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

Child Development Clinical Trial

— FIRST  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02078271
• Other study ID #: FIRST
• Status: Active, not recruiting
• Phase: Phase 3
• First received: February 24, 2014
• Last updated: March 3, 2014
• Start date: January 2011
• Est. completion date: May 2014

Study information

• Verified date: March 2014
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Indonesia: Committee of The Medical Research Ethics of the Faculty of Medicine University of Indonesia
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 480
• Est. completion date: May 2014
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 9 Months to 11 Months

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Child Development
• Nutritional Anemia

Intervention

Other:
• FBDG group
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
• Control group

Locations

Country	Name	City	State
Indonesia	South East Asian Ministers of Education Organization, Regional Center for Food and Nutrition (SEAMEO-RECFON)	Jakarta	Java

Sponsors (2)

Lead Sponsor	Collaborator
Indonesia University	Nestlé Foundation

Country where clinical trial is conducted

Indonesia, 

References & Publications (11)

Adu-Afarwuah S, Lartey A, Brown KH, Zlotkin S, Briend A, Dewey KG. Home fortification of complementary foods with micronutrient supplements is well accepted and has positive effects on infant iron status in Ghana. Am J Clin Nutr. 2008 Apr;87(4):929-38. — View Citation

Bradley RH, Corwyn RF, McAdoo HP, Coll CG. The home environments of children in the United States part I: variations by age, ethnicity, and poverty status. Child Dev. 2001 Nov-Dec;72(6):1844-67. — View Citation

Engle PL, Zeitlin M. Active feeding behavior compensates for low interest in food among young Nicaraguan children. J Nutr. 1996 Jul;126(7):1808-16. — View Citation

Ferguson EL, Darmon N, Briend A, Premachandra IM. Food-based dietary guidelines can be developed and tested using linear programming analysis. J Nutr. 2004 Apr;134(4):951-7. — View Citation

Ferguson EL, Darmon N, Fahmida U, Fitriyanti S, Harper TB, Premachandra IM. Design of optimal food-based complementary feeding recommendations and identification of key "problem nutrients" using goal programming. J Nutr. 2006 Sep;136(9):2399-404. — View Citation

Gardner JM, Powell CA, Baker-Henningham H, Walker SP, Cole TJ, Grantham-McGregor SM. Zinc supplementation and psychosocial stimulation: effects on the development of undernourished Jamaican children. Am J Clin Nutr. 2005 Aug;82(2):399-405. — View Citation

Hamadani JD, Huda SN, Khatun F, Grantham-McGregor SM. Psychosocial stimulation improves the development of undernourished children in rural Bangladesh. J Nutr. 2006 Oct;136(10):2645-52. — View Citation

Santika O, Fahmida U, Ferguson EL. Development of food-based complementary feeding recommendations for 9- to 11-month-old peri-urban Indonesian infants using linear programming. J Nutr. 2009 Jan;139(1):135-41. doi: 10.3945/jn.108.092270. Epub 2008 Dec 3. — View Citation

Walker SP, Chang SM, Powell CA, Grantham-McGregor SM. Effects of early childhood psychosocial stimulation and nutritional supplementation on cognition and education in growth-stunted Jamaican children: prospective cohort study. Lancet. 2005 Nov 19;366(9499):1804-7. — View Citation

Walker SP, Chang SM, Powell CA, Simonoff E, Grantham-McGregor SM. Early childhood stunting is associated with poor psychological functioning in late adolescence and effects are reduced by psychosocial stimulation. J Nutr. 2007 Nov;137(11):2464-9. — View Citation

Walker SP, Chang SM, Powell CA, Simonoff E, Grantham-McGregor SM. Effects of psychosocial stimulation and dietary supplementation in early childhood on psychosocial functioning in late adolescence: follow-up of randomised controlled trial. BMJ. 2006 Sep 2;333(7566):472. Epub 2006 Jul 28. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No