MalnutritionNCT01985243
Building Capacity for Sustainable Livelihoods and Health
A study testing Nutrition and agriculture and Iron-rich food & business literacy in people with Malnutrition and Anemia, run by McGill University at 3 sites in 2 countries.
Trial summary
Despite recent economic growth in Ghana, the prevalence of childhood malnutrition remains high. Wasting prevalence affected 29% among 6- to 8-months-old infants in 2008. Poor nutrition contributes to about one-third of child mortality, diminishes cognitive development, and is a major determinant of maternal mortality. Read more about this study
- Who is it for?
- Ages 1 day to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Malnutrition, Anemia
- What is being tested?
- Nutrition and agriculture and Iron-rich food & business literacy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,390 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Nov 2013to 5 Aug 2018
- 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 1 day to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- household with infant < 12 mo or adolescent 10-15 y
- Living in selected communities of Upper Manya Krobo District (Ghana)
Who cannot join
- infant or adolescent has medical condition that limits dietary intakes or growth
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Canada2 sites
McGill University
Montreal, Quebec, H9W3V9
World Vision
Toronto, Ontario
About this study
Official title: Building Capacity for Sustainable Livelihoods and Health Through Public-private Linkages in Agriculture and Health Systems
Despite recent economic growth in Ghana, the prevalence of childhood malnutrition remains high. Wasting prevalence affected 29% among 6- to 8-months-old infants in 2008. Poor nutrition contributes to about one-third of child mortality, diminishes cognitive development, and is a major determinant of maternal mortality. The specific objectives of the 5-year project are to: (1) enhance human capacity of government, civil, and private institutions through improvement of knowledge and skills of personnel in agriculture, nutrition and health, entrepreneurship, and pedagogy; (2) identify information needs of local institutions that are not presently met and develop a representative and sustainable longitudinal data system to support evidence-based decision-making in programs; (3) increase vulnerable households' access to quality services in agriculture/fisheries, nutrition and health, and finance; (4) implement integrated intervention activities to improve infant and young child and adolescent nutrition outcomes; and (5) examine differential benefits of the interventions for diverse vulnerable populations. The project comprises two major activities: part I - the creation of a longitudinal data system to support evidence-based decision-making in programs, and part II - the implementation of intervention activities to improve nutrition outcomes.
The survey will include demographic, socioeconomic, health, diet, and nutritional status information collected annually from a representative same of 1500 households with infants (0-12 mo) and 1500 households with adolescents (9-12 y). The data will be analyzed and presented rapidly each year to district program and policy leaders to assist them in developing their activity plans for the following year.
Read the detailed description
This study will develop a district-level intervention package that builds capacity of local institutions to improve economic well-being, food security, health and social and cognitive development of populations living in rural Upper Manya Krobo District (UMKD) of Ghana. The UMKD Geographic Information Systems Registry estimates a rural population of 74,290 in 190 communities.
Selection process:
- Of those UMKD communities that are accessible, 136 communities will be randomly selected.
- All households with infants 0-12 mo of age in a village will be invited to be enrolled. We will continue to enroll households until we reach our sample size of 1500 households. If necessary, we will expand our number of sampled communities.
- All households with adolescents 10-15 y of age in a village, who are not part of the infant cohort, will be invited to be enrolled. We will continue to enroll households until we reach our sample size of 1500 households.
Enrollment The survey will be carried out over one day for each community. The field staff will briefly explain the purpose and study activity to the caregiver (parent or legal guardian who is responsible for the child) of the target child. If the caregiver is interested in participating, they will be given the consent form to read, or if illiterate, the consent form will be read to them. They will be given time to ask questions and decide if they wish to participate. For those who consent, they will sign the consent form or provide their finger print as proof of consent. Adolescents will be asked to provide assent. Only once consent (and assent for adolescents) is obtained, will the field staff begin the survey.
Data collection
The annual survey will consist of questions (drafts are attached) on:
- the household demographics, socioeconomic status, agricultural production, government services use,
- mother's caregiving practices, microcredit use, business activities, physical and mental health, anthropometry (weight, height), iron status
- infant's diet, anthropometry (weight, height, circumference), iron status
- adolescent's diet, anthropometry (weight, height, circumference), iron status, educational activities, finance knowledge
The survey will be administered in the home with the child's caregiver, in a private location. THe adolescent will be interviewed privately unless the mother requests to be present. It is expected to be about 60-90 minutes in length. All data will be recorded solely with the study identification number. The participant's name and home address will be kept secure and separately.
THe interventions will take place with a subgroup of those participating in the annual survey. Our two main integrated interventions target critical periods of the life course when gender inequalities can have important effects on the short-term and long-term health of both men and women. Our first intervention which will begin in January 2014 will offer intensive nutrition, health, and agricultural training, along with provision of home gardens and small animal husbandry to about 302 of our households with at least one child under the age of 1 y. As these will be household-level interventions, both men and women and male and female infants (and older siblings) living in these households will benefit from this intervention. We will assess the extent to which women retain decision-making authority about the allocation of these agricultural resources and whether they benefit their children's health and nutrition, using our primary indicators of child diet and nutritional status.
Our second integrated intervention will focus on reducing anemia among female school-aged children. The intervention will start after the baseline with the beginning of the school year, September 2014. These interventions will benefit both girls and boys as boys also suffer from high rates of anaemia in this district and both sexes continue to have a high burden of parasitic infections. In addition, since older girls (starting in primary grade 4) are less likely to stay in school and, hence, are disadvantaged with respect to their access to these programs, we plan to implement a savings account intervention for girls who successfully complete primary grade 5. The amount of the savings account will be relatively small (e.g., to cover school uniforms) but along with opening these savings accounts girls will gain financial literacy and learn the importance of savings accounts and budgets. Increasing girls' education is one of the most effective ways to decrease child mortality. According to a recent study, about half of the decline in child mortality in developing countries since 1979 can be attributed to women's increased education. Moreover, since our integrated intervention will include means to improve iron status of the girls, , we expect to significantly lower rates of preconception rates of anaemia among these girls. This intervention will help meet one of the key recommendations of The Lancet Maternal and Child Nutrition Series, which notes that "A clear need exists to introduce promising evidence-based interventions in the preconception period and in adolescents in countries with a high burden of undernutrition and young age at first pregnancies" .
- Conditions
- Malnutrition, Anemia
- Being tested
- Nutrition and agriculture, Iron-rich food & business literacy
- Keywords
- Dietary diversity, Infant and young child, Adolescents, Anemia, Rural health
- Medical subject headings
- Malnutrition, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition and agricultureBehavioural
The intervention includes two components: (1) nutrition education on infant and young child nutrition, and (2) agriculture and small animal husbandry intervention to increase women's income and the accessibility of animal source foods for infants and young children.
Iron-rich food & business literacyBehavioural
The intervention includes two components: (1) a behavioural change intervention to improve school meals and increase the available iron in adolescents' diets, (2) savings \& business literacy program for young female adolescents to encourage them to stay in school.
| Study group | Role | What they receive |
|---|---|---|
| Nutrition and agriculture | Experimental | Intervention arm with integrated nutrition and agriculture education, skill building, and animal husbandry promotion Receives: Behavioral: Nutrition and agriculture |
| Iron-rich food & business literacy | Experimental | Integrated business literacy and food supplementation program to promote school retention among female adolescents Receives: Behavioral: Iron-rich food & business literacy |
| IYC Comparison | No intervention | Comparison group of infants and young children for the nutrition-agriculture intervention |
| Adolescent comparison | No intervention | Comparison group for the adolescent business-food supplement intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary diversity
Dietary diversity of infants and young children, based on the World Health Organization's 7 food group list. This will be assessed at enrollment (which 0-11.9 mo of age) and then every 12 months for 5 years.
Measured: At enrollment and every 12 months for 5 years
Anemia prevalence
Anemia prevalence in adolescent girls will be assessed at enrollment and every 12 months for 4 years
Measured: at enrollment and every 12 months for 4 years
Secondary outcomes (1)
Wasting prevalence
Weight-for-height of infants and young children will be assessed at at enrollment and every 12 months for 5 years
Measured: at enrollment and every 12 months for 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2013 (estimated)
- Study startNov 2013
- Primary completion31 Mar 2018
- Study completion5 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,390 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Collaborators
- Foreign Affairs, Trade and Development, Canada, World Vision
- Responsible party
- Principal investigator, Grace S. Marquis, McGill University
- Investigators
- Grace S Marquis, PhD, Principal investigator, McGill UniversityEsi K Colecraft, PhD, Principal investigator, University of GhanaBridgett Aidams, PhD, Principal investigator, World Vision
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01985243
- Sponsor's protocol ID
- S065653
- Status last verified
- Aug 2018
- First submitted
- 27 Oct 2013
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Goh YE, Marquis GS, Colecraft EK, Aryeetey R. Participating in a Nutrition-Sensitive Agriculture Intervention Is Not Associated with Less Maternal Time for Care in a Rural Ghanaian District. Curr Dev Nutr. 2022 Sep 29;6(10):nzac145. doi: 10.1093/cdn/nzac145. eCollection 2022 Oct.
PubMed 36475016Dallmann D, Marquis GS, Colecraft EK, Kanlisi R, Aidam BA. Maternal Participation Level in a Nutrition-Sensitive Agriculture Intervention Matters for Child Diet and Growth Outcomes in Rural Ghana. Curr Dev Nutr. 2022 Feb 1;6(3):nzac017. doi: 10.1093/cdn/nzac017. eCollection 2022 Mar.
PubMed 35295712
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Capacity for Sustainable Livelihoods and Health Through Public-private Linkages in Agriculture and Health Systems
- ClinicalTrials.gov ID
- NCT01985243
- Acronym / sponsor ID
- S065653
- Conditions
- Malnutrition, Anemia
- Keywords
- Dietary diversity, Infant and young child, Adolescents, Anemia, Rural health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,390 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- Foreign Affairs, Trade and Development, Canada, World Vision
- Study start
- Nov 2013 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 5 Aug 2018 (actual)
- First posted
- 15 Nov 2013 (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.
Despite recent economic growth in Ghana, the prevalence of childhood malnutrition remains high. Wasting prevalence affected 29% among 6- to 8-months-old infants in 2008. Poor nutrition contributes to about one-third of child mortality, diminishes cognitive development, and is a major determinant of maternal mortality. The specific objectives of the 5-year project are to: (1) enhance human capacity of government, civil, and private institutions through improvement of knowledge and skills of personnel in agriculture, nutrition and health, entrepreneurship, and pedagogy; (2) identify information needs of local institutions that are not presently met and develop a representative and sustainable longitudinal data system to support evidence-based decision-making in programs; (3) increase vulnerable households' access to quality services in agriculture/fisheries, nutrition and health, and finance; (4) implement integrated intervention activities to improve infant and young child and adolescent nutrition outcomes; and (5) examine differential benefits of the interventions for diverse vulnerable populations. The project comprises two major activities: part I - the creation of a longitudinal data system to support evidence-based decision-making in programs, and part II - the implementation of intervention activities to improve nutrition outcomes.
The survey will include demographic, socioeconomic, health, diet, and nutritional status information collected annually from a representative same of 1500 households with infants (0-12 mo) and 1500 households with adolescents (9-12 y). The data will be analyzed and presented rapidly each year to district program and policy leaders to assist them in developing their activity plans for the following year.
Detailed description
This study will develop a district-level intervention package that builds capacity of local institutions to improve economic well-being, food security, health and social and cognitive development of populations living in rural Upper Manya Krobo District (UMKD) of Ghana. The UMKD Geographic Information Systems Registry estimates a rural population of 74,290 in 190 communities.
Selection process:
- Of those UMKD communities that are accessible, 136 communities will be randomly selected.
- All households with infants 0-12 mo of age in a village will be invited to be enrolled. We will continue to enroll households until we reach our sample size of 1500 households. If necessary, we will expand our number of sampled communities.
- All households with adolescents 10-15 y of age in a village, who are not part of the infant cohort, will be invited to be enrolled. We will continue to enroll households until we reach our sample size of 1500 households.
Enrollment The survey will be carried out over one day for each community. The field staff will briefly explain the purpose and study activity to the caregiver (parent or legal guardian who is responsible for the child) of the target child. If the caregiver is interested in participating, they will be given the consent form to read, or if illiterate, the consent form will be read to them. They will be given time to ask questions and decide if they wish to participate. For those who consent, they will sign the consent form or provide their finger print as proof of consent. Adolescents will be asked to provide assent. Only once consent (and assent for adolescents) is obtained, will the field staff begin the survey.
Data collection
The annual survey will consist of questions (drafts are attached) on:
- the household demographics, socioeconomic status, agricultural production, government services use,
- mother's caregiving practices, microcredit use, business activities, physical and mental health, anthropometry (weight, height), iron status
- infant's diet, anthropometry (weight, height, circumference), iron status
- adolescent's diet, anthropometry (weight, height, circumference), iron status, educational activities, finance knowledge
The survey will be administered in the home with the child's caregiver, in a private location. THe adolescent will be interviewed privately unless the mother requests to be present. It is expected to be about 60-90 minutes in length. All data will be recorded solely with the study identification number. The participant's name and home address will be kept secure and separately.
THe interventions will take place with a subgroup of those participating in the annual survey. Our two main integrated interventions target critical periods of the life course when gender inequalities can have important effects on the short-term and long-term health of both men and women. Our first intervention which will begin in January 2014 will offer intensive nutrition, health, and agricultural training, along with provision of home gardens and small animal husbandry to about 302 of our households with at least one child under the age of 1 y. As these will be household-level interventions, both men and women and male and female infants (and older siblings) living in these households will benefit from this intervention. We will assess the extent to which women retain decision-making authority about the allocation of these agricultural resources and whether they benefit their children's health and nutrition, using our primary indicators of child diet and nutritional status.
Our second integrated intervention will focus on reducing anemia among female school-aged children. The intervention will start after the baseline with the beginning of the school year, September 2014. These interventions will benefit both girls and boys as boys also suffer from high rates of anaemia in this district and both sexes continue to have a high burden of parasitic infections. In addition, since older girls (starting in primary grade 4) are less likely to stay in school and, hence, are disadvantaged with respect to their access to these programs, we plan to implement a savings account intervention for girls who successfully complete primary grade 5. The amount of the savings account will be relatively small (e.g., to cover school uniforms) but along with opening these savings accounts girls will gain financial literacy and learn the importance of savings accounts and budgets. Increasing girls' education is one of the most effective ways to decrease child mortality. According to a recent study, about half of the decline in child mortality in developing countries since 1979 can be attributed to women's increased education. Moreover, since our integrated intervention will include means to improve iron status of the girls, , we expect to significantly lower rates of preconception rates of anaemia among these girls. This intervention will help meet one of the key recommendations of The Lancet Maternal and Child Nutrition Series, which notes that "A clear need exists to introduce promising evidence-based interventions in the preconception period and in adolescents in countries with a high burden of undernutrition and young age at first pregnancies" .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Nutrition and agriculture | Experimental | Behavioral: Nutrition and agricultureIntervention arm with integrated nutrition and agriculture education, skill building, and animal husbandry promotion |
| Iron-rich food & business literacy | Experimental | Behavioral: Iron-rich food & business literacyIntegrated business literacy and food supplementation program to promote school retention among female adolescents |
| IYC Comparison | No intervention | –Comparison group of infants and young children for the nutrition-agriculture intervention |
| Adolescent comparison | No intervention | –Comparison group for the adolescent business-food supplement intervention |
Who may qualify
- Ages
- 1 day to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- household with infant < 12 mo or adolescent 10-15 y
- Living in selected communities of Upper Manya Krobo District (Ghana)
Key exclusion criteria (1 listed)
- infant or adolescent has medical condition that limits dietary intakes or growth
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 |
|---|---|---|
| Nutrition and agricultureThe intervention includes two components: (1) nutrition education on infant and young child nutrition, and (2) agriculture and small animal husbandry intervention to increase women's income and the accessibility of animal source foods for infants and young children. | Behavioural | Nutrition and agriculture |
| Iron-rich food & business literacyThe intervention includes two components: (1) a behavioural change intervention to improve school meals and increase the available iron in adolescents' diets, (2) savings \& business literacy program for young female adolescents to encourage them to stay in school. | Behavioural | Iron-rich food & business literacy |
Primary outcome
Dietary diversity
Time frame: At enrollment and every 12 months for 5 years
Dietary diversity of infants and young children, based on the World Health Organization's 7 food group list. This will be assessed at enrollment (which 0-11.9 mo of age) and then every 12 months for 5 years.
Anemia prevalence
Time frame: at enrollment and every 12 months for 4 years
Anemia prevalence in adolescent girls will be assessed at enrollment and every 12 months for 4 years
1 secondary outcome
Wasting prevalence
Time frame: at enrollment and every 12 months for 5 years
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 22 Aug 2018.
- Derived from this study: PubMed 36475016Goh YE, Marquis GS, Colecraft EK, Aryeetey R. Participating in a Nutrition-Sensitive Agriculture Intervention Is Not Associated with Less Maternal Time for Care in a Rural Ghanaian District. Curr Dev Nutr. 2022 Sep 29;6(10):nzac145. doi: 10.1093/cdn/nzac145. eCollection 2022 Oct.
- Derived from this study: PubMed 35295712Dallmann D, Marquis GS, Colecraft EK, Kanlisi R, Aidam BA. Maternal Participation Level in a Nutrition-Sensitive Agriculture Intervention Matters for Child Diet and Growth Outcomes in Rural Ghana. Curr Dev Nutr. 2022 Feb 1;6(3):nzac017. doi: 10.1093/cdn/nzac017. eCollection 2022 Mar.
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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.
Grace S Marquis, PhD principal investigator
McGill University
Esi K Colecraft, PhD principal investigator
University of Ghana
Bridgett Aidams, PhD principal investigator
World Vision
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition and agriculture and Iron-rich food & business literacy in people with Malnutrition and Anemia, run by McGill University at 3 sites in 2 countries.
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 2 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 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada, Ghana. 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?
Dietary diversity (time frame: At enrollment and every 12 months for 5 years). The study lists 2 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 NCT01985243, which also lists 2 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 22 Aug 2018.