Improving the Nutrition Status of Infants in South-Western Uganda

Growth Clinical Trial

Official title:

Improving the Nutrition Status of 6 to 8 Months Old Children Through Diet Diversification and Better Dietary Intakes in the Kabale and Kisoro Districts in South-Western Uganda

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02098031
• Other study ID #: 100
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: August 2016

Study information

• Verified date: November 2019
• Source: University of Oslo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 is planned for the period January 2019 - December 2022.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 511
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 10 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Cognitive Development
• Growth
• Infant Malnutrition
• Infant Nutrition Disorders
• Malnutrition
• Nutrition Knowledge

Intervention

Other:
• Improving nutrition knowledge among mothers

Locations

Country	Name	City	State
Uganda	Kyambogo University	Kampala

Sponsors (1)

Lead Sponsor	Collaborator
University of Oslo

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in mean weight-for-age z-score	The investigators will measure the change in mean weight for age z-score between the three indicated time periods.	6-8, 12-16 and 20-24, 36 months, 7-10 years
Secondary	Change in mean weight-for-height z-score	The investigators will measure the change in mean weight for height z-score between the three indicated time periods.	6-8, 12-16, 20-24, 36 months, 7-10 years
Secondary	Change in mean Mid Upper Arm Circumference (MUAC) z-score	The investigators will measure the change in MUAC between the three indicated time periods.	6-8, 12-16, 20-24, 36 months, 7-10 years
Secondary	Change in mean diet diversification score (DDS)	The investigators will measure the change in DDS between the three indicated time periods.	6-8, 12-16, 20-24, 36 months
Secondary	Change in Ages and Stages Questionnaire Scores (AQS)	The investigators will measure the change in AQS between the three indicated time periods.	6-8, 12-16, 20-24, 36 months
Secondary	Change in The Kaufman Assessment Battery for Children (2nd ed.; KABC-II) and the Test of Variable of Attention (TOVA)	The investigators will measure the change in the scores of these tests at indicated time periods.	7-10 years
Secondary	Change in Bayley Child Development test 3 ed.	The investigators will measure the change in Bayley Child Development test 3 ed. between the three indicated time periods.	6-8, 12-16, 20-24, 36 months
Secondary	Change in gut microbiota	Fecal samples will be collected and the investigators will measure the change in gut microbiota between the three indicated time periods.	20-24, 36 months, 7-10 years
Secondary	Change in oral microbiota	Saliva samples will be collected and the investigators will measure the change in oral microbiota at indicated time periods.	36 months, 7-10 years
Secondary	Change in Mullens test	The investigators will measure the change in Mullens test between the two groups after 36 months.	36 months
Secondary	Change in Becks Depression Inventory II questionnaire to determine the maternal self-reported depression symptoms	The investigators will measure the change in this test between the two groups at indicated time periods	7-10 years
Secondary	Change in the Center for Epidemiological Studies Depression Scale questionnaires to determine the maternal self-reported depression symptoms	The investigators will measure the change in this test between the two groups at indicated time periods	7-10 years
Secondary	Oral health	The investigators will assay caries using photographs	7-10 years