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

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

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.

Study Overview

• Status: Completed
• Conditions: Stunting
• Intervention / Treatment: Dietary supplement: Lipid based nutrient Supplements (LNS):; Device: Growth Charts

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 2291
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • BS
    • Basel, BS, Switzerland, 4051
      • Swiss Tropical and Public Health Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 1 year (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 6-11 months of age in selected enumeration areas

Exclusion Criteria:

• intend to migrate within 12 months of study beginning

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Access to standard care.
Experimental: LNS only; Children in this arm will receive lipid-based nutrient supplements (LNS) for 12-18 months. 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. The LNS used in this study will be Nutributter plus.	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.
Experimental: Growth Charts Only; Children in this arm will receive a growth chart that can be installed at children's homes. 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. After the home installation of growth charts, caregivers will be given a short introduction on how to use them and on how to interpret the measurements by study staff.	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.
Experimental: LNS and Growth Charts; Children in the combined arm will receive both growth charts and LNS.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Swiss Tropical & Public Health Institute
• Collaborators: Boston University; Innovations for Poverty Action
• Investigators: Principal Investigator: Günther Fink, PhD, Swiss TPH

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: November 2, 2021
• First Submitted That Met QC Criteria: November 2, 2021
• First Posted (Actual): November 15, 2021

Study Record Updates

• Last Update Posted (Estimated): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Growth Disorders
• Other Study ID Numbers: ZamCharts

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We plan to make de-identified data available to the public after publication of the trial.
• IPD Sharing Time Frame: After publication
• IPD Sharing Access Criteria: On journal webpage or public repository
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No