LULUN PROJECT II - Cohort Follow-up Study
Condition: Stunting
MeSH terms: Growth Disorders
Study type: Observational

Summary: 
      Child stunting and micronutrient deficiencies are a major problem in developing countries,
      affecting millions of children.

      Beginning at 6 months children need foods to complement nutrients received through
      breastfeeding; however, complementary feeding diets are well-documented to be inadequate in
      the developing world. Eggs, which are widely available and low-cost relative to other highly
      nutritious foods are underutilized and could potentially improve child growth and
      development. Prior to the Lulun Project RCT, no research had been conducted to evaluate their
      efficacy in improving micronutrient status. Lulun filled an important gap in the literature
      by examining, through a randomized controlled trial, the effect of egg consumption on
      biochemical markers of choline, vitamin B12, lipids, and amino acids in young children in a
      poor rural area of Ecuador. However, there is still scarce data on how early child
      complementary feeding interventions, such as the Lulun egg intervention, might impact child
      growth long-term.

      This study will be designed as a follow-up cohort study to the Lulun Project RCT conducted in
      Cotopaxi Province from March-December 2015. The proposed follow-up study will investigate the
      potential long-term impacts of the egg intervention on child growth. Children and mother
      (caregiver) dyads with endline anthropometric measures from Lulun Project will be invited to
      participate in the follow-up study. Data will be collected on demographic, socioeconomic, and
      environmental information, morbidities, and child diet (including egg preparation and
      consumption), as well as child anthropometry (height, weight, head circumference).
      Additionally, the study will pilot test and compare radiographic measures of child bone
      maturity and organ size (kidney, liver, and spleen) using an app-based ultrasound.
      Investigators from Universidad de San Franscisco de Quito (USFQ), Washington University in
      St. Louis, and Mathile Institute will collaborate to conduct the study.

      This project will also include a gender assessment component designed to ascertain how gender
      norms may affect prospects for successful scale up of smallholder poultry production. To this
      end, qualitative data will be collected from a small sample of participating mothers
      (caregivers) and key community stakeholders, in the form of in-depth interviews and/or focus
      groups.
    

Detailed description: 
      All mother (caregiver)-child dyads from the Lulun RCT will be contacted by mobile phone and
      invited to participate. A community meeting will first be held including community leaders
      and Lulun Project participants to present findings and explain the new follow-up study, Lulun
      Project II. This will give mothers (caregivers) the opportunity over at least a one week
      period to decide whether or not to participate and to discuss with family and friends. A
      field study team consisting of two individuals who participated in first trial and two
      students from Washington University will then contact mothers or caregivers and asked to come
      to various community sites used in the Lulun Project. Using processes and protocols from the
      original trial, mothers (caregivers) will first go through the informed consent and
      enrollment processes.

      Eligibility criteria will include: 1) participant in the Lulun Project I; and 2) child
      healthy, without fever or severely malnourished. Mothers or primary caregivers of children
      will be given a written informed consent statement in Spanish to read and sign, indicating
      their consent and consent on behalf of their child. If the mothers/primary caregiver is less
      than 18 years of age, informed consent process will be sought from their parents or
      guardians. Participants with limited literacy will be offered the option to have the
      statement read to them. Caregivers will be invited to ask any questions about the nature of
      the study during this time.

      For the gender analysis component of the study, a small number (10-20) of prospective mother
      (caregiver) participants, their partners, and key stakeholders will be contacted by phone by
      the Field Manager who will explain the nature and (qualitative) method of this part of the
      study. They will be invited to participate. Consent process for mothers, partners, and
      community stakeholders will occur after they agree to participate and just prior to interview
      or focus group.
    

Intervention name(s): Egg
Intervention type(s): Other
Intervention description(s): One egg per day for 6 months
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Lulun Project II is a longitudinal follow-up study of the Lulun Project, which was
        conducted in Cotopaxi Province, Ecuador.
      
Keywords: Complementary Feeding; Animal Source Foods; Bone Age; Stunting; Ecuador; Follow Up Cohort