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Clinical Trials/NCT05878379
NCT05878379CompletedNot Applicable

The Effects of a Dietary Iron Program on Iron Status and Cognitive Function Amoung School Children in Phatthalung Province, Southern Thailand

Mahidol University1 site in 1 country34 target enrollmentStarted: May 2, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
34
Locations
1
Primary Endpoint
Iron Status

Study Overview

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).

Detailed Description

  1. Objective The objective of this study was to determine whether an education-based dietary iron program that involved school teachers, parents and children could increase iron status and intelligence quotient (IQ) score in a group of schoolchildren.
  2. Methods

2.1 Study design A quasi-experimental study (pre-test post-test design with follow-up) was used in this study that was based on the Health Belief Model as its theoretical framework.

2.2 Study Setting and Participants Child-parent/caregiver dyads were recruited from one purposively selected government-administered primary school in Phatthalung province. Schools were not involved in any other programs, located in a rural area, and had at least 200 children studying in grades 4-5. Hookworm screening was done 6 weeks before program implementation by the local government screening program. All children who were studying in grades 4-5 in the selected school were invited to participate. Out of 190 children, 34 children who were mildly anemic were enrolled in the study, together with their parents/caregivers. Sample size was calculated based on serum ferritin concentrations among school-aged children from a study by Rahman et al. [17]. Informed written consent was obtained from child-parent/caregiver dyads prior to program implementation.

2.3 Procedure for the intervention The Health Belief Model underpinned the development of the dietary iron program, which focused on the importance of adequate dietary iron consumption and emphasized prevention of iron deficiency (ID) and iron deficiency anemia (IDA). It was implemented from weeks 2 to 15 of the study. Child-parent/caregiver dyads and teachers received an ID/IDA booklet that included information about anemia, causes of ID, iron-rich food, iron concentration in traditional foods, dietary enhancers and inhibitors of iron absorption, and recipes for iron-rich local and culturally appropriate meals for teachers, parents/caregivers and children, as part of the dietary iron program.

Teachers who were involved in school lunch design participated for discussing and planning iron-rich school lunch menus, and observed teaching and learning process with the use of media and games during the iron lessons for children. Four lessons were conducted for parents/caregivers. The first lesson was discussion that addressed parental perceptions about children's susceptibility to ID and IDA and the severity of ID and IDA concerning cognitive function. In the second lesson, parents/caregivers were asked to list the benefits and barriers for changing behavior with regards to preparing more iron-rich foods in the home. Then, the principal researcher invited parents/caregivers to brainstorm and share ways to overcome these barriers. Cooking classes for preparing iron-rich meals at home were conducted. Parents/caregivers voted for two iron-rich meals that they wanted to cook and then they prepared and cooked them in the classes. For the final lesson, the principal researcher visited each parent/caregiver to discuss the barriers they faced when trying to incorporate more iron-rich meals into their child's diet at home. Three lessons were conducted for the children, one per month. In the first lesson, group talks and games were used to engage the children about the causes and effects of ID and IDA. The second lesson focused on iron-rich food. After that, the children partook in games that entailed writing names of food ingredients that contained iron and circling pictures of iron-rich foods, and describing the sensations associated with consuming these foods. Both positive and negative answers from children were selected for discussion, and approaches for consuming more iron-rich food were brainstormed. A market assignment was set to help the children remember the names of iron-rich food and recognize the foods when they visited a market with their parents. The last lesson was a cooking class. After each cooking class finished, the researcher and a teacher encouraged them to eat this meal together.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
9 Years to 11 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • 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

Arms & Interventions

Dietary Iron Program

Experimental

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

Intervention: Dietary Iron Program (Behavioral)

Outcomes

Primary Outcomes

Iron Status

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

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

Secondary Outcomes

  • 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))

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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