Clinical trial NCT05878886: Mangrove-sword Bean-food Bar on the Weight and Weight for Age Z Score of Under-five Children
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutrition Poor
Keywords: Older people
under-five children
disaster
weight
mangrove-sword bean-food bar
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2023-05-26
Enrollment: 34
Sex: ALL
Minimum age (years): 12
Maximum age (years): 49
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Two weeks
Secondary outcomes:
measure: Change of mothers' balanced nutrition knowledge
timeFrame: Two weeks
Other outcomes:
Locations:
city: Sumedang
country: Indonesia
facility: Cihanjuang Village
state: West Java
Study officials:
affiliation: UI
name: Fatmah Fatmah, Dr
role: PRINCIPAL_INVESTIGATOR
References: