LULUN PROJECT II - Cohort Follow-up Study

NCT03902145 | Completed

• 1 other identifier: 201704100
• Study Type: observational
• Target: 270
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stunting

Keywords

Complementary Feeding; Animal Source Foods; Bone Age; Stunting; Ecuador; Follow Up Cohort

Outcome Measures

Primary Outcomes (1)

• Height for Age Z-Score

  One time point

Secondary Outcomes (5)

• Bone Age Z Score

  One time point

• Weight for Age Z Score

  One time point

• Weight for Height Z Score

  One time point

• BMI Z-Score

  One time point

• Head Circumference for Age Z-Score

  One time point

Study Arms (2)

Intervention Group

Children previously in the intervention group received one egg per day for 6 months beginning when the child was between 6-9 months of age.

Other: Egg

Control Group

Interventions

Egg OTHER

One egg per day for 6 months

Intervention Group

Eligibility Criteria

• Age: 30 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• Participant in the Lulun Project I
• Child healthy, without fever or severely malnourished

You may not qualify if:

• Child not previously in the Lulun Project I
• Child has fever or is severely malnourished

Sponsors & Collaborators

• Washington University School of Medicine: lead
• The Mathile Institute for the Advancement of Human Nutrition: collaborator
• Universidad San Francisco de Quito: collaborator
• University of California, Davis: collaborator
• RTI International: collaborator

Study Sites (1)

Universidad San Francisco de Quito

Quito, Pichincha, 170901, Ecuador

Location

MeSH Terms

Conditions

Growth Disorders

Interventions

Eggs

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Lora Iannotti, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 3, 2019
• Study Start: June 1, 2017
• Primary Completion: August 31, 2017
• Study Completion: August 31, 2017
• Last Updated: April 3, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

EC (1)