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

NCT05878886 | Completed

• 2 other identifiers: Universitas Indonesia (UI)PUTI Q1 Grants 2023
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Nutrition Poor

Keywords

Older people; under-five children; disaster; weight; mangrove-sword bean-food bar

Outcome Measures

Primary Outcomes (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

  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.

  Two weeks

Secondary Outcomes (1)

• Change of mothers' balanced nutrition knowledge

  Two weeks

Study Arms (2)

Treatment group

EXPERIMENTAL

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

Dietary Supplement: Emergency Food Product

Control group

PLACEBO COMPARATOR

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

Dietary Supplement: Emergency Food Product

Interventions

Emergency Food Product 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.

Also known as: Mangrove sword bean food bar

Control group; Treatment group

Eligibility Criteria

• Age: 12 Months - 49 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Suffered from infectious or chronical diseases

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cihanjuang Village

Sumedang, West Java, Indonesia

Location

MeSH Terms

Conditions

Malnutrition; Body Weight

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Fatmah Fatmah, Dr

  UI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 13, 2023
• First Posted: May 26, 2023
• Study Start: August 1, 2022
• Primary Completion: August 15, 2022
• Study Completion: October 30, 2022
• Last Updated: May 31, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)