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

NCT02078271 | Unknown Phase 3

• 1 other identifier: FIRST
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

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.

Conditions

Nutritional Anemia; Child Development

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (4)

FBDG group

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.

Other: FBDG group

Stimulation group

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.

Other: Stimulation

Combined (FBDG and Stimulation)

EXPERIMENTAL

The group received both FBDG and psychosocial stimulation

Other: FBDG group; Other: Stimulation; Other: Combinded FBDG and stimulation

Control

OTHER

The group received standard health education messages from existing health care system.

Other: Control group

Interventions

FBDG group OTHER

The group received food based dietary guidelines for complementary feeding

Also known as: Food Based Dietary Guidelines

Combined (FBDG and Stimulation); FBDG group

Stimulation OTHER

The group received psychosocial stimulation

Combined (FBDG and Stimulation); Stimulation group

Combinded FBDG and stimulation OTHER

The group received both FBDG and psychosocial stimulation

Combined (FBDG and Stimulation)

Control group OTHER

Control

Eligibility Criteria

• Age: 9 Months - 11 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• children aged 9-11 month on enrolment,
• weight-for-age Z-score \<-1.00 but \>-3.00

You may not qualify if:

• having mental or physical disabilities

Sponsors & Collaborators

• Indonesia University: lead
• Nestlé Foundation: collaborator

Study Sites (1)

South East Asian Ministers of Education Organization, Regional Center for Food and Nutrition (SEAMEO-RECFON)

Jakarta, Java, 10430, Indonesia

Location

Related Publications (12)

• 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. doi: 10.1093/ajcn/87.4.929.

  PMID: 18400716 BACKGROUND

• 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. doi: 10.1111/1467-8624.t01-1-00382.

  PMID: 11768149 BACKGROUND

• 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. doi: 10.1093/jn/126.7.1808.

  PMID: 8683342 BACKGROUND

• 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. doi: 10.1093/jn/134.4.951.

  PMID: 15051853 BACKGROUND

• 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. doi: 10.1093/jn/136.9.2399.

  PMID: 16920861 BACKGROUND

• 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. doi: 10.1093/jn/136.10.2645.

  PMID: 16988140 BACKGROUND

• 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. doi: 10.1093/ajcn.82.2.399.

  PMID: 16087985 BACKGROUND

• 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.

  PMID: 19056658 BACKGROUND

• 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. doi: 10.1016/S0140-6736(05)67574-5.

  PMID: 16298218 BACKGROUND

• 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. doi: 10.1136/bmj.38897.555208.2F. Epub 2006 Jul 28.

  PMID: 16877454 BACKGROUND

• 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. doi: 10.1093/jn/137.11.2464.

  PMID: 17951486 BACKGROUND

• Fahmida U, Kolopaking R, Santika O, Sriani S, Umar J, Htet MK, Ferguson E. Effectiveness in improving knowledge, practices, and intakes of "key problem nutrients" of a complementary feeding intervention developed by using linear programming: experience in Lombok, Indonesia. Am J Clin Nutr. 2015 Mar;101(3):455-61. doi: 10.3945/ajcn.114.087775. Epub 2014 Dec 24.

  PMID: 25733629 DERIVED

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Umi Fahmida, PhD

  SEAMEO-RECFON, University of Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: February 24, 2014
• First Posted: March 5, 2014
• Study Start: January 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: May 1, 2014
• Last Updated: March 5, 2014

Record last verified: 2014-03

Locations

ID (1)