Food-Based Intervention and Psychosocial Stimulation to Improve Growth & Development of < 24 Month Indonesian Children
NCT ID: NCT02078271
Last Updated: 2014-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
480 participants
INTERVENTIONAL
2011-01-31
2014-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SINGLE
Study Groups
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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.
FBDG group
The group received food based dietary guidelines for complementary feeding
Stimulation group
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
Combined (FBDG and Stimulation)
The group received both FBDG and psychosocial stimulation
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
The group received standard health education messages from existing health care system.
Control group
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* weight-for-age Z-score \<-1.00 but \>-3.00
Exclusion Criteria
9 Months
11 Months
ALL
Yes
Sponsors
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Nestlé Foundation
OTHER
Indonesia University
OTHER
Responsible Party
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Umi Fahmida
PhD
Principal Investigators
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Umi Fahmida, PhD
Role: PRINCIPAL_INVESTIGATOR
SEAMEO-RECFON, University of Indonesia
Locations
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South East Asian Ministers of Education Organization, Regional Center for Food and Nutrition (SEAMEO-RECFON)
Jakarta, Java, Indonesia
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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FIRST
Identifier Type: -
Identifier Source: org_study_id
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