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

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ClinicalTrials.gov Identifier: NCT02078271
Recruitment Status : Unknown
Verified March 2014 by Umi Fahmida, Indonesia University.
Recruitment status was:  Active, not recruiting
First Posted : March 5, 2014
Last Update Posted : March 5, 2014
Sponsor:
Collaborator:
Nestlé Foundation
Information provided by (Responsible Party):
Umi Fahmida, 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.


Condition or disease Intervention/treatment Phase
Nutritional Anemia Child Development Other: FBDG group Other: Stimulation Other: Combinded FBDG and stimulation Other: Control group Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: Food-Based Intervention and Psychosocial Stimulation to Improve Growth & Development of < 24 Month Indonesian Children
Study Start Date : January 2011
Actual Primary Completion Date : December 2011
Estimated Study Completion Date : May 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Other: FBDG group
The group received food based dietary guidelines for complementary feeding
Other Name: Food Based Dietary Guidelines

Experimental: 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.
Other: Stimulation
The group received psychosocial stimulation

Experimental: Combined (FBDG and Stimulation)
The group received both FBDG and psychosocial stimulation
Other: FBDG group
The group received food based dietary guidelines for complementary feeding
Other Name: Food Based Dietary Guidelines

Other: Stimulation
The group received psychosocial stimulation

Other: 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.
Other: Control group



Primary Outcome Measures :
  1. Nutritional status [ Time Frame: 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

  2. Child development [ Time Frame: 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).



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Ages Eligible for Study:   9 Months to 11 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02078271


Locations
Indonesia
South East Asian Ministers of Education Organization, Regional Center for Food and Nutrition (SEAMEO-RECFON)
Jakarta, Java, Indonesia, 10430
Sponsors and Collaborators
Indonesia University
Nestlé Foundation
Investigators
Principal Investigator: Umi Fahmida, PhD SEAMEO-RECFON, University of Indonesia

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Umi Fahmida, PhD, Indonesia University
ClinicalTrials.gov Identifier: NCT02078271     History of Changes
Other Study ID Numbers: FIRST
First Posted: March 5, 2014    Key Record Dates
Last Update Posted: March 5, 2014
Last Verified: March 2014