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

NCT ID: NCT05120427

Last Updated: 2023-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2291 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2023-09-30

Brief Summary

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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.

Detailed Description

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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

Conditions

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Stunting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study used a 2x2 factorial design testing growth charts and supplements.
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
Assessors and investigators will be blinded to the treatment assignment.

Study Groups

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Control

Access to standard care.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Lipid based nutrient Supplements (LNS):

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Growth Charts

Intervention Type 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.

LNS and Growth Charts

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

Group Type EXPERIMENTAL

Lipid based nutrient Supplements (LNS):

Intervention Type 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.

Growth Charts

Intervention Type 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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 6-11 months of age in selected enumeration areas

Exclusion Criteria

* intend to migrate within 12 months of study beginning
Minimum Eligible Age

6 Months

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston University

OTHER

Sponsor Role collaborator

Innovations for Poverty Action

OTHER

Sponsor Role collaborator

Swiss Tropical & Public Health Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Günther Fink, PhD

Role: PRINCIPAL_INVESTIGATOR

Swiss TPH

Locations

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Swiss Tropical and Public Health Institute

Basel, Canton of Basel-City, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type BACKGROUND
PMID: 27717614 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32860401 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18206223 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28835364 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21929633 (View on PubMed)

Lauer JM, Odom AR, Rani A, Story G, Chembe M, Henderson S, Parkerson D, Fink G, Rockers PC, Sela D, Locks LM. Breastfeeding, the gut microbiome, and growth among infants in Lusaka, Zambia. J Nutr. 2025 Oct 23:S0022-3166(25)00648-0. doi: 10.1016/j.tjnut.2025.10.026. Online ahead of print.

Reference Type DERIVED
PMID: 41138757 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39551093 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38297266 (View on PubMed)

Other Identifiers

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ZamCharts

Identifier Type: -

Identifier Source: org_study_id