Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03704649 |
| Other study ID # |
QES01 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 26, 2018 |
| Est. completion date |
November 1, 2019 |
Study information
| Verified date |
May 2024 |
| Source |
McGill University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Adolescent girls in the Upper Manya Krobo (UMK) district, Ghana are disproportionately
burdened by ill-health in relation to their male counterparts. Research also shows that this
demographic lacks access to nutrition education and health services. This research aims to
assess the feasibility and influence of an intervention that utilizes a participatory video
education model on adolescent girls' nutrition knowledge, dietary habits and health
behaviour. To address our research objectives, we will conduct a school-based cluster
randomized control pilot trial with adolescent girls, 12-16 years of age, who are part of
existing girls' clubs in 20 schools of the Upper Manya Krobo district. The intervention group
(10 schools) will use a participatory video education model and the control group consists of
standard-of-care education received in regular girls' club gatherings. The intervention
groups develop a storyboard and produce a short 5-7 minute film on a nutritional issue. These
videos can be used by teachers as a means of sharing nutrition information with students and
in stimulating discussion around the nutrition topic. Baseline and end line surveys will be
conducted to assess nutrition literacy indicators and nutrition behaviour. We will use
surveys to assess nutritional knowledge and attitude; food frequency questionnaire to record
dietary intakes; and in-depth interviews with participants and school staff to assess
challenges and strengths of the nutrition education model being delivered.
Description:
Although there are a number of health and nutrition services targeted to adolescent girls in
rural Ghana, there continues to be a high prevalence of anemia, preventable ailments, and
teen pregnancies among adolescent girls in the Upper Manya Krobo district. This project
builds on a health literacy framework and social cognitive theory and explores salient
features in nutrition education delivery with adolescent girls in the Upper Manya Krobo
district of Ghana, and investigates their influence on nutritional knowledge and behaviour.
The primary research objective is (1) to assess the feasibility of a participatory nutrition
education model in the Upper Manya Krobo district and, (2) to determine if there is a
difference in adolescent girls' nutrition literacy between the intervention and control
groups. The research will provide a process evaluation and offer insight into a replicable
and feasible protocol that can implemented in other schools. We hypothesize that there will
be a difference in nutrition literacy indicators and dietary patterns between intervention
and control groups.
To address our research objectives, we will conduct a school-based cluster randomized control
pilot trial with adolescent girls, 12-16 years of age, who are part of existing girls' clubs
in 20 schools of the Upper Manya Krobo district. Eligible clusters consist of primary and/or
junior high schools in UMK district that are implementing standardized girls' clubs and who
intend to continue to implement girls' clubs for the upcoming 2018-2019 school year (n = 59).
Clusters will be stratified based on 1) the presence of the school feeding program and 2)
accessibility to the school. Accessibility will be based on the quality of roads and time
needed to travel to the cluster from the district capital, Asesewa. After stratification,
clusters will be randomized into control and treatment arms. In each cluster, approximately
20 female adolescent girls' club participants who are 12-16 years of age will be randomly
selected and enrolled in the study through seeking informed guardian's consent and
adolescent's assent.
The control groups (10 schools) represent the standard-of-care. Participants in these clubs
meet on a weekly basis during designated time for club activities in the school schedule.
With the guidance of their club facilitator they talk about a variety of health and nutrition
topics. The intervention groups (10 schools) will follow a similar curriculum and will
include a participatory video education model. The intervention groups develop a storyboard
and produce a short 5-7 minute film on a nutritional issue where they are the individuals who
draft the script, create the characters, video-record the shots, and act (if they wish) in
the video. These videos will be used in the group as a means of sharing nutrition information
with students and in stimulating discussion around the nutrition topic.
Data Collection Procedures
Phase 1: Baseline survey and weight/height.
Baseline surveys will be conducted to assess nutrition literacy indicators and nutrition
behaviour. Survey questionnaires will be administered at baseline by trained research
assistants using electronic tablets. The Open Data Kit (ODK) software will be downloaded onto
Samsung Tab3 tablets that will be used to record survey questionnaire responses. This survey
will take about 30-45 minutes and will be conducted in a private location on the student's
school campus. We will use surveys to assess nutritional knowledge and attitude;
questionnaires to record dietary intakes. She will be asked about herself and her family (for
example, age, schooling, occupation), what she knows about food and nutrition, her diet, and
how she spends her free time. Her weight and height will be taken.
Phase 2: Intervention.
The proposed intervention entails the active engagement of key community members,
community-based organizations and governmental institutions in the UMK district. A community
advisory board (CAB) is formed by key stakeholders, including health professionals, community
health workers, government officials, and influential community members. Their primary role
is to follow the development of the project, help to identify key health and nutrition
messages, to ensure the credibility of the health message being disseminated, and to help
strengthen community connections necessary for the seamless execution of the research-related
activities.
A minimum of two girl club facilitators per school will attend a training to review health
and nutrition themes dictated in the girls' club standard curriculum. Facilitators from
intervention schools will participate in additional film production workshops where they are
trained on how to write storyboards and scripts, and use microphones and cameras to make
short 5-7 minute films. In the intervention girls' clubs sessions, the facilitators lead a
discussion on nutrition topics and assist the girls to develop a scenario, storyboard and
script for the educational video they will produce. A script is written in the local Krobo
dialect and auditions are held in their club to cast the various roles. After the video is
produced, it is viewed and approved by members of the CAB, to ensure that material is
culturally appropriate and that the nutrition information is accurate. The video is made
available to girls' club teachers who will screen it for the students with the use of a
battery operated pico projector and speakers, after which the audience is prompted to reflect
on the video being watched. Each intervention group will produce two videos on the nutrition
topics covered in the girls' club session.
Throughout this time, observations will be gathered regarding attendance and the content of
the nutrition messages delivered in the girls' club sessions.
Phase 3 - In-depth interview and Focus group discussion.
In-depth interviews will be conducted with participants. Whether the female participant is in
the intervention group or not, she may be selected to be interviewed based on the
recommendation of her club facilitator through purposive typical case sampling. This is done
so as to gain insight on the influence of the educational curriculum and/or intervention on
the average student. The purpose of this interview is to better understand her experience in
the girls' club, what nutrition information she remembers from the lessons, what helped her
and what challenges she faced in putting into practice what she learned. The most significant
change methodology is used in the interview guide design. The interview will be about 30
minutes.These interviews will be conducted in a private location at their schools after the
guardian's informed consent and participant informed assent is given.
Focus group discussions will also be conducted with staff and community members that were
associated to the girls' club activities. The purpose of this focus group discussion is to
better understand their experience with the girls' club sessions. Focus group discussions
will provide insights into helpful aspects or challenges that were faced when supporting the
girls' club activities. Other questions will focus on the changes they may have noticed in
the participant's understanding and attitude towards nutrition and changes in their eating
behaviour. The focus group discussion will be about 30-45 minutes.
Phase 4 - Post-intervention surveys and weight/height.
Surveys will be conducted with the girl participants at the end of the school year when the
intervention is completed. Surveys will be used to assess changes in nutrition literacy
indicators and nutrition behaviour.
Data management and analysis.
Data from these surveys will be downloaded into a password protected and secured laptop at
the end of every day and then deleted off the tablet. Data will be backed up on an external
hard drive that is located in a locked cabinet of the offices in the Nutrition Research and
Training Centre in Asesewa.
Each participant will be given a code number to protect the participant's identity. With
their guardian's consent and the participant's assent interviews will be audio-recorded and
then translated and written out for our records. Audio files of interviews will be deleted
off equipment after the study is finished and they are only for the use of the researcher.
All equipment used in collecting or storing data will be password protected. Hard copies of
consent forms, transcripts, and demographic data will be stored in a locked storage cabinet
at University of Ghana and McGill University. In addition to the researchers, community
health workers and school teachers tied to the girls' clubs will have a copy of the final
films made by the girls to use in their educational activities.
