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

Study Overview
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Brief Summary
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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.

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

Conditions
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Nutritional Anemia, Child Development

Intervention / Treatment
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* Other: FBDG group
* Other: Stimulation
* Other: Combinded FBDG and stimulation
* Other: Control group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 9 Months
Maximum Age: 11 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FBDG group<br>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. | Other: FBDG group<br>* The group received food based dietary guidelines for complementary feeding<br>* Other names: Food Based Dietary Guidelines;|
| Experimental: Stimulation group<br>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. | Other: Stimulation<br>* The group received psychosocial stimulation<br>|
| Experimental: Combined (FBDG and Stimulation)<br>The group received both FBDG and psychosocial stimulation | Other: FBDG group<br>* The group received food based dietary guidelines for complementary feeding<br>* Other names: Food Based Dietary Guidelines;Other: Stimulation<br>* The group received psychosocial stimulation<br>Other: Combinded FBDG and stimulation<br>* The group received both FBDG and psychosocial stimulation<br>|
| Other: Control<br>The group received standard health education messages from existing health care system. | Other: Control group<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutritional status | 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 | baseline (before intervention), endline (6 months after intervention), and follow up (2 years after endline) | 
| Child development | 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). | baseline (before intervention), endline (6 months after intervention), and follow up (2 years after endline) |