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临床试验/NCT02078271
NCT02078271Unknown3 期

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

Indonesia University2 个研究点 分布在 1 个国家目标入组 480 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
3 期
入组人数
480
试验地点
2
主要终点
Nutritional status

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Single (Participant)

入排标准

年龄范围
9 Months 至 11 Months(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • having mental or physical disabilities

结局指标

主要结局

Nutritional status

时间窗: 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

Child development

时间窗: 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).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Umi Fahmida

PhD

Indonesia University

研究点 (2)

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