NCT02098031

Brief Summary

Undernutrition and growth restriction due to poor diet and inadequate nutrient intake continues to be a global challenge, particularly in the developing countries including Uganda. The etiology of inadequate nutrient supply to infants may relate to lack of resources or knowledge or a combination of both. Poor nutrient intake and impaired growth may affect brain and cognitive development. This study aims to evaluate nutrient intake, growth and cognitive function among children between 6 and 36 months living in the fertile Kabale and Kisoro region in south-western Uganda. The investigators hypothesize that nutrition education to mothers can bring about improved dietary intake and nutritional status among children aged 6-36 months. A follow-up study was conducted during the period January - July 2022.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
511

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2014

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 27, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

November 20, 2024

Status Verified

November 1, 2024

Enrollment Period

2.4 years

First QC Date

March 21, 2014

Last Update Submit

November 17, 2024

Conditions

Keywords

Child Nutrition SciencesGrowth and DevelopmentDeveloping Countries

Outcome Measures

Primary Outcomes (1)

  • Change in the prevalence of stunting (<-2 SD of the WHO, 2006 growth reference standards)

    The investigators will measure the change in stunting between the three indicated time points.

    6-8, 12-16, 20-24 (main outcome time point), 36 months, 7-10 years

Secondary Outcomes (13)

  • Change in mean weight-for-age z-score

    6-8, 12-16 and 20-24, 36 months, 7-10 years

  • Change in mean weight-for-height z-score

    6-8, 12-16, 20-24, 36 months, 7-10 years

  • Change in mean Mid Upper Arm Circumference (MUAC) z-score

    6-8, 12-16, 20-24, 36 months, 7-10 years

  • Change in mean diet diversification score (DDS)

    6-8, 12-16, 20-24, 36 months

  • Change in Ages and Stages Questionnaire Scores (AQS)

    6-8, 12-16, 20-24, 36 months

  • +8 more secondary outcomes

Study Arms (2)

control

NO INTERVENTION

intervention

EXPERIMENTAL

Nutritional intervention (nutrition education)

Other: Improving nutrition knowledge among mothers

Interventions

Eligibility Criteria

Age6 Months+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • A lead caretaker with a 6-8 months infant (child/lead caretaker pair) who will have given consent to participate in the study. If there is more than one child of the age in the household, the younger one will be taken as the index/study child.

You may not qualify if:

  • Is older than 8 months at baseline
  • Congenital malformations or physical handicap that may influence growth or interfere with taking of anthropometric measurements
  • Disability that will influence nutrient intake
  • Been diagnosed with mental or brain illness as evidenced by mother or health worker.
  • If the family that is likely to emigrate during the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyambogo University

Kampala, Uganda

Location

Related Publications (5)

  • Atukunda P, Ngari M, Chen X, Westerberg AC, Iversen PO, Muhoozi G. Longitudinal assessments of child growth: A six-year follow-up of a cluster-randomized maternal education trial. Clin Nutr. 2021 Sep;40(9):5106-5113. doi: 10.1016/j.clnu.2021.08.007. Epub 2021 Aug 20.

  • Kakwangire P, Moss C, Matovu N, Atukunda P, Westerberg AC, Iversen PO, Muhoozi G. The association between dietary diversity and development among children under 24 months in rural Uganda: analysis of a cluster-randomised maternal education trial. Public Health Nutr. 2021 Sep;24(13):4286-4296. doi: 10.1017/S136898002100077X. Epub 2021 Mar 12.

  • Atukunda P, Muhoozi GK, Diep LM, Berg JP, Westerberg AC, Iversen PO. The association of urine markers of iodine intake with development and growth among children in rural Uganda: a secondary analysis of a randomised education trial. Public Health Nutr. 2021 Aug;24(12):3730-3739. doi: 10.1017/S1368980020001603. Epub 2020 Jul 13.

  • Atukunda P, Muhoozi GKM, van den Broek TJ, Kort R, Diep LM, Kaaya AN, Iversen PO, Westerberg AC. Child development, growth and microbiota: follow-up of a randomized education trial in Uganda. J Glob Health. 2019 Jun;9(1):010431. doi: 10.7189/jogh.09.010431.

  • Muhoozi GKM, Atukunda P, Diep LM, Mwadime R, Kaaya AN, Skaare AB, Willumsen T, Westerberg AC, Iversen PO. Nutrition, hygiene, and stimulation education to improve growth, cognitive, language, and motor development among infants in Uganda: A cluster-randomized trial. Matern Child Nutr. 2018 Apr;14(2):e12527. doi: 10.1111/mcn.12527. Epub 2017 Sep 19.

MeSH Terms

Conditions

Infant Nutrition Disorders

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

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
Professor

Study Record Dates

First Submitted

March 21, 2014

First Posted

March 27, 2014

Study Start

March 1, 2014

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

November 20, 2024

Record last verified: 2024-11

Locations