Odukoya Oluwakemi Ololade, Manortey Steve, Takemoto Michelle, Alder Steve, Okuyemi Kolawole S
1Department of Community Health and Primary Care, College of Medicine, University of Lagos, State, Lagos, Nigeria.
2Non-Communicable Disease Research Group, University of Lagos, State, Lagos, Nigeria.
Pilot Feasibility Stud. 2020 May 7;6:59. doi: 10.1186/s40814-020-00600-6. eCollection 2020.
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.
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 . The second treatment arm, i.e., , will retain all the components of 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.
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.
Pan African Clinical Trials Registry on 12th July 2018. PACTR201807136835945. Available at https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=3481.
缺乏身体活动和不健康饮食是导致可预防的非传染性疾病（NCDs）的两个主要行为风险因素。在高收入国家，使用社区参与方法来应对这些风险的循证干预措施（EBI）比比皆是。相比之下，在非传染性疾病死亡率更高的低收入和中等收入国家，此类干预措施的证据却很少。本文描述了在尼日利亚拉各斯的教会环境中，对两种循证干预措施（即“身心”和“健康身体 健康精神”）进行文化适应和试点测试的方案制定。此外，我们还描述了在其中一个治疗组中纳入额外组成部分（即基于信仰的短信）的过程。我们的目标是评估开发和实施适应性干预措施的可行性，最终目标是开展一项全面的试验。
这项试点研究将评估在12个随机选择的英国国教教堂（每组4个）中进行的三臂整群随机试点试验的设计和实施情况。首先，我们将对这两种循证干预措施进行文化适应，以形成一种多方面的综合干预措施，称为“ ”。第二个治疗组，即“ ”，将保留“ ”的所有组成部分，并加入使用手机发送的基于信仰的短信。对照组的参与者将收到旨在增加身体活动和健康食品消费的信息传单。结果指标包括参与者的招募和保留情况、项目参与度和满意度以及数据收集完成率。拟进行的确定性试验的结果将是在基线、3个月和6个月随访时评估每天的水果和蔬菜摄入量以及中度至剧烈身体活动的分钟数。将使用定性和定量方法评估实施结果。
该研究将增进对如何使用基于社区的参与性方法在教会环境中最佳设计和实施行为干预措施的理解。它还将为确定性随机对照试验的开展提供信息。
于2018年7月12日在泛非临床试验注册中心注册。注册号为PACTR201807136835945。可在https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=3481查询。
