Follow Up of Severely Malnourished Children (FUSAM): Effectiveness of a Combined Nutrition Psychosocial Intervention on Health and Development.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 427
- 试验地点
- 1
- 主要终点
- Child motor, cognitive, emotional and social development assessed with Ages and Stages Questionnaire
研究概览
简要总结
The overall objective of the research is to assess the long-term and cost-effectiveness of a combined nutrition psychosocial intervention to a stand-alone nutritional treatment of children with Severe Acute Malnutrition (SAM) aged 6 to 24 months in the Saptari District of Nepal.
详细描述
In Nepal, the majority of SAM children are treated with therapeutic food in community/home-based care, and little is known about the long-term sustainability of the nutritional and health benefits of treatment after rehabilitation. The two treatments will be compared in terms of costs of treatment and convened health benefits (child nutritional status and development, cured rate and relapse, maternal mental health, and family care practices) at both short and long-term periods after admission. The proposed complementary psychosocial intervention focuses directly on the key underlying determinants of acute malnutrition within children's early years, such as child care practices and stimulation, parent-child relationships and maternal mental health. It includes the mother/caregiver as patient of psychosocial support, but also empowers her as the key ally in the treatment of the undernourished child. Adding a brief psychosocial component to the standard medico-nutritional treatment is expected to pay off in terms of sustainable recovery, health, and development outcomes of children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 23 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 6-23 months
- •Diagnosis: uncomplicated severe acute malnutrition requiring follow-up outpatient therapeutic feeding unit (OTPs), supported by Action Contre la Faim in Saptari district
- •Weight-for-height (WH) <-3 Standard Deviation compared to the WHO reference and/or MUAC <115 mm
- •And / or nutritional oedema moderate (+ or + +)
- •And successful test of appetite
- •And no medical complications
- •New cases
- •Presence of mother / father or legal guardian aged > 18 years.
- •Understanding of the consent and information letter
- •Follow-up possible
排除标准
- •Age <6 months or> 24 months
- •Moderate Acute Malnutrition
- •Severe Acute Malnutrition complicated
- •Weight for height <-3 Standard Deviation compared to the WHO reference and / or MUAC <115mm but failure to test appetite OR medical complications OR severe oedema + + + OR kwashiorkor, marasmus (malnutrition with the same criteria, with oedema mild or severe).
- •Relapse or if already registered in the past two months;
- •Any child with developmental anomalies, known chronic illnesses like epilepsy, twins and multiple births, parents not consenting,
结局指标
主要结局
Child motor, cognitive, emotional and social development assessed with Ages and Stages Questionnaire
时间窗: up to 11 months after inclusion
The Ages and Stages Questionnaire (Squires et al, 1999), is a low-cost, easily administered, parent-report screening test of development in communication, motor, problem-solving and personal-social domains. The questionnaire has been adapted and used in low- and middle-income countries in Africa, Asia and Latin America, where it has demonstrated sensitivity to child nutritional status and psychosocial stimulation. While it is not a diagnostic test, it offers an opportunity to systematically obtain information about children's development with an instrument that does not require extensive training
次要结局
- Mother-child interaction(Up to 11 months after inclusion)
- Child stimulation(Up to 11 months after inclusion)
- Child Care Practices(Up to 11 months after inclusion)
- Maternal perinatal mental health(Up to 11 months after inclusion)
- Child nutritional status defined by Weight-For-Height Z-score(Up to 11 months after inclusion)
- Child death (mortality rate)(Up to 11 months after inclusion)
- Perceived Social Support(Up to 11 months after inclusion)
- Maternal self-esteem(Up to 11 months after inclusion)
- Maternal mental health(Up to 11 months after inclusion)
- Child growth (height)(Up to 11 months after inclusion)
- Child nutritional status defined by Mid-Upper Arm Circumference (MUAC)(Up to 11 months after inclusion)
- Child nutritional status defined by height-for-Age Z score(Up to 11 months after inclusion)
- Child health status (morbidity rate)(Up to 11 months after inclusion)