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

148 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Maternal Nutrition Education for children with Sickle Cell Disease?

Research on individual nutrition education in anemic pregnant women shows that it can improve nutritional knowledge and adherence to iron-folic acid intake, which may suggest potential benefits for maternal nutrition education in managing sickle cell disease. ^{1 2 3 4 5}

Is maternal nutrition education generally safe for humans?

Maternal nutrition education, including smartphone-based programs, has been studied in various contexts and is generally considered safe for humans. It has shown benefits like improved nutritional status and reduced risk of anemia during pregnancy, although more research is needed to confirm these findings. ^{3 6 7 8 9}

How does the treatment Maternal Nutrition Education differ from other treatments for children with sickle cell disease?

Maternal Nutrition Education is unique because it focuses on educating mothers about proper nutrition, which can help improve the dietary intake and overall health of children with sickle cell disease. Unlike standard medical treatments, this approach emphasizes the role of nutrition in managing the condition, addressing common deficiencies in vitamins and minerals that are often seen in these children. ^{1 5 8 10 11}

What is the purpose of this trial?

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.

Research Team

Lauren R. Klein, MD, MS

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

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

I have been diagnosed with sickle cell disease.

My child is between 6 to 18 months old.

Timeline

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

Treatment Details

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.

Participant Groups

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+

References

1. Brazil pubmed.ncbi.nlm.nih.gov

Maternal malnutrition during pregnancy among women with sickle cell disease. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Brief report: parent perspectives of nutritional status and mealtime behaviors in children with sickle cell disease. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Epidemiology of Maternal Nutritional Status and Risk of Adverse Birth Outcomes in Undernourished Mothers with Sickle Cell Disease: A Systematic Review and Meta-Analysis Protocol. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Effect of individual nutrition education on perceptions of nutritional iron supplementation, adherence to iron - folic acid intake and Hb levels among a cohort of anemic South Indian pregnant women. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Iron status of children with sickle cell disease. [2017]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Smartphone-Based Maternal Education for the Complementary Feeding of Undernourished Children Under 3 Years of Age in Food-Secure Communities: Randomised Controlled Trial in Urmia, Iran. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Feasibility trial for the management of severe acute malnutrition in older children with sickle cell anemia in Nigeria. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Impact of acute illness on nutritional status of infants and young children with sickle cell disease. [2004]

9. England pubmed.ncbi.nlm.nih.gov

Nutrition education and counselling provided during pregnancy: effects on maternal, neonatal and child health outcomes. [2022]

10. Brazil pubmed.ncbi.nlm.nih.gov

SOCIOECONOMIC AND NUTRITIONAL CHARACTERISTICS OF CHILDREN AND ADOLESCENTS WITH SICKLE CELL ANEMIA: A SYSTEMATIC REVIEW. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Adequacy of dietary intake declines with age in children with sickle cell disease. [2022]