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

Primary Purpose

Weight Gain

Status
Unknown status
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
nutrition and psychosocial intervention with community participatory
Sponsored by
SEAMEO Regional Centre for Food and Nutrition
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Weight Gain focused on measuring underfive children, post-disaster recovery, optimized food based recommendation, growth, development, psycho-social stimulation

Eligibility Criteria

6 Months - 49 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Seameo Regional Center for Food and NutritionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

nutrition and psychosocial intervention arm

control arm

Arm Description

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

no intervention is given to this arm

Outcomes

Primary Outcome Measures

nutritional status
weight gain in g/kg.day

Secondary Outcome Measures

protein intake
protein intake (gram/day)
development
Bayley Scales of Infant Development (BSID) as total score (range 0 - >115)
psycho-social care
HOME Inventory score as total score (range 0-45)
iron intake
iron intake (mg/day)
zinc intake
zinc intake (mg/day)

Full Information

First Posted
February 23, 2019
Last Updated
March 30, 2019
Sponsor
SEAMEO Regional Centre for Food and Nutrition
Collaborators
Indonesia-MoH, Indonesia University
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1. Study Identification

Unique Protocol Identification Number
NCT03895398
Brief Title
Post Disaster Nutrition Intervention for Under-two-year-old Children in Lombok Indonesia
Acronym
NIELombok
Official Title
Effectiveness of Post Disaster Nutrition Intervention to Optimize Growth and Development of Under-two-year-old Children in Lombok, Indonesia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 12, 2018 (Actual)
Primary Completion Date
October 30, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
SEAMEO Regional Centre for Food and Nutrition
Collaborators
Indonesia-MoH, Indonesia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Gain
Keywords
underfive children, post-disaster recovery, optimized food based recommendation, growth, development, psycho-social stimulation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
480 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
nutrition and psychosocial intervention arm
Arm Type
Experimental
Arm Description
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
Arm Title
control arm
Arm Type
No Intervention
Arm Description
no intervention is given to this arm
Intervention Type
Other
Intervention Name(s)
nutrition and psychosocial intervention with community participatory
Intervention Description
community participation to ensure the intervention is given to the study subject (underfive children)
Primary Outcome Measure Information:
Title
nutritional status
Description
weight gain in g/kg.day
Time Frame
6 months of intervention
Secondary Outcome Measure Information:
Title
protein intake
Description
protein intake (gram/day)
Time Frame
6 months of intervention
Title
development
Description
Bayley Scales of Infant Development (BSID) as total score (range 0 - >115)
Time Frame
6 months of intervention
Title
psycho-social care
Description
HOME Inventory score as total score (range 0-45)
Time Frame
6 months of intervention
Title
iron intake
Description
iron intake (mg/day)
Time Frame
6 months of intervention
Title
zinc intake
Description
zinc intake (mg/day)
Time Frame
6 months of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
49 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Umi Fahmida, PhD
Phone
+628176060820
Email
umifahmida@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Indriani Oka Anak Agung Sagung
Phone
+6281233369657
Email
indrianioka@seameo-recfon.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grace Wangge
Organizational Affiliation
SEAMEO RECFON
Official's Role
Study Chair
Facility Information:
Facility Name
Seameo Regional Center for Food and Nutrition
City
Jakarta Pusat
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Secretariat seameo recfon
Phone
+622131930205
Email
information@seameo-recfon.org

12. IPD Sharing Statement

Citations:
PubMed Identifier
28698515
Citation
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.
Results Reference
background
PubMed Identifier
25639135
Citation
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.
Results Reference
background
Links:
URL
https://reliefweb.int/report/world/unhcr-emergency-handbook
Description
UNHCR Emergency Handbook REPORTfrom UN High Commissioner for Refugees Published on 12 Jun 2015
URL
https://www.ennonline.net/whocompfeedingconsultation
Description
Special issue on WHO Expert consultation on complementary feeding & 2001 meeting report Author: WHO Year: 2001 Resource type: Meetings and Workshops

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

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