NCT03895398

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
480

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 12, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 29, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

April 2, 2019

Status Verified

March 1, 2019

Enrollment Period

11 months

First QC Date

February 23, 2019

Last Update Submit

March 30, 2019

Conditions

Keywords

underfive childrenpost-disaster recoveryoptimized food based recommendationgrowthdevelopmentpsycho-social stimulation

Outcome Measures

Primary Outcomes (1)

  • nutritional status

    weight gain in g/kg.day

    6 months of intervention

Secondary Outcomes (5)

  • protein intake

    6 months of intervention

  • development

    6 months of intervention

  • psycho-social care

    6 months of intervention

  • iron intake

    6 months of intervention

  • zinc intake

    6 months of intervention

Study Arms (2)

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

Other: nutrition and psychosocial intervention with community participatory

control arm

NO INTERVENTION

no intervention is given to this arm

Interventions

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

nutrition and psychosocial intervention arm

Eligibility Criteria

Age6 Months - 49 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • has chronic / congenital diseases
  • have sibling that already join the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seameo Regional Center for Food and Nutrition

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

RECRUITING

Related Publications (2)

  • 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.

    PMID: 28698515BACKGROUND
  • 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.

    PMID: 25639135BACKGROUND

Related Links

MeSH Terms

Conditions

Weight Gain

Interventions

Nutritional StatusPsychosocial Intervention

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation CharacteristicsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Grace Wangge

    SEAMEO RECFON

    STUDY CHAIR

Central Study Contacts

Umi Fahmida, PhD

CONTACT

Indriani Oka Anak Agung Sagung

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 23, 2019

First Posted

March 29, 2019

Study Start

December 12, 2018

Primary Completion

October 30, 2019

Study Completion

December 31, 2019

Last Updated

April 2, 2019

Record last verified: 2019-03

Locations