StuntingZamChartsNCT05120427
The Impact of Growth Charts and Nutritional Supplements on Child Growth in Zambia
A study testing Lipid based nutrient Supplements (LNS): and Growth Charts in people with Stunting, run by Swiss Tropical & Public Health Institute at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 6 to 12 months
- Conditions the study is for
- Stunting
- What is being tested?
- Lipid based nutrient Supplements (LNS): and Growth Charts
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,291 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2020to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 6-11 months of age in selected enumeration areas
Who cannot join
- intend to migrate within 12 months of study beginning
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Swiss Tropical and Public Health Institute
Basel, Canton of Basel-City, 4051
About this study
Official title: 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.
Read the 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
- Conditions
- Stunting
- Being tested
- Lipid based nutrient Supplements (LNS):, Growth Charts
- Medical subject headings
- Growth Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Growth ChartsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Growth Charts |
| LNS and Growth Charts | Experimental | Children in the combined arm will receive both growth charts and LNS. Receives: Dietary Supplement: Lipid based nutrient Supplements (LNS):; Device: Growth Charts |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months of age
Secondary outcomes (2)
Stunting rates at age 2
Proportion of children with a height-for-age z-score < -2 at 2 years of age
Measured: 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.
Measured: 24 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start1 Sep 2020
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for StuntingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study used a 2x2 factorial design testing growth charts and supplements.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 2,291 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Tropical & Public Health Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Boston University, Innovations for Poverty Action
- Responsible party
- Sponsor
- Investigators
- Günther Fink, PhD, Principal investigator, Swiss TPH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05120427
- Sponsor's protocol ID
- ZamCharts
- Acronym
- ZamCharts
- Status last verified
- Dec 2023
- First submitted
- 2 Nov 2021
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to make de-identified data available to the public after publication of the trial.
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.
PubMed 27717614Vaivada 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.
PubMed 32860401Victora 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.
PubMed 18206223Fink 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.
PubMed 28835364Dewey 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.
PubMed 21929633Lauer 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.
PubMed 41138757Lauer 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.
PubMed 39551093Fink 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.
PubMed 38297266
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Growth Charts and Nutritional Supplements on Child Growth in Zambia: A Randomized Controlled Trial (ZamCharts)
- ClinicalTrials.gov ID
- NCT05120427
- Acronym / sponsor ID
- ZamCharts / ZamCharts
- Conditions
- Stunting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,291 participants (actual)
- Lead sponsor
- Swiss Tropical & Public Health InstituteUniversity, hospital or other
- Collaborators
- Boston University, Innovations for Poverty Action
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 15 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- The study used a 2x2 factorial design testing growth charts and supplements.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Access to standard care. |
| LNS only | Experimental | Dietary Supplement: Lipid based nutrient Supplements (LNS):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. |
| Growth Charts Only | Experimental | Device: Growth ChartsChildren 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. |
| LNS and Growth Charts | Experimental | Dietary Supplement: Lipid based nutrient Supplements (LNS):, Device: Growth ChartsChildren in the combined arm will receive both growth charts and LNS. |
Who may qualify
- Ages
- 6 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 6-11 months of age in selected enumeration areas
Key exclusion criteria (1 listed)
- intend to migrate within 12 months of study beginning
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | LNS and Growth Charts, LNS only |
| Growth ChartsGrowth 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. | Device | Growth Charts Only, LNS and Growth Charts |
Primary outcome
Average height-for-age z-score at age 24 months
Time frame: 24 months of age
Children's height will be measured at 24 months of age and normalized using WHO growth standards.
2 secondary outcomes
Stunting rates at age 2
Time frame: 24 months of age
Average child development at age 2
Time frame: 24 months of age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Background: PubMed 27717614Black 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.
- Background: PubMed 32860401Vaivada 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.
- Background: PubMed 18206223Victora 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.
- Background: PubMed 28835364Fink 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.
- Background: PubMed 21929633Dewey 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.
- Derived from this study: PubMed 41138757Lauer 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.
- Derived from this study: PubMed 39551093Lauer 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.
- Derived from this study: PubMed 38297266Fink 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.
- Individual participant dataSharing planned: Yes. We plan to make de-identified data available to the public after publication of the trial.
Related trials for Stunting
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
RecruitingObservational study
Study of Proteus Syndrome and Related Congenital Disorders
Proteus Syndrome, PIK3CA Related Overgrowth Spectrum
Active, not recruitingPhase 2
Maternal Probiotic Intervention to Improve Gut Health-Trial II-Pakistan
Environmental Enteric Dysfunction (EED), Stunting
Recruiting
STV Analysis Versus Visual Evaluation of Cardiotocography in FGR
Fetal Growth Retardation
RecruitingPhase 2
Statin Intervention for Severe Early-Onset Placental Insufficiency. (STATIN-PRE Trial)
Preeclampsia (PE), Intrauterine Growth Restriction (IUGR)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Günther Fink, PhD principal investigator
Swiss TPH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lipid based nutrient Supplements (LNS): and Growth Charts in people with Stunting, run by Swiss Tropical & Public Health Institute at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average height-for-age z-score at age 24 months (time frame: 24 months of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05120427, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2023.