Develop and evaluate effectiveness of providing improved take home foods in combination with behaviour change intervention to improve nutritional status in children in selected districts of six states of India
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- ICMR
- 入组人数
- 600
- 试验地点
- 6
- 主要终点
- • To assess the effectiveness of the intervention package integrating a combination of improved THR and improved SBCC strategy targeted at children aged 6-36 months compared to the existing THR and SBCC strategy on change in weight-for-age z score (WAZ) from baseline.
研究概览
简要总结
The primary goal of this study is to develop and evaluate the effectiveness of a combined approach involving improved take-home food (THR) and socio-culturally appropriate social and behavior change communication (SBCC) interventions targeted at children aged 6 to 36 months in selected regions across six states in India. The implementation of this integrated package is likely to lead to a notable improvement in nutritional status, specifically an increase in the weight-for-age z-score by at least 0.3 standard deviations (SD) after a minimum of 18 months, compared to the existing strategies. The primary objective is to evaluate the impact of the integrated approach on the weight-for-age z-score after 18 months. Secondary objectives include assessing the current status of THR and SBCC strategies, developing a culturally appropriate intervention package, evaluating its impact on undernutrition indicators and IYCF practices, and documenting its cost-effectiveness compared to existing strategies. An exploratory cross-sectional study, participatory research, and cluster randomized trial will be employed for the study. These will be conducted in selected districts across six states: Rajasthan (North Zone), Madhya Pradesh (Central), Maharashtra (West), Odisha (East), Karnataka (South), Meghalaya (Northeast), chosen for their representation of different geographic regions and operational feasibility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 6.00 Month(s) 至 36.00 Month(s)（—）
- 性别
- All
入选标准
- •In the selected clusters (AWCs), all the age-eligible children (and their caretakers and family members) shall be eligible for the THR and SBCC package, as per the arm allocated.
- •In each of the clusters, the AWWs and the study team shall update the eligible children list, and their AWC registration status through house-to-house visits.
- •For the children not registered in the AWCs, the caretakers and household head shall be counselled for registration in the AWC.
- •All the children aged 6-36 months (and their parents/caretakers) in the selected AWC area (cluster) shall be eligible for the THR and SBCC, as per the allocated arm.
排除标准
- •Non-consenting, SAM and sick children will be excluded.
结局指标
主要结局
• To assess the effectiveness of the intervention package integrating a combination of improved THR and improved SBCC strategy targeted at children aged 6-36 months compared to the existing THR and SBCC strategy on change in weight-for-age z score (WAZ) from baseline.
时间窗: baseline 6 12 18 and 24 months
次要结局
- • To assess the effectiveness of the intervention package integrating a combination of improved THR and improved SBCC strategy targeted at aged 6-36 months compared to the existing programmatic context (THR and SBCC) on(o Stunting (length /height-for-age z score, LAZ/HAZ))
研究者
Arun M Kokane
All India Institute of Medical Sciences Bhopal