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

May 26, 2023 updated by: Fatmah Fatmah, Indonesia University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • West Java
      • Sumedang, West Java, Indonesia
        • Cihanjuang Village

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group
Treatment group received 50 g mangrove sword bean food bar during 15 days.
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.
Other Names:
  • Mangrove sword bean food bar
Placebo Comparator: Control group
Control group received 50 g sword bean food bar during 15 days.
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.
Other Names:
  • Mangrove sword bean food bar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Two weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Investigators

  • Principal Investigator: Fatmah Fatmah, Dr, UI

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Actual)

August 15, 2022

Study Completion (Actual)

October 30, 2022

Study Registration Dates

First Submitted

May 13, 2023

First Submitted That Met QC Criteria

May 24, 2023

First Posted (Actual)

May 26, 2023

Study Record Updates

Last Update Posted (Actual)

May 31, 2023

Last Update Submitted That Met QC Criteria

May 26, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Universitas Indonesia (UI)
  • PUTI Q1 Grants 2023 (Other Grant/Funding Number: University of Indonesia)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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