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

Phase 3

• Conditions: Child Development; Nutritional Anemia
• Interventions: Other: FBDG group; Other: Control group; Other: Stimulation; Other: Combinded FBDG and stimulation

• Registration Number: NCT02078271
• Lead Sponsor: Indonesia University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2011-12
• Study First Submitted: 2014-02-24
• Status Verified: 2014-03
• Study First Submitted QC: 2014-03-03
• Last Update Submitted: 2014-03-03
• Study First Posted: 2014-03-05
• Last Update Posted: 2014-03-05
• Study Completion: 2014-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 480

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combined (FBDG and Stimulation)	Stimulation	The group received both FBDG and psychosocial stimulation
Stimulation group	Stimulation	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.
FBDG group	FBDG group	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.
Control	Control group	The group received standard health education messages from existing health care system.
Combined (FBDG and Stimulation)	FBDG group	The group received both FBDG and psychosocial stimulation
Combined (FBDG and Stimulation)	Combinded FBDG and stimulation	The group received both FBDG and psychosocial stimulation

Primary Outcome Measures

Name	Time	Method
Nutritional status	baseline (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 development	baseline (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).

Trial Locations

Locations (1)

South East Asian Ministers of Education Organization, Regional Center for Food and Nutrition (SEAMEO-RECFON); 🇮🇩 Jakarta, Java, Indonesia