The Effect of an Intervention Program for Primary Caregivers on the Development of Children With Severe Malnutrition: A Cluster Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 181
- 试验地点
- 1
- 主要终点
- Malawi Developmental Assessment Tool Score
研究概览
简要总结
This cluster-randomized controlled trial will evaluate the effectiveness of a four-day hospital-based intervention program for primary caregivers of children with severe malnutrition.
详细描述
Mortality rates remain high in hospitalized children with severe malnutrition and long-term impairments in child development exist in children that do survive. Hospitalized children with severe malnutrition will be allocated to an intervention or standard of care group in each one-week cycle. The intervention package consists of a counseling and support program that includes three modules: 1) psychosocial stimulation; 2) nutrition and feeding; and 3) water, sanitation and hygiene. Assessments will be done at baseline (t=0) and follow-up (t=6 months). The primary outcome is child development, which will be assessed using the Malawi Developmental Assessment Tool, a validated tool for gross and fine motor, language, and social development.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child 6-59 months of age with severe malnutrition
- •Child admitted to hospital because of severe malnutritionwith medical complications as defined by the current World Health Organization guidelines or has no appetite if there are no complications
- •Primary caregiver (self-identified) present at hospital.
排除标准
- •Primary caregiver declined to give informed consent;
- •Child with a known terminal illness (i.e. in the opinion of the treating physician the child is likely to die within six months)
- •Child requires a surgical procedure.
研究组 & 干预措施
Standard of Care
Comparison group will receive the current standard of care. Nurses are instructed to tell mothers about nutrition and water, sanitation and hygiene at any point prior to discharge from hospital. In addition, nurses will tell primary caregivers to play with their children even while they are receiving treatment in a play area with toys available.
干预措施: Standard of Care (Behavioral)
Counseling Intervention Package
Primary caregivers in the intervention group receive group education sessions involving psychosocial stimulation, nutrition and feeding, and water, sanitation and hygiene components during a total of four days.
干预措施: Counseling Intervention Package (Behavioral)
结局指标
主要结局
Malawi Developmental Assessment Tool Score
时间窗: 6 months post-discharge from hospital
Gross motor, fine motor, language, and social development
次要结局
- Readmission(Within 6 months post-discharge from hospital)
- Nutritional status based on: mid-upper arm circumference (MUAC)(6 months post-discharge from hospital)
- Nutritional status based on: World Health Organization (WHO) z-scores(6 months post-discharge from hospital)
- Nutritional status based on: nutritionally-induced bilateral pitting oedema(6 months post-discharge from hospital)
- Duration of hospital stay(During hospitalization; up to three days before enrollment until discharge from hospital (e.g., up to 30 days))
- Appetite(During hospitalization; up to three days before enrollment until discharge from hospital (e.g., up to 30 days))
- Clinical deterioration(During hospitalization; up to three days before enrollment until discharge from hospital (e.g., up to 30 days))
- Mortality(Within 6 months post-discharge from hospital)
研究者
Robert Bandsma
Staff Gastroenterologist
The Hospital for Sick Children