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

Primary Purpose

Stunting

Status
Active
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Lipid based nutrient Supplements (LNS):
Growth Charts
Sponsored by
Swiss Tropical & Public Health Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stunting

Eligibility Criteria

6 Months - 12 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 6-11 months of age in selected enumeration areas

Exclusion Criteria:

  • intend to migrate within 12 months of study beginning

Sites / Locations

  • Swiss Tropical and Public Health Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Control

LNS only

Growth Charts Only

LNS and Growth Charts

Arm Description

Access to standard care.

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.

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Stunting rates at age 2
Proportion of children with a height-for-age z-score < -2 at 2 years 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.

Full Information

First Posted
November 2, 2021
Last Updated
December 3, 2022
Sponsor
Swiss Tropical & Public Health Institute
Collaborators
Boston University, Innovations for Poverty Action
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1. Study Identification

Unique Protocol Identification Number
NCT05120427
Brief Title
The Impact of Growth Charts and Nutritional Supplements on Child Growth in Zambia
Acronym
ZamCharts
Official Title
The Impact of Growth Charts and Nutritional Supplements on Child Growth in Zambia: A Randomized Controlled Trial (ZamCharts)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swiss Tropical & Public Health Institute
Collaborators
Boston University, Innovations for Poverty Action

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stunting

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study used a 2x2 factorial design testing growth charts and supplements.
Masking
InvestigatorOutcomes Assessor
Masking Description
Assessors and investigators will be blinded to the treatment assignment.
Allocation
Randomized
Enrollment
2291 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Access to standard care.
Arm Title
LNS only
Arm Type
Experimental
Arm Description
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.
Arm Title
Growth Charts Only
Arm Type
Experimental
Arm Description
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.
Arm Title
LNS and Growth Charts
Arm Type
Experimental
Arm Description
Children in the combined arm will receive both growth charts and LNS.
Intervention Type
Dietary Supplement
Intervention Name(s)
Lipid based nutrient Supplements (LNS):
Intervention Description
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
Device
Intervention Name(s)
Growth Charts
Intervention Description
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.
Primary Outcome Measure Information:
Title
Average height-for-age z-score at age 24 months
Description
Children's height will be measured at 24 months of age and normalized using WHO growth standards.
Time Frame
24 months of age
Secondary Outcome Measure Information:
Title
Stunting rates at age 2
Description
Proportion of children with a height-for-age z-score < -2 at 2 years of age
Time Frame
24 months of age
Title
Average child development at age 2
Description
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.
Time Frame
24 months of age

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 6-11 months of age in selected enumeration areas Exclusion Criteria: intend to migrate within 12 months of study beginning
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Günther Fink, PhD
Organizational Affiliation
Swiss TPH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Swiss Tropical and Public Health Institute
City
Basel
State/Province
BS
ZIP/Postal Code
4051
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
27717614
Citation
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.
Results Reference
background
PubMed Identifier
32860401
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.
Results Reference
background
PubMed Identifier
18206223
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.
Results Reference
background
PubMed Identifier
28835364
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.
Results Reference
background
PubMed Identifier
21929633
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.
Results Reference
background

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

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