NCT01612442

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
367

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 5, 2012

Completed
Last Updated

June 5, 2012

Status Verified

June 1, 2012

Enrollment Period

1.8 years

First QC Date

May 27, 2012

Last Update Submit

June 3, 2012

Conditions

Keywords

complementary feedingmothers6-24 months childrencommunity health volunteersnutrition educationagricultural education

Outcome Measures

Primary Outcomes (1)

  • growth (change in weight and length)

    9 months

Secondary Outcomes (1)

  • maternal nutrition knowledge

    9 months

Study Arms (3)

Integrated education

EXPERIMENTAL
Behavioral: nutrition and agricultural education

Control

NO INTERVENTION

Nutrition education

EXPERIMENTAL
Behavioral: nutrition education

Interventions

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

Integrated 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.

Nutrition education

Eligibility Criteria

Age6 Months - 11 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • child aged 6-11 months old and attending monthly growth monitoring clinic
  • mother and child living in the study area

You may not qualify if:

  • birth defects which results in difficulty in feeding of child

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Upper Manya Krobo district

Assesewa, Eastern Region, Ghana

Location

MeSH Terms

Interventions

Nutritional StatusNutrition Assessment

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation CharacteristicsData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Grace S Marquis, PhD

    McGill University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator (student)

Study Record Dates

First Submitted

May 27, 2012

First Posted

June 5, 2012

Study Start

June 1, 2010

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

June 5, 2012

Record last verified: 2012-06

Locations