NCT05576363

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 12, 2022

Completed
10 months until next milestone

Study Start

First participant enrolled

July 28, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2023

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2024

Completed
Last Updated

October 12, 2022

Status Verified

October 1, 2022

Enrollment Period

Same day

First QC Date

September 8, 2022

Last Update Submit

October 7, 2022

Conditions

Keywords

Food security, Pregnancy, Nutritional status, Infant

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Association between level of food security and nutritional status status.

    January 2023- June 2023

Other Outcomes (1)

  • Association between maternal nutritional status and birth outcomes outcomes.

    January 2024- April 2024

Study Arms (1)

Maternal

Second trimester

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Pregnant mother at second trimester

You may qualify if:

  • 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

You may not qualify if:

  • Multiple pregnancy
  • Uncontrolled medical illness
  • Have pregnancy complications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    BACKGROUND

Study Officials

  • DR. BIBI NABIHAH ABDUL HAKIM, PHD

    Universiti Malaysia Sabah

    PRINCIPAL INVESTIGATOR

Central Study Contacts

DR. BIBI NABIHAH ABDUL HAKIM, PHD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 8, 2022

First Posted

October 12, 2022

Study Start

July 28, 2023

Primary Completion

July 28, 2023

Study Completion

August 15, 2024

Last Updated

October 12, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share