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

Sponsor
Indonesia University (Other)
Overall Status
Completed
CT.gov ID
NCT05878886
Collaborator
(none)
34
Enrollment
1
Location
2
Arms
3
Actual Duration (Months)
11.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Emergency Food Product
 N/A

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
Actual Enrollment :
34 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
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.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:
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.
Primary Purpose:
Prevention
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
Actual Study Start Date :
Aug 1, 2022
Actual Primary Completion Date :
Aug 15, 2022
Actual Study Completion Date :
Oct 30, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 [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 Outcome Measures

    1. Change of mothers' balanced nutrition knowledge [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Months to 49 Months
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cihanjuang Village Sumedang West Java Indonesia

    Sponsors and Collaborators

    • Indonesia University

    Investigators

    • Principal Investigator: Fatmah Fatmah, Dr, UI

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fatmah Fatmah, Principal Investigator, Indonesia University
    ClinicalTrials.gov Identifier:
    NCT05878886
    Other Study ID Numbers:
    • Universitas Indonesia (UI)
    • PUTI Q1 Grants 2023
    First Posted:
    May 26, 2023
    Last Update Posted:
    May 31, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Fatmah Fatmah, Principal Investigator, Indonesia University
    Older people
    under-five children
    disaster
    weight
    mangrove-sword bean-food bar
    Additional relevant MeSH terms:
    Malnutrition

    Study Results

    No Results Posted as of May 31, 2023