Improving Nutrition and Health Outcomes in Intibuca, Honduras
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 639
- 主要终点
- Height and weight
研究概览
简要总结
The purpose of this research study is to better understand how to prevent malnutrition in children under age 5 years in Intibuca, Honduras. A randomized community trial design was used to implement a nutrition program, including a complementary nutrition supplement, educational sessions, and growth and health monitoring integrated into the basic primary care package, to participants living in communities in the intervention group. Participants living in the control group communities will receive the nutrition supplement for one year following the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children between the ages of 6 months and under 5 years at the time enrollment who reside in Concepcion.
排除标准
- •Children with congenital anomalies, mental retardation, severe physical handicap, undernutrition caused by medical conditions that contribute to undernutrition such as heart disease, kidney failure, face and throat problems that interfere with swallowing, medical problems interfering with the absorption of food, and chronic diseases such as tuberculosis, etc.
- •Plans to move or change place of residence outside the intervention region in the next 2 months.
- •Children whose weight for age z score falls below -
- •Children whose weight for age z score is above 3.
结局指标
主要结局
Height and weight
时间窗: Every other month for 12 months
Participating children are measured and weighed by trained staff every other month during the 12 month intervention.
Hemoglobin
时间窗: Baseline, month 6, and month 12
Hemoglobin values are measured using a One STAT Site M meter instrument and recorded to the nearest g/dL at baseline, month 6, and month 12 of the intervention.
Retinol binding protein, transferrin receptor, and C-Reactive Protein
时间窗: Baseline, month 6, and month 12
Retinol binding protein, transferrin, and C-Reactive Protein are measured from dried blood spots collected at baseline, month 6, and month 12 of the intervention.
次要结局
- Food insecurity(Baseline, month 6, and month 12)
- Health outcomes(Baseline, month 6, and month 12)
- Acceptability/Sustainability of nutrition supplement(Baseline, month 3, and month 8)