Clinical Trial: Improving the Nutrition Status of Infants in South-Western Uganda

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: University of Oslo

Current Primary Outcome: Change in the prevalence of stunting (<-2 SD of the WHO, 2006 growth reference standards) [ Time Frame: 6-8, 12-16, 20-24 (main outcome time point), 36 months ]

Original Primary Outcome:

• Change in the prevalence of stunting (<-2 SD of the WHO, 2006 growth reference standards) [ Time Frame: 6-8, 12-14, 18-20, 36 months ]
  We will measure the change in stunting between the three indicated time points.
• Change in the Bayley Mental Development Index [ Time Frame: 12-14, 18-20, 36 months ]
  We will measure the change in Bayley Mental Development Index between the three indicated time periods.

Current Secondary Outcome:

• Change in mean weight-for-age z-score [ Time Frame: 6-8, 12-16 and 20-24, 36 months ]
  We will measure the change in mean weight for age z-score between the three indicated time periods.
• Change in mean weight-for-height z-score [ Time Frame: 6-8, 12-16, 20-24, 36 months ]
  We will measure the change in mean weight for height z-score between the three indicated time periods.
• Change in mean Mid Upper Arm Circumference (MUAC) z-score [ Time Frame: 6-8, 12-16, 20-24, 36 months ]
  We will measure the change in MUAC between the three indicated time periods.
• Change in mean diet diversification score (DDS) [ Time Frame: 6-8, 12-16, 20-24, 36 months ]
  We will measure the change in DDS between the three indicated time periods.
• Change in Ages and Stages Questionnaire Scores (AQS) [ Time Frame: 6-8, 12-16, 20-24, 36 months ]
  We will measure the change in AQS between the three indicated time periods.
• Change in Bayley Child Development test 3 ed. [ Time Frame: 6-8, 12-16, 20-24, 36 months ]
  We will measure the change in Bayley Child Development test 3 ed. between the three indicated time periods.
• Change in gut microbiota [ Time Frame: 20-24, 36 months ]
  Fecal samples will be collected and we will measure the change in gut microbiota between the three indicated time periods.
• Change in Mullens test [ Time Frame: 36 months ]
  We will measure the change in Mullens test between the two groups after 36 months.

Original Secondary Outcome:

• Change in mean weight-for-age z-score [ Time Frame: 6-8, 12-14 and 18-20, 36 months ]
  We will measure the change in mean weight for age z-score between the three indicated time periods.
• Change in mean weight-for-height z-score [ Time Frame: 6-8, 12-14, 18-20, 36 months ]
  We will measure the change in mean weight for height z-score between the three indicated time periods.
• Change in mean Mid Upper Arm Circumference (MUAC) [ Time Frame: 6-8, 12-14, 18-20, 36 months ]
  We will measure the change in MUAC between the three indicated time periods.
• Change in mean diet diversification score (DDS) [ Time Frame: 6-8, 12-14, 18-20, 36 months ]
  We will measure the change in DDS between the three indicated time periods.
• Change in Ages and Stages Questionnaire Scores (ASS) [ Time Frame: 6-8, 12-14, 18-20, 36 months ]
  We will measure the change in ASS between the three indicated time periods.
• Change in Bayley Child Development test 3 ed. [ Time Frame: 6-8, 12-14, 18-20, 36 months ]
  We will measure the change in Bayley Child Development test 3 ed. between the three indicated time periods.
• Change in gut microbiota [ Time Frame: 12-14, 18-20, 36 months ]
  Fecal samples will be collected and we will measure the change in gut microbiota between the three indicated time periods.
• Change in Kaufman Assessment Battery for Children (KABC) [ Time Frame: 36 months ]
  We will measure the change in KABC between the two groups after 36 months.

Information By: University of Oslo

Dates:
Date Received: March 21, 2014
Date Started: March 2014
Date Completion:
Last Updated: August 19, 2016
Last Verified: August 2016