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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01612442
Other study ID # 290-0310
Secondary ID
Status Completed
Phase N/A
First received May 27, 2012
Last updated June 3, 2012
Start date June 2010
Est. completion date March 2012

Study information

Verified date June 2012
Source McGill University
Contact n/a
Is FDA regulated No
Health authority Ghana: Noguchi Memorial Institute for Medical Research Ethics Review BoardGhana: Ghana Health Service Ethics Review BoardCanada: School of Dietetics and Human Nutrition, McGill University
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 367
Est. completion date March 2012
Est. primary completion date March 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 6 Months to 11 Months
Eligibility Inclusion Criteria:

- child aged 6-11 months old and attending monthly growth monitoring clinic

- mother and child living in the study area

Exclusion Criteria:

- birth defects which results in difficulty in feeding of child

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
nutrition and agricultural education
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 education
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.

Locations

Country Name City State
Ghana Upper Manya Krobo district Assesewa Eastern Region

Sponsors (2)

Lead Sponsor Collaborator
McGill University International Development Research Centre, Canada

Country where clinical trial is conducted

Ghana, 

Outcome

Type Measure Description Time frame Safety issue
Primary growth (change in weight and length) 9 months No
Secondary maternal nutrition knowledge 9 months No