Dietary Intake, Health and Micronutrient Status in Haiti

January 20, 2023 updated by: University of California, Davis

Dietary Intake, Health and Micronutrient Status in Haiti: Establishing a Baseline to Manage and Evaluate a National Food Fortification Program

The general objective of this project is to collect information on dietary intake and nutritional status of women and young children in Haiti, to inform the design and management of national and subnational micronutrient intervention programs, with a focus on large-scale food fortification, and to serve as a reference point for program evaluation.

Study Overview

Detailed Description

Women of reproductive age and young children are especially vulnerable to micronutrient deficiencies which may lead to life-long disabilities. In Haiti, deficiencies in micronutrients such as iron, zinc, and vitamin A, are likely prevalent, but recent national estimates of the burden are not available. The most recent Demographic and Health Survey reported that 49% of women of reproductive age and 66% of preschool children were anemic. In addition, the Haitian population also has a high prevalence of overweight and obesity, with 38.5% classified as either overweight or obese. Fortification of staple foods with micronutrients is considered a cost-effective intervention to reduce the burden of micronutrient deficiencies. Through the Copenhagen Consensus Haiti Priorise exercise, fortification of flour with iron and folic acid was identified as the Number 2 development priority for Haiti. Prior to implementing a large-scale fortification program, however, the World Health Organization recommends the collection of detailed baseline information on nutritional status and dietary intake in the target population. In addition, information on certain biochemical indicators of nutritional status is needed to confirm the need for program implementation and to establish a baseline for later program evaluation and modification. Data on dietary patterns and nutrient intake are needed to 1) adapt nutrition intervention programs to match dietary nutrient gaps, and 2) design and manage complementary programs to address nutritional deficiencies in at-risk population subgroups that may not be reached or effectively covered by large-scale fortification programs.

The general objective of this project is to collect information on dietary intake and nutritional status of women and young children in Haiti, to inform the design and management of national and subnational micronutrient intervention programs, with a focus on large-scale food fortification, and to serve as a reference point for later program evaluation.

The specific objectives of the project are:

  1. To describe the prevalence, at national and subnational levels, of anemia and selected micronutrient deficiencies among women and young children in Haiti (in addition to health indicators such as systemic inflammation, malaria infection, and anthropometric indices), to serve as a reference point for management and evaluation of a large-scale food fortification program, and other nutrition-related programs.
  2. To measure dietary intake of micronutrients and potentially fortifiable foods, using 24-hour dietary recalls and the Fortification Assessment Coverage Toolkit (FACT), to confirm appropriate food vehicles for fortification, and to determine the specific micronutrients and fortification levels to be included in the program.
  3. To measure micronutrient content in wheat flour samples collected from households, markets and/or bakeries to assess the current reach and fortification levels of fortified wheat flour.
  4. To collect information on access to and use of public and private health care services and government programs (including food aid), to identify platforms, and their associated costs, for delivering nutrition programs to individuals not reached by large-scale food fortification.
  5. To assess biological and behavioral risk factors for noncommunicable diseases, including blood glucose and lipid levels, to identify associations with health and nutritional status among women.
  6. To measure micronutrient concentrations in human milk to assess micronutrient status of mothers and micronutrient intake of breastfeeding children.
  7. To collect images to assist in the development of a novel digital anthropometric assessment method (technology for measurement of body size using photos).

The study will be designed as a stratified cluster survey with three ecological strata. Enumeration areas (clusters) and households within each cluster will be selected such that the sample is representative at the stratum level and national level.

Study Type

Observational

Enrollment (Actual)

143

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Pétion-Ville, Haiti, HT6141
        • Partners of the Americas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 49 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study will be designed as a stratified cluster survey with 3 ecological strata. Enumeration areas (clusters) and households within each cluster will be selected such that the sample is representative at the stratum level and national level. The study will include households in which there is a child 6-59 months of age and a woman 15-49 years of age who serves as the child's primary caregiver.

Description

Inclusion Criteria:

  • There is at least one child 6-59 months of age (the index child) in the household
  • The primary or secondary female caregiver of the child who is 15-49 years of age (the index caregiver) is present in the household

Exclusion Criteria:

  • The index child or index caregiver has fever, diarrhea with dehydration, or another serious health problem, or had any one of these conditions beginning on the day before the eligibility interview.

In addition, any lactating woman in the household is eligible for inclusion in the human milk assessment if she is breastfeeding an infant that is at least 30 days old. The lactating woman will be excluded from participating in the human milk assessment if she has a fever, diarrhea with dehydration, or another serious health problem, or had any of these conditions beginning on the day before the eligibility interview.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Ecologic or Community
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Port-au-Prince metropolitan area
No intervention
Other urban areas
No intervention
Rural areas
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Household-level consumption of "fortifiable" foods
Time Frame: Previous 7 days
Measured using the Fortification Assessment Coverage Toolkit
Previous 7 days
Individual consumption of "fortifiable" foods
Time Frame: Previous 24 hours
Assessed using repeated 24-hour dietary recalls
Previous 24 hours
Vitamin A status among women and children
Time Frame: Single time point (1 day)
Retinol in plasma or breast milk, and retinol-binding protein in plasma (micromol/L)
Single time point (1 day)
Zinc status among women and children
Time Frame: Single time point (1 day)
Plasma zinc concentration (micrograms per dL)
Single time point (1 day)
Iron status among women and children
Time Frame: Single time point (1 day)
Plasma ferritin concentrations (micrograms per L)
Single time point (1 day)
Folate status among women
Time Frame: Single time point (1 day)
Red blood cell folate concentrations (nmol/L)
Single time point (1 day)
Vitamin B12 status among women and children
Time Frame: Single time point (1 day)
Plasma vitamin B12 concentrations (pmol/L)
Single time point (1 day)
Micronutrient content of wheat flour samples collected from markets and bakeries
Time Frame: Single time point (1 day)
Concentration of iron and zinc in wheat flour samples (mg/kg)
Single time point (1 day)
Usual nutrient intakes among women and children
Time Frame: 30 days (Previous month)
Estimated population usual intakes of energy, fat, protein, carbohydrate, vitamin A, iron, zinc, folate, vitamin B12, thiamin, riboflavin, and niacin (based on combined data from 24-h dietary recalls and 30-day supplement questionnaire)
30 days (Previous month)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body mass index among women
Time Frame: Single time point (1 day)
Body mass index, calculated as kg/m^2
Single time point (1 day)
Mid-upper arm circumference among children
Time Frame: Single time point (1 day)
Mid-upper arm circumference, measured in mm
Single time point (1 day)
Height-for-age Z-score among children
Time Frame: Single time point (1 day)
Height-for-age Z-score calculated using the WHO Growth Standard
Single time point (1 day)
Weight-for-age Z-score among children
Time Frame: Single time point (1 day)
Weight-for-age Z-score calculated using the WHO Growth Standard
Single time point (1 day)
Weight-for-length Z-score among children
Time Frame: Single time point (1 day)
Weight-for-length Z-score calculated using the WHO Growth Standard
Single time point (1 day)
Prevalence of malnutrition among children
Time Frame: Single time point (1 day)
Prevalence of height-for-age, weight-for-age, or weight-for-height Z-score below <-2SD
Single time point (1 day)
Glucose concentration
Time Frame: Single time point (1 day)
Glucose concentration in whole blood
Single time point (1 day)
Concentration of total cholesterol
Time Frame: Single time point (1 day)
Concentration of total cholesterol in whole blood, mg/dL
Single time point (1 day)
Hemoglobin A1C concentrations
Time Frame: Single time point (1 day)
Hemoglobin A1C concentrations in whole blood
Single time point (1 day)
Concentration of HDL cholesterol
Time Frame: Single time point (1 day)
Concentration of HDL cholesterol in whole blood, mg/dL
Single time point (1 day)
Concentration of triglycerides
Time Frame: Single time point (1 day)
Concentration of triglycerides in whole blood, mg/dL
Single time point (1 day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Joseline Marhone Pierre, PhD, Ministère de la Sante Publique et de la Population, Haiti
  • Principal Investigator: Reina Engle-Stone, PhD, University of California, Davis
  • Principal Investigator: Stephen A Vosti, PhD, University of California, Davis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 26, 2019

Primary Completion (Actual)

February 7, 2019

Study Completion (Actual)

February 7, 2019

Study Registration Dates

First Submitted

February 27, 2019

First Submitted That Met QC Criteria

July 23, 2019

First Posted (Actual)

July 26, 2019

Study Record Updates

Last Update Posted (Actual)

January 23, 2023

Last Update Submitted That Met QC Criteria

January 20, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 1284500
  • 1718-68 (Other Identifier: Comité National de Bioéthique, Haiti)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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