跳至主要内容
临床试验/NCT02098031
NCT02098031已完成不适用

Improving the Nutrition Status of 6 to 8 Months Old Children Through Diet Diversification and Better Dietary Intakes in the Kabale and Kisoro Districts in South-Western Uganda

University of Oslo1 个研究点 分布在 1 个国家目标入组 511 人开始时间: 2014年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
511
试验地点
1
主要终点
Change in the prevalence of stunting (<-2 SD of the WHO, 2006 growth reference standards)

研究概览

简要总结

Undernutrition and growth restriction due to poor diet and inadequate nutrient intake continues to be a global challenge, particularly in the developing countries including Uganda. The etiology of inadequate nutrient supply to infants may relate to lack of resources or knowledge or a combination of both. Poor nutrient intake and impaired growth may affect brain and cognitive development.

This study aims to evaluate nutrient intake, growth and cognitive function among children between 6 and 36 months living in the fertile Kabale and Kisoro region in south-western Uganda. The investigators hypothesize that nutrition education to mothers can bring about improved dietary intake and nutritional status among children aged 6-36 months.

A follow-up study was conducted during the period January - July 2022.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
6 Months 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • A lead caretaker with a 6-8 months infant (child/lead caretaker pair) who will have given consent to participate in the study. If there is more than one child of the age in the household, the younger one will be taken as the index/study child.

排除标准

  • Is older than 8 months at baseline
  • Congenital malformations or physical handicap that may influence growth or interfere with taking of anthropometric measurements
  • Disability that will influence nutrient intake
  • Been diagnosed with mental or brain illness as evidenced by mother or health worker.
  • If the family that is likely to emigrate during the study period

结局指标

主要结局

Change in the prevalence of stunting (<-2 SD of the WHO, 2006 growth reference standards)

时间窗: 6-8, 12-16, 20-24 (main outcome time point), 36 months, 7-10 years

The investigators will measure the change in stunting between the three indicated time points.

次要结局

  • Oral health(7-10 years)
  • Change in mean weight-for-age z-score(6-8, 12-16 and 20-24, 36 months, 7-10 years)
  • Change in mean weight-for-height z-score(6-8, 12-16, 20-24, 36 months, 7-10 years)
  • Change in mean diet diversification score (DDS)(6-8, 12-16, 20-24, 36 months)
  • Change in The Kaufman Assessment Battery for Children (2nd ed.; KABC-II) and the Test of Variable of Attention (TOVA)(7-10 years)
  • Change in Bayley Child Development test 3 ed.(6-8, 12-16, 20-24, 36 months)
  • Change in gut microbiota(20-24, 36 months, 7-10 years)
  • Change in Becks Depression Inventory II questionnaire to determine the maternal self-reported depression symptoms(7-10 years)
  • Change in Mullens test(36 months)
  • Change in the Center for Epidemiological Studies Depression Scale questionnaires to determine the maternal self-reported depression symptoms(7-10 years)
  • Change in mean Mid Upper Arm Circumference (MUAC) z-score(6-8, 12-16, 20-24, 36 months, 7-10 years)
  • Change in Ages and Stages Questionnaire Scores (AQS)(6-8, 12-16, 20-24, 36 months)
  • Change in oral microbiota(36 months, 7-10 years)

研究者

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

Per Ole Iversen, MD

Professor

University of Oslo

研究点 (1)

Loading locations...

相似试验