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临床试验/NCT04688515
NCT04688515已完成不适用

Effectiveness of a Nutrition Program Using Positive Deviance Approach to Reduce Undernutrition Among Urban Poor Children Under Five in Kuala Lumpur, Malaysia: A Two-armed Cluster Randomized Controlled Trial

Universiti Putra Malaysia1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2022年3月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
74
试验地点
1
主要终点
Changes in height-for-age z score after 3 months of intervention in children

研究概览

简要总结

Globally, childhood malnutrition remains a public health concern. Malnutrition can be diverse from undernutrition to overnutrition. A young child, primarily refers to those under the age of 5, is suffering from undernutrition when the child is lacking of adequate nutrition that necessary for proper growth and health due to direct or indirect causes such as not having enough food. In fully urbanized area such as Kuala Lumpur, urban poor children tend to face greater deprivations such as lower education and poor health which significantly influence their daily diet and nutritional status. Hence, urban poor children who are living and growing up in such underprivileged environment should not be neglected. Since young children are generally depending on maternal feeding for daily diet, intervention that focus on encouraging positive change in maternal feeding practices might be efficient in reducing childhood undernutrition. The positive deviance (PD) approach may consider as a better alternative to empower mothers by promoting new behaviour to feed their children. Hence, this study aims to evaluate the effectiveness of a nutrition program using PD approach in reducing undernutrition among urban poor children aged 3 to 5 years old in Kuala Lumpur.

详细描述

Background:

Undernourished children who fail to grow in height and weight as other normal children can be underweight, stunting or wasting. In fully urbanized area such as Kuala Lumpur in Malaysia, the consequences of undernutrition are more detrimental in urban poor young children. Since young children are generally depending on maternal feeding for daily diet, alternative intervention that focus on encouraging positive change in maternal behaviour when feeding children might be efficient in reducing childhood undernutrition. The positive deviance (PD) approach is one such alternative intervention. This approach emphases the identification of positive deviant, individuals who successfully discover a way to solve a problem by performing some uncommon but advantageous actions or behaviours in the same underprivileged environment as their peers. In the context of child nutrition, positive deviance is more frequently referred to as adaptive child care practices, positive hygiene practices and feeding practices that enable children to develop appropriately in a harsh environment with limited resources. The nutrition program developed using this approach helps to discover positive deviant, spread local wisdom from mothers of well-nourished children to mothers of undernourished children, and initiate positive behavioural change as a preliminary step to promote healthy weight gain in children.

Methods:

This is a mixed method study which will be carried out in two phases. Phase I of the study will involve focus group discussion (FGD) with semi-structured interview to explore maternal feeding practices and also foods being fed to children. Mothers of children aged 3 to 5 years old will be recruited through purposive sampling or until saturation point is reached. Phase II of the study will involve a two-armed randomized controlled trial to evaluate effectiveness of nutrition program. A total of 164 mother-child dyads will be recruited, in which 82 of them will be recruited separately and randomly from different PPR flats with 1:1 allocation to form intervention and comparison groups. Ethical approval will be obtained from the Ethics Committee for Research Involving Human Subjects Universiti Putra Malaysia (JKEUPM). Permission to conduct this study in PPR flats and the list of PPR flats in KL will be obtained from the Kuala Lumpur City Hall. Intervention group will need to participate in a nutrition program for 3 months that consists of education session with peer-led cooking session and rehabilitation session. The comparison group will be given all the materials used in the program for reference after the last data collection. The height and weight of children will be measured by researcher. Mothers will be interviewed on the dietary intake of their children. Mothers will also need to answer a Malay language self-administered questionnaire to obtain information on socio-demographic characteristics, nutrition knowledge and food security status. These measurements will be taken at the baseline (before intervention), immediate post-intervention and 3-month post-intervention for both intervention and comparison groups.

研究设计

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

入排标准

年龄范围
3 Years 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Malaysian
  • Children aged 3 to 5 years old
  • Mothers aged above 18 years old
  • Living in public low-cost PPR flat

排除标准

  • Children who are taken care by other adults rather than mothers such as father, grandparents and caregivers
  • Mothers with mental disabilities
  • Children with history of chronic diseases including congenital heart disease, liver disease, renal failure or sickle cell disease and any congenital abnormalities
  • Children who are under treatment for communicable disease such as measles and chickenpox
  • Children with learning disabilities
  • Mother-child dyads involved in any other intervention or clinical research
  • Children who are overweight or obese
  • The respondents' selection criteria in Phase 2 are almost similar as in Phase 1 except for the second inclusion criterion that is related to children. In Phase 2, only undernourished children (either underweight, stunting or wasting) aged 3 to 5 years old will be recruited in order to evaluate the effectiveness of the intervention in this particular group. The exclusion criteria in Phase 2 are similar to the exclusion criteria in Phase 1.

结局指标

主要结局

Changes in height-for-age z score after 3 months of intervention in children

时间窗: 3 months

height-for-age z score in standard deviation

Changes in body weight after 3 months of intervention in children

时间窗: 3 months

body weight in kg

Changes in weight-for-age z score after 3 months of intervention in children

时间窗: 3 months

weight-for-age z score in standard deviation

Changes in dietary intake after 3 months of intervention in children

时间窗: 3 months

24-hour diet recall (3 days) in kcal

Changes in weight-for-height z score after 3 months of intervention in children

时间窗: 3 months

weight-for-height z score in standard deviation

Changes in diet quality after 3 months of intervention in children

时间窗: 3 months

Healthy Eating Index (HEI) for Malaysians; composite HEI scores range from 0 to 100%; score \<51% indicates poor diet quality, 51 to 80% indicates diet required improvement, and \>80% indicates good diet quality

次要结局

  • Changes in nutrition knowledge after 3 months of intervention in mothers(3 months)
  • Assessment of food security level after 3 months of intervention in mothers(3 months)

研究者

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

Gan Wan Ying

Associate Professor

Universiti Putra Malaysia

研究点 (1)

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