Abstract:
Background: Physical inactivity and unhealthy eating are two leading behavioral risk factors contributing to
preventable non-communicable diseases (NCDs). Evidence-based interventions (EBI) using community-engaged
approaches to address these risks abound in high-income countries. Comparatively, evidence of such interventions
is sparse in low- and middle-income countries, where NCD mortality is greater. This paper describes the protocol
for the development of the cultural adaptation and pilot testing of a combination of two EBI (i.e., Body and Soul
and the Healthy Body Healthy Spirit), in church-based settings in Lagos, Nigeria. In addition, we describe the
development of the inclusion of an additional component, i.e., faith-based text messages, into one of the treatment
arms. Our objective is to assess the feasibility of developing and implementing the adapted interventions with the
ultimate aim of developing a fully powered trial.
Methods: This pilot study will assess the design and implementation of a three-arm cluster-randomized pilot trial in
12 randomly selected Anglican churches (4 in each arm). First, we will design a cultural adaptation of the two EBI’s
to form a multifaceted combined intervention known as the Body Soul and Spirit. The second treatment arm, i.e.,
Body Soul and Spirit Plus, will retain all the components of Body Soul and Spirit with the inclusion of faith-based text
messages using mobile phones. Participants in the control arm will receive information leaflets designed to increase
physical activity and healthy food consumption. The outcome measures include participant recruitment and
retention, program participation and satisfaction, and data collection completion rates. The outcomes for the
proposed definitive trial will be the number of servings of fruit and vegetables and minutes of moderate to
vigorous physical activity per day will be assessed at baseline, 3 and 6-month follow-up. Implementation outcomes
will be assessed using qualitative and quantitative methods.
Discussion: The study will enhance the understanding of how best to design and implement behavioral
interventions in church-based settings using community-based participatory approaches. It will also inform the
development of a definitive randomized controlled trial.
