Building Capacity for Sustainable Livelihoods and Health

Anemia Clinical Trial

Official title:

Building Capacity for Sustainable Livelihoods and Health Through Public-private Linkages in Agriculture and Health Systems

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01985243
• Other study ID #: S065653
• Status: Completed
• Phase: N/A
• Start date: November 2013
• Est. completion date: August 5, 2018

Study information

• Verified date: August 2018
• Source: McGill University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Despite recent economic growth in Ghana, the prevalence of childhood malnutrition remains high. Wasting prevalence affected 29% among 6- to 8-months-old infants in 2008. Poor nutrition contributes to about one-third of child mortality, diminishes cognitive development, and is a major determinant of maternal mortality. The specific objectives of the 5-year project are to: (1) enhance human capacity of government, civil, and private institutions through improvement of knowledge and skills of personnel in agriculture, nutrition and health, entrepreneurship, and pedagogy; (2) identify information needs of local institutions that are not presently met and develop a representative and sustainable longitudinal data system to support evidence-based decision-making in programs; (3) increase vulnerable households' access to quality services in agriculture/fisheries, nutrition and health, and finance; (4) implement integrated intervention activities to improve infant and young child and adolescent nutrition outcomes; and (5) examine differential benefits of the interventions for diverse vulnerable populations. The project comprises two major activities: part I - the creation of a longitudinal data system to support evidence-based decision-making in programs, and part II - the implementation of intervention activities to improve nutrition outcomes.

The survey will include demographic, socioeconomic, health, diet, and nutritional status information collected annually from a representative same of 1500 households with infants (0-12 mo) and 1500 households with adolescents (9-12 y). The data will be analyzed and presented rapidly each year to district program and policy leaders to assist them in developing their activity plans for the following year.

Description:

This study will develop a district-level intervention package that builds capacity of local institutions to improve economic well-being, food security, health and social and cognitive development of populations living in rural Upper Manya Krobo District (UMKD) of Ghana. The UMKD Geographic Information Systems Registry estimates a rural population of 74,290 in 190 communities.

Selection process:

1. Of those UMKD communities that are accessible, 136 communities will be randomly selected.

2. All households with infants 0-12 mo of age in a village will be invited to be enrolled. We will continue to enroll households until we reach our sample size of 1500 households. If necessary, we will expand our number of sampled communities.

3. All households with adolescents 10-15 y of age in a village, who are not part of the infant cohort, will be invited to be enrolled. We will continue to enroll households until we reach our sample size of 1500 households.

Enrollment The survey will be carried out over one day for each community. The field staff will briefly explain the purpose and study activity to the caregiver (parent or legal guardian who is responsible for the child) of the target child. If the caregiver is interested in participating, they will be given the consent form to read, or if illiterate, the consent form will be read to them. They will be given time to ask questions and decide if they wish to participate. For those who consent, they will sign the consent form or provide their finger print as proof of consent. Adolescents will be asked to provide assent. Only once consent (and assent for adolescents) is obtained, will the field staff begin the survey.

Data collection

The annual survey will consist of questions (drafts are attached) on:

1. the household demographics, socioeconomic status, agricultural production, government services use,

2. mother's caregiving practices, microcredit use, business activities, physical and mental health, anthropometry (weight, height), iron status

3. infant's diet, anthropometry (weight, height, circumference), iron status

4. adolescent's diet, anthropometry (weight, height, circumference), iron status, educational activities, finance knowledge

The survey will be administered in the home with the child's caregiver, in a private location. THe adolescent will be interviewed privately unless the mother requests to be present. It is expected to be about 60-90 minutes in length. All data will be recorded solely with the study identification number. The participant's name and home address will be kept secure and separately.

THe interventions will take place with a subgroup of those participating in the annual survey. Our two main integrated interventions target critical periods of the life course when gender inequalities can have important effects on the short-term and long-term health of both men and women. Our first intervention which will begin in January 2014 will offer intensive nutrition, health, and agricultural training, along with provision of home gardens and small animal husbandry to about 302 of our households with at least one child under the age of 1 y. As these will be household-level interventions, both men and women and male and female infants (and older siblings) living in these households will benefit from this intervention. We will assess the extent to which women retain decision-making authority about the allocation of these agricultural resources and whether they benefit their children's health and nutrition, using our primary indicators of child diet and nutritional status.

Our second integrated intervention will focus on reducing anemia among female school-aged children. The intervention will start after the baseline with the beginning of the school year, September 2014. These interventions will benefit both girls and boys as boys also suffer from high rates of anaemia in this district and both sexes continue to have a high burden of parasitic infections. In addition, since older girls (starting in primary grade 4) are less likely to stay in school and, hence, are disadvantaged with respect to their access to these programs, we plan to implement a savings account intervention for girls who successfully complete primary grade 5. The amount of the savings account will be relatively small (e.g., to cover school uniforms) but along with opening these savings accounts girls will gain financial literacy and learn the importance of savings accounts and budgets. Increasing girls' education is one of the most effective ways to decrease child mortality. According to a recent study, about half of the decline in child mortality in developing countries since 1979 can be attributed to women's increased education. Moreover, since our integrated intervention will include means to improve iron status of the girls, , we expect to significantly lower rates of preconception rates of anaemia among these girls. This intervention will help meet one of the key recommendations of The Lancet Maternal and Child Nutrition Series, which notes that "A clear need exists to introduce promising evidence-based interventions in the preconception period and in adolescents in countries with a high burden of undernutrition and young age at first pregnancies" .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3390
• Est. completion date: August 5, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 15 Years

Eligibility

Inclusion Criteria:

• household with infant < 12 mo or adolescent 10-15 y

• Living in selected communities of Upper Manya Krobo District (Ghana)

Exclusion Criteria:

• infant or adolescent has medical condition that limits dietary intakes or growth

Related Conditions & MeSH terms

• Anemia
• Malnutrition

Intervention

Behavioral:
• Nutrition and agriculture
The intervention includes two components: (1) nutrition education on infant and young child nutrition, and (2) agriculture and small animal husbandry intervention to increase women's income and the accessibility of animal source foods for infants and young children.
• Iron-rich food & business literacy
The intervention includes two components: (1) a behavioural change intervention to improve school meals and increase the available iron in adolescents' diets, (2) savings & business literacy program for young female adolescents to encourage them to stay in school.

Locations

Country	Name	City	State
Canada	McGill University	Montreal	Quebec
Canada	World Vision	Toronto	Ontario
Ghana	University of Ghana	Legon

Sponsors (3)

Lead Sponsor	Collaborator
McGill University	Foreign Affairs, Trade and Development, Canada, World Vision

Countries where clinical trial is conducted

Canada,  Ghana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Women's income	Income-generation of child bearing-aged women will be assessed at enrollment and every 12 months for 5 years	at enrollment and every 12 months for 5 years
Primary	Dietary diversity	Dietary diversity of infants and young children, based on the World Health Organization's 7 food group list. This will be assessed at enrollment (which 0-11.9 mo of age) and then every 12 months for 5 years.	At enrollment and every 12 months for 5 years
Primary	Anemia prevalence	Anemia prevalence in adolescent girls will be assessed at enrollment and every 12 months for 4 years	at enrollment and every 12 months for 4 years
Secondary	Wasting prevalence	Weight-for-height of infants and young children will be assessed at at enrollment and every 12 months for 5 years	at enrollment and every 12 months for 5 years