Post Disaster Nutrition Intervention for Under-two-year-old Children in Lombok Indonesia

NCT ID: NCT03895398

Last Updated: 2019-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-12

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Weight Gain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

nutrition and psychosocial intervention arm

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

Group Type EXPERIMENTAL

nutrition and psychosocial intervention with community participatory

Intervention Type OTHER

community participation to ensure the intervention is given to the study subject (underfive children)

control arm

no intervention is given to this arm

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

nutrition and psychosocial intervention with community participatory

community participation to ensure the intervention is given to the study subject (underfive children)

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* has chronic / congenital diseases
* have sibling that already join the study
Minimum Eligible Age

6 Months

Maximum Eligible Age

49 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Indonesia-MoH

OTHER_GOV

Sponsor Role collaborator

Indonesia University

OTHER

Sponsor Role collaborator

SEAMEO Regional Centre for Food and Nutrition

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr.Umi Fahmida

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Grace Wangge

Role: STUDY_CHAIR

SEAMEO RECFON

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Seameo Regional Center for Food and Nutrition

Jakarta Pusat, DKI Jakarta, Indonesia

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Indonesia

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Umi Fahmida, PhD

Role: CONTACT

+628176060820

Indriani Oka Anak Agung Sagung

Role: CONTACT

+6281233369657

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Secretariat seameo recfon

Role: primary

+622131930205

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 28698515 (View on PubMed)

Fahmida 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.

Reference Type BACKGROUND
PMID: 25639135 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

https://reliefweb.int/report/world/unhcr-emergency-handbook

UNHCR Emergency Handbook REPORTfrom UN High Commissioner for Refugees Published on 12 Jun 2015

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NIELombok

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

WASH Benefits Bangladesh
NCT01590095 UNKNOWN NA