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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03895398
Other study ID # NIELombok
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 12, 2018
Est. completion date December 31, 2019

Study information

Verified date March 2019
Source SEAMEO Regional Centre for Food and Nutrition
Contact Umi Fahmida, PhD
Phone +628176060820
Email umifahmida@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 480
Est. completion date December 31, 2019
Est. primary completion date October 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Months to 49 Months
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
nutrition and psychosocial intervention with community participatory
community participation to ensure the intervention is given to the study subject (underfive children)

Locations

Country Name City State
Indonesia Seameo Regional Center for Food and Nutrition Jakarta Pusat DKI Jakarta

Sponsors (3)

Lead Sponsor Collaborator
SEAMEO Regional Centre for Food and Nutrition Indonesia University, Ministry of Health, Indonesia

Country where clinical trial is conducted

Indonesia, 

References & Publications (2)

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. — View 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). pii: E748. doi: 10.3390/ijerph14070748. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary nutritional status weight gain in g/kg.day 6 months of intervention
Secondary protein intake protein intake (gram/day) 6 months of intervention
Secondary development Bayley Scales of Infant Development (BSID) as total score (range 0 - >115) 6 months of intervention
Secondary psycho-social care HOME Inventory score as total score (range 0-45) 6 months of intervention
Secondary iron intake iron intake (mg/day) 6 months of intervention
Secondary zinc intake zinc intake (mg/day) 6 months of intervention
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