Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06154655 |
| Other study ID # |
K43TW011046 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2023 |
| Est. completion date |
May 2024 |
Study information
| Verified date |
November 2023 |
| Source |
University of Ibadan |
| Contact |
Tobi Fatodu, MPH |
| Phone |
+2348134002671 |
| Email |
tobifatodu[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The goal of this clinical trial is to develop a hybrid E-zine health education intervention
integrated within a mental Health package for adolescent perinatal depression.
The main objective is to:
- Develop a hybrid Health Educational Intervention offering health promotion and disease
prevention services on climate change to perinatal adolescents and their caregivers.
- Study the feasibility, acceptability, and usability of E-zineMH in a pilot trial among
perinatal adolescents and their caregivers in comparison to a control arm that delivers
face-to-face health education in routine antenatal clinics.
Participants will be expected to attend routine antenatal appointments for the duration of
the study.
In addition to the face-to-face health education delivered to both groups, the intervention
group will be exposed to e-magazines on climate change.
Description:
Rising temperatures in tropical regions threaten the mental and overall wellbeing of
perinatal adolescents and their infants, increasing their risks of depression and adverse
obstetric complications such as miscarriages, preterm birth, low infant birth weight and
still births. Integrated health promotion and prevention programmes within collaborative
mental health packages in antenatal clinics that recognise the vital roles of family and
other caregivers while also offering conveniently accessible services are crucial to
implementing behavioural change interventions to address the negative impact of climate
change (CCH) in the perinatal adolescent population.
In Nigeria, perinatal adolescents do not enjoy the privileges of division of labour in their
households. However, they continue to engage in formal family or informal services (e.g.,
street hawking, outdoor errands) for extended periods in temperatures of up to 44 °C (111.2
°F). Also, pre-existing multidimensional health vulnerabilities in this population are
compounded by (1) continuous exposure to household pollution from indoor cooking fuelled with
biomass and use of poisonous pesticides. (2) Droughts and floods from extreme temperatures in
tropical climates have increased food insecurity, reduced access to portable clean water, and
worsened risks of infectious diseases like malaria and zika virus. The United Nations
recommends health education as a key approach to addressing the detrimental effects of CCH.
Despite the effectiveness of health education programmes in the antenatal population in areas
of nutrition intake, family planning methods, obstetrics complications, and common infections
in the perinatal period, very little recognition has been given to themes of CCH as part of
essential services in antenatal clinics in primary care in Nigeria. Barriers to implementing
environmental health care as part of integrated packages in primary care in Nigeria are high
at the needs (context-relevant), service (capacity of providers), and consumer awareness
(uptake of services) levels.
Our proposed study addresses context-relevant needs, health workers capacity, and service
uptake gaps, by leveraging Virtual space to deliver a Health Education intervention to
address impact of CC in perinatal adolescents. Services on health promotion and prevention
will be delivered electronically (eHealth) through E-zine (electronic magazine) photos to
perinatal adolescents and their caregivers (e.g., parents, partner or guardian). The E-zine
would be integrated within an existing hybrid mental health collaborative model in primary
care to promote healthy practices to prevent adverse health outcomes of CCH. E-zine photo
system development will be guided by key constructs of the Transtheoretical model. Health
prevention and promotion content of the E-zine photos will 1) utilise social support to
address unhealthy behaviours 2) use context relevant materials to educate and raise awareness
on CCH to affect attitudes and beliefs of perinatal adolescents and their caregivers 3)
provide risk mitigation information through a pros and cons analysis to create decisional
balance, and 4) address self-efficacy to maintain healthy behaviours.
This application builds on the evidence and lessons learned from studies conducted by the PI
(Dr. Kola's-K43TW011046-4) in Nigeria on mhGAP -perinatal depression integrated model within
primary care, mHealth and technology strategy testing, and implementation system development
research. As part of a K43 emerging global leader award, the investigators designed and
developed a self-management mobile phone application as an adjunct treatment and part of a
hybrid (face-to-face + mobile phone follow-up care) intervention for perinatal adolescents.
The intervention was designed to deliver treatment that promote positive mental and overall
wellbeing in perinatal adolescents using an age and culturally appropriate approach.
Health Education Intervention in the perinatal population. Health Education Intervention in
the perinatal population-HEI have been effective in positively impacting knowledge and
behavioural attitudes of pregnant women to enable them control and change their lifestyles
for improved health outcomes. Notwithstanding the success of HEI in addressing areas of
nutrition intake, family planning methods, obstetrics complications, and common infections of
perinatal women in Nigeria, very little recognition have been given to themes of CCH as part
of essential services in antenatal clinics in primary care. Barriers to implementing HEI for
environmental health care as part of an integrated packages in primary care in Nigeria are
high at the needs (context-relevant), service (capacity of providers), and consumer (uptake
of services) levels. Specifically, there are no well documented information presenting health
needs assessment of CCH in the perinatal adolescents as a way of defining and systematic
identifying the unmet needs to this population. Services on health related impact of CCH are
currently not part of the health education services delivered in majority of the antennal
clinics in Nigeria and care givers also lack knowledge on the relevance of CCH and it impact
on the health of perinatal women.
Health decision making for perinatal adolescents. Family members are important and highly
influential in the care of pregnant adolescents. Due to the social circumstances surrounding
many adolescent pregnancies, and given that many of the girls' pregnancies are unplanned,
perinatal adolescents in Nigeria often forfeit the "Power to Decide" on key areas of their
living circumstances. Such power are often relinquished to the main care provider who in many
cases are their mothers, mothers-in-laws, partners or other family members who are willing to
take them on in the period. Their power to make and enact health related decisions are
therefore to a large degree influenced by parents, partners or guardians.
Importance of the Knowledge to be Gained Nigerian pregnant adolescents and young mothers
encounter significant unmet mental health service needs and significant psychosocial
distress, which has contributed to increasing poor mental and public health burden in the
country. The proposed study addresses these important service and perinatal adolescent mental
health research gaps. Results can be useful for improving our knowledge in implementation
research and build sustainable capacity for early prevention and intervention in perinatal
adolescent mental health services and sustainable capacity building and supportive
supervision models for health care workers in primary health services.
Data Collection:
Methodology for Aim 1: Develop an hybrid Health Educational Intervention of health promotion
and disease prevention services on climate change for perinatal adolescents and their
caregivers. This will be delivered through E-zine photos and face to face health education,
within an existing integrated mental health (E-zineMH) model in primary care. The team will
employ a participatory approach that engaging perinatal adolescents, their caregivers, care
providers and relevant expert groups to develop new photos and adapt context-relevant ones
for E-zine from existing videos of a self-management mobile phone application of a mental
care, for perinatal adolescents. E-zinemH will deliver services through photos that are
practical, culturally relevant and engaging to the study population and their caregivers.
Step 1. Conduct focus group discussions and one to one key informant interviews with
purposively selected health care providers, perinatal adolescents, and care givers of
perinatal adolescent groups (n=10 per groups of 3; N=30) to assess current knowledge,
attitude and practices of CCH that are injurious to health of perinatal adolescents. Also,
the team will explore mitigation plans to identified risks as part of our intervention
development plan. Milestone: Context relevant information for the development for E-zineMH
Step 2: Expert workshop. A 5 day consultative workshop consisting of 10 maternal and child
health specialists, and experts in maternal mental health, environmental health, community
health care and digital health will be conducted to develop treatment mitigation plans to
identified risks from the activities in step one. The aims of the workshop will be to develop
contents for E-zine photos as it relates to CCH and its impact of young mothers; and also to
adapt relevant photos of mental and overall wellbeing from existing videos of a
self-management application for depression care.
The E-zine structure will be guided by key constructs of the transtheoretical model. For
health changes to take place, the transtheoretical model posits the need for 1) social
support for changing behaviour, 2) awareness of health benefits and risks as strategies of
health promotion and prevention, 3) the need for decisional balance that will be achieved by
weighing pros and cons of change, and 4) the need to build self-efficacy -confidence and
ability to perform and maintain behaviour to prevent temptation to revert to unhealthy
behaviour. These constructs are illustrated in the stages for behavioural changes which
include pre-contemplation, contemplation, preparation, action, maintenance.
Blueprint of the E-zineMH system: The investigators anticipate the E-zine system will use
positive reinforcement at the end of every theme (session) to encourage the usage of the
workshop, system. Praise words with cultural appellations (for example, "Cheers to good
health, please proceed to the next session") will be used. Cases of incomplete sessions will
also receive encouragement for continuing use (for example "health cannot be bought, just a
little bit more effort").
Development of EzineMH prototype.The team will then work with a graphic artist to convert the
contents of the narrative scripts into culturally appropriate characters after which will
work with the Co-Creation Hub an identified team of local expert programmers with expertise
to produce a beta version of the mHealth system (PI, Kola, will lead this effort). The beta
version will undergo functional testing through laboratory usability assessments with 3 users
(one perinatal adolescent, one caregiver, and one care provider). Based on previous
experience it is expected 2 to 3 iterations before testing out in real life in a pilot trial.
Milestone: The production of E-zine system to deliver Aim 2: Study the feasibility,
acceptability, and usability of e-zineMH in a pilot trial among perinatal adolescents and
their caregivers in comparison to a control arm that delivers face to face health education
as part of routine health talk in antenatal clinics. A pilot trial will be conducted with 60
randomly selected perinatal adolescents 30 in the E-zineMH arm and 30 in the control arm).
The trial is not power to test significance different between study arms but designed to
provide enough data on feasibility, acceptability and functionality of the E-zineMH system.
E-zineMH arm: Trained health care providers in primary will deliver health education contents
of CCH including effects of extreme weather, heat, flooding, and drought on mental health and
overall wellbeing in pregnancy and how adolescent mothers are more at risk due cultural
practices. Following the health education session perinatal adolescents present will be
invited to participate in the study by a study research assistant who will give details of
the study. Next, caregivers of consenting perinatal adolescents will be invited to the clinic
the next day after which the care provider and the research assistant will invite them to
participate in the study. Perinatal adolescents in the study will receive a mobile phone with
password assess to intervention content of E-zineMH. Consenting care givers will be given
user names and password to assess of the E-zineMH system online. Trained care providers will
follow up perinatal adolescents' use of E-zineMH through separate phone calls to them and
their caregivers every two weeks to encourage use.
Control Arm: The treatment package includes health education on CCH: a brief overview of CCH,
how it affects pregnant women, how perinatal adolescents are more vulnerable because of
cultural norms and practices, impact of CCH on mental (depression and anxiety) and overall
wellbeing of perinatal adolescents and their infants, and risk mitigation strategies.
In between baseline assessments and 4 months follow in both intervention and control clinics,
health care providers will deliver face to face health education in routine antenatal clinic.
A trained senior research assistant with background training in health promotion and
prevention will assess health provider's fidelity to delivery of health education with the
team developed checklist used during the training.
