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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202205591282906 Date of Registration: 13/05/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Testing the Applicability of the South African Diabetes Prevention Programme in the Eastern Cape Province
Official scientific title Testing the Applicability of the South African Diabetes Prevention Programme in the Eastern Cape Province
Brief summary describing the background and objectives of the trial Background: With 6% of the sub-Saharan African (SSA) population, it is estimated that South Africa (SA) is currently home to almost 14% of the estimated 19 million people living with diabetes in SSA. Recent population-based surveys have revealed a particularly high prevalence of diabetes (13-28%) and pre-diabetes (12-20%) among previously underserved Black and Coloured South Africans. Therefore, urgent efforts are needed both to diagnose and appropriately manage South Africans with diabetes, as well as to prevent the progression to diabetes among those at high risk. While, there is convincing and definitive evidence on the effectiveness of lifestyle interventions in preventing the progression of diabetes among high risk people in high income countries, little is known about appropriate intervention methods and approaches to be used in SA (within all nine provinces) and other SSA countries. The South African Diabetes Prevention Programme (SA- DPP) was initiated to generate such evidence for SA and inform similar initiatives in other countries in the region. The ultimate goal of the SA-DPP is to prevent or delay the occurrence of diabetes among high risk South Africans, with benefits extending to other major cardiometabolic risk factors that share behavioural determinants with T2DM. Objective: The purpose of this project is to implement and evaluate the suitability, applicability and appropriateness of the SA-DPP developed and tailored in urban populations in the Western Cape Province, in peri-urban populations in the Eastern Cape Province of South Africa. Methods: We propose to implement and evaluate a diabetes prevention programme that has been adapted for South Africa, which was based on interventions previously shown to be effective in Finland and Australia, and is currently been trialed in other developing countries, such as India. The SA-DPP trial is in its intermediate phases in Cape Town. We will use an open-labelled cluster randomized control design (CRT), with optional implementation of the intervention in the control clusters at the end of the study. 24 clusters across peri-urban communities in OR Tambo, Eastern Cape will be randomly allocated to participate in a lifestyle intervention facilitated by teams of non-professional health workers (NPHW). The project will be led by the Walter Sisulu University and the South African Medical Council along with collaboration from other leading national universities and research organisations, with further input from an international advisory group including both African and non-African based institutions. Study outcomes: The success of the programme will be assessed by comparing at 12-months participants in the clusters receiving the intervention and those in the clusters not yet receiving the intervention for: 1) change in body weight and body mass index; 2) change in blood glucose, lipids, blood pressure, and insulin sensitivity, diabetes risk score, albuminuria; 3) and incident diabetes; 4) safety and participant satisfaction. 4) Economic impact of the programme. Expected outcomes: The processes and results of this study will lead to a model for the prevention of diabetes and other diseases of lifestyles in South Africa and other countries in the region.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ECDPP
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 28/03/2022
Actual trial start date 28/03/2022
Anticipated date of last follow up 30/09/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 480
Actual target sample size (number of participants)
Recruitment status 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 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 Eastern Cape Diabetes Prevention Programme The intervention will be delivered in six sessions (excluding one introductory session) of two hours each, over a seven-week period, with SMS text messages to support the intervention from the beginning of the intervention, until nine months. The six group sessions will include education and goal setting around: Diabetes and its prevention, Diet and Nutrition, Physical Activity, Smoking, Alcohol and Stress. The overall intervention is based on empowerment ideology. 9 months The intervention The SA-DPP is an intervention comprised of three key components: (1) Home/community-based screening by non-professional health workers (NPHW) to identify those at high future risk of diabetes; (2) Delivery by NPHW (assisted by nurses and/or dieticians) of a group-based task- oriented and culturally tailored socio-behavioural counselling programme that targets the lifestyle change objectives (diet and physical activity) of the original Finnish Diabetes Prevention Study [i.e. A) <30% of total energy intake from fat; B) <10% of total energy intake from saturated fat; C) >15 grams of fibre/1000 kcal; D)>4h/week moderate level of physical activity; and E) >5% BMI reduction][37]; and (3) Structured cell-phone messaging to enhance adherence and retention. NPHW will undergo 2-weeks of training using a standardized programme, training manuals, and practical exercises. Delivery of the intervention (slightly adapted from the SA-DPP to suit funding timeline) The intervention will be delivered in six sessions (excluding one introductory session) of two hours each, over a seven-week period, with SMS text messages to support the intervention from the beginning of the intervention, until nine months. The six group sessions will include education and goal setting around: Diabetes and its prevention, Diet and Nutrition, Physical Activity, Smoking, Alcohol and Stress. The overall intervention is based on empowerment ideology [47], emphasising the participant’s ability of making informed choices, and his/her role as an independent decision-maker who takes responsibility and regulates his/her own actions. The role of NPHW (assisted by nurses and/or dieticians) will be to facilitate and moderate the discussion, giving assignments and strengthening the peer support role of the groups. Text-messaging will be used to facilitate the group session, engage participants in discussions, and for ongoing support and motivation after the group intervention. It will be informed by the model of the Indian text-messaging DP trial [48]. The programme will also encourage accessing of local community resources and support in the intervention cluster, as is recommended [49] and extensively used in DP elsewhere [50]. The SA-DPP work package tools have been developed and validated in the SA-DPP population and contains a curriculum booklet, a participant workbook and a facilitator workbook. The curriculum booklet and participant workbook has been translated into isiXhosa, which in the most spoken language in the Eastern Cape [PDFs attached as separate addendums]. Duration of intervention and follow-up evaluations The total duration of face-to-face intervention is seven weeks and the planned duration of follow-up from baseline to 12 months. Participants will receive twice weekly maintenance support in the form of text-messaging for a period of nine months from the start of the intervention. Control groups Following screening, participants in the control group will receive standard care. As there is no uniform management in South Africa for those at high risk of developing T2DM, control group participants will receive advice in the form of a healthy living resource guide that has been used in similar trials [51]. This guide will comprise culturally appropriate written and pictorial information about healthy lifestyle and lowering diabetes risk. 240
Control Group Eastern Cape Diabetes Prevention Programme The control group will receive no intervention. They will receive an optional delayed intervention, should the intervention prove successful. The control group will receive no intervention. They will receive an optional delayed intervention, should the intervention prove successful. The control group will receive no intervention. They will receive an optional delayed intervention, should the intervention prove successful. 240 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Potentially eligible participants will be identified via screening of individuals. Individuals will be included if all the following are satisfied: A. Adults (30-65 years); B. Fluent Xhosa or other dominant languages in the area (Afrikaans, English). C. Being able to give informed consent and willing to participate in a lifestyle intervention trial. D. Participants with known HIV (1/3 of adult population) fulfilling all other criteria will be included. 1. Known Diabetes 2. Active TB 3. Active Cancer 4. Pregnancy Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 30 Year(s) 65 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 29/06/2021 SAMRC Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Francie Van Zijl Drive, Parowvallei Cape Town 7505 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To determine the weight change of participants receiving a healthy lifestyle intervention at 12 months. 12 monts
Secondary Outcome To determine, at 12 months of the control and the intervention group: 1) Attainment of lifestyle intervention objectives (dietary, physical activity); 2) Mean differences in fasting blood glucose, HbA1c, BMI; 3) Changes in blood pressure, lipid profile and waist circumference; 4) Change in insulin sensitivity; 5) Change in diabetes risk score; 6) Incident diabetes 12 months
Secondary Outcome Tertiary Objective: 1) Descriptive analysis of the process involved in the intervention; 2) Qualitative feedback from intervention participants; 3) Analysis of impact on lifestyle (i.e. quality of life, dietary and physical activity behavioural changes); 4) Economic impact of the intervention. 12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
OR Tambo District Nelson Mandela Drive, Mthatha, Eastern Cape, South Africa Mthatha 5117 South Africa
O.R. Tambo district Nelson Mandela Drive, Mthatha, Eastern Cape, South Africa Tsolo South Africa
O.R. Tambo district Nelson Mandela Drive, Mthatha, Eastern Cape, South Africa Port St Johns South Africa
O.R. Tambo district Nelson Mandela Drive, Mthatha, Eastern Cape, South Africa Qumbu South Africa
O.R. Tambo district Nelson Mandela Drive, Mthatha, Eastern Cape, South Africa Flagstaff South Africa
O.R. Tambo district Nelson Mandela Drive, Mthatha, Eastern Cape, South Africa Libode South Africa
OR Tambo District Nelson Mandela Drive, Mthatha, Eastern Cape, South Africa Lusikisiki South Africa
O.R. Tambo district Nelson Mandela Drive, Mthatha, Eastern Cape, South Africa Mqanduli South Africa
O.R. Tambo district Nelson Mandela Drive, Mthatha, Eastern Cape, South Africa Ngqeleni South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Grants Innovation and Product Development South African Medical Research Council Francie Van Zijl Drive, Parowvallei Cape Town 7505 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Non Communicable Research Unit South African Medical Research Unit Francie Van Zyl Drive, Tygerberg Hospital Campus Cape Town 7505 South Africa Medical Research Council
COLLABORATORS
Name Street address City Postal code Country
Walter Sisulu University Nelson Mandela Drive, Mthatha, Eastern Cape, South Africa Mthatha South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Jillian Hill jillian.hill@mrc.ac.za +27219380811 Francie van Zyl Drive, Tygerberg Hospital Campus
City Postal code Country Position/Affiliation
Cape Town South Africa Specialist Scientist
Role Name Email Phone Street address
Principal Investigator Yandisa Yako yayako@wsu.ac.za +27475011591 Nelson Mandela Drive, Mthatha, Eastern Cape, South Africa
City Postal code Country Position/Affiliation
Mthatha South Africa Senior Lecturer and Medical Scientist
Role Name Email Phone Street address
Scientific Enquiries Jillian Hill jillian.hill@mrc.ac.za +27219380811 Francie van Zyl Drive, Tygerberg Hospital Campus
City Postal code Country Position/Affiliation
Cape Town South Africa Specialist Scientist
Role Name Email Phone Street address
Public Enquiries Jillian Hill jillian.hill@mrc.ac.za +27219380811 Francie van Zyl Drive, Tygerberg Hospital Campus
City Postal code Country Position/Affiliation
Cape Town South Africa Specialist Scientist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The data sharing policy of our organisation is still under development. As such, initially, datasets will be available for collaborative exploitation by investigators on the study. Furthermore, we will be open to collaborations with outside investigators with specific research questions to address using our data. Once the organisation’s policy on data sharing is in place, we will develop clear plans for enabling data storage while making them discoverable and accessible to potential users. These plans will address issues such as data security, compliance with participant consent, oversight structures, access policies, transparency of processes and management of resources, and appropriate recognition of dataset’s creators and maintainers. These plans will comply with applicable SA legislation including the Protection of Personal Information Act and the Promotion of Access to Information Act. Once data collection is complete, a technical description of the study and variables for use by the research community will be available on the SAMRC website, under the study webpage. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol The IPD and additional documents will be made available once the trial is complete and results have been published in an peer reviewed accredited journal. The data sharing policy of our organisation is still under development. As such, initially, datasets will be available for collaborative exploitation by investigators on the study. Furthermore, we will be open to collaborations with outside investigators with specific research questions to address using our data. Once the organisation’s policy on data sharing is in place, we will develop clear plans for enabling data storage while making them discoverable and accessible to potential users. These plans will address issues such as data security, compliance with participant consent, oversight structures, access policies, transparency of processes and management of resources, and appropriate recognition of dataset’s creators and maintainers. These plans will comply with applicable SA legislation including the Protection of Personal Information Act and the Promotion of Access to Information Act. Once data collection is complete, a technical description of the study and variables for use by the research community will be available on the SAMRC website, under the study webpage.
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