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

NCT05120427 | Completed

• 1 other identifier: ZamCharts
• Study Type: interventional
• Target: 2,291
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stunting

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Stunting rates at age 2

  24 months of age

• Average child development at age 2

  24 months of age

Study Arms (4)

Control

NO INTERVENTION

Access to standard care.

LNS only

EXPERIMENTAL

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):

Growth Charts Only

EXPERIMENTAL

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

LNS and Growth Charts

EXPERIMENTAL

Children in the combined arm will receive both growth charts and LNS.

Dietary Supplement: Lipid based nutrient Supplements (LNS):; Device: Growth Charts

Interventions

Lipid based nutrient Supplements (LNS): DIETARY_SUPPLEMENT

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.

LNS and Growth Charts; LNS only

Growth Charts DEVICE

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.

Growth Charts Only; LNS and Growth Charts

Eligibility Criteria

• Age: 6 Months - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• months of age in selected enumeration areas

You may not qualify if:

• intend to migrate within 12 months of study beginning

Sponsors & Collaborators

• Swiss Tropical & Public Health Institute: lead
• Boston University: collaborator
• Innovations for Poverty Action: collaborator

Study Sites (1)

Swiss Tropical and Public Health Institute

Basel, Canton of Basel-City, 4051, Switzerland

Location

Related Publications (8)

• 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.

  PMID: 27717614 BACKGROUND

• 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.

  PMID: 32860401 BACKGROUND

• 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.

  PMID: 18206223 BACKGROUND

• 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.

  PMID: 28835364 BACKGROUND

• 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.

  PMID: 21929633 BACKGROUND

• Lauer JM, Odom AR, Rani A, Story G, Chembe M, Henderson S, Parkerson D, Fink G, Rockers PC, Sela DA, Locks LM. Breastfeeding, the Gut Microbiome, and Growth among Infants in Lusaka, Zambia. J Nutr. 2025 Dec;155(12):4253-4263. doi: 10.1016/j.tjnut.2025.10.026. Epub 2025 Oct 23.

  PMID: 41138757 DERIVED

• Lauer JM, Pyykko J, Chembe M, Billima-Mulenga T, Sikazwe D, Chibwe B, Henderson S, Parkerson D, Leppanen JM, Fink G, Locks LM, Rockers PC. Markers of Environmental Enteric Dysfunction are Associated with Poor Growth and Developmental Outcomes among Young Children in Lusaka, Zambia. J Pediatr. 2025 Feb;277:114408. doi: 10.1016/j.jpeds.2024.114408. Epub 2024 Nov 17.

  PMID: 39551093 DERIVED

• Fink G, Chembe M, Henderson S, Rockers PC, Parkerson D. Feasibility of caregiver-administered anthropometric measurements of children under age 5: evidence from Zambia. Popul Health Metr. 2024 Jan 31;22(1):2. doi: 10.1186/s12963-024-00322-4.

  PMID: 38297266 DERIVED

MeSH Terms

Conditions

Growth Disorders

Interventions

Hypoxanthine Phosphoribosyltransferase; Growth Charts

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pentosyltransferases; Glycosyltransferases; Transferases; Enzymes; Enzymes and Coenzymes; Reference Standards; Weights and Measures; Investigative Techniques

Study Officials

• Günther Fink, PhD

  Swiss TPH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Assessors and investigators will be blinded to the treatment assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study used a 2x2 factorial design testing growth charts and supplements.

Study Record Dates

• First Submitted: November 2, 2021
• First Posted: November 15, 2021
• Study Start: September 1, 2020
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: December 11, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After publication
• Access Criteria: On journal webpage or public repository

Locations

CH (1)