Prevention of Malnutrition in Children with Sickle Cell Disease (PMC-SCD)

Vanderbilt University Medical Center

Status: Invitation-only

Conditions: Malnutrition; Sickle Cell Disease

Treatments: Behavioral: Maternal Nutrition Education; Behavioral: Standard Care

Study type: Interventional

Funder types: Other

Identifiers

NCT06397118

240090

Details and patient eligibility

About

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.

Full 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.

Enrollment: 148 estimated patients

Sex: All

Ages: 6 to 18 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• laboratory confirmed SCD (HbSS, HbSβ0 thalassemia, or HbSC)
• aged 6 to 18 months.

Exclusion criteria

• severe acute malnutrition (weight-for-length z-score <-3 or mid-upper arm circumference <11.5 cm)
• diagnosis of HIV or other chronic illnesses

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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148 participants in 2 patient groups

Standard Care plus Maternal Nutrition Education

Experimental group

Description:

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)

Treatment:

Behavioral: Standard Care

Behavioral: Maternal Nutrition Education

Standard Care Only

Active Comparator group

Description:

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.

Treatment:

Behavioral: Standard Care