Clinical trial NCT02078271: Food-Based Intervention and Psychosocial Stimulation to Improve Growth & Development of < 24 Month Indonesian Children
Official title: Food-Based Intervention and Psychosocial Stimulation to Improve Growth & Development of < 24 Month Indonesian Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Nutritional Anemia
Child Development
Lead sponsor: Indonesia University
Sponsor class: OTHER
Collaborators: name: Nestlé Foundation
First posted: 2014-03-05
Enrollment: 480
Sex: ALL
Minimum age (years): 9
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: WHO has urged all developing countries to develop programmes to improve complementary-feeding (CF) practices because of their importance for optimal growth, development and health of infants and young children While supplementation programmes and/or highly-fortified "super-foods" have limited success in improving CF-practices in disadvantaged environments, population-specific food-based dietary guidelines (FBDG), based on locally-available foods and requires minimal changes to local food pattern, will enhance the chances of programme success.

Our previous study was able to identify the need for, potential and finally develop FBDG for CF of 6-8mo and 9-11mo infants using combined linear-and-goal programming approach (LP approach). This research is therefore being made to support the next phase of the study i.e. to assess the efficacy of FBDG, for improving CF/dietary-practices and growth in \<24mo children (window of opportunity). As growth and development is inter-related, home-based stimulation will be included in this trial to see the effect on child development. While studies have shown that stimulation at early age benefits children through their late adolescence; evidence from Indonesia is lacking. This study therefore aims to see the effect on growth and development of community trial using food-based dietary guideline and stimulation. It is expected that findings from this study will provide scientific evidence as the basis for program formulation.


Eligibility criteria: Inclusion Criteria:

* children aged 9-11 month on enrolment,
* weight-for-age Z-score \<-1.00 but \>-3.00

Exclusion Criteria:

* having mental or physical disabilities

Primary outcomes:
measure: Nutritional status
timeFrame: baseline (before intervention), endline (6 months after intervention), and follow up (2 years after endline)
measure: Child development
timeFrame: baseline (before intervention), endline (6 months after intervention), and follow up (2 years after endline)
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: South East Asian Ministers of Education Organization, Regional Center for Food and Nutrition (SEAMEO-RECFON)
state: Java
Study officials:
affiliation: SEAMEO-RECFON, University of Indonesia
name: Umi Fahmida, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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