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Completed

NCT Number: NCT05878886

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

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.

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Key information

Age range

12 month–49 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cihanjuang Village

Sumedang, West Java, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Emergency Food Product

Dietary Supplement

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.

Other names: Mangrove sword bean food bar

Primary outcomes

  1. 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

    Time frame: Two weeks

    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.

Secondary outcomes

  1. Change of mothers' balanced nutrition knowledge

    Time frame: Two weeks

    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.

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study 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

Acronym: MFB

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 26, 2023
Registry last updated
May 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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