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Food-Based Intervention and Psychosocial Stimulation to Improve Growth & Development of < 24 Month Indonesian Children

Food-Based Intervention and Psychosocial Stimulation to Improve Growth & Development of < 24 Month Indonesian Children

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02078271
Acronym
FIRST
Enrollment
480
Registered
2014-03-05
Start date
2011-01-31
Completion date
2014-05-31
Last updated
2014-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutritional Anemia, Child Development

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.

Interventions

OTHERFBDG group

The group received food based dietary guidelines for complementary feeding

The group received psychosocial stimulation

OTHERCombinded FBDG and stimulation

The group received both FBDG and psychosocial stimulation

OTHERControl group

Sponsors

Nestlé Foundation
CollaboratorOTHER
Indonesia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
9 Months to 11 Months
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Nutritional statusbaseline (before intervention), endline (6 months after intervention), and follow up (2 years after endline)Anthropometry status (Height for age, weight for height, weight for age, BMI for age), Hemoglobin, iron status (serum ferritin, transferrin receptor), vitamin A status (RBP). Iron and vitamin A status were measured only at follow up
Child developmentbaseline (before intervention), endline (6 months after intervention), and follow up (2 years after endline)Child development was measured using Bayley Scale of Infant Development II (BSID-II) at baseline and 6mo after the intervention (endline). Two years after the endline (the follow-up), child development was measured using Wechsler Preschool and Primary Scale of Intelligence - Fourth Edition (WPPSI-IV).

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026