NCT01882335

Brief Summary

The study will estimate the effect of peer-counseling for exclusive breast feeding (EBF) in the first 6 months of life on cognition and other determinants of human capital formation including behavioral and emotional status; school readiness and attainment; health status; fine and gross motor skills; physical growth; and household economic status.

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 Apr 2013

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

April 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 20, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

August 2, 2013

Status Verified

April 1, 2013

Enrollment Period

1 year

First QC Date

June 18, 2013

Last Update Submit

August 1, 2013

Conditions

Poor Performance StatusNeurologic DeficitsMixed Behavior and Emotional DisorderMalnutritionInfections, Hospital

Keywords

Human capital formation

Outcome Measures

Primary Outcomes (1)

  • Cognitive function

    Proportion of children with impaired cognitive function in intervention compared to the control group

    one year

Secondary Outcomes (1)

  • Cost-effectiveness of promoting peer-counselling for exclusive breastfeeding in the first six months of life to support human capital formation

    3 months

Other Outcomes (6)

  • School attainment

    One year

  • School readiness

    One year

  • Physical growth

    One year

  • +3 more other outcomes

Study Arms (2)

Behavioral

EXPERIMENTAL

Peer support for mothers to encourage them to exclusively breastfeed their babies for 6 months

Behavioral: Peer support for exclusive breastfeeding

Control

NO INTERVENTION

No peer support for exclusive breastfeeding

Interventions

Peer support for exclusive breastfeedingBEHAVIORAL

Pregnant women were identified and randomized to peer support for exclusive breastfeeding in clusters. They were followed up for 6 months post delivery.

Also known as: Peer support
Behavioral

Eligibility Criteria

Age4 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children whose mothers participated in the original intervention of peer support for exclusive breastfeeding (EBF).
  • Informed caregiver consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Makerere University

Kampala, Uganda

Location

Related Publications (2)

  • Engebretsen IMS, Nalugya JS, Skylstad V, Ndeezi G, Akol A, Babirye JN, Nankabirwa V, Tumwine JK. "I feel good when I drink"-detecting childhood-onset alcohol abuse and dependence in a Ugandan community trial cohort. Child Adolesc Psychiatry Ment Health. 2020 Oct 24;14:42. doi: 10.1186/s13034-020-00349-z. eCollection 2020.

    PMID: 33110445DERIVED

  • Tumwine JK, Nankabirwa V, Diallo HA, Engebretsen IMS, Ndeezi G, Bangirana P, Sanou AS, Kashala-Abotnes E, Boivin M, Giordani B, Elgen IB, Holding P, Kakooza-Mwesige A, Skylstad V, Nalugya J, Tylleskar T, Meda N. Exclusive breastfeeding promotion and neuropsychological outcomes in 5-8 year old children from Uganda and Burkina Faso: Results from the PROMISE EBF cluster randomized trial. PLoS One. 2018 Feb 23;13(2):e0191001. doi: 10.1371/journal.pone.0191001. eCollection 2018.

    PMID: 29474479DERIVED

MeSH Terms

Conditions

Neurologic ManifestationsMalnutritionCross Infection

Condition Hierarchy (Ancestors)

Nervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNutrition DisordersNutritional and Metabolic DiseasesInfectionsIatrogenic DiseaseDisease AttributesPathologic Processes

Study Officials

  • James K Tumwine, PhD

    Makerere University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2013

First Posted

June 20, 2013

Study Start

April 1, 2013

Primary Completion

April 1, 2014

Study Completion

October 1, 2014

Last Updated

August 2, 2013

Record last verified: 2013-04

Locations

UG(1)