Transition to Scale of an Integrated Program of Nutritional Care and Psychosocial Stimulation to Improve Malnourished Children's Development in Bangladesh
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Moderate and Severe Undernutrition
- 发起方
- International Centre for Diarrhoeal Disease Research, Bangladesh
- 入组人数
- 6400
- 试验地点
- 1
- 主要终点
- Anthropometry multiple measures, viz. Weight, length/height and head circumference
- 状态
- 已完成
- 最后更新
- 7年前
概览
简要总结
We hypothesize that it is feasible to integrate a program of Nutritional Care and Pychosocial Stimulation into the Community Clinics in Bangladesh and thereby improve malnourished children's growth and development after a year of intervention.
详细描述
Over 200 million children \<5 yrs do not reach their full potential due to poor nutrition and inadequate cognitive stimulation. Nutritional Care (NC) alone is insufficient to correct developmental deficit in malnourished children and psychosocial stimulation (PS) is also required. Objectives: 1. Pilot two intervention methods and different delivery models of providing NC+PS to refine the intervention and identify any difficulties. 2. Conduct a cluster randomized controlled trial (CRCT) of NC+PS on malnourished children. 3. Pilot the feasibility of providing NC+PS to groups of mothers instead of individuals through a quasi-experimental design. Methods: The study consists of 3 different sub-studies: 1. The pilot will be a qualitative study conducted in 10 Community Clinics (CCs) involving 40 children (aged 6-33 months) per CC. Mothers and children will attend the clinic every 2 weeks for an hour play session in groups of 2 or 6. We will explore different delivery models and assess problems through focus group discussions with parents and staff of the CCs. 2. For the CRCT we will survey all children aged 6-24 mo in 140 CCs to identify those malnourished. We will then randomize the CCs to NC+PS or control, randomly select 40 children from each CC and evaluate a random subsample of 6 children from each of the CCs using anthropometry, Bayley-III, Wolke's behavior rating and family care indicators (FCI) at baseline and endline. 3. The quasi experimental study will be conducted in 10 CCs randomized to group-intervention or control with 40 mothers and children per CC. Mothers will come to the CCs in groups of 6 with their children every fortnight. The children will be tested at the beginning and after 12 months using the same tools in the main study. Outcome variable: The main outcomes are children's language, mental and psychomotor development measured on Bayley-III. In addition we expect improvements in FCI and mother's child rearing knowledge and practices. We will also conduct cost analysis and based on the success indicators, cost per successful outcome will be calculated from total cost of intervention program.
研究者
入排标准
入选标准
- •Moderately and Severely malnourished children WAZ\<-2SD
- •Age: 6-24 months
- •Both male and female children
- •Living within 30 minutes walk from the Community Clinic
- •Parents giving consent to participate in the study
排除标准
- •Severe Acute Malnutrition with complications requiring close monitoring and/or hospitalization
- •Severe clinical pallor
- •Known chronic diseases like epilepsy, cerebral palsy, mental retardation
- •Twin/multiple birth
- •Children with above exclusion criteria or those whose parents do not wish to sign the consent form will not be included in the evaluation sample but if they wish they will receive the stimulation.
结局指标
主要结局
Anthropometry multiple measures, viz. Weight, length/height and head circumference
时间窗: 12 months
Children's weight, length/height and head circumference will be measured using standard methods.
Behaviour
时间窗: 12 months
The outcome is measured using Wolke's behaviour ratings during the Bayley-III test.
Cognitive, Language and Motor Composite Scores
时间窗: 12 months
The outcomes are measured on Bayley-III test.
次要结局
- Family Care Indicators(12 months)