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: pactr.samrc.ac.za
Trial no.: PACTR202012477957726 Date of Approval: 04/12/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A social media based lifestyle intervention program: Project SWAY
Official scientific title Randomised trial of a social media based lifestyle intervention program for the prevention of noncommunicable diseases in adults: Project SWAY
Brief summary describing the background and objectives of the trial This research project was developed to help prevent and minimize the impact of NCDs in low to middle income countries. Considering the growing use of social media in Africa, this suggest a possible means to achieving scalability in addressing NCD risk factors. With the paucity of published research reporting on Facebook use in seeking to change lifestyle behaviours and health outcomes in combination with health professionals to support, educate and motivate adults, the SWAY research aims to contribute towards the effective adoption of health behaviour and improved health outcomes by developing, implementing and examining the effectiveness of a scientifically based social media lifestyle intervention program at improving estimated 10-year CHD risk score using the FRS which incorporates age, gender, blood pressure, fasting cholesterol levels (total and high density lipoprotein (HDL)) or body mass index (BMI), smoking habits and diabetes status.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Non-Communicable Diseases
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 01/09/2019
Anticipated date of last follow up 30/11/2020
Actual Last follow-up date 30/11/2020
Anticipated target sample size (number of participants) 300
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL https://journals.lww.com/joem/Abstract/9000/Social_Network_Lifestyle_Interventions_Reduce.97672.aspx
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 Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Facebook plus Health Professionals Content generated by the research team was posted each weekday (Monday to Friday) on the Facebook pages to encourage interactions or engagement between participants by liking and commenting on each other’s posts or the researcher’s posts 12 months Randomly selected participants were invited to the Facebook and Health Professionals group private page. On acceptance, they had access to two health professionals (Dietician and Biokineticist) who formed part of the private Facebook group. Study participants contacted them via Facebook Messenger when they need help or guidance in achieving their health goals. 100
Experimental Group Facebook group only Content generated by the research team was posted each weekday (Monday to Friday) on the Facebook pages to encourage interactions or engagement between participants by liking and commenting on each other’s posts or the researcher’s posts 12 months Participants in the Facebook group were allocated to a separate private Facebook group with similar content posted by the researcher described in the Facebook and Allied Health Professional group. However, the Dietician and Biokineticist were not part of this group. 100
Control Group Newsletter Group Received emailed newsletter monthly 12 months Participants in the control group were sent monthly newsletters via email over the 12 month intervention period. The newsletters contained content on health topics relevant to address behavioural lifestyle behaviours (physical activity and sedentary behaviour, smoking cessation, alcohol consumption and dietary intake) 100 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
a)aged 18 to 63 years, b) had a Facebook account, c) had one or more cardiovascular risk factors (BMI: ≥25 kg/m2, waist circumference >102 cm for men and >88 cm for women , BP ≥140/90 mmHg, total cholesterol ≥ 5.0 mmol/L, current smoker, random blood glucose > 7 mmol/L, <5 servings of fruit and vegetables per day; and < 150 minutes of moderate physical activity per week). a) if they were pregnant, b)had an eating disorder c)or a medical condition which prohibited from participating in physical activity Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 63 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 01/02/2020 University of Pretoria Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Room 4-60, Level 4, Tswelopele Building, University of Pretoria, Private Bag x323 Pretoria 0007 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome was the percentage change in Framingham score at 12 months relation to baseline. The non-laboratory based CVD risk score (Framingham) was used to calculate the predicted 10-year risk of cardiovascular disease (CVD) (%) based on age, sex, systolic blood pressure, treatment of hypertension, body mass index (BMI), smoking and diabetes status (Loeppke, Edington & Bég, 2010). Baseline and 12 months
Secondary Outcome Changes in single NCD risk factor levels at 12 months relative to baseline. Baseline to 12 months
Secondary Outcome An NCD risk category change, based on the number of risk factors for NCDs (0-8), was also determined for each participant. All eight NCD risk factors were summed and the risk for each participant was categorised as follows: low risk (0-2 risk factors), moderate risk (3-4 risk factors) or high risk (≥5 risk factors).(Loeppke, Edington & Bég, 2010). Baseline and 12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Bankmed 302B, Melrose Arch, 34 Whiteley Rd, Birnam, Johannesburg 2076 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Primary Investigator 2993B Shrike Street, Thatchfield Hills Centurion 0157 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor IOC Research Center Faculty of Health Sciences, University of Pretoria, South Africa Pretoria 0020 South Africa University
Secondary Sponsor Medical Research Council Francie Van Zijl Dr, Parow Valley Cape Town 7501 South Africa Research Council
Secondary Sponsor Oglivy South Africa The Brand Building, 15 Sloane Street, Bryanston Johannesburg 2152 South Africa Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Paola Wood paola.wood@up.ac.za +27124206046 Department of Physiology, School of Medicine, University of Pretoria
City Postal code Country Position/Affiliation
Pretoria 0020 South Africa Supervisor
Role Name Email Phone Street address
Principal Investigator Nceba Hene ncebahene@hotmail.com +27835787410 2993B Shrike Street, Thatchfield Hills
City Postal code Country Position/Affiliation
Centurion 0157 South Africa PhD Student
Role Name Email Phone Street address
Public Enquiries Nceba Hene ncebahene@hotmail.com +27835787410 2993B Shrike Street, Thatchfield Hills
City Postal code Country Position/Affiliation
Centurion 0157 South Africa PhD Student
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared. The Study Protocol, Statistical Analysis Plan, Informed and Consent form will be made available. Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication and no end date Proposal should be directed to ncebahene@hotmail.com. To gain access, data requestors will need to sign a data access agreement. Data are available for 20 years at the university data warehouse.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 09/02/2022 29/12/2021
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 09/02/2022
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information