Pan African Clinical Trials Registry

South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: www.pactr.org
Trial no.: PACTR201807136835945 Date of Approval: 16/07/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Body, Soul and Spirit, an intervention promoting physical activity and healthy eating among adults in faith-based settings in Lagos, Nigeria: a three-arm cluster randomized control pilot trial.
Official scientific title Body, Soul and Spirit, an adaptation of two efficacious interventions promoting physical activity and healthy eating among adults in faith-based settings in Lagos, Nigeria: a three-arm cluster randomized control trial.
Brief summary describing the background and objectives of the trial Several evidence-based interventions addressing known risk factors for NCDs like physical activity and unhealthy eating exist. However, a large gap is evident, as the bulk of research evidence is often generated in high-income countries (HIC), while the burden of disease and ill-health occur predominantly in LMICs. It is not known whether or how interventions generated in HIC may work in local low and middle-income country (LMIC) settings with different religious, socio-economic and cultural environments. Religious environments play an important role in promoting physical activity and healthy eating. In addition, the use of mobile phones has increased tremendously in Nigeria over the past 15 years. Nigeria ranks second, only to South Africa, with the highest proportion of mobile phone users in Africa. This may provide a window of opportunity to develop mobile phone interventions to promote physical activity (PA) and healthy food consumption (HFC) as has been done in some HIC. Few interventions have considered the use of faith-based text message prompters to improve the effect of interventions in faith-based settings and none of these studies were conducted in a highly religious low-and-middle income country (LMIC) like Nigeria. The primary objective of this study is to design and determine the feasibility and initial effects of a cultural adaptation of the effective components of two National Cancer Institute (NCI) evidence-based interventions in church settings, i.e., Body and Soul and the Healthy Body Healthy Spirit, to increase physical activity (PA) and health food consumption (HFC) in a church-based LMIC setting. The secondary objective is to understand how faith-based text messages may be used to improve the effects of this adapted intervention.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) BSS
Disease(s) or condition(s) being studied Cancer,Cardiology
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 01/06/2019
Actual trial start date
Anticipated date of last follow up 30/06/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 300
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table from a statistics book Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Body Soul and Spirit a series of church activities over a 6 moth period Six months Five components make up the Body soul and Spirit intervention arm: a) Individual education: i. An adapted version of a cookbook with low-fat recipes, cooking techniques, shopping and storage tips for fruits and vegetables and health benefits of lowering fat/increasing fruit and vegetable intake. (both BS & HBHS) ii. An adapted version of an exercise manual and exercise documentary video with biblical themes and scripture woven throughout. (HBHS) b) Group education: Each church will receive a single copy of an adapted version of "Forgotten Miracles," an 18-minute video that targets fruit and vegetable intake using both spiritual and secular motivational messages. Churches will be asked to organize public screenings of the video and to make the copy available to members on request. (both BS &HBHS). c) Campaigns and promotions: i. Formation of a project coordination committee ii. Church events: A project kick-off event, at least one nutrition event and an additional event involving the church vicar. Examples of events included in the parent trials are: serving fruit and vegetables after church services, at other church programs or during the kick-off event; sponsoring food demonstrations or taste tests; organizing tours of food markets for parishioners, inviting guest speakers or having priest sermons related to health. (BS). iii. Faith-based work-out audio CD: Participants will receive an adapted version of workout audio compact disc containing gospel music with biblical quotes and brief sound bytes of priest sermons sliced between songs. (HBHS). d) Supportive relationships: Motivational interviewing phone calls to selected church parishioners delivered by trained church volunteers (both BS & HBHS) e) Policy change: Churches will agree to implement at least one policy change. Potential policy changes include establishing guidelines for the types of foods served at church functions, changing snacks served at youth camps, or creating a food pantry. (BS) 100
Experimental Group Body Soul and spirit Plus A series of core components delivered over a six month period. In addition, two or three text messages weekly over the six month period Six months In addition to all the components of the Body soul and spirit, Participants will receive the following Spiritually themed text message prompters promoting physical activity and healthy eating. 100
Control Group Control Once Once in the six month period Information leaflets on healthy food consumption and physical activity will be distributed to parishioners in the churches in this group after a church service. 100 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Church inclusion: Eligible churches must be: Registered under the Diocese of Lagos Mainland, Anglican Communion of the Church of Nigeria. Have at least 100 "active" members. We define “active” as members who attend church services at least weekly. Participant inclusion: Adults aged 18 years and above Must have been "active" members of the church for at least six months Church exclusion: Churches with less than 100 active members Churches who do not consent to participate in the study Participant exclusion: Persons physically or mentally unable to participate due to lack or consent or reasons of ill health. 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 100 Year(s) Both
Church inclusion: Eligible churches must be: Registered under the Diocese of Lagos Mainland, Anglican Communion of the Church of Nigeria. Have at least 100 "active" members. We define “active” as members who attend church services at least weekly. Participant inclusion: Adults aged 18 years and above Must have been "active" members of the church for at least six months Church exclusion: Churches with less than 100 active members Churches who do not consent to participate in the study Participant exclusion: Persons physically or mentally unable to participate due to lack or consent or reasons of ill health. 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 100 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 27/04/2018 Health Research and Ethics Committee College of Medicine University of Lagos
Ethics Committee Address
Street address City Postal code Country
College of Medicine University of Lagos Idi araba 12003 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Fruit and vegetable intake and the number of minutes spent on moderate to vigorous activities each week. baseline, 3 months and six months
Secondary Outcome Food consumption and fat intake, vegetable preparation practices, intrinsic/extrinsic motivation and self-efficacy to eat fruit and vegetables and to increase Moderate to vigorous physical activity. Baseline, 3 months and six months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Diocese of Lagos Mainland Anglican Communion church of Nigeria Freeman street, Ebute Metta Ebute metta Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Fogarty International Center of the National Institutes of Health 31 Center Dr, Bethesda MD 20892 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Fogarty International Center 31 Center Dr, Bethesda MD 20892 United States of America Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Kolawole Okuyemi University of Utah School of Medicine 375 Chipeta Way, Ste. Salt Lake City 84108 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Oluwakemi Odukoya koodukoya@unilag.edu.ng +2348023200770 Ishaga road
City Postal code Country Position/Affiliation
Idi araba 12003 Nigeria Senior Lecturer Department of Community health and Primary Care College of Medicine University of Lagos Nigeria
Role Name Email Phone Street address
Public Enquiries Oluwakemi Odukoya koodukoya@unilag.edu.ng +2348023200770 Ishaga road
City Postal code Country Position/Affiliation
Idi araba 12003 Nigeria Senior Lecturer Department of Community health and Primary Care College of Medicine University of Lagos Nigeria
Role Name Email Phone Street address
Scientific Enquiries Oluwakemi Odukoya koodukoya@unilag.edu.ng +2348023200770 Ishaga road
City Postal code Country Position/Affiliation
Idi Araba 12003 Nigeria Senior Lecturer Department of Community health and Primary Care College of Medicine University of Lagos Nigeria
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial type 16/07/2018 This is because our study is a cluster randomized trial and not a participant randomized trial. Being unfamiliar with the acronym CCT, RCT was initially selected. This has now been corrected. RCT CCT
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial type 16/07/2018 Clusters are randomised CCT RCT
Section Name Field Name Date Reason Old Value Updated Value
Study Design Allocation to intervention 16/07/2018 Clusters are randomised Non-randomised Randomised
Section Name Field Name Date Reason Old Value Updated Value
Study Design Allocation sequence 16/07/2018 Clusters will be randomised using a table of random numbers. Simple randomization using a randomization table from a statistics book