Acceptability of LNS for Infants and Young Children in Guatemala

NCT01148641 | Completed

• 1 other identifier: 201017829
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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 was conducted in three phases. Phase 1 was 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 received a 2-week supply of one of the LNS products, which they consumed 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 (FGD) were 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 hypothesized that both flavors of LNS would be accepted by Guatemalan infants and young children children and their mothers or caregivers.

Conditions

Malnutrition

Keywords

Lipid-based supplements; LNS; Acceptability; Infant nutrition; Guatemala; Malnutrition

Outcome Measures

Primary Outcomes (3)

• amount of LNS consumed

  Amount of LNS consumed in the test trial in grams

  2 weeks

• time of consumption

  Avg how long it takes to eat the LNS mins

  2 weeks

• amount of LNS sachets consumed in the home-use trial

  \# of sachets consumed

  2 weeks

Secondary Outcomes (1)

• qualitative assessment of mothers and caregivers opinions

  2 weeks

Study Arms (2)

LNS-regular

Lipid-based nutrient supplement, regular (peanut) flavor

Dietary Supplement: LNS

LNS-cinnamon

Lipid-based nutrient supplement, cinnamon flavor

Dietary Supplement: LNS

Interventions

LNS DIETARY_SUPPLEMENT

Infants and young children will receive 10 g of LNS for test trial during 3 consecutive days (crossover design) and thereafter, 20 g per day for 14 days.

Also known as: Lipid-based nutrient supplement

LNS-cinnamon; LNS-regular

Eligibility Criteria

• Age: 6 Months - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

\- Children 6-18 months of age.

You may qualify if:

• Children 6-18 months of age.
• Consuming solid foods for at least the past 30 days.
• Apparently healthy and not presently suffering from an acute illness (e.g., fever, diarrhea, acute respiratory tract infection).
• No known allergy to peanuts or other food products (as reported on the screening questionnaire by the mother/primary caregiver).
• Not severely malnourished \[mid-upper arm circumference (MUAC) \> 115 mm\].
• Maternal/caregiver willingness to feed the infant with LNS over a maximum 3 test days, and over the 2 week home-use period, and report on his/her consumption and reactions and practices for daily use. Willingness to participate in discussion groups.
• Planning to remain in study area for at least the following three weeks.

You may not qualify if:

• Children under 6 months of age.
• All subjects with known peanut, soy or milk allergies.
• In poor health or ill at the time of recruitment.
• Severely malnourished children \[mid-upper arm circumference (MUAC) \< 115 mm\].
• Not willing to participate in study procedures.
• Leaving the study area in the following three weeks.

Sponsors & Collaborators

• University of California, Davis: lead
• FHI 360: collaborator

Study Sites (1)

Fundacion de la Caficultura para el Dessarrollo Rural (FUNCAFE)

Mazatenango, Departamento de Suchitepéquez, zona 1, Guatemala

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Kathryn G Dewey, PhD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2010
• First Posted: June 22, 2010
• Study Start: May 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: November 1, 2010
• Last Updated: January 29, 2018

Record last verified: 2018-01

Locations

GU (1)