Clinical trial NCT04034381: Dietary Intake, Health and Micronutrient Status in Haiti
Official title: Dietary Intake, Health and Micronutrient Status in Haiti: Establishing a Baseline to Manage and Evaluate a National Food Fortification Program
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Micronutrient Deficiency
Malnutrition, Child
Malnutrition
Chronic Disease
Keywords: Micronutrient deficiency
Dietary intake
Food fortification
National survey
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Le Ministère de la Santé Publique et de la Population, Haiti
name: United States Agency for International Development (USAID)
name: Global Alliance for Improved Nutrition
name: Partners of the Americas
First posted: 2019-07-26
Enrollment: 143
Sex: ALL
Minimum age (years): 6
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
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.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Household-level consumption of "fortifiable" foods
timeFrame: Previous 7 days
measure: Individual consumption of "fortifiable" foods
timeFrame: Previous 24 hours
measure: Vitamin A status among women and children
timeFrame: Single time point (1 day)
measure: Zinc status among women and children
timeFrame: Single time point (1 day)
measure: Iron status among women and children
timeFrame: Single time point (1 day)
measure: Folate status among women
timeFrame: Single time point (1 day)
measure: Vitamin B12 status among women and children
timeFrame: Single time point (1 day)
measure: Micronutrient content of wheat flour samples collected from markets and bakeries
timeFrame: Single time point (1 day)
measure: Usual nutrient intakes among women and children
timeFrame: 30 days (Previous month)
Secondary outcomes:
measure: Body mass index among women
timeFrame: Single time point (1 day)
measure: Mid-upper arm circumference among children
timeFrame: Single time point (1 day)
measure: Height-for-age Z-score among children
timeFrame: Single time point (1 day)
measure: Weight-for-age Z-score among children
timeFrame: Single time point (1 day)
measure: Weight-for-length Z-score among children
timeFrame: Single time point (1 day)
measure: Prevalence of malnutrition among children
timeFrame: Single time point (1 day)
measure: Glucose concentration
timeFrame: Single time point (1 day)
measure: Concentration of total cholesterol
timeFrame: Single time point (1 day)
measure: Hemoglobin A1C concentrations
timeFrame: Single time point (1 day)
measure: Concentration of HDL cholesterol
timeFrame: Single time point (1 day)
measure: Concentration of triglycerides
timeFrame: Single time point (1 day)
Other outcomes:
Locations:
city: Pétion-Ville
country: Haiti
facility: Partners of the Americas
Study officials:
affiliation: Ministère de la Sante Publique et de la Population, Haiti
name: Joseline Marhone Pierre, PhD
role: STUDY_CHAIR
affiliation: University of California, Davis
name: Reina Engle-Stone, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Davis
name: Stephen A Vosti, PhD
role: PRINCIPAL_INVESTIGATOR
References: