Overview

This trial is active, not recruiting.

Conditions nutritional anemia, child development
Treatments fbdg group, stimulation, combinded fbdg and stimulation, control group
Phase phase 3
Sponsor Indonesia University
Collaborator Nestlé Foundation
Start date January 2011
End date December 2011
Trial size 480 participants
Trial identifier NCT02078271, FIRST

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Arm
(Experimental)
The group received Food Based Dietary Guidelines for feeding recommendation. Monthly-session with group of mothers involving interactive activities e.g. cooking session, cooking competition and games.
fbdg group Food Based Dietary Guidelines
The group received food based dietary guidelines for complementary feeding
(Experimental)
The children received psychosocial stimulation from the mothers. Mothers were taught on psychosocial module which was developed using locally existing resources and was directed at improving four aspects of child development, namely gross motoric, fine motor, language and socio-emotional developments.
stimulation
The group received psychosocial stimulation
(Experimental)
The group received both FBDG and psychosocial stimulation
fbdg group Food Based Dietary Guidelines
The group received food based dietary guidelines for complementary feeding
stimulation
The group received psychosocial stimulation
combinded fbdg and stimulation
The group received both FBDG and psychosocial stimulation
(Other)
The group received standard health education messages from existing health care system.
control group

Primary Outcomes

Measure
Nutritional status
time frame: baseline (before intervention), endline (6 months after intervention), and follow up (2 years after endline)
Child development
time frame: baseline (before intervention), endline (6 months after intervention), and follow up (2 years after endline)

Eligibility Criteria

Male or female participants from 9 months up to 11 months old.

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

Additional Information

Official title Food-Based Intervention and Psychosocial Stimulation to Improve Growth & Development of < 24 Month Indonesian Children
Principal investigator Umi Fahmida, PhD
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by Indonesia University.