Community Interventions to Improve Iron and Iodine Status in Mother and Child Dyads in Northern Ghana

NCT03754998 | Completed

• 1 other identifier: WSong
• Study Type: interventional
• Target: 239
• Locations: 1 country
• Sites: 1

Brief Summary

BACKGROUND Ghana has reduced food insecurity prevalence by 49.2% in two decades. However, prevalence of malnutrition especially stunting (in \<children5yr) has not matched the changes in food security levels. Of several key nutritional factors that lead to stunting, nutritional status of such trace minerals as iodine, iron and zinc has not been studied. Nutritional inadequacy of these trace minerals may be detected by estimation of dietary intake, and time-consuming and costly biochemical measurements of respective biomarkers. Since there is no means to estimate dietary intake of the trace minerals in Ghana, due to incomplete food composition data of the nutrients, identifying validated non-invasive, dietary approaches to predict the biomarker status of these trace minerals are critical in counteracting the challenges surrounding the persistent stunting due to micronutrient deficiencies in Ghana. Additionally, exploring alternative approaches to providing access to foods rich in trace minerals at household level is crucial. STUDY AIMS AND HYPOTHESIS The ultimate goal of this research is to increase knowledge base on improving trace mineral status in mother-child (6-23 mo) dyads through a sustainable community-based interventions in northern Ghana. Investigators will begin with iron and iodine that impair mothers and young children's growth and cognitive development most with three aims: 1) to develop dietary screening tools that are validated by biomarkers for early detection of deficiencies, 2) to determine efficacy (dose responses) of feeding indigenous nutrient-rich meals in preventing deficiencies and improving iron and iodine status, and 3) to demonstrate sustainable and scalable improvement of food systems through a container gardening project for iron-rich Hibiscus sabdarifa for consumption and income by empowering women during the dry/lean season in northern Ghana.

• Aims 1: To develop dietary screening tools that are validated by biomarkers for early detection of deficiencies among children 6-23 months and their mothers H1.1: Dietary diversity score can predict iron deficiency among children 6-23 months and their mothers. H1.2: Dietary diversity score can predict iodine status deficiency among children 6-23 months and their mothers.
• Aims 2: Indigenous nutrient-rich meals of hibiscus sabdarifa improves iron and iodine status of dyads H2.1: Indigenous nutrient-rich meals of hibiscus sabdarifa improves iron status of dyads H2.2: Indigenous nutrient-rich meals of hibiscus sabdarifa improves iodine status of dyads
• Aims 3: to demonstrate that container gardening can provide sustainable and scalable improvement of food systems for iron-rich Hibiscus sabdarifa for consumption and income during the dry/lean season in northern Ghana H3.1: Container gardening can provide adequate amounts of vegetables for mother and child dyad during the dry season H3.2: Container gardening can provide adequate income to purchase iodized salt and Amani for mother and child dyad during the dry season SIGNIFICANCE This project addresses the gap in our knowledge and practices pertaining to serious and persisting trace mineral deficiencies that result in stunting and cognitive impairment in northern Ghana. Early detection of iron and iodine deficiencies with validated non-invasive dietary screening tools (aim 1), effective indigenous nutrient-rich meal-based programs (aim 2) and sustainable/scalable and women-led community-based food-system changing agricultural project (aim 3) are expected to be the most creative approach to counteract iron and iodine deficiencies in northern Ghana. This project will utilize science and education to change practices, environments and policies to reduce the prevalence of trace mineral deficiencies at the local, regional, national and global levels.

Conditions

Iron Deficiency (ID); General Anemia; Iron Deficiency Anemia (IDA)

Outcome Measures

Primary Outcomes (6)

• Iron Deficiency (ID)

  ID measured using serum transferrin receptor (Stfr). Cut off for ID (women - stfr\>4.40ug/l, children - stfr\>2.85ug/l).

  12 weeks

• General Anemia

  General anemia measured using hemoglobin levels (Hb). Cut off for General anemia (women - Hb\<12g/dl, children - Hb\<11g/dl)

  12 weeks

• Iron Deficiency Anemia (IDA)

  IDA is measured by concurrent presence of general anemia (women - Hb\<12g/dl, children - Hb\<11g/dl) and ID (women-stfr\>4.40ug/l, children - stfr\>2.85ug/l).

  12 weeks

• Iodine status of participants

  Iodine status will be measured by urinary iodine concentration (ug/l)

  12 weeks

• Hibiscus Sabdariffa produced/harvested from container gardening

  Quantity of Hibiscus Sabdariffa leaves (kg) per container

  15 weeks

• Income generated form container gardening

  Income (cedis) generated from cabbage produced per container

  15 weeks

Study Arms (1)

Intervention Group

EXPERIMENTAL

The participating dyads in intervention communities were invited to consume veo soup/meal (HSM) three times a week and provided weekly supply of iodized salt (450 g) for the household usage as well as being engaged in dry season container gardening. The veo soup/meal is a local Ghanaian soup/meal mainly made of Hibiscus Sabdarifa leaves. It is a soup when prepared a bit watery and consumed with 'tou zaafi' (millet or corn based cooked paste). It is also a meal when prepared thick and eaten by itself. The Hibiscus Sabdariffa leaves meal (HSM) used in the present study was made of 18 kg Hibiscus Sabdariffa leaves, 8 kg groundnut, 1.1 kg dawadawa (fermented African locust beans), 3 kg dried fish plus 0.045 kg iodized salt, cooked with about 23 L (23 kg) water to yield 52.5 kg HSM. In each community, groups of ten women took turns to share the cooking activities, washing of bowls, and making water available for cooking. No treatment provided in our control communities.

Behavioral: Intervention Group

Interventions

Intervention Group BEHAVIORAL

The participating dyads in intervention communities were invited to consume veo soup/meal (HSM) three times a week and provided weekly supply of iodized salt (450 g) for the household usage as well as being engaged in dry season container gardening. The veo soup/meal is a local Ghanaian soup/meal mainly made of Hibiscus Sabdarifa leaves. It is a soup when prepared a bit watery and consumed with 'tou zaafi' (millet or corn based cooked paste). It is also a meal when prepared thick and eaten by itself. The Hibiscus Sabdariffa leaves meal (HSM) used in the present study was made of 18 kg Hibiscus Sabdariffa leaves, 8 kg groundnut, 1.1 kg dawadawa (fermented African locust beans), 3 kg dried fish plus 0.045 kg iodized salt, cooked with about 23 L (23 kg) water to yield 52.5 kg HSM. In each community, groups of ten women took turns to share the cooking activities, washing of bowls, and making water available for cooking. No treatment provided in our control communities.

Intervention Group

Eligibility Criteria

• Age: 15 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Be a woman (15-49 y) and having a child (6 - 23 months)
• Live in research settings for the entire research duration (May 2016 - September 2017)
• Live in selected communities in the Kassena Nankana West and Builsa North Districts of the Upper East Region of Ghana
• Selected districts should be among the top five food insecure districts
• Households in selected communities should have access to water throughout the dry season without shortages
• Selected communities should have sizeable number of children (6 - 23 months old) for a good sampling frame

Sponsors & Collaborators

• Michigan State University: lead

Study Sites (1)

Builsa North and Kessena Nankana West Districts

Bolgatanga, Upper East Region, 00233, Ghana

Location

MeSH Terms

Conditions

Iron Deficiencies; Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Clement Professor Won Song

  Michigan State University

  STUDY CHAIR

• Clement Kubuga

  University for Development Studies - Ghana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Quasi experimental

Study Record Dates

• First Submitted: November 14, 2018
• First Posted: November 27, 2018
• Study Start: May 20, 2017
• Primary Completion: September 8, 2017
• Study Completion: September 29, 2017
• Last Updated: November 27, 2018

Record last verified: 2018-11

Locations

GH (1)