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

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Haiti
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Port-au-Prince metropolitan area
Other: No intervention (descriptive survey only)
No intervention
Other urban areas
Other: No intervention (descriptive survey only)
No intervention
Rural areas
Other: No intervention (descriptive survey only)
No intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, Davis

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
United States Agency for International Development (USAID)
Global Alliance for Improved Nutrition
Le Ministère de la Santé Publique et de la Population, Haiti
Partners of the Americas

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 26, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 7, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 7, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 27, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 26, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 23, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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