutritional status status. Assess the association of food security on anthropometry and dietary data using correlation January 2023- June 2023
See also
  Status Clinical Trial Phase
Completed NCT05017974 - Research on Improving Sleep During Pregnancy N/A
Completed NCT03284515 - Vaccination In Pregnancy Gene Signature: VIP Signature Study
Recruiting NCT05969795 - Comparison of Live Birth Rate in Natural Cycle Single Euploid FET Versus Without Luteal Phase Support Phase 1
Recruiting NCT06051201 - Innovation for Small-scale Experiments: ReceptIVFity Test N/A
Recruiting NCT04828382 - Prospective Study of Pregnancy in Women With Cystic Fibrosis
Enrolling by invitation NCT04527926 - STEPuP: Prenatal Provider Education and Training to Improve Medication-assisted Treatment Use During Pregnancy N/A
Recruiting NCT04278651 - Early Antenatal Support for Iron Deficiency Anemia Phase 4
Recruiting NCT04405700 - Measuring Adverse Pregnancy and Newborn Congenital Outcomes
Recruiting NCT06258902 - Odevixibat Pregnancy and Lactation Surveillance Program: A Study to Evaluate the Safety of Odevixibat During Pregnancy and/or Lactation
Completed NCT05487196 - Effectiveness of Clonidine, Dexmedetomidine, and Fentanyl Adjuncts for Labor Epidural Analgesia Phase 2
Completed NCT03750968 - Lutein & Zeaxanthin in Pregnancy - Carotenoid Supplementation During Pregnancy: Ocular and Systemic Effects Phase 2
Enrolling by invitation NCT06127277 - Next4You: A Fully Mobile Relationships Based Program for Youth in Foster Care N/A
Completed NCT05897697 - Assessing Women's Preferences for Postpartum Thromboprophylaxis: the Prefer-Postpartum Study
Recruiting NCT05899101 - The Impact of Opioid and Cannabis Exposure on Fetal Growth
Completed NCT05502510 - Assessing the Effectiveness and Efficacy of the MyHealthyPregnancy Application
Completed NCT04296396 - Opioid Prescription After Cesarean Trial Phase 3
Not yet recruiting NCT06069869 - Multiple Micronutrient Supplementation (MMS) Iron Dose Acceptability Crossover Trial Phase 3
Not yet recruiting NCT06069856 - Multiple Micronutrient Supplementation (MMS) IFA- Iron Dose Acceptability Crossover Trial Phase 3
Not yet recruiting NCT06163651 - Evaluating a One-Year Version of the Parent-Child Assistance Program N/A
Not yet recruiting NCT06079918 - Multiple Micronutrient Supplementation for Maternal Anemia Prevention in Tanzania Phase 3