Prevention of Malnutrition in Children with Sickle Cell Disease
- Conditions
- Sickle Cell DiseaseMalnutrition
- Interventions
- Behavioral: Standard CareBehavioral: Maternal Nutrition Education
- Registration Number
- NCT06397118
- Lead Sponsor
- Vanderbilt University Medical Center
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 148
- laboratory confirmed SCD (HbSS, HbSβ0 thalassemia, or HbSC)
- aged 6 to 18 months.
- severe acute malnutrition (weight-for-length z-score <-3 or mid-upper arm circumference <11.5 cm)
- diagnosis of HIV or other chronic illnesses
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard Care Only Standard Care 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. Standard Care plus Maternal Nutrition Education 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: 1. appropriate feeding frequency 2. dietary diversity using local foods 3. Complementary food preparation 4. adequate portions 5. individualized, tailored economic education regarding the cost of purchasing foods that can fill nutrient gaps (self-efficacy) Standard Care plus Maternal Nutrition Education Standard Care 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: 1. appropriate feeding frequency 2. dietary diversity using local foods 3. Complementary food preparation 4. adequate portions 5. individualized, tailored economic education regarding the cost of purchasing foods that can fill nutrient gaps (self-efficacy)
- Primary Outcome Measures
Name Time Method Change in weight for the for-age z score. 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.
- Secondary Outcome Measures
Name Time Method Prevalence of vitamin A deficiency 24 weeks Continuous unadjusted and inflammation-adjusted retinol levels and the corresponding prevalence of vitamin A deficiency
Percentage of children receiving the minimum dietary adequacy 24 weeks percentage of young children with a World Health Organization-defined minimum acceptable diet based on dietary diversity and feeding frequency
Trial Locations
- Locations (1)
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States