Mangrove-sword Bean-food Bar on the Weight and Weight for Age Z Score of Under-five Children

Nutrition Poor Clinical Trial

— MFB  

Official title:

Effect of Mangrove-sword Bean-food Bar on the Weight and Weight-for-Age Z Score of Under-five Children Affected by Landslide Disaster. The Pre-post Intervention Study Towards 34 Under-five Children During 15 Days

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05878886
• Other study ID #: Universitas Indonesia (UI)
• Secondary ID: PUTI Q1 Grants 2
• Status: Completed
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: October 30, 2022

Study information

• Verified date: May 2023
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to assess the effect of the food bar made from api-api mangrove (Avicennia marina) and sword bean (Canavalia ensiformis) blends on the weight and Weight-for-Age Z score affected by a landslide disaster. The main questions aimed to answer are: - Food bar supplementation can effect the weight and WAZ score of under-five children affected by landslides disaster? - Balanced nutrition education can increase the mothers' knowledge on the balanced nutrition of under-five children? Participants divided in to two group i.e.: - Treatment/intervention group consumed 50 g mangrove sword bean food bar each day during 15 days. - Control group consumed 50 g sword bean food bar each day during 15 days. - Each group received balanced nutrition for mothers once at the first week of study.

Description:

Eligibility Criteria for Under-five children: - Aged between 12 and 59 months - Male and female - Living in Cihanjuang Village of Sumedang District which affected by the landslide disaster - Had malnutrition, normal, or over-nutrition status, and not suffering from infectious diseases.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: October 30, 2022
• Est. primary completion date: August 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Months to 49 Months

Eligibility

Inclusion Criteria:

• Aged between 12 and 59 months
• Male and female living in Cihanjuang Village of Sumedang District who affected by the landslide disaster
• Had malnutrition, normal, or over-nutrition status
• Not suffering from infectious diseases
• Willing to avoid consumption of any snacks other than the food bars and plain water

Exclusion Criteria:

• Suffered from infectious or chronical diseases

Related Conditions & MeSH terms

• Malnutrition
• Nutrition Poor

Intervention

Dietary Supplement:
• Emergency Food Product
Each subjects of treatment group consumed 50 g food bar during 15 days. Monitoring of compliance undertaken by home visit to recall daily food consumption three days a week and to record the food bar stocks at home during study, and also weekly weight measurement.

Locations

Country	Name	City	State
Indonesia	Cihanjuang Village	Sumedang	West Java

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of mangrove-sword bean-food bar on the weight and Weight-for-Age Z score (WAZ) of under-five children affected by landslide disaster	Change of weight measured by digital weighing. Change of Weight for Age Z score measured by using Nutri Survey Software. Mean difference of weight and Weight-for-Age Z score were calculated as the value at two weeks minus the value at baseline.	Two weeks
Secondary	Change of mothers' balanced nutrition knowledge	Knowledge score of mothers of underfive children on the balanced nutrition at pre-post study measured by baseline and end-line questionnaires.; Mean difference of balanced nutrition knowledge of mothers was calculated as the value at two weeks minus the value at baseline.	Two weeks