Improving Young Child NutritionNCT01612442
Integrated Education Intervention to Improve Infant and Young Child Nutrition and Growth in Ghana
A study testing nutrition and agricultural education and nutrition education in people with Improving Young Child Nutrition, run by McGill University at 1 site in Ghana.
Trial summary
In Ghana the level of malnutrition is high among children below five years of age, particularly in rural areas. The objective of the study was to investigate the effects of an education intervention aimed at addressing poor complementary feeding (CF) practices on the food intakes and growth of young children in the… Read more about this study
- Who is it for?
- Ages 6 to 11 monthsHealthy volunteers can take part
- Conditions the study is for
- Improving Young Child Nutrition
- What is being tested?
- nutrition and agricultural education and nutrition education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 367 participants
- Where
- 1 siteGhana
- Study dates
- Jun 2010to Mar 2012
- 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 11 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- child aged 6-11 months old and attending monthly growth monitoring clinic
- mother and child living in the study area
Who cannot join
- birth defects which results in difficulty in feeding of child
Trial locations and contacts
1 site in 1 country.
About this study
In Ghana the level of malnutrition is high among children below five years of age, particularly in rural areas. The objective of the study was to investigate the effects of an education intervention aimed at addressing poor complementary feeding (CF) practices on the food intakes and growth of young children in the Upper Manya Krobo district of Ghana.
Interviews and focus group discussions involving community health and agricultural workers, as well as caregivers of children 6-24 months old were conducted to investigate the facilitators and challenges to optimal CF practices and education on CF. The trials of improved practices (TIPs) method was used to test the feasibility and acceptability of potential education messages among mothers of young children (6-24 months) living in the study area. Child welfare clinic centers in the area were randomly assigned to one of three groups which were control, nutrition education and integrated education. Mothers of children 6-24 months in the integrated education group received monthly nutrition education from community health volunteers and agricultural education from agricultural extension agents for six months in addition to standard monthly child growth monitoring services from community health nurses. Mothers in the nutrition education group received monthly nutrition education from community health volunteers for six months in addition to standard care. Mothers of 6-24 months in the control group received only the standard monthly child monitoring services. The effects of the educational intervention on maternal knowledge on optimal complementary feeding, as well as food intakes and growth of young children were determined among 367 mother-child dyads over a period of at least six months. The study hypothesised that mothers receiving the education would have improved knowledge on good complementary feeding practices compared to those in the control group. The study also hypothesised that young children in the integrated education would have better nutrient intakes and growth compared those in the nutrition education and control groups, and those in the nutrition education group would have better nutrient intakes and growth than the children in the control group.
Read more
From the interviews and focus group discussions, reported initiation of CF was satisfactory, while other reported practices such as the addition of animal source foods, vegetables and fruits to young children's diet were found to be sub-optimal. Poverty and maternal time constraints were identified as the main challenges of optimal complementary feeding, while farming was seen as a facilitator. Lack of education materials, language barrier, maternal time constraints and lack of in-service training for health workers were the main challenges to education on complementary feeding. From the TIPS study, mothers expressed their willingness to improve the diets of their 6-24 months old children by adding or increasing the amount of animal source foods, dark-green leafy vegetables and fruits, as well as increasing feeding frequency daily. However, availability and affordability of protein-rich foods like animal source foods, groundnut paste and soya beans powder was a challenge for some mothers.
The intervention did not lead to a significant improvement in maternal knowledge on complementary feeding practices. However, it showed a tendency to reverse a general decreasing trend in knowledge among mothers on appropriate complementary feeding practices in the study area. Significantly more children in the integrated education group consumed animal source foods compared those in the other two groups when compared at nine months after baseline. However, the intervention did not improve the general nutrient intakes and growth of the young children in the study area.
- Conditions
- Improving Young Child Nutrition
- Being tested
- nutrition and agricultural education, nutrition education
- Keywords
- complementary feeding, mothers, 6-24 months children, community health volunteers, nutrition education, agricultural education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutrition and agricultural educationBehavioural
Mothers of children aged 6-24 months received monthly nutrition education delivered by community health volunteers and agricultural education delivered by agricultural extension agents, in addition to standard monthly child welfare services delivered by Ghana Health Service
nutrition educationBehavioural
Mothers of children aged 6-24 months received monthly nutrition education delivered by community health volunteers in addition to standard child growth monitoring services provided by the Ghana Health Service.
| Study group | Role | What they receive |
|---|---|---|
| Integrated education | Experimental | Not described Receives: Behavioral: nutrition and agricultural education |
| Control | No intervention | Not described |
| Nutrition education | Experimental | Not described Receives: Behavioral: nutrition education |
What is being measured
The primary outcome is the main question the study is designed to answer.
growth (change in weight and length)
Measured: 9 months
Secondary outcomes (1)
maternal nutrition knowledge
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2012 (estimated)
- Study startJun 2010
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Improving Young Child NutritionStudies 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
- 367 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Collaborators
- International Development Research Centre, Canada
- Responsible party
- Principal investigator, Agartha Cofie, McGill University
- Investigators
- Grace S Marquis, PhD, Study director, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01612442
- Sponsor's protocol ID
- 290-0310
- Status last verified
- Jun 2012
- First submitted
- 27 May 2012
- Last updated
- 5 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Education Intervention to Improve Infant and Young Child Nutrition and Growth in Ghana
- ClinicalTrials.gov ID
- NCT01612442
- Acronym / sponsor ID
- 290-0310
- Conditions
- Improving Young Child Nutrition
- Keywords
- complementary feeding, mothers, 6-24 months children, community health volunteers, nutrition education, agricultural education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 367 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- International Development Research Centre, Canada
- Study start
- Jun 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 5 Jun 2012 (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.
In Ghana the level of malnutrition is high among children below five years of age, particularly in rural areas. The objective of the study was to investigate the effects of an education intervention aimed at addressing poor complementary feeding (CF) practices on the food intakes and growth of young children in the Upper Manya Krobo district of Ghana.
Interviews and focus group discussions involving community health and agricultural workers, as well as caregivers of children 6-24 months old were conducted to investigate the facilitators and challenges to optimal CF practices and education on CF. The trials of improved practices (TIPs) method was used to test the feasibility and acceptability of potential education messages among mothers of young children (6-24 months) living in the study area. Child welfare clinic centers in the area were randomly assigned to one of three groups which were control, nutrition education and integrated education. Mothers of children 6-24 months in the integrated education group received monthly nutrition education from community health volunteers and agricultural education from agricultural extension agents for six months in addition to standard monthly child growth monitoring services from community health nurses. Mothers in the nutrition education group received monthly nutrition education from community health volunteers for six months in addition to standard care. Mothers of 6-24 months in the control group received only the standard monthly child monitoring services. The effects of the educational intervention on maternal knowledge on optimal complementary feeding, as well as food intakes and growth of young children were determined among 367 mother-child dyads over a period of at least six months. The study hypothesised that mothers receiving the education would have improved knowledge on good complementary feeding practices compared to those in the control group. The study also hypothesised that young children in the integrated education would have better nutrient intakes and growth compared those in the nutrition education and control groups, and those in the nutrition education group would have better nutrient intakes and growth than the children in the control group.
From the interviews and focus group discussions, reported initiation of CF was satisfactory, while other reported practices such as the addition of animal source foods, vegetables and fruits to young children's diet were found to be sub-optimal. Poverty and maternal time constraints were identified as the main challenges of optimal complementary feeding, while farming was seen as a facilitator. Lack of education materials, language barrier, maternal time constraints and lack of in-service training for health workers were the main challenges to education on complementary feeding. From the TIPS study, mothers expressed their willingness to improve the diets of their 6-24 months old children by adding or increasing the amount of animal source foods, dark-green leafy vegetables and fruits, as well as increasing feeding frequency daily. However, availability and affordability of protein-rich foods like animal source foods, groundnut paste and soya beans powder was a challenge for some mothers.
The intervention did not lead to a significant improvement in maternal knowledge on complementary feeding practices. However, it showed a tendency to reverse a general decreasing trend in knowledge among mothers on appropriate complementary feeding practices in the study area. Significantly more children in the integrated education group consumed animal source foods compared those in the other two groups when compared at nine months after baseline. However, the intervention did not improve the general nutrient intakes and growth of the young children in the study area.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Integrated education | Experimental | Behavioral: nutrition and agricultural education |
| Control | No intervention | – |
| Nutrition education | Experimental | Behavioral: nutrition education |
Who may qualify
- Ages
- 6 to 11 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- child aged 6-11 months old and attending monthly growth monitoring clinic
- mother and child living in the study area
Key exclusion criteria (1 listed)
- birth defects which results in difficulty in feeding of child
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 agricultural educationMothers of children aged 6-24 months received monthly nutrition education delivered by community health volunteers and agricultural education delivered by agricultural extension agents, in addition to standard monthly child welfare services delivered by Ghana Health Service | Behavioural | Integrated education |
| nutrition educationMothers of children aged 6-24 months received monthly nutrition education delivered by community health volunteers in addition to standard child growth monitoring services provided by the Ghana Health Service. | Behavioural | Nutrition education |
Primary outcome
growth (change in weight and length)
Time frame: 9 months
1 secondary outcome
maternal nutrition knowledge
Time frame: 9 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 5 Jun 2012.
Related trials for Improving Young Child Nutrition
Recruiting
Cooking HEalthy and Facilitating Early Childhood Development: CHEF-ED Study
Teaching Healthy Cooking Skills to Parents and Their Preschool Children
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 study director
McGill 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 nutrition and agricultural education and nutrition education in people with Improving Young Child Nutrition, run by McGill University at 1 site in Ghana.
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 5 Jun 2012. 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 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?
growth (change in weight and length) (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jun 2012.