Prevention of Malnutrition in Children With Sickle Cell Disease Living in Northern Nigeria
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 2
- 主要终点
- Change in weight for the for-age z score.
研究概览
简要总结
The investigators are studying how to prevent malnutrition in children with sickle cell disease (SCD) in northern Nigeria. Community health workers will teach mothers about nutritious local foods that might help children grow better than the usual advice from doctors. The investigators will enroll 148 children with SCD aged 6 to 18 months old. The investigators will determine if their weight and diet improve and check for low vitamin A levels. This information will help us find better ways to improve growth for children with SCD.
详细描述
Despite efforts to improve nutrition, 45% of under-5 mortality is at least partially attributable to malnutrition. Children with SCD have high nutrient demands and energy expenditures with a risk of impaired growth. The investigators will test the hypothesis that maternal nutrition education on locally available nutrient-dense foods will lead to improved childhood growth compared to standard pediatrician-delivered nutrition counseling. The research will involve a randomized controlled trial with 148 children aged 6 to 18 months with SCD, assessing changes in weight-for-age z-scores and dietary adequacy, as well as determining the prevalence of vitamin A deficiency. These preliminary findings will inform evidence-based interventions for the primary prevention of malnutrition (underweight and vitamin A deficiency) in children with SCD.
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
- Single (Outcomes Assessor)
盲法说明
A trained anthropometrist will be masked to the study allocation.
入排标准
- 年龄范围
- 6 Months 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •laboratory confirmed SCD (HbSS, HbSβ0 thalassemia, or HbSC)
- •aged 6 to 18 months.
排除标准
- •severe acute malnutrition (weight-for-length z-score <-3 or mid-upper arm circumference <11.5 cm)
- •diagnosis of HIV or other chronic illnesses
研究组 & 干预措施
Standard Care plus Maternal Nutrition Education
Mothers whose infants are assigned to this group will be provided individually by a community health worker during weeks 0, 8, and 16. In addition to receiving nutrition counseling, maternal nutrition education will emphasize utilizing locally available foods to enhance the nutritional well-being of young children and families, all while respecting local cultural and religious customs. To reinforce these educational messages, visual aids will be incorporated. The following educational messages will be addressed:
- appropriate feeding frequency
- dietary diversity using local foods
- Complementary food preparation
- adequate portions
- individualized, tailored economic education regarding the cost of purchasing foods that can fill nutrient gaps (self-efficacy)
干预措施: Standard Care (Behavioral)
Standard Care plus Maternal Nutrition Education
Mothers whose infants are assigned to this group will be provided individually by a community health worker during weeks 0, 8, and 16. In addition to receiving nutrition counseling, maternal nutrition education will emphasize utilizing locally available foods to enhance the nutritional well-being of young children and families, all while respecting local cultural and religious customs. To reinforce these educational messages, visual aids will be incorporated. The following educational messages will be addressed:
- appropriate feeding frequency
- dietary diversity using local foods
- Complementary food preparation
- adequate portions
- individualized, tailored economic education regarding the cost of purchasing foods that can fill nutrient gaps (self-efficacy)
干预措施: Maternal Nutrition Education (Behavioral)
Standard Care Only
Mothers whose infants are assigned to the control group will receive standard nutrition education from the provider at the SCD clinic during weeks 0, 8, and 16.
干预措施: Standard Care (Behavioral)
结局指标
主要结局
Change in weight for the for-age z score.
时间窗: 24 weeks
Mean change in weight-for-age z score in the randomly allocated groups, standard care versus the novel maternal intervention. This is a continuous outcome where a higher z-score indicates a positive outcome.
次要结局
- Prevalence of vitamin A deficiency(24 weeks)
- Percentage of children receiving the minimum dietary adequacy(24 weeks)
研究者
Lauren Klein
Instructor of Pediatric Gastroenterology, Hepatology, and Nutrition
Vanderbilt University Medical Center