The Impact of Growth Charts and Nutritional Supplements on Child Growth in Zambia

Stunting Clinical Trial

— ZamCharts  

Official title:

The Impact of Growth Charts and Nutritional Supplements on Child Growth in Zambia: A Randomized Controlled Trial (ZamCharts)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05120427
• Other study ID #: ZamCharts
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: September 30, 2023

Study information

• Verified date: December 2023
• Source: Swiss Tropical & Public Health Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

According to the latest estimates, 144 million children under age five experience growth faltering. Early life growth faltering or stunting is predictive of a wide array of negative long-term outcomes, including reduced adult height and productivity, diminished health and reduced lifetime incomes.

This study builds on a previous pilot study, which suggests that providing parents with tools to measure children's growth at home may be an effective way to prevent early life growth faltering. The objectives of this study are to assess 1) the impact of growth charts on early childhood linear growth; and 2) whether the impact of growth charts can be increased with the provision of food supplements to parents.

Description:

More than 250 million children under the age of five are currently estimated to not reach their developmental potential due to poverty, malnutrition and infectious diseases. According to the latest estimates, 21% of children under age 5 in LMICs are more than two standard deviations shorter than the global reference median and thus considered stunted according to WHO guidelines. Early life growth faltering interferes with children's ability to learn and has been associated with reduced subsequent development and physical growth. Stunting has also been linked to delayed school enrollment, reduced educational attainment, poor health, and decreased well-being.

There is a growing consensus among scientists, the global public health and development community as well as among governments that addressing stunting is a top priority for promoting children's development and well being, and for increasing children's future economic potential. While a large literature has highlighted the importance of favorable environmental and socioeconomic factors for the prevention of early growth faltering, effective interventions to reduce growth faltering in low income settings remain scarce. Among families of affected children, stunting often goes unrecognized in communities where growth faltering is common. Even children with substantial delays in their physical development may be perceived as of normal size in comparison to peer children in their community. In many Low and Middle Income Countries (LMICs), height measurements are not routinely conducted as part of child health checkups. In Zambia, many parents were found to be unaware of their child's growth deficits, which makes it difficult for them to act to combat chronic malnutrition and stunting.

In a previous pilot study, the investigator team found that simple growth charts installed at children's homes can be an effective tool for increasing parental awareness of children's nutritional need and growth trajectories. The objective of this trial is thus to rigorously assess these growth charts through a cluster-randomized controlled trial to be conducted in three districts of Zambia. Given that larger improvements in height may only be possible with additional nutritional input in this setting, the trial will also assess the extent to which early life growth can be improved through the provision of lipid-based nutrient supplements (LNS).

The overall objective of this project is to assess the impact of growth charts as well as nutritional supplements on children's physical growth in a representative sample of Zambia communities. This larger objective can be divided into three specific aims:

Specific Aim 1: Assess the impact of growth charts installed in children's homes on children's physical growth.

Specific Aim 2: Assess the extent to which growth trajectories can be modified through the provision of LNS.

Specific Aim 3: Assess the extent to which growth trajectories can be modified through the joint provision of LNS and home-installed growth charts

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2291
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 12 Months

Eligibility

Inclusion Criteria:

• 6-11 months of age in selected enumeration areas

Exclusion Criteria:

• intend to migrate within 12 months of study beginning

Related Conditions & MeSH terms

• Growth Disorders
• Stunting

Intervention

Dietary Supplement:
• Lipid based nutrient Supplements (LNS):
LNS are 20 g/~110 calorie nutrient supplements that provide energy, protein, essential fatty acids and a wide range of micronutrients critical for children ages 6 to 24 months of age. They are designed to complement diets without displacing breastmilk and local dietary preferences and can be mixed into the child's meal or eaten directly from the sachet.

Device:
• Growth Charts
Growth charts have been locally developed to allow parents an easy assessment of their children's height at their home. Charts will be placed on walls inside homes and will provide parents the opportunity to measure their child whenever they want, and will also contain information on the most suitable local foods as well as the importance of diverse diets and frequent feeding.

Locations

Country	Name	City	State
Switzerland	Swiss Tropical and Public Health Institute	Basel	BS

Sponsors (3)

Lead Sponsor	Collaborator
Swiss Tropical & Public Health Institute	Boston University, Innovations for Poverty Action

Country where clinical trial is conducted

Switzerland, 

References & Publications (5)

Black MM, Walker SP, Fernald LCH, Andersen CT, DiGirolamo AM, Lu C, McCoy DC, Fink G, Shawar YR, Shiffman J, Devercelli AE, Wodon QT, Vargas-Baron E, Grantham-McGregor S; Lancet Early Childhood Development Series Steering Committee. Early childhood development coming of age: science through the life course. Lancet. 2017 Jan 7;389(10064):77-90. doi: 10.1016/S0140-6736(16)31389-7. Epub 2016 Oct 4. — View Citation

Dewey KG, Begum K. Long-term consequences of stunting in early life. Matern Child Nutr. 2011 Oct;7 Suppl 3(Suppl 3):5-18. doi: 10.1111/j.1740-8709.2011.00349.x. — View Citation

Fink G, Levenson R, Tembo S, Rockers PC. Home- and community-based growth monitoring to reduce early life growth faltering: an open-label, cluster-randomized controlled trial. Am J Clin Nutr. 2017 Oct;106(4):1070-1077. doi: 10.3945/ajcn.117.157545. Epub 2017 Aug 23. — View Citation

Vaivada T, Akseer N, Akseer S, Somaskandan A, Stefopulos M, Bhutta ZA. Stunting in childhood: an overview of global burden, trends, determinants, and drivers of decline. Am J Clin Nutr. 2020 Sep 14;112(Suppl 2):777S-791S. doi: 10.1093/ajcn/nqaa159. — View Citation

Victora CG, Adair L, Fall C, Hallal PC, Martorell R, Richter L, Sachdev HS; Maternal and Child Undernutrition Study Group. Maternal and child undernutrition: consequences for adult health and human capital. Lancet. 2008 Jan 26;371(9609):340-57. doi: 10.1016/S0140-6736(07)61692-4. Erratum In: Lancet. 2008 Jan 26;371(9609):302. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average height-for-age z-score at age 24 months	Children's height will be measured at 24 months of age and normalized using WHO growth standards.	24 months of age
Secondary	Stunting rates at age 2	Proportion of children with a height-for-age z-score < -2 at 2 years of age	24 months of age
Secondary	Average child development at age 2	Global Scales of Early Development (GSED) z-score at age 2. GSED scores are normalized to mean zero and a standard deviation of 1. Higher scores imply improved developmental outcomes.	24 months of age