NCT05878379

Brief Summary

Iron deficiency (ID) continues to be one of the most prevalent disorders, which can adversely affect cognitive ability in childhood. Our aim was to determine the effect of a dietary iron education program (DIP) on children's iron status and intelligence quotient (IQ) score. This pre-test (week 1) post-test (week 16) quasi-experimental study with follow-up (week 18) utilized constructs from the Health Belief Model. Children and caregivers participated in the DIP which incorporated group talks, presentations, brainstorming, game-based learning and cooking sessions from weeks 2-15. Knowledge of ID and dietary iron, perceived susceptibility and severity, benefits and barriers for changing behavior, dietary intake, iron status and IQ score were determined at all timepoints (weeks 1, 16, and 18).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 2, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2018

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

April 5, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 26, 2023

Completed
Last Updated

May 26, 2023

Status Verified

May 1, 2023

Enrollment Period

6 months

First QC Date

April 5, 2023

Last Update Submit

May 18, 2023

Conditions

Keywords

Iron deficiencyIron statusCognitive functioneducation

Outcome Measures

Primary Outcomes (1)

  • Iron Status

    For outcome 1, individuals were categorized as either: (1.) iron replete, (2.) Iron deficient, (3.) Iron deficient with mild-moderate anemia (4.) mild-moderately anemic

    Change from baseline (week 1) to post-test (week 16), and change from post-test (week 16) to follow-up (week 18)

Secondary Outcomes (1)

  • Intelligence quotient (IQ) score

    Change from baseline (week 1) to post-test (week 16), and change from post-test (week 16) to follow-up (week 18)

Study Arms (1)

Dietary Iron Program

EXPERIMENTAL

The dietary iron program was administered from weeks 2 to 15 in between pre-test and post-test measurements

Behavioral: Dietary Iron Program

Interventions

Teachers Lesson 1: Discuss about causes, prevention and effects of anemia and ID, dietary iron, dietary enhancers and inhibitors of iron absorption, and school lunch menu Lesson 2: Participate in and observe how to teach children in an iron curriculum Caregivers Lesson 1: Presentation and group talk about causes, prevention, and effects of anemia and ID, dietary iron, and dietary enhancers and inhibitors of iron absorption Lesson 2: Discuss benefits and barriers of changing to an iron-rich meal at home Lesson 3: Cooking class for preparing an iron-rich meal at home (2 times) Lesson 4: Home visit Children Lesson 1: Group talk about causes and effects of anemia and ID Games: "Where are you from?" Lesson 2: Presentation and group talk about dietary iron, and dietary enhancers and inhibitors of iron absorption, and iron-rich food Games: "What is the winner?" Assignment: Market assignment Lesson 3: Cooking class (2 times)

Dietary Iron Program

Eligibility Criteria

Age9 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children who were studying in grades 4 and 5 of the selected school

You may not qualify if:

  • Severe illness, including severe anemia (hemoglobin \<4.96 mmol/L or \<80 g/L)
  • Post-menarche
  • Use of vitamin or mineral supplements up to 30 days before program implementation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ms Witchada Simla

Phatthalung, Phattalung Province, 93210, Thailand

Location

MeSH Terms

Conditions

Iron Deficiencies

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Witchada Simla, MSc

    Thaksin University (Phatthalung Campus), Thailand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Quasi-experimental (pre-test post-test) design with follow-up / Behavioral intervention, based on the Health Belief Model
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2023

First Posted

May 26, 2023

Study Start

May 2, 2018

Primary Completion

October 30, 2018

Study Completion

October 30, 2018

Last Updated

May 26, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

IDP will not be shared with researchers outside of the research team.

Locations