NCT02249754

Brief Summary

Building on the success of community-based peer education and counselling in breastfeeding, it is possible to address young child feeding and health practices in the surveyed district. Opportunities that can optimise success and encourage behaviour change in the district include mothers willingness to modify some feeding options; support of family members; seasonal availability and accessibility of foods; established set-up of village peers and existence of health centres and health staff in some villages. This study has developed a feasible, context-specific nutrition education package for use in rural Tanzania. The package is composed of 4 components, namely 1) education and counselling of mothers, 2) training of community-based nutrition counsellors, 3) sensitisation meetings with health staff and family members, and 4) supervision of community-based nutrition counsellors. The intervention will use a parallel cluster-randomised controlled trial design where infants will be recruited when aged 6 months and followed up for 9 months. The intervention expects to provide information and, where appropriate, recommendations to strengthen the nutrition component in the health education programme of the Tanzania child health services. The study hypothesises that the nutrition education package will be more effective than the routine health education in improving feeding practices, dietary adequacy and growth of infants and young children. Specific objectives of the study include:

  • To evaluate the effectiveness of a nutrition education package on feeding practices and dietary adequacy
  • To determine the effectiveness of a nutrition education package in improving growth and health of infants and young children
  • To document the process of implementation of the nutrition education package to promote optimal feeding and health practice

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2014

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 26, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

November 19, 2014

Status Verified

November 1, 2014

Enrollment Period

11 months

First QC Date

September 23, 2014

Last Update Submit

November 17, 2014

Conditions

Keywords

Nutrition educationMaternal counsellingComplementary feedingInfant growthMicronutrientsTanzania

Outcome Measures

Primary Outcomes (1)

  • Linear growth: Mean change from baseline in length-for-age Z-scores at at 9-, 12- and 15-months-old

    Linear growth (length-for-age Z-scores): WHO 2006 Growth Standards

    Length-for-age Z-scores: Baseline (6 months-old), Month 9, Month 12 and Month 15

Secondary Outcomes (5)

  • Weight-for-length: Mean change from baseline in weight-for-length Z-scores at 9-, 12- and 15-months-old

    Weight-for-length Z-scores: Baseline (6 months-old), Month 9, Month 12 and Month 15

  • Mean intake of energy, fat, iron and zinc from complementary foods at 12 months-old

    Mean intake of energy, fat, iron and zinc from complementary foods: Baseline (6 months-old), Month 12

  • Proportion of children consuming foods from 4 or more food groups at 9-, 12- and 15-months-old

    Proportion of children consuming foods from 4 or more food groups: Baseline (6 months-old), Month 9, Month 12 and Month 15

  • Proportion of children consuming the recommended number of semi-solid/soft meals and snacks per day at 9-, 12- and 15-months-old

    Proportion of children consuming the recommended number of semi-solid/soft meals and snacks per day: Baseline (6 months-old), Month 9, Month 12 and Month 15

  • Maternal level of knowledge and practice of recommended feeding and health practices at 9-, 12- and 15-months-old

    Maternal level of knowledge and practice of recommended feeding and health practices: Month 9, Month 12 and Month 15

Study Arms (2)

Routine health education

ACTIVE COMPARATOR

Routine health education alone

Behavioral: Routine health education

Nutrition education package

EXPERIMENTAL

Nutrition education package and routine health education

Behavioral: Nutrition educationBehavioral: Routine health education

Interventions

This group will receive the nutrition education package. The package is composed of: 1) education and counselling of mothers when the child is aged 6 (baseline), 9 and 12 months; 2) training community-based nutrition counsellors at baseline and 12 months and monthly home visits, 3) supervision of community-based nutrition counsellors' work every 2 months, and 4) sensitisation meetings with family members and health staff responsible for child health at baseline and repeated at 12 months. In addition, the group will continue to attend routine health education given at health facilities every month.

Nutrition education package

This group will receive routine health education every month. It is a standard government health service offered monthly in all health facilities by health staff. It is given to mothers of children below the age of five years during growth monitoring and immunisation contacts. The sessions take 10-15 minutes focusing on general health issues including child feeding, prevention of diseases such as malaria and importance of immunisations.

Nutrition education packageRoutine health education

Eligibility Criteria

Age6 Months - 7 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Infants aged 6-7 months at the time of recruitment into the study
  • Infants currently being breastfed
  • Parents (or caregivers) anticipated local residence for the study duration

You may not qualify if:

  • Congenital or chronic abnormalities impairing feeding or physical growth measurements
  • Oedema
  • Severely ill or clinical complications warranting hospitalisation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mpwapwa District

Mpwapwa, Dodoma, Tanzania

RECRUITING

Related Publications (1)

  • Kulwa KB, Verstraeten R, Bouckaert KP, Mamiro PS, Kolsteren PW, Lachat C. Effectiveness of a nutrition education package in improving feeding practices, dietary adequacy and growth of infants and young children in rural Tanzania: rationale, design and methods of a cluster randomised trial. BMC Public Health. 2014 Oct 16;14:1077. doi: 10.1186/1471-2458-14-1077.

MeSH Terms

Conditions

Malnutrition

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Prof. Patrick W. Kolsteren, PhD

    Institute of Tropical Medicine (Belgium) and Ghent University (Belgium)

    STUDY CHAIR
  • Kissa BM Kulwa, MSc.

    Sokoine University of Agriculture and Ghent University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Prof. Patrick W. Kolsteren, PhD

CONTACT

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
Lecturer

Study Record Dates

First Submitted

September 23, 2014

First Posted

September 26, 2014

Study Start

September 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

November 19, 2014

Record last verified: 2014-11

Locations