MalnutritionQPMNCT02710760
Translating Adoption of Improved Varieties Into Nutritional Impact
A study testing Adoption Encouragement Treatment and Consumption Encouragement Treatment in people with Malnutrition, run by Harvard School of Public Health (HSPH).
Trial summary
The purposes of this study are (1) to determine whether child nutrition-focused adoption encouragement messages focused on Quality Protein Maize (QPM) and the availability of small quantities of QPM seed can be effective at increasing QPM adoption and health outcomes for young children, and (2) to determine whether… Read more about this study
- Who is it for?
- Ages 6 to 35 monthsHealthy volunteers can take part
- Conditions the study is for
- Malnutrition
- What is being tested?
- Adoption Encouragement Treatment and Consumption Encouragement Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 978 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Jul 2016
- 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 35 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Households with at least one child in the 6-35 month age range in August 2015, who had at least one household member attend a field day demonstrating Quality Protein Maize, and who provided informed consent for participation and data collection were eligible for inclusion.
Who cannot join
- Households in the study areas that do not have a member who attends a field day demonstrating Quality Protein Maize or who do not have a child in the appropriate age range are excluded from the study. Furthermore, households where the mother or children did not intend on staying in the region for the study duration (until the completion of the endline survey) were excluded from the study. Finally, we excluded participants who do not have access to land for crop cultivation.
About this study
Official title: Translating Adoption of Improved Varieties Into Nutritional Impact for Young Children: An RCT Exploring Strategies to Increase Consumption of Quality Protein Maize in Ethiopia
The purposes of this study are (1) to determine whether child nutrition-focused adoption encouragement messages focused on Quality Protein Maize (QPM) and the availability of small quantities of QPM seed can be effective at increasing QPM adoption and health outcomes for young children, and (2) to determine whether consumption encouragement messages and techniques (e.g., containers for earmarking) can be effective at increasing QPM targeting to and health outcomes for young children.
- Conditions
- Malnutrition
- Being tested
- Adoption Encouragement Treatment, Consumption Encouragement Treatment
- Keywords
- Biomarkers, Child Nutrition Sciences, Economics, Behavioral
- Medical subject headings
- Malnutrition, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adoption Encouragement TreatmentOther
Households in the Adoption Encouragement Treatment received child nutrition focused guidance on the nutritional and agronomic benefits of Quality Protein Maize (QPM) adoption, and the opportunity to order up to 6 kg of QPM seed to plant in their own fields.
Consumption Encouragement TreatmentOther
Households in the Consumption Encouragement Treatment received the same guidance as households in the Adoption Encouragement Treatment, as well as additional guidance on the importance of specifically targeting foods made with QPM to young children and tools to help households keep the grain separate and remember to feed QPM-based foods to the young children.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Households in the control group receive no special treatment. |
| Adoption Encouragement Treatment | Experimental | Households in the Adoption Encouragement Treatment group were visited between March and April 2015 and offered "child nutrition focused" adoption encouragement. Both the male household head and the primary female caregiver were invited to attend these meetings (though the household head is the primary target), where the nutritional benefits of Quality Protein Maize (QPM) adoption for children were emphasized along with the agronomic properties. In addition, the fact that only small amounts of QPM are necessary to nourish children was highlighted and small seed bag sizes were offered. During the adoption encouragement visit, we offered the option to order up to three 2 kg bags of QPM for free. Receives: Other: Adoption Encouragement Treatment |
| Consumption Encouragement Treatment | Experimental | In addition to receiving the Adoption Encouragement Treatment, households in the Consumption Encouragement Treatment group received additional information, targeted to the caregiver, and tools for separating Quality Protein Maize and targeting it to young children in the household in August 2015. They will additionally receive further guidance in February 2016. Receives: Other: Adoption Encouragement Treatment; Other: Consumption Encouragement Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consumption of any QPM by the index child in the last 24 hours
Measured: 6-7 months
Amount of QPM consumed by the index child in the last 24 hours
Measured: 6-7 months
Index child's proportion of total maize consumption that was QPM in the last 24 hours
Measured: 6-7 months
Consumption of any QPM by the index child in the last week
Measured: 6-7 months
Number of days in the last week that the index child ate any QPM
Measured: 6-7 months
Number of days in the last week that caregiver cooked a QPM-based food that was primarily for target children
Measured: 6-7 months
Height-for-age Z-score of index child
Measured: 6-7 months
Weight-for-height Z-score of index child
Measured: 6-7 months
Weight-for-age Z-score of index child
Measured: 6-7 months
Mid-upper arm circumference-for-age Z-score of index child
Measured: 6-7 months
Insulin-like growth factor I (continuous measurement)
Measured: 6-7 months
Amount of QPM reserved for home consumption
Measured: 6-7 months
Hectares of QPM planted
Measured: 6-7 months
Serum transthyretin
Measured: 6-7 months
Consumption of any QPM by the index child in the last 24 hours
Measured: 10-11 months
Amount of QPM consumed by the index child in the last 24 hours
Measured: 10-11 months
Index child's proportion of total maize consumption that was QPM in the last 24 hours
Measured: 10-11 months
Consumption of any QPM by the index child in the last week
Measured: 10-11 months
Number of days in the last week that the index child ate any QPM
Measured: 10-11 months
Number of days in the last week that caregiver cooked a QPM-based food that was primarily for target children
Measured: 10-11 months
Height-for-age Z-score of index child
Measured: 10-11 months
Weight-for-height Z-score of index child
Measured: 10-11 months
Weight-for-age Z-score of index child
Measured: 10-11 months
Mid-upper arm circumference-for-age Z-score of index child
Measured: 10-11 months
Amount of QPM reserved for home consumption
Measured: 10-11 months
Change in Height-for-age Z-score of index child
Measured: 6-7 months
Change in Height-for-age Z-score of index child
Measured: 10-11 months
Change in Weight-for-height Z-score of index child
Measured: 6-7 months
Change in Weight-for-height Z-score of index child
Measured: 10-11 months
Change in Mid-upper arm circumference-for-age Z-score of index child
Measured: 6-7 months
Change in Mid-upper arm circumference-for-age Z-score of index child
Measured: 10-11 months
Change in Weight-for-age Z-score of index child
Measured: 6-7 months
Change in Weight-for-age Z-score of index child
Measured: 10-11 months
Secondary outcomes (2)
Serum lysine
Measured: 6-7 months
Serum tryptophan
Measured: 6-7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study startJul 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 978 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- CIMMYT International Maize and Wheat Improvement Center, Ethiopian Public Health Institute, Agricultural Technology Adoption Initiative
- Responsible party
- Principal investigator, Jessica Cohen, Harvard School of Public Health (HSPH)
- Investigators
- Jessica Cohen, PhD, Principal investigator, Harvard Chan School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02710760
- Sponsor's protocol ID
- IRB14-3255
- Acronym
- QPM
- Status last verified
- Mar 2017
- First submitted
- 29 Feb 2016
- Last updated
- 9 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: We will share completely deidentified data upon request after primary analyses have been been completed.
Publications
Black RE, Victora CG, Walker SP, Bhutta ZA, Christian P, de Onis M, Ezzati M, Grantham-McGregor S, Katz J, Martorell R, Uauy R; Maternal and Child Nutrition Study Group. Maternal and child undernutrition and overweight in low-income and middle-income countries. Lancet. 2013 Aug 3;382(9890):427-451. doi: 10.1016/S0140-6736(13)60937-X. Epub 2013 Jun 6.
PubMed 23746772Victora 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 18206223Ruel MT, Alderman H; Maternal and Child Nutrition Study Group. Nutrition-sensitive interventions and programmes: how can they help to accelerate progress in improving maternal and child nutrition? Lancet. 2013 Aug 10;382(9891):536-51. doi: 10.1016/S0140-6736(13)60843-0. Epub 2013 Jun 6.
PubMed 23746780Masset E, Haddad L, Cornelius A, Isaza-Castro J. Effectiveness of agricultural interventions that aim to improve nutritional status of children: systematic review. BMJ. 2012 Jan 17;344:d8222. doi: 10.1136/bmj.d8222.
PubMed 22251864Girard AW, Self JL, McAuliffe C, Olude O. The effects of household food production strategies on the health and nutrition outcomes of women and young children: a systematic review. Paediatr Perinat Epidemiol. 2012 Jul;26 Suppl 1:205-22. doi: 10.1111/j.1365-3016.2012.01282.x.
PubMed 22742612Ghosh S, Suri D, Uauy R. Assessment of protein adequacy in developing countries: quality matters. Br J Nutr. 2012 Aug;108 Suppl 2:S77-87. doi: 10.1017/S0007114512002577.
PubMed 23107551Donato K, McConnell M, Han D, Gunaratna NS, Tessema M, De Groote H, Cohen J. Behavioural insights to support increased consumption of quality protein maize by young children: a cluster randomised trial in Ethiopia. BMJ Glob Health. 2020 Dec;5(12):e002705. doi: 10.1136/bmjgh-2020-002705.
PubMed 33355261
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translating Adoption of Improved Varieties Into Nutritional Impact for Young Children: An RCT Exploring Strategies to Increase Consumption of Quality Protein Maize in Ethiopia
- ClinicalTrials.gov ID
- NCT02710760
- Acronym / sponsor ID
- QPM / IRB14-3255
- Conditions
- Malnutrition
- Keywords
- Biomarkers, Child Nutrition Sciences, Economics, Behavioral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 978 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- CIMMYT International Maize and Wheat Improvement Center, Ethiopian Public Health Institute, Agricultural Technology Adoption Initiative
- Study start
- Jul 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 17 Mar 2016 (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 purposes of this study are (1) to determine whether child nutrition-focused adoption encouragement messages focused on Quality Protein Maize (QPM) and the availability of small quantities of QPM seed can be effective at increasing QPM adoption and health outcomes for young children, and (2) to determine whether consumption encouragement messages and techniques (e.g., containers for earmarking) can be effective at increasing QPM targeting to and health outcomes for young children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Households in the control group receive no special treatment. |
| Adoption Encouragement Treatment | Experimental | Other: Adoption Encouragement TreatmentHouseholds in the Adoption Encouragement Treatment group were visited between March and April 2015 and offered "child nutrition focused" adoption encouragement. Both the male household head and the primary female caregiver were invited to attend these meetings (though the household head is the primary target), where the nutritional benefits of Quality Protein Maize (QPM) adoption for children were emphasized along with the agronomic properties. In addition, the fact that only small amounts of QPM are necessary to nourish children was highlighted and small seed bag sizes were offered. During the adoption encouragement visit, we offered the option to order up to three 2 kg bags of QPM for free. |
| Consumption Encouragement Treatment | Experimental | Other: Adoption Encouragement Treatment, Other: Consumption Encouragement TreatmentIn addition to receiving the Adoption Encouragement Treatment, households in the Consumption Encouragement Treatment group received additional information, targeted to the caregiver, and tools for separating Quality Protein Maize and targeting it to young children in the household in August 2015. They will additionally receive further guidance in February 2016. |
Who may qualify
- Ages
- 6 to 35 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Households with at least one child in the 6-35 month age range in August 2015, who had at least one household member attend a field day demonstrating Quality Protein Maize, and who provided informed consent for participation and data collection were eligible for inclusion.
Key exclusion criteria (1 listed)
- Households in the study areas that do not have a member who attends a field day demonstrating Quality Protein Maize or who do not have a child in the appropriate age range are excluded from the study. Furthermore, households where the mother or children did not intend on staying in the region for the study duration (until the completion of the endline survey) were excluded from the study. Finally, we excluded participants who do not have access to land for crop cultivation.
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 |
|---|---|---|
| Adoption Encouragement TreatmentHouseholds in the Adoption Encouragement Treatment received child nutrition focused guidance on the nutritional and agronomic benefits of Quality Protein Maize (QPM) adoption, and the opportunity to order up to 6 kg of QPM seed to plant in their own fields. | Other | Adoption Encouragement Treatment, Consumption Encouragement Treatment |
| Consumption Encouragement TreatmentHouseholds in the Consumption Encouragement Treatment received the same guidance as households in the Adoption Encouragement Treatment, as well as additional guidance on the importance of specifically targeting foods made with QPM to young children and tools to help households keep the grain separate and remember to feed QPM-based foods to the young children. | Other | Consumption Encouragement Treatment |
Primary outcome
Consumption of any QPM by the index child in the last 24 hours
Time frame: 6-7 months
Amount of QPM consumed by the index child in the last 24 hours
Time frame: 6-7 months
Index child's proportion of total maize consumption that was QPM in the last 24 hours
Time frame: 6-7 months
Consumption of any QPM by the index child in the last week
Time frame: 6-7 months
Number of days in the last week that the index child ate any QPM
Time frame: 6-7 months
Number of days in the last week that caregiver cooked a QPM-based food that was primarily for target children
Time frame: 6-7 months
Height-for-age Z-score of index child
Time frame: 6-7 months
Weight-for-height Z-score of index child
Time frame: 6-7 months
Weight-for-age Z-score of index child
Time frame: 6-7 months
Mid-upper arm circumference-for-age Z-score of index child
Time frame: 6-7 months
Insulin-like growth factor I (continuous measurement)
Time frame: 6-7 months
Amount of QPM reserved for home consumption
Time frame: 6-7 months
Hectares of QPM planted
Time frame: 6-7 months
Serum transthyretin
Time frame: 6-7 months
Consumption of any QPM by the index child in the last 24 hours
Time frame: 10-11 months
Amount of QPM consumed by the index child in the last 24 hours
Time frame: 10-11 months
Index child's proportion of total maize consumption that was QPM in the last 24 hours
Time frame: 10-11 months
Consumption of any QPM by the index child in the last week
Time frame: 10-11 months
Number of days in the last week that the index child ate any QPM
Time frame: 10-11 months
Number of days in the last week that caregiver cooked a QPM-based food that was primarily for target children
Time frame: 10-11 months
Height-for-age Z-score of index child
Time frame: 10-11 months
Weight-for-height Z-score of index child
Time frame: 10-11 months
Weight-for-age Z-score of index child
Time frame: 10-11 months
Mid-upper arm circumference-for-age Z-score of index child
Time frame: 10-11 months
Amount of QPM reserved for home consumption
Time frame: 10-11 months
Change in Height-for-age Z-score of index child
Time frame: 6-7 months
Change in Height-for-age Z-score of index child
Time frame: 10-11 months
Change in Weight-for-height Z-score of index child
Time frame: 6-7 months
Change in Weight-for-height Z-score of index child
Time frame: 10-11 months
Change in Mid-upper arm circumference-for-age Z-score of index child
Time frame: 6-7 months
Change in Mid-upper arm circumference-for-age Z-score of index child
Time frame: 10-11 months
Change in Weight-for-age Z-score of index child
Time frame: 6-7 months
Change in Weight-for-age Z-score of index child
Time frame: 10-11 months
2 secondary outcomes
Serum lysine
Time frame: 6-7 months
Serum tryptophan
Time frame: 6-7 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 9 Mar 2017.
- Background: PubMed 23746772Black RE, Victora CG, Walker SP, Bhutta ZA, Christian P, de Onis M, Ezzati M, Grantham-McGregor S, Katz J, Martorell R, Uauy R; Maternal and Child Nutrition Study Group. Maternal and child undernutrition and overweight in low-income and middle-income countries. Lancet. 2013 Aug 3;382(9890):427-451. doi: 10.1016/S0140-6736(13)60937-X. Epub 2013 Jun 6.
- 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 23746780Ruel MT, Alderman H; Maternal and Child Nutrition Study Group. Nutrition-sensitive interventions and programmes: how can they help to accelerate progress in improving maternal and child nutrition? Lancet. 2013 Aug 10;382(9891):536-51. doi: 10.1016/S0140-6736(13)60843-0. Epub 2013 Jun 6.
- Background: PubMed 22251864Masset E, Haddad L, Cornelius A, Isaza-Castro J. Effectiveness of agricultural interventions that aim to improve nutritional status of children: systematic review. BMJ. 2012 Jan 17;344:d8222. doi: 10.1136/bmj.d8222.
- Background: PubMed 22742612Girard AW, Self JL, McAuliffe C, Olude O. The effects of household food production strategies on the health and nutrition outcomes of women and young children: a systematic review. Paediatr Perinat Epidemiol. 2012 Jul;26 Suppl 1:205-22. doi: 10.1111/j.1365-3016.2012.01282.x.
- Background: PubMed 23107551Ghosh S, Suri D, Uauy R. Assessment of protein adequacy in developing countries: quality matters. Br J Nutr. 2012 Aug;108 Suppl 2:S77-87. doi: 10.1017/S0007114512002577.
- Derived from this study: PubMed 33355261Donato K, McConnell M, Han D, Gunaratna NS, Tessema M, De Groote H, Cohen J. Behavioural insights to support increased consumption of quality protein maize by young children: a cluster randomised trial in Ethiopia. BMJ Glob Health. 2020 Dec;5(12):e002705. doi: 10.1136/bmjgh-2020-002705.
- Individual participant dataSharing planned: Yes. We will share completely deidentified data upon request after primary analyses have been been completed.
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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.
Jessica Cohen, PhD principal investigator
Harvard Chan School of Public Health
Questions about this trial
What is this clinical trial studying?
A study testing Adoption Encouragement Treatment and Consumption Encouragement Treatment in people with Malnutrition, run by Harvard School of Public Health (HSPH).
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 9 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Consumption of any QPM by the index child in the last 24 hours (time frame: 6-7 months). The study lists 33 primary outcomes in all. 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 NCT02710760, which also lists 7 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 9 Mar 2017.