Maternal Nutrition Education for Children with Sickle Cell Disease

(PMC-SCD Trial)

Overseen By Tiffany Bess, MA

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Severe malnutrition, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to find better ways to prevent malnutrition in young children with sickle cell disease (SCD) in northern Nigeria. It examines whether teaching mothers about nutritious local foods can improve children's growth compared to standard medical advice. Mothers will receive guidance on using local foods, feeding frequency, and preparing balanced meals. This maternal nutrition education is the study's primary focus. The study targets children aged 6 to 18 months with SCD, specifically those types confirmed by lab tests. Participants must not have severe malnutrition or chronic conditions like HIV. As an unphased study, this trial offers a unique opportunity to contribute to important research that could improve the health of children with SCD.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this maternal nutrition education is safe for children with sickle cell disease?

Research has shown that teaching mothers about nutrition can improve the health of children with sickle cell disease (SCD). This education emphasizes using local, nutritious foods to support better growth in children. It remains safe because it involves advice on diet and food choices, not medication or other treatments.

No reports of negative effects have emerged from this type of education. It provides mothers with useful knowledge, which is generally safe and well-received. This method has been applied in other health education areas without safety issues. Therefore, participating in this study should not pose health risks to mothers or their children with SCD. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how maternal nutrition education can impact the health of children with sickle cell disease (SCD). Unlike standard care options that primarily focus on managing symptoms with medications like hydroxyurea or blood transfusions, this approach aims to improve nutritional well-being through education. By teaching mothers about using locally available foods and respecting cultural customs, this method empowers families to make dietary choices that could enhance their children's health. This holistic approach could lead to better overall health outcomes for children with SCD by addressing nutrition gaps that are often overlooked in traditional treatments.

What evidence suggests that maternal nutrition education is effective for improving growth in children with sickle cell disease?

This trial will compare two approaches: standard care only and standard care plus maternal nutrition education. Studies have shown that teaching mothers about nutrition can significantly increase their understanding of sickle cell disease (SCD), from 12.4% to 85.9%. This education emphasizes using locally available, nutrient-rich foods to support children's growth. Research suggests that this approach can prevent malnutrition in children with SCD, aiding in weight gain and improving vitamin levels. By learning to use a variety of local foods and prepare balanced meals, families can fill nutrient gaps while respecting local cultural practices. ^{1 3 6 7 8}

Who Is on the Research Team?

Lauren R. Klein, MD, MS

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

This trial is for children aged 6 to 18 months with confirmed sickle cell disease (SCD) in northern Nigeria. It aims to prevent malnutrition by educating mothers on nutritious local foods, as opposed to standard advice from doctors.

Inclusion Criteria

My child is between 6 to 18 months old.

I have been diagnosed with sickle cell disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Mothers receive nutrition education from community health workers and standard care at weeks 0, 8, and 16

24 weeks

3 visits (in-person)

Follow-up

Participants are monitored for changes in weight-for-age z-scores, dietary adequacy, and vitamin A levels

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Maternal Nutrition Education

Trial Overview The study compares the effectiveness of maternal nutrition education against standard care in preventing malnutrition among young children with SCD. The child's growth, diet quality, and vitamin A levels will be monitored to assess improvement.

How Is the Trial Designed?

Group I: Standard Care plus Maternal Nutrition Education Experimental Treatment 2 Interventions

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)

Group II: Standard Care Only Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Aminu Kano Teaching Hospital

Collaborator

Trials

18

Recruited

8,900+

Murtala Muhammed Specialist Hospital

Collaborator

Trials

5

Recruited

1,300+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36627609/

The efficacy of maternal health education and ... - PubMed The proportion of participants with good knowledge of SCD had significantly increased to 85.9% from 12.4% at baseline following the education ...

2. mdpi.com mdpi.com/2409-9279/6/5/88

Epidemiology of Maternal Nutritional Status and Risk ... In pregnancies complicated by sickle cell disease (SCD), the maternal-fetal dyad is at high risk for mortality and morbidity.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06397118?term=SCD%20diet&viewType=Table&rank=7

Prevention of Malnutrition in Children with Sickle Cell ... The investigators will test the hypothesis that maternal nutrition education on locally available nutrient-dense foods will lead to improved childhood growth ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11046861/

Health education to promote knowledge about sickle cell ... This pilot study aimed to assess the effect of education on the knowledge about SCD and NBS among pregnant women using the Healthy Beginning Initiative.

5. auctoresonline.org auctoresonline.org/article/maternal-outcomes-in-women-complicated-with-sickle-cell-disease

Maternal Outcomes in Women Complicated with sickle Cell ... Results: Over the course of the study, the mean maternal age in the SCD patients was 23.14 ± 4.21 years, compared to 22.11 ± 3.11 years in the control group (P= ...

6. nhlbi.nih.gov nhlbi.nih.gov/news/2023/pregnant-and-living-sickle-cell-disease-push-better-outcomes

Pregnant and Living with Sickle Cell Disease - NHLBI - NIH Their finding: pregnant people with SCD had an eight to 11 times higher chance of developing thrombosis, compared to pregnant people without SCD ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2352302623003101

A comprehensive view of pregnancy in patients with sickle ... Infant mortality linked to sickle cell disease has decreased rapidly and is estimated to be less than 5% in Europe and the USA.2, 3 In many countries, early ...

8. bmcpregnancychildbirth.biomedcentral.com bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-024-06498-9

Health education to promote knowledge about sickle cell ... This pilot study aimed to assess the effect of education on the knowledge about SCD and NBS among pregnant women using the Healthy Beginning Initiative.