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

NCT ID: NCT05878886

Last Updated: 2023-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2022-10-30

Brief Summary

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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

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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.

Conditions

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Nutrition Poor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Treatment 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. Mothers of two groups received balanced nutrition education once at the first week of study.

The compliance of subject consumed food bar undertaken by home visit of field enumerators to subjects' house.

They collected three days food recalls and monitored the distribution and stocks of food bar at the subjects' house.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
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.

Study Groups

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Treatment group

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

Group Type EXPERIMENTAL

Emergency Food Product

Intervention Type 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.

Control group

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

Group Type PLACEBO_COMPARATOR

Emergency Food Product

Intervention Type 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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Mangrove sword bean food bar

Eligibility Criteria

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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
Minimum Eligible Age

12 Months

Maximum Eligible Age

49 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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Fatmah Fatmah

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fatmah Fatmah, Dr

Role: PRINCIPAL_INVESTIGATOR

UI

Locations

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Cihanjuang Village

Sumedang, West Java, Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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PUTI Q1 Grants 2023

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Universitas Indonesia (UI)

Identifier Type: -

Identifier Source: org_study_id

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