Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03869853 |
| Other study ID # |
108766 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2019 |
| Est. completion date |
September 15, 2022 |
Study information
| Verified date |
March 2023 |
| Source |
McGill University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Over one-third of rural Ghanaians live below the poverty line and women and children living
in poverty are at the highest risk of poor nutrition and health. Sustained integrated
approaches that increase agricultural productivity and value addition, diversify incomes, and
enhance knowledge and skills among all stakeholders are required to improve the well-being of
rural communities. There exists a unique opportunity, building on the results of the
Nutrition Links (NL) project, to test sustainable district-level approaches that support
women agripreneurs and address existing gender inequities in rural Ghana. This project will
test different approaches to enhance the sustainability of activities that will (i) increase
access to resources and services for agricultural production and, where relevant, value
addition for women, (ii) facilitate access to markets that will enhance women's
entrepreneurship, and (iii) help district partners integrate targets and activities to meet a
common goal. The 3-y project will include quantitative and qualitative data collection to
implement a trial to test a sustainable approach for engaging female agripreneurs in farmers'
associations and improving their business successes, with different approaches to integrate
new activities in district institutions' programs. The project will be guided by the team of
institutions working together with district stakeholders to improve the quality of life of
rural Ghanaian women agripreneurs and their families.
Description:
This project includes quantitative cross-sectional surveys, qualitative data collection, and
a quasi-experimental behavioural trial. The description of the study is shown below by
specific objective.
Specific objective 1. Identify (i) individual, (ii) organizational, and (iii)
social/community/institutional factors that facilitate or impede women's participation in
farming entrepreneur associations, and that can be modified through intervention.
Quantitative hypothesis Women's enrolment and active participation in women farmer
entrepreneur associations is associated with individual characteristics (e.g.,
self-confidence) as well as organizational (e.g., having a functional association) and
social/community/institutional factors (e.g., having community leadership support to join)
that may be modifiable through interventions.
Qualitative research questions (i) What gender inequalities exist within the context of the
local organizations (e.g., meetings held in locations and times that are inconvenient for
women) and community/institutions (e.g., norms that prevent women from doing business in the
community) that have implications for the entrepreneurial activities and well-being of women
farmers? (ii) What organizational and community/institutional factors contributing to gender
inequalities are modifiable through interventions to improve women's entrepreneurial
activities and well-being?
Activity 1.1. Cross-sectional survey in contiguous districts. Data collection will be carried
out in the two districts contiguous to Upper Manya Krobo District (UMKD) to collect data
among members of four associations identified (20-30 women/group, total of approximately 100
women) as well as from their matched non-member neighbours (approximately 100 women of
similar non-modifiable characteristics).
Specific questions on facilitators and barriers about joining a farmers' association and
specific questions about perceived gender differences in access to resources and services
will be included. The results will identify modifiable factors that can then influence how
district-level service providers interact with women farmers.
Analysis of data. The analysis will test for the cluster effect of the association.
Unadjusted bivariate analyses will test the relationship between the outcome and possible
covariates using independent Student's t-test for continuous variables and Pearson's
Goodness-of-fit chi-squared for categorical variables and those with a p<0.20 will be
included initially in the model. The investigators will use a logistic regression model with
standard errors corrected for clustering, using a backward elimination stepwise variable
selection procedure. Variables with a p-value of < 0.10 will remain in the model.
Activity 1.2. Focus group discussions and in-depth interviews. Qualitative methods will be
used to examine gender inequalities at the institutional level. Of interest is the programs
and services that institutions provide and their influence on the lives and work of women
agripreneurs as well as institutional staff. The number of interviews and focus groups will
depend on reaching saturation; however, the investigators expect to conduct at least 6
in-depth interviews with institutional staff (both men and women) in each of the three
districts. The staff will be key informants selected based on their role or personal
knowledge about the existing associations and institutional responsibilities. The women will
be selected from the association membership and survey lists to represent different levels of
entrepreneurship. The focus group discussion and interviews will focus on (1) identifying
gender gaps in services and access to resources; (2) analyzing existing programs and how they
address the different needs of women and men; and (3) discussing policies and resource
allocation decisions and whether they support gender equality. The study interest is in the
perception of the staff on how their role with the programs and services for women is
assessed and valued within the institution and the barriers they face in supporting women.
The interviews will be followed up with four focus groups (~10 /group) with women farmer
entrepreneurs (two in UMKD and two in the two surrounding districts; total = 40 women) to
examine the gender institutional inequalities from the viewpoint of women agripreneurs. In
addition, women's perception of the role of their own empowerment (how they define
empowerment, understand its importance for their participation and entrepreneurial success,
view limitations to their or others' empowerment) and how this perception is linked to their
interactions with the institutions is of interest.
Analysis of data. The transcripts (about 28 hours of data) will be translated, coded and
analyzed using a content analysis approach with a priori and emerging themes.
Specific Objective 2. Develop approaches that enhance both the improved outcomes of women
agripreneurs (knowledge, skills, and empowerment; entrepreneurial success; nutrition/health)
as well as improved outcomes for the institutional stakeholders (program
participation/clientele reached, effective/efficient service provided, staff knowledge and
skills, job satisfaction).
Activity 2.1. Focus group discussions and in-depth interviews. Qualitative methods will be
used to discuss with women and staff the value of incentives and their importance for
participation in associations. The selection of participants and the number of interviews and
focus groups have been described above in Study 1.2. The discussion for these questions with
both women and staff will focus on different types of incentives, their value to women, and
their value compared to the cost of participation at association meetings. With only staff,
the investigators will discuss different types of incentives that encourage staff to support
meetings.
Analysis of data. The analysis will be carried out as described under Study 1.2.
Activity 2.2. The project will develop approaches to support the training of women farmers
and facilitate continued education training of district staff to strengthen associations and
to enhance staff knowledge and skills to address local challenges that members face. The
investigators will carry out a formative assessment with interviews with staff and
administration on local training needs.
The investigators expect that some of the approaches may include activities to address the
following:
(1) How can the district staff be incentivized to work with the women's association and
create demand for their services?; (2) How can the institution empower private sector
value-chain entrepreneurs to provide high quality information to women agripreneurs?; (4) How
can the bank better reach women agripreneurs?
Data collection will focus highly on the process evaluation to document what happens in each
tested approach, perceptions of what works/does not work, and the perception of
sustainability of the specific activity. The method of evaluation will depend on the specific
approach. Whenever possible, indicators that are regularly collected by the institution will
be used to assess the results (e.g., number of women agripreneurs assisted by the district
veterinarian). Both quantitative and qualitative data will be collected, as is appropriate.
The specific approaches will be determined after the cross-sectional survey is completed.
Activity 2.3. Two-arm quasi-experimental trial. The focus is to test an intervention that is
feasible within the context of permanent institutions, thus the package must be
self-sustaining. The primary outcomes of interest are (i) participation in the association,
(ii) small business economic outcomes, and (iii) women's well-being. The study includes women
who are members of women farmer associations in the three designated districts. The
intervention will use Heifer's Passing-on-the-Gift approach that could be replicated in the
future without project intervention. Women's groups will be randomly assigned to treatment
(intervention, control) and to a group cycle (1, 2). The weekly project activities (starting
with Group 1) are repeated over 4 months. At the end of the cycle of 4 months, Group 2
initiates the intervention, using resources from the first group's "passing on the gift®" for
the financial base. The two groups alternate cycles so that over a 16-month period, group 1
and group 2 both receive the intervention package for 8 months.
In addition to the quantitative analysis, a case study approach will be used to examine women
agripreneurs and the role that the association had in their success. The first goal is to
develop a consensus on what is "success". This will be obtained through focus group
discussions, examining the question: "What would one expect to see in the life of a woman who
is doing well in her poultry business?" The investigators will direct the discussion to
include women's empowerment, financial stability, and maternal and child well-being. Based on
the criteria developed on "success", as well as the project's own criteria, the investigators
will identify among the association members the ten most successful and the ten "less
successful" entrepreneurs. The researchers will carry out in-depth interviews with the 20
women on life histories, experience with the association, and perceived successes, failures,
and obstacles. Additional interviews will be carried out with two household members and three
business colleagues per case to examine further the woman's experiences to have a complete
picture. Direct observation (~ 2 hr/visit) of each case at home and at her business location
will be carried out to have a full picture of the woman's activities, environment, and social
interactions in each site.
Finally, there is interest in understanding the pathways by which the outcomes of interest
are attained for women participating in associations. The project includes repeated surveys
(baseline, 8 months, 16 months) to analyze changes that occur with participation in
associations and allow us to estimate the means by which the associations influence lives.
Analysis of data. The outcomes of interest from the trial will all be continuous. The data
will come from a cluster-assigned, quasi-experimental trial. Unadjusted bivariate analyses
will test the relationship between the outcomes and possible covariates using independent
Student's t-test for continuous variables and Pearson's Goodness-of-fit chi-squared for
categorical variables and those with a p<0.20 will be included initially in the model. The
analysis will use a multiple linear regression model with standard errors corrected for
clustering, using a backward elimination stepwise variable selection. Variables with a
p-value of < 0.10 will remain in the model.
The analysis of the case studies will follow the process used by the team previously. The
focus groups and interviews will be translated and transcribed. There will be a systematic
review of the focus groups (and confirmed with the individual interviews) to identify
individual characteristics and factors that are associated with success. The next step is to
generate theoretical explanations of how success is achieved or not achieved.
Content analysis of transcripts and observations will be employed to generate themes around
experiences that will be grouped into generalizations about successful women. While the focus
is on 'successful' women, data from the 'less successful' women will be used as a
counterfactual to cross-examine the data. The case studies will provide a rich understanding
of the factors that are needed to support women at different times of developing their small
businesses as well as the consequences for the woman and the family.
The results from the repeated surveys on pathways will use repeated measures analysis. The
approach will be similar to that described above for the randomized trial outcome analysis.
