Weight GainNIELombokNCT03895398
Post Disaster Nutrition Intervention for Under-two-year-old Children in Lombok Indonesia
A study testing nutrition and psychosocial intervention with community participatory in people with Weight Gain, run by SEAMEO Regional Centre for Food and Nutrition at 1 site in Indonesia.
Trial summary
In 2018, multiple earthquake with magnitude range from 6 to 7 hit Lombok Island, West Nusa Tenggara Province, Indonesia. Following the situational analysis and baseline study in December 2018 (4 months after the first earthquake), it was found that the prevalence of wasting and underweight of underfive children in the… Read more about this study
- Who is it for?
- Ages 6 to 49 monthsHealthy volunteers can take part
- Conditions the study is for
- Weight Gain
- What is being tested?
- nutrition and psychosocial intervention with community participatory
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteIndonesia
- Study dates
- 12 Dec 2018to 31 Dec 2019
- 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 6 to 49 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- age ranged between 6-13 months and 24-49 months
- live with their mother / main caregiver
- parents consent to join the study
- live in affected areas
Who cannot join
- has chronic / congenital diseases
- have sibling that already join the study
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Seameo Regional Center for Food and Nutrition
Jakarta Pusat, DKI Jakarta, 10430
Secretariat seameo recfon, +622131930205, information@seameo-recfon.org
About this study
Official title: Effectiveness of Post Disaster Nutrition Intervention to Optimize Growth and Development of Under-two-year-old Children in Lombok, Indonesia
In 2018, multiple earthquake with magnitude range from 6 to 7 hit Lombok Island, West Nusa Tenggara Province, Indonesia. Following the situational analysis and baseline study in December 2018 (4 months after the first earthquake), it was found that the prevalence of wasting and underweight of underfive children in the affected population is moderate (10.2% and 28.8%) but the prevalence of stunting and anemia is considered of highly significant public health problem (33.3% and 43.8%). Various organizations have provided support at the emergency phase but there is no specific program for nutrition support at the rehabilitation phase.
Draft of intervention model which utilize early child education (ECE) centers as center of nutrition recovery in the community has been discussed with the local education and health officers. Training will be delivered to ECE teachers and community health officers. ECE teachers are expected to have regular parenting class for nutrition education and activities, whilst the community health officers will monitor the activities and provide technical guidance as needed. Mothers of the underfive children will be invited to attend weekly parenting class at nearby ECE center in which they receive messages related to infant and young child feeding (IYCF), including distribution of liver and fish floss as nutrient dense food supplement to their children, and provision of appropriate psychosocial care.This parenting class will be held for 6 months with regular monitoring from the researchers and health personnel from public health center. Effectiveness of the intervention will be assessed in improving IYCF practices and psychosocial care of mothers and nutrient intakes, nutritional status and developmental outcomes of the underfives children.
Read the detailed description
This study aims to strengthen management of nutrition program during post-disaster recovery for underfive children. In this study the following steps will be carried out.
Phase 1: Situation analysis is carried out with two approaches. The first approach is to analyze secondary data in the form of data related to nutrition, health and description of the affected population. The second approach is primary data collection by conducting a qualitative study in the form of in-depth interviews and focus group discussion (FGD) involving the local government and other parties related to the disaster management in East Lombok. Then, interviews and FGDs will be conducted to chief of villages and staff, community leaders and refugees, especially mothers with children under five children to complete data on the status and IYCF practices. The results of this situation analysis will be reported to the local government and also used as a basis for improving the implementation of the next stage.
Phase 2: Preparation of technical guidelines for the nutrition recovery program for underfive children by the research team based on situation analysis and literature review which has been carried out previously.
Stage 3: Representatives from ECE teachers and health workers from Public Health Centers will be trained on the implementation of parenting class and its monitoring. Then, together with the researchers, ECE teachers and community health workers will carry out the weekly parenting class, periodic monitoring and program evaluation.
Stage 4: At this stage there will be an intervention in the form of nutrient-dense food supplementation and psychosocial care for mothers with the concept of "Community Participation". Mothers and community members such as cadres will be involved in joint activities to provide nutrient-dense food for underfives children.
Stage 5: At the end of the activity an evaluation and monitoring program will be conducted by the research team in collaboration with the district health office.
- Conditions
- Weight Gain
- Being tested
- nutrition and psychosocial intervention with community participatory
- Keywords
- underfive children, post-disaster recovery, optimized food based recommendation, growth, development, psycho-social stimulation
- Medical subject headings
- Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutrition and psychosocial intervention with community participatoryOther
community participation to ensure the intervention is given to the study subject (underfive children)
| Study group | Role | What they receive |
|---|---|---|
| nutrition and psychosocial intervention arm | Experimental | 12 selected ECE centers will be selected to be the intervention group. ECE teachers will be trained on psychosocial and nutrition care for children and expected to deliver the information and parenting class to mother.
Community health officers will be trained on how to monitored the activities regularly and providing technical assistance to ECE teachers if needed.
mothers will received weekly parenting class. in the parenting class mothers will be informed on how to provide appropriate feeding and psychosocial stimulus to their children. nutrient dense food supplementation in the form of liver and fish floss will be prepared together and distributed.
underfive children will received nutrient dense food supplementation in the form of liver and fish floss and expected to be eaten everyday for 6 months Receives: Other: nutrition and psychosocial intervention with community participatory |
| control arm | No intervention | no intervention is given to this arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
nutritional status
weight gain in g/kg.day
Measured: 6 months of intervention
Secondary outcomes (5)
protein intake
protein intake (gram/day)
Measured: 6 months of intervention
development
Bayley Scales of Infant Development (BSID) as total score (range 0 - >115)
Measured: 6 months of intervention
psycho-social care
HOME Inventory score as total score (range 0-45)
Measured: 6 months of intervention
iron intake
iron intake (mg/day)
Measured: 6 months of intervention
zinc intake
zinc intake (mg/day)
Measured: 6 months of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start12 Dec 2018
- Primary completion30 Oct 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Weight GainStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- in the intervention arm: ECE teachesr, community health officers, mother, and children will received treatment in the form of trainings (for ECE teachers and community health officers), parenting class (for mother), and nutrient dense food supplementation (for children) whilst in the control arm will received nothing as comparison to the intervention arm.
- Masking
- None (open label)
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SEAMEO Regional Centre for Food and Nutrition
- Sponsor type
- University, hospital or other
- Collaborators
- Indonesia-MoH, Universitas Indonesia
- Responsible party
- Principal investigator, Dr.Umi Fahmida, SEAMEO Regional Centre for Food and Nutrition
- Investigators
- Grace Wangge, Study chair, SEAMEO RECFON
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03895398
- Sponsor's protocol ID
- NIELombok
- Acronym
- NIELombok
- Status last verified
- Mar 2019
- First submitted
- 23 Feb 2019
- Last updated
- 2 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sioen GB, Sekiyama M, Terada T, Yokohari M. Post-Disaster Food and Nutrition from Urban Agriculture: A Self-Sufficiency Analysis of Nerima Ward, Tokyo. Int J Environ Res Public Health. 2017 Jul 10;14(7):748. doi: 10.3390/ijerph14070748.
PubMed 28698515Fahmida U, Santika O, Kolopaking R, Ferguson E. Complementary feeding recommendations based on locally available foods in Indonesia. Food Nutr Bull. 2014 Dec;35(4 Suppl):S174-9. doi: 10.1177/15648265140354S302.
PubMed 25639135
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Post Disaster Nutrition Intervention to Optimize Growth and Development of Under-two-year-old Children in Lombok, Indonesia
- ClinicalTrials.gov ID
- NCT03895398
- Acronym / sponsor ID
- NIELombok / NIELombok
- Conditions
- Weight Gain
- Keywords
- underfive children, post-disaster recovery, optimized food based recommendation, growth, development, psycho-social stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- SEAMEO Regional Centre for Food and NutritionUniversity, hospital or other
- Collaborators
- Indonesia-MoH, Universitas Indonesia
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- 30 Oct 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 29 Mar 2019 (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.
In 2018, multiple earthquake with magnitude range from 6 to 7 hit Lombok Island, West Nusa Tenggara Province, Indonesia. Following the situational analysis and baseline study in December 2018 (4 months after the first earthquake), it was found that the prevalence of wasting and underweight of underfive children in the affected population is moderate (10.2% and 28.8%) but the prevalence of stunting and anemia is considered of highly significant public health problem (33.3% and 43.8%). Various organizations have provided support at the emergency phase but there is no specific program for nutrition support at the rehabilitation phase.
Draft of intervention model which utilize early child education (ECE) centers as center of nutrition recovery in the community has been discussed with the local education and health officers. Training will be delivered to ECE teachers and community health officers. ECE teachers are expected to have regular parenting class for nutrition education and activities, whilst the community health officers will monitor the activities and provide technical guidance as needed. Mothers of the underfive children will be invited to attend weekly parenting class at nearby ECE center in which they receive messages related to infant and young child feeding (IYCF), including distribution of liver and fish floss as nutrient dense food supplement to their children, and provision of appropriate psychosocial care.This parenting class will be held for 6 months with regular monitoring from the researchers and health personnel from public health center. Effectiveness of the intervention will be assessed in improving IYCF practices and psychosocial care of mothers and nutrient intakes, nutritional status and developmental outcomes of the underfives children.
Detailed description
This study aims to strengthen management of nutrition program during post-disaster recovery for underfive children. In this study the following steps will be carried out.
Phase 1: Situation analysis is carried out with two approaches. The first approach is to analyze secondary data in the form of data related to nutrition, health and description of the affected population. The second approach is primary data collection by conducting a qualitative study in the form of in-depth interviews and focus group discussion (FGD) involving the local government and other parties related to the disaster management in East Lombok. Then, interviews and FGDs will be conducted to chief of villages and staff, community leaders and refugees, especially mothers with children under five children to complete data on the status and IYCF practices. The results of this situation analysis will be reported to the local government and also used as a basis for improving the implementation of the next stage.
Phase 2: Preparation of technical guidelines for the nutrition recovery program for underfive children by the research team based on situation analysis and literature review which has been carried out previously.
Stage 3: Representatives from ECE teachers and health workers from Public Health Centers will be trained on the implementation of parenting class and its monitoring. Then, together with the researchers, ECE teachers and community health workers will carry out the weekly parenting class, periodic monitoring and program evaluation.
Stage 4: At this stage there will be an intervention in the form of nutrient-dense food supplementation and psychosocial care for mothers with the concept of "Community Participation". Mothers and community members such as cadres will be involved in joint activities to provide nutrient-dense food for underfives children.
Stage 5: At the end of the activity an evaluation and monitoring program will be conducted by the research team in collaboration with the district health office.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- in the intervention arm: ECE teachesr, community health officers, mother, and children will received treatment in the form of trainings (for ECE teachers and community health officers), parenting class (for mother), and nutrient dense food supplementation (for children) whilst in the control arm will received nothing as comparison to the intervention arm.
| Arm | Type | Receives |
|---|---|---|
| nutrition and psychosocial intervention arm | Experimental | Other: nutrition and psychosocial intervention with community participatory12 selected ECE centers will be selected to be the intervention group. ECE teachers will be trained on psychosocial and nutrition care for children and expected to deliver the information and parenting class to mother. Community health officers will be trained on how to monitored the activities regularly and providing technical assistance to ECE teachers if needed. mothers will received weekly parenting class. in the parenting class mothers will be informed on how to provide appropriate feeding and psychosocial stimulus to their children. nutrient dense food supplementation in the form of liver and fish floss will be prepared together and distributed. underfive children will received nutrient dense food supplementation in the form of liver and fish floss and expected to be eaten everyday for 6 months |
| control arm | No intervention | –no intervention is given to this arm |
Who may qualify
- Ages
- 6 to 49 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- age ranged between 6-13 months and 24-49 months
- live with their mother / main caregiver
- parents consent to join the study
- live in affected areas
Key exclusion criteria (2 listed)
- has chronic / congenital diseases
- have sibling that already join the study
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 |
|---|---|---|
| nutrition and psychosocial intervention with community participatorycommunity participation to ensure the intervention is given to the study subject (underfive children) | Other | nutrition and psychosocial intervention arm |
Primary outcome
nutritional status
Time frame: 6 months of intervention
weight gain in g/kg.day
5 secondary outcomes
protein intake
Time frame: 6 months of intervention
development
Time frame: 6 months of intervention
psycho-social care
Time frame: 6 months of intervention
iron intake
Time frame: 6 months of intervention
zinc intake
Time frame: 6 months of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2019.
- Background: PubMed 28698515Sioen GB, Sekiyama M, Terada T, Yokohari M. Post-Disaster Food and Nutrition from Urban Agriculture: A Self-Sufficiency Analysis of Nerima Ward, Tokyo. Int J Environ Res Public Health. 2017 Jul 10;14(7):748. doi: 10.3390/ijerph14070748.
- Background: PubMed 25639135Fahmida U, Santika O, Kolopaking R, Ferguson E. Complementary feeding recommendations based on locally available foods in Indonesia. Food Nutr Bull. 2014 Dec;35(4 Suppl):S174-9. doi: 10.1177/15648265140354S302.
- UNHCR Emergency Handbook REPORTfrom UN High Commissioner for Refugees Published on 12 Jun 2015Link provided by the sponsor.
- Indicators for assessing infant and young child feeding practices Part I: definition Authors: World Health OrganizationLink provided by the sponsor.
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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.
Grace Wangge study chair
SEAMEO RECFON
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nutrition and psychosocial intervention with community participatory in people with Weight Gain, run by SEAMEO Regional Centre for Food and Nutrition 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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 2 Apr 2019. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Umi Fahmida, PhD (+628176060820, umifahmida@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
nutritional status (time frame: 6 months of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03895398, which also lists 2 linked publications.
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 2 Apr 2019.