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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05878379
Other study ID # MUPH 2018-048
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2, 2018
Est. completion date October 30, 2018

Study information

Verified date May 2023
Source Mahidol University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Dietary Iron Program
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)

Locations

Country Name City State
Thailand Ms Witchada Simla Phattalung Phattalung Province

Sponsors (1)

Lead Sponsor Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Intelligence quotient (IQ) score Outcome 2 was measured as the number of IQ points (continuous data) Change from baseline (week 1) to post-test (week 16), and change from post-test (week 16) to follow-up (week 18)
See also
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Recruiting NCT04095884 - An Observational Study Designed to Elucidate the Pathways by Which Inflammation Contributes to Anaemia in Sick Rural African Children From 6 Months to 36 Months
Completed NCT02941081 - A Novel Nano-iron Supplement to Safely Combat Iron Deficiency and Anaemia in Young Children: a Doubleblind Randomised Controlled Trial Phase 2