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

Primary Purpose

Nutrition Poor

Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Emergency Food Product
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nutrition Poor focused on measuring Older people, under-five children, disaster, weight, mangrove-sword bean-food bar

Eligibility Criteria

12 Months - 49 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Cihanjuang Village

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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 Outcome Measures

Change of mothers' balanced nutrition knowledge
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.

Full Information

First Posted
May 13, 2023
Last Updated
May 26, 2023
Sponsor
Indonesia University
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1. Study Identification

Unique Protocol Identification Number
NCT05878886
Brief Title
Mangrove-sword Bean-food Bar on the Weight and Weight for Age Z Score of Under-five Children
Acronym
MFB
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
August 15, 2022 (Actual)
Study Completion Date
October 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutrition Poor
Keywords
Older people, under-five children, disaster, weight, mangrove-sword bean-food bar

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
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.
Allocation
Non-Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Treatment group received 50 g mangrove sword bean food bar during 15 days.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Control group received 50 g sword bean food bar during 15 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
Emergency Food Product
Other Intervention Name(s)
Mangrove sword bean food bar
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Two weeks
Secondary Outcome Measure Information:
Title
Change of mothers' balanced nutrition knowledge
Description
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.
Time Frame
Two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
49 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatmah Fatmah, Dr
Organizational Affiliation
UI
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cihanjuang Village
City
Sumedang
State/Province
West Java
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
No

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

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