Acceptability of LNS for Infants and Young Children in Guatemala
Recruitment status was Recruiting
This study aims to assess the acceptability of lipid-based nutrient supplements (LNS) for use as nutritional supplements for infants and young children in Guatemala.
The study will be conducted in three phases. Phase 1 will be a test-feeding to compare the acceptability of two different flavors of LNS (peanut and cinnamon) in infants and young children and their mothers or caregivers in terms of taste, smell and texture, as well as amount of the test-dose consumed. In Phase 2, children in the Phase 1 trial will receive a 2-week supply of one of the LNS products, which they will consume daily in their homes for 14 days under real-life conditions. Direct observation of supplement use and in-depth interviews with mothers, caregivers and health staff providing services in communities will be part of this phase too. In Phase 3, focus group discussions will be held with participants (mothers and caregivers) as well as with health staff providing services in communities to discuss different aspects of infant and child feeding and best ways for the LNS product to be used in the context of Guatemala.
We hypothesize that both flavors of LNS will be accepted by Guatemalan infants and young children children and their mothers or caregivers.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Acceptability of Lipid-based Nutrient Supplements (LNS) for Infants and Young Children in Guatemala|
- Acceptability of LNS [ Time Frame: Baseline ] [ Designated as safety issue: No ]Outcome will be assessed by amount of LNS consumed in the test trial, time of consumption, amount of LNS sachets consumed in the home-use trial and qualitative assessment of mothers and caregivers opinions.
|Study Start Date:||May 2010|
|Estimated Study Completion Date:||October 2010|
|Estimated Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
Test-trial of two LNS flavors.
Dietary Supplement: Lipid-based supplement (LNS)
Infants and young children will receive 10 g of LNS for test trial during 3 consecutive days and thereafter, 20 g per day for 14 days.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01148641
|Contact: Kathryn G Dewey, PhDfirstname.lastname@example.org|
|Contact: Ana B Perez-Exposito, PhDemail@example.com|
|Fundacion de la Caficultura para el Dessarrollo Rural (FUNCAFE)||Recruiting|
|Mazatenango, Suchitepequez, Guatemala, zona 1|
|Contact: Ana B Perez-Exposito, PhD 50-5747104 firstname.lastname@example.org|
|Principal Investigator: Ana B Perez-Exposito, PhD|
|Principal Investigator:||Kathryn G Dewey, PhD||University of California, Davis|