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Behavioral Intervention

Maternal Nutrition Education for Children with Sickle Cell Disease (PMC-SCD Trial)

N/A

Waitlist Available

Led By Lauren J Klein, MD

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

laboratory confirmed SCD (HbSS, HbSβ0 thalassemia, or HbSC)

aged 6 to 18 months.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to find ways to prevent malnutrition in children with sickle cell disease in northern Nigeria. Community health workers will educate mothers about nutritious local foods that may help children grow better. The study

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial focuses on nutrition education rather than medication or medical procedures, there are no direct side effects related to interventions being studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with sickle cell disease.

Select...

My child is between 6 to 18 months old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in weight for the for-age z score.

Secondary study objectives

Percentage of children receiving the minimum dietary adequacy

Prevalence of vitamin A deficiency

Other study objectives

Change in length-for-age z-score

Change in mid-upper arm circumference measurement

Change in weight-for-length z-score

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Standard Care plus Maternal Nutrition EducationExperimental Treatment2 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 OnlyActive Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Standard Care

2018

Completed Phase 4

~3720

0 / 2Eligibility criteria met