Nutrition PoorMFBNCT05878886
Mangrove-sword Bean-food Bar on the Weight and Weight for Age Z Score of Under-five Children
A study testing Emergency Food Product in people with Nutrition Poor, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 49 monthsHealthy volunteers can take part
- Conditions the study is for
- Nutrition Poor
- What is being tested?
- Emergency Food Product
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Aug 2022to 30 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 49 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Suffered from infectious or chronical diseases
Trial locations and contacts
1 site in 1 country.
About this study
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
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:
Read more
- 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.
Read the 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.
- Conditions
- Nutrition Poor
- Being tested
- Emergency Food Product
- Keywords
- Older people, under-five children, disaster, weight, mangrove-sword bean-food bar
- Medical subject headings
- Malnutrition, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emergency Food ProductDietary supplement
Also called Mangrove sword bean food bar
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Treatment group received 50 g mangrove sword bean food bar during 15 days. Receives: Dietary Supplement: Emergency Food Product |
| Control group | Placebo comparator | Control group received 50 g sword bean food bar during 15 days. Receives: Dietary Supplement: Emergency Food Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two weeks
Secondary outcomes (1)
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.
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start1 Aug 2022
- Primary completion15 Aug 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition PoorStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatmah Fatmah, Universitas Indonesia
- Investigators
- Fatmah Fatmah, Dr, Principal investigator, UI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05878886
- Sponsor's protocol ID
- Universitas Indonesia (UI)
- Other IDs
- PUTI Q1 Grants 2023
- Acronym
- MFB
- Status last verified
- May 2023
- First submitted
- 13 May 2023
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05878886
- Acronym / sponsor ID
- MFB / Universitas Indonesia (UI)
- Conditions
- Nutrition Poor
- Keywords
- Older people, under-five children, disaster, weight, mangrove-sword bean-food bar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 15 Aug 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 26 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Dietary Supplement: Emergency Food ProductTreatment group received 50 g mangrove sword bean food bar during 15 days. |
| Control group | Placebo comparator | Dietary Supplement: Emergency Food ProductControl group received 50 g sword bean food bar during 15 days. |
Who may qualify
- Ages
- 12 to 49 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Suffered from infectious or chronical diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emergency Food ProductAlso: Mangrove sword bean food barEach 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. | Dietary supplement | Control group, Treatment group |
Primary outcome
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
Time frame: 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.
1 secondary outcome
Change of mothers' balanced nutrition knowledge
Time frame: Two weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatmah Fatmah, Dr principal investigator
UI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emergency Food Product in people with Nutrition Poor, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.