Growth AccelerationNCT02484495
Extended Pilot Project Community Based Production of Complementary Food in Ethiopia
A study testing Program evaluation (impact assessment) in people with Growth Acceleration and Infant Morbidity, run by Ethiopian Public Health Institute at 1 site in Ethiopia.
Trial summary
The purpose of the study is to evaluate the impact of a package of interventions including production and distribution of locally produced complementary foods (via so-called "Grain-banks") and Micronutrient Powders (MNPs) supplementation, and optimized food based Complementary Feeding Recommendation, on growth and… Read more about this study
- Who is it for?
- Ages 6 to 29 monthsHealthy volunteers can take part
- Conditions the study is for
- Growth Acceleration, Infant Morbidity
- What is being tested?
- Program evaluation (impact assessment)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,800 participants
- Where
- 1 siteEthiopia
- Study dates
- Mar 2015to Aug 2017
- 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 29 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children between 6-23 m of age who receive Complementary Food (CF) through grain bank or commercial central production
- Living in one of the selected clusters(for intervention and nonintervention clusters)
- Those who receive MNP (15 sachets/month/child)
- Receive enhanced IYCF counselling
- Receive food based Complementary Food Recommendation (CFR)
- Free of chronic conditions that may impact their health
Who cannot join
- Children between 6-23 m of age who do not get CF either through grain bank program or central production
- Those who do not get MNP
- Those who do not receive food based CFR
- Children with a chronic disease and/or chronic use of medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluate the Impact of Package of Interventions on Growth and Micronutrient Status of Infant and Young Children
The purpose of the study is to evaluate the impact of a package of interventions including production and distribution of locally produced complementary foods (via so-called "Grain-banks") and Micronutrient Powders (MNPs) supplementation, and optimized food based Complementary Feeding Recommendation, on growth and micronutrient status of infants and young children. The impact of the intervention package will be evaluated in a quasi-experimental matched-control cluster design in infants and young children between 6 - 29 months of age. The impact, outcome, and output indicators of infants/children will be assessed in cross-sectional samples at baseline, after 9 and 18 months. A total of60 pair clusters are selected in which 15 households per cluster will be identified from the eligible population. A total of 1800 children from intervention and match-controlled clusters, will be sampled in the target age groups. Qualitative and quantitative data will be collected to gather information on Knowledge, Attitude and Practice (KAP), Infant and Young Child Feeding practices, anthropometry and anemia, following the impact pathway developed for the study.
Research questions to be answered in this program evaluation are:
- What impact does the extended pilot (implementation of local complementary food production and MNP) have on:
- Growth in children 17-29 months of age
- Infant and Young Child Feeding practices in children (6-23m), and
- Anemia status in children 11-23 m?
- What are determining factors for the impact/no impact related to:
- Immediate outcomes: skills and capacity; knowledge, attitude and practices; and improved access
- Intermediate outcomes: utilization; provision, and ensuring enabling environment
- Program performance as measured by program monitoring data on output and activities?
Read the detailed description
The aim of this study is to assess the impact/effectiveness of the improved interventions on infant growth and micronutrient status so as to measure what would have happened in the absence of interventions. The study will be conducted in the same four regions in Ethiopia where the program intervention is taking place namely, Amhara, Tigray, Oromiya, and South Nations Nationalities and Peoples Region (SNNPR) regions.
- Sample size calculations assume an expected difference of 0.2 Standard Deviation (SD) in HAZ, and 5% difference in feeding practices, 80% power, and α-error of 5%; and a cluster effect of approximately 2.
- A total of 1800 children will be sampled in both intervention and non-intervention (control) villages. A total of 120 clusters are chosen for both groups. Each intervention cluster will be matched with a control cluster selected to be similar in geographical and ecological conditions, access to a health-care centre, status of food security and the existence of Community Based Nutrition (CBN) programme. Within each pair of clusters, households will be randomly selected after the complete listing of eligible households. A total of 15 households will be identified in each 120 clusters.
- Demographics and socio-economic status indicators will be collected using Demographic Health Surveys (DHS) methods.
- Infant and Young Child feeding indicators will be assessed in all children 6-23 months at baseline, mid- and endline
- Knowledge attitude and practices concerning the intervention exposure indicators including perceptions and utilization of complementary food, MNP, and the use and perceptions on the grain banks will be assessed at baseline, mid- and endline in caregivers.
Data analysis include:
- For demographic and socio- economic characteristics of the study participants descriptive statistics will be used.
- To calculate the nutritional status of children 6-23 months, Epi-Info/Emergency Nutrition Action (ENA) for SMART software will be used.
- The median (min, max) of the weight or number of MNP consumed per day during the intervention period will be calculated as measure of compliance; however analyses will be done based on intention-to-treat.
- Qualitative data will be recorded in digital recorders which will be transcribed first to local language then to English. Then specific themes will be identified and matrices will be prepared and data will be analysed.
- The qualitative data will be analysed separately and triangulation will be made to compare the results.
- All analysis will be done on an intention-to-treat basis, taking into account the matched-controlled design. For continuous variables we will use linear mixed models that include cluster, household and child as random effects to account for clustered observations. Fixed effects to be included in the model are covariates such as child's sex, age, household socio-economic status and relevant baseline values. Normality will be examined by creating a Quantile-Quantile (QQ) plot and subsequent visual inspection. Equal variances will be assured with Levene's test.
- For categorical variables mixed-effects logistic regression models will be used with random effects for cluster and households.
- Conditions
- Growth Acceleration, Infant Morbidity
- Being tested
- Program evaluation (impact assessment)
- Keywords
- Complementary feeding recommendation, Program evaluation, Process and impact evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Program evaluation (impact assessment)Other
The program activities include: processed complementary food rations which will be distributed to all children 6-23 months of age, in a grain bank based on bartering of raw materials; enhanced Infant and Young Child Nutrition (IYCN) counselling will be given to the mothers of children 6-23 month of age, using improved Behavior messages based Change Intervention (BCI) on formative research.
Monthly 15 MNPs sachets will be provided to all children 6-23 months of age with the instruction to add them to their complementary food, to enable point-of-use fortification on every alternate day.
| Study group | Role | What they receive |
|---|---|---|
| Program evaluation in intervention areas | Experimental | A quasi-experimental matched-control cluster design will be used in which outcomes are compared in intervention and non-intervention areas. The program evaluation will have three points of data collection to assess effect of the program on the nutritional status of children 6-29 months. Sixty intervention clusters have been purposively selected whereas the data will be collected from randomly selected subjects. The following interventions will be provided:
* Processed complementary food rations will be distributed to all children 6-23 months of age, from a grain bank based on bartering of raw materials.
* Monthly 15 sachets of MNP will be provided to all children 6-23 months of age with the instruction to add them to their complementary food, to enable point-of-use fortification. Receives: Other: Program evaluation (impact assessment) |
| Non intervention areas | No intervention | A quasi-experimental matched-control cluster design will be used in which outcomes will be compared in intervention and non-intervention clusters. The program evaluation will have three points of data collection to assess effect of the program on the nutritional status of children 6-29 months. Matching sixty non-intervention clusters have been purposively selected out of the predetermined non- intervention districts whereas study subjects will be randomly selected from the identified clusters on a population based sampling method both groups. These non-intervention areas do not get processed complementary food rations and do not receive MNPs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
% of children 17-29 months of age with HAZ < -2 SD
The ultimate outcomes of the program are improved nutritional status of children which include improved Z-scores for height-for-age (HAZ) according to the child growth standard.
Measured: Up to 18 months
Secondary outcomes (6)
Mean height
Mean Height : Measured using standardized instruments
Measured: Up to 18 months
Z score:
Change in weight-for-length Z-score (WHZ), and weight-for-age Z-score (WAZ)
% of wasted and underweight children Number of stunted, wasted, underweight children/Number of normal childrenX100
Measured: Up to 18 months
Morbidity
- including incidence of acute diarrhea episodes (>3 loose stools/day)-incidence of respiratory infection episodes (cough and/or difficult breathing with or without fever, accompanied by rapid breathing and chest in drawing) in the last 2 weeks prior to the survey
Measured: Up to 18 months
Anemia status
Hemoglobin level as measured by Hemocue and adjusted for altitude
Measured: Up to 18 months
% of children 6-23 months of age who were fed an minimum acceptable diet
Measured using 24 hr recall method
Measured: Up to 18 months
Mean weight
Mean weight: Measured using standardized instruments
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2015 (estimated)
- Study startMar 2015
- Primary completionMay 2016
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Growth AccelerationStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethiopian Public Health Institute
- Sponsor type
- Other government
- Collaborators
- Micronutrient Initiative, Wageningen University
- Responsible party
- Sponsor
- Investigators
- Saskia JM Osendarp, PhD, Study chair, Micronutrient InitiativeInge D Brouwer, PhD, Study director, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02484495
- Sponsor's protocol ID
- EPHI_FSNRD_CF_MNP002
- Status last verified
- Feb 2017
- First submitted
- 16 Jun 2015
- Last updated
- 31 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Menon P, Rawat R, Ruel M. Bringing rigor to evaluations of large-scale programs to improve infant and young child feeding and nutrition: the evaluation designs for the Alive & Thrive initiative. Food Nutr Bull. 2013 Sep;34(3 Suppl):S195-211. doi: 10.1177/15648265130343S206.
PubMed 24261077Ton G. The Mixing of Methods: A Three-Step Process for Improving Rigour in Impact Evaluations, LEI, In: RESEARCH WUA, CENTER eds. THE NETHERLANDS.; 2012
Kusters CSLea. Making evaluations Matter: A practical guide for evaluators. Center for Development Innovations. . In: Wageningen University and Research centre ed. Wageningen, The Netherlands; 2011
WHO. Indicators for assessing infant and young child feeding practices. Part I definitions. 2008
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Impact of Package of Interventions on Growth and Micronutrient Status of Infant and Young Children
- ClinicalTrials.gov ID
- NCT02484495
- Acronym / sponsor ID
- EPHI_FSNRD_CF_MNP002
- Conditions
- Growth Acceleration, Infant Morbidity
- Keywords
- Complementary feeding recommendation, Program evaluation, Process and impact evaluation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,800 participants (actual)
- Lead sponsor
- Ethiopian Public Health InstituteOther government
- Collaborators
- Micronutrient Initiative, Wageningen University
- Study start
- Mar 2015
- Primary completion
- May 2016 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 29 Jun 2015 (estimated)
- 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.
The purpose of the study is to evaluate the impact of a package of interventions including production and distribution of locally produced complementary foods (via so-called "Grain-banks") and Micronutrient Powders (MNPs) supplementation, and optimized food based Complementary Feeding Recommendation, on growth and micronutrient status of infants and young children. The impact of the intervention package will be evaluated in a quasi-experimental matched-control cluster design in infants and young children between 6 - 29 months of age. The impact, outcome, and output indicators of infants/children will be assessed in cross-sectional samples at baseline, after 9 and 18 months. A total of60 pair clusters are selected in which 15 households per cluster will be identified from the eligible population. A total of 1800 children from intervention and match-controlled clusters, will be sampled in the target age groups. Qualitative and quantitative data will be collected to gather information on Knowledge, Attitude and Practice (KAP), Infant and Young Child Feeding practices, anthropometry and anemia, following the impact pathway developed for the study.
Research questions to be answered in this program evaluation are:
- What impact does the extended pilot (implementation of local complementary food production and MNP) have on:
- Growth in children 17-29 months of age
- Infant and Young Child Feeding practices in children (6-23m), and
- Anemia status in children 11-23 m?
- What are determining factors for the impact/no impact related to:
- Immediate outcomes: skills and capacity; knowledge, attitude and practices; and improved access
- Intermediate outcomes: utilization; provision, and ensuring enabling environment
- Program performance as measured by program monitoring data on output and activities?
Detailed description
The aim of this study is to assess the impact/effectiveness of the improved interventions on infant growth and micronutrient status so as to measure what would have happened in the absence of interventions. The study will be conducted in the same four regions in Ethiopia where the program intervention is taking place namely, Amhara, Tigray, Oromiya, and South Nations Nationalities and Peoples Region (SNNPR) regions.
- Sample size calculations assume an expected difference of 0.2 Standard Deviation (SD) in HAZ, and 5% difference in feeding practices, 80% power, and α-error of 5%; and a cluster effect of approximately 2.
- A total of 1800 children will be sampled in both intervention and non-intervention (control) villages. A total of 120 clusters are chosen for both groups. Each intervention cluster will be matched with a control cluster selected to be similar in geographical and ecological conditions, access to a health-care centre, status of food security and the existence of Community Based Nutrition (CBN) programme. Within each pair of clusters, households will be randomly selected after the complete listing of eligible households. A total of 15 households will be identified in each 120 clusters.
- Demographics and socio-economic status indicators will be collected using Demographic Health Surveys (DHS) methods.
- Infant and Young Child feeding indicators will be assessed in all children 6-23 months at baseline, mid- and endline
- Knowledge attitude and practices concerning the intervention exposure indicators including perceptions and utilization of complementary food, MNP, and the use and perceptions on the grain banks will be assessed at baseline, mid- and endline in caregivers.
Data analysis include:
- For demographic and socio- economic characteristics of the study participants descriptive statistics will be used.
- To calculate the nutritional status of children 6-23 months, Epi-Info/Emergency Nutrition Action (ENA) for SMART software will be used.
- The median (min, max) of the weight or number of MNP consumed per day during the intervention period will be calculated as measure of compliance; however analyses will be done based on intention-to-treat.
- Qualitative data will be recorded in digital recorders which will be transcribed first to local language then to English. Then specific themes will be identified and matrices will be prepared and data will be analysed.
- The qualitative data will be analysed separately and triangulation will be made to compare the results.
- All analysis will be done on an intention-to-treat basis, taking into account the matched-controlled design. For continuous variables we will use linear mixed models that include cluster, household and child as random effects to account for clustered observations. Fixed effects to be included in the model are covariates such as child's sex, age, household socio-economic status and relevant baseline values. Normality will be examined by creating a Quantile-Quantile (QQ) plot and subsequent visual inspection. Equal variances will be assured with Levene's test.
- For categorical variables mixed-effects logistic regression models will be used with random effects for cluster and households.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Program evaluation in intervention areas | Experimental | Other: Program evaluation (impact assessment)A quasi-experimental matched-control cluster design will be used in which outcomes are compared in intervention and non-intervention areas. The program evaluation will have three points of data collection to assess effect of the program on the nutritional status of children 6-29 months. Sixty intervention clusters have been purposively selected whereas the data will be collected from randomly selected subjects. The following interventions will be provided: * Processed complementary food rations will be distributed to all children 6-23 months of age, from a grain bank based on bartering of raw materials. * Monthly 15 sachets of MNP will be provided to all children 6-23 months of age with the instruction to add them to their complementary food, to enable point-of-use fortification. |
| Non intervention areas | No intervention | –A quasi-experimental matched-control cluster design will be used in which outcomes will be compared in intervention and non-intervention clusters. The program evaluation will have three points of data collection to assess effect of the program on the nutritional status of children 6-29 months. Matching sixty non-intervention clusters have been purposively selected out of the predetermined non- intervention districts whereas study subjects will be randomly selected from the identified clusters on a population based sampling method both groups. These non-intervention areas do not get processed complementary food rations and do not receive MNPs. |
Who may qualify
- Ages
- 6 to 29 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children between 6-23 m of age who receive Complementary Food (CF) through grain bank or commercial central production
- Living in one of the selected clusters(for intervention and nonintervention clusters)
- Those who receive MNP (15 sachets/month/child)
- Receive enhanced IYCF counselling
- Receive food based Complementary Food Recommendation (CFR)
Key exclusion criteria (4 listed)
- Children between 6-23 m of age who do not get CF either through grain bank program or central production
- Those who do not get MNP
- Those who do not receive food based CFR
- Children with a chronic disease and/or chronic use of medications
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 |
|---|---|---|
| Program evaluation (impact assessment)The program activities include: processed complementary food rations which will be distributed to all children 6-23 months of age, in a grain bank based on bartering of raw materials; enhanced Infant and Young Child Nutrition (IYCN) counselling will be given to the mothers of children 6-23 month of age, using improved Behavior messages based Change Intervention (BCI) on formative research. Monthly 15 MNPs sachets will be provided to all children 6-23 months of age with the instruction to add them to their complementary food, to enable point-of-use fortification on every alternate day. | Other | Program evaluation in intervention areas |
Primary outcome
% of children 17-29 months of age with HAZ < -2 SD
Time frame: Up to 18 months
The ultimate outcomes of the program are improved nutritional status of children which include improved Z-scores for height-for-age (HAZ) according to the child growth standard.
6 secondary outcomes
Mean height
Time frame: Up to 18 months
Z score:
Time frame: Up to 18 months
Morbidity
Time frame: Up to 18 months
Anemia status
Time frame: Up to 18 months
% of children 6-23 months of age who were fed an minimum acceptable diet
Time frame: Up to 18 months
Mean weight
Time frame: Up to 18 months
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 31 Jan 2018.
- Background: PubMed 24261077Menon P, Rawat R, Ruel M. Bringing rigor to evaluations of large-scale programs to improve infant and young child feeding and nutrition: the evaluation designs for the Alive & Thrive initiative. Food Nutr Bull. 2013 Sep;34(3 Suppl):S195-211. doi: 10.1177/15648265130343S206.
- BackgroundTon G. The Mixing of Methods: A Three-Step Process for Improving Rigour in Impact Evaluations, LEI, In: RESEARCH WUA, CENTER eds. THE NETHERLANDS.; 2012
- BackgroundKusters CSLea. Making evaluations Matter: A practical guide for evaluators. Center for Development Innovations. . In: Wageningen University and Research centre ed. Wageningen, The Netherlands; 2011
- BackgroundWHO. Indicators for assessing infant and young child feeding practices. Part I definitions. 2008
- Sponsor's websiteLink provided by the sponsor.
Related trials for Growth Acceleration
Recruiting
Probiotic Supplementation in Extremely Preterm Infants in Scandinavia
Necrotizing Enterocolitis, Death
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.
Saskia JM Osendarp, PhD study chair
Micronutrient Initiative
Inge D Brouwer, PhD study director
Wageningen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Program evaluation (impact assessment) in people with Growth Acceleration and Infant Morbidity, run by Ethiopian Public Health Institute at 1 site in Ethiopia.
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 6 inclusion and 4 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 31 Jan 2018. 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 Ethiopia. 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?
% of children 17-29 months of age with HAZ < -2 SD (time frame: Up to 18 months). 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 NCT02484495, which also lists 4 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 31 Jan 2018.