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临床试验/NCT02249754
NCT02249754Unknown不适用

Effectiveness of a Nutrition Education Package in Improving Feeding Practices, Dietary Adequacy and Growth of Infants and Young Children in Rural Tanzania

Sokoine University of Agriculture1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2014年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
600
试验地点
1
主要终点
Linear growth: Mean change from baseline in length-for-age Z-scores at at 9-, 12- and 15-months-old

研究概览

简要总结

Building on the success of community-based peer education and counselling in breastfeeding, it is possible to address young child feeding and health practices in the surveyed district. Opportunities that can optimise success and encourage behaviour change in the district include mothers willingness to modify some feeding options; support of family members; seasonal availability and accessibility of foods; established set-up of village peers and existence of health centres and health staff in some villages. This study has developed a feasible, context-specific nutrition education package for use in rural Tanzania. The package is composed of 4 components, namely 1) education and counselling of mothers, 2) training of community-based nutrition counsellors, 3) sensitisation meetings with health staff and family members, and 4) supervision of community-based nutrition counsellors. The intervention will use a parallel cluster-randomised controlled trial design where infants will be recruited when aged 6 months and followed up for 9 months. The intervention expects to provide information and, where appropriate, recommendations to strengthen the nutrition component in the health education programme of the Tanzania child health services.

The study hypothesises that the nutrition education package will be more effective than the routine health education in improving feeding practices, dietary adequacy and growth of infants and young children. Specific objectives of the study include:

  • To evaluate the effectiveness of a nutrition education package on feeding practices and dietary adequacy
  • To determine the effectiveness of a nutrition education package in improving growth and health of infants and young children
  • To document the process of implementation of the nutrition education package to promote optimal feeding and health practice

详细描述

Design:

A parallel cluster randomised controlled trial will be conducted in rural central Tanzania in 9 intervention and 9 control villages. A simple randomisation with a 1:1 allocation using a list of random numbers generated in Microsoft Excel 2007 will be used to randomise villages to either control or intervention group. Generation of allocation sequence and randomisation of clusters will be done by a statistician blinded to study groups and not participating in the research.

Recruitment and collection of baseline information:

After cluster randomisation, sub-village leaders will identify all infants aged 6 months and their parents in a systematic door-to-door survey. Parents will be invited to a meeting where the nature and purpose of the trial and eligibility criteria will be explained. Thereafter, their infants will be screened for eligibility.

Parents and infants who meet the inclusion criteria, agree to participate in the trial and give a written informed consent will have their infants recruited. Baseline information of recruited infants and their parents (i.e. household's, parents' and infant's characteristics) will be collected using a structured questionnaire. Structured interviews with village and sub-village leaders will also be conducted to collect village information (i.e. population, health facility, water supply, schools, livelihoods, resources, economic opportunities).

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 7 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Infants aged 6-7 months at the time of recruitment into the study
  • Infants currently being breastfed
  • Parents (or caregivers) anticipated local residence for the study duration

排除标准

  • Congenital or chronic abnormalities impairing feeding or physical growth measurements
  • Severely ill or clinical complications warranting hospitalisation

结局指标

主要结局

Linear growth: Mean change from baseline in length-for-age Z-scores at at 9-, 12- and 15-months-old

时间窗: Length-for-age Z-scores: Baseline (6 months-old), Month 9, Month 12 and Month 15

Linear growth (length-for-age Z-scores): WHO 2006 Growth Standards

次要结局

  • Proportion of children consuming the recommended number of semi-solid/soft meals and snacks per day at 9-, 12- and 15-months-old(Proportion of children consuming the recommended number of semi-solid/soft meals and snacks per day: Baseline (6 months-old), Month 9, Month 12 and Month 15)
  • Proportion of children consuming foods from 4 or more food groups at 9-, 12- and 15-months-old(Proportion of children consuming foods from 4 or more food groups: Baseline (6 months-old), Month 9, Month 12 and Month 15)
  • Maternal level of knowledge and practice of recommended feeding and health practices at 9-, 12- and 15-months-old(Maternal level of knowledge and practice of recommended feeding and health practices: Month 9, Month 12 and Month 15)
  • Weight-for-length: Mean change from baseline in weight-for-length Z-scores at 9-, 12- and 15-months-old(Weight-for-length Z-scores: Baseline (6 months-old), Month 9, Month 12 and Month 15)
  • Mean intake of energy, fat, iron and zinc from complementary foods at 12 months-old(Mean intake of energy, fat, iron and zinc from complementary foods: Baseline (6 months-old), Month 12)

研究者

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

Kissa B.M. Kulwa, MSc.

Lecturer

Sokoine University of Agriculture

研究点 (1)

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