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Clinical Trials/NCT05878886
NCT05878886CompletedNot Applicable

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

Indonesia University1 site in 1 country34 target enrollmentStarted: August 1, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
34
Locations
1
Primary Endpoint
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

Study Overview

Brief 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.

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 Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Participant)

Masking Description

All subjects at treatment group given mangrove sword bean food bar during 15 days to examine their weight and WAZ score at pre-post study.

Eligibility Criteria

Ages
12 Months to 49 Months (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Treatment group

Experimental

Treatment group received 50 g mangrove sword bean food bar during 15 days.

Intervention: Emergency Food Product (Dietary Supplement)

Control group

Placebo Comparator

Control group received 50 g sword bean food bar during 15 days.

Intervention: Emergency Food Product (Dietary Supplement)

Outcomes

Primary Outcomes

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

  • Change of mothers' balanced nutrition knowledge(Two weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Fatmah Fatmah

Principal Investigator

Indonesia University

Study Sites (1)

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