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Nutritional AnemiaPhase 3FIRSTNCT02078271

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

A Phase 3 study testing FBDG group, Stimulation and Combinded FBDG and stimulation in people with Nutritional Anemia and Child Development, run by Universitas Indonesia at 1 site in Indonesia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 9 to 11 monthsHealthy volunteers can take part
Conditions the study is for
Nutritional Anemia, Child Development
What is being tested?
FBDG group, Stimulation and Combinded FBDG and stimulation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
480 participants
Where
1 siteIndonesia
Study dates
Jan 2011to May 2014
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 9 to 11 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

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

Who cannot join

  • having mental or physical disabilities

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

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

    Jakarta, Java, 10430

Other trials in Indonesia

About this study

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.

Being tested
FBDG group, Stimulation, Combinded FBDG and stimulation, Control group

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FBDG groupOther

    Also called Food Based Dietary Guidelines

    The group received food based dietary guidelines for complementary feeding

  • StimulationOther

    The group received psychosocial stimulation

  • Combinded FBDG and stimulationOther

    The group received both FBDG and psychosocial stimulation

  • Control groupOther

Study groups in NCT02078271
Study groupRoleWhat they receive
FBDG groupExperimentalThe 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.
Receives: Other: FBDG group
Stimulation groupExperimentalThe 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.
Receives: Other: Stimulation
Combined (FBDG and Stimulation)ExperimentalThe group received both FBDG and psychosocial stimulation
Receives: Other: FBDG group; Other: Stimulation; Other: Combinded FBDG and stimulation
ControlOtherThe group received standard health education messages from existing health care system.
Receives: Other: Control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: baseline (before intervention), endline (6 months after intervention), and follow up (2 years after endline)

  2. 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).

    Measured: baseline (before intervention), endline (6 months after intervention), and follow up (2 years after endline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2014 (estimated)
  2. Study startJan 2011
  3. Primary completionDec 2011
  4. Study completionMay 2014 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
480 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02078271
Sponsor's protocol ID
FIRST
Acronym
FIRST
Status last verified
Mar 2014
First submitted
24 Feb 2014
Last updated
5 Mar 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 18400716

  • 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.

    PubMed 11768149

  • 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.

    PubMed 8683342

  • 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.

    PubMed 15051853

  • 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.

    PubMed 16920861

  • 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.

    PubMed 16988140

  • 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.

    PubMed 16087985

  • 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.

    PubMed 19056658

  • 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.

    PubMed 16298218

  • 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.

    PubMed 16877454

  • 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.

    PubMed 17951486

  • 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.

    PubMed 25733629

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing FBDG group, Stimulation and Combinded FBDG and stimulation in people with Nutritional Anemia and Child Development, run by Universitas Indonesia at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Nutritional status (time frame: baseline (before intervention), endline (6 months after intervention), and follow up (2 years after endline)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02078271, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2014.

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