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.: PACTR201805003336174 Date of Approval: 20/04/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title IINDIAGO
Official scientific title An integrated health system intervention aimed at reducing type 2 diabetes risk in women after gestational diabetes in South Africa (IINDIAGO): a randomized controlled trial
Brief summary describing the background and objectives of the trial Background Women with a history of gestational diabetes (GDM) are at high risk of later development of type 2 diabetes and cardiovascular disease. In South Africa, data from unpublished ongoing studies show that there is a high prevalence of GDM (15%) and a high proportion of women with a history of GDM progress to type 2 diabetes (>40%) in the 5-year period after the pregnancy. IINDIAGO is a health system intervention, which aims to integrate the provision of post-natal care and intervention to prevent progression to T2DM in the mother with the scheduled post-partum care of her baby. Methods IINDIAGO is a convergent parallel mixed methods study with the main component being a phase 2, 2-arm parallel individually randomised controlled trial, which will be carried out at 4 major referral centres and up to 12 well-baby clinics in the Western Cape and Gauteng provinces of South Africa. Participants in the trial will be randomized 1:1 to either intervention or control using standard techniques, 390 participants with GDM (with no history of either type 1 or type 2 diabetes) will be recruited into the study at 32 to 33 weeks¿ gestational age. Data collection will take place between 29 and 33 weeks¿ pregnancy and at 6-8 weeks after delivery and again at 12 months. Each participant will be followed up for 12 months. The intervention will consist of a number of behavioural change components administered at various time points; during the hospital stay or hospital based GDM clinic visits, at Well-Baby clinics and in the community. Controls will receive standard usual care. The primary outcomes for the trial will be the completion of a 2-hour oral glucose tolerance test at 6-8 weeks after the pregnancy and a composite (percentage weight change>5%, percentage change in waist circumference >3%, normoglycaemia) diabetes risk reduction indicator at 12 months. Ethics approval has been granted by UCT, Wits U, Stellenbosch U and at U Montreal.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) IINDIAGO
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine,Pregnancy and Childbirth,type 2 diabetes, gestational diabetes
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 24/04/2018
Actual trial start date
Anticipated date of last follow up 31/05/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 370
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL not yet published
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 Permuted block randomisation (please state block size and whether or not the block size was variable) and Stratified allocation where factors such as age, gender, centre, or previous treatment are used in the stratification (please specify factors used for stratification) Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Post-partum lifestyle interventions for the prevention of progression to T2DM among GDM women Brief counseling sessions, of variable duration 1 year 1. Hospital based antenatal intervention: 2 brief, face-to-face counselling sessions. 2. Post-partum clinic based intervention: point of care OGTT at the routine 6-week post-partum visit. 3. Brief behavior change counselling: 4 brief, face-to-face counselling sessions. 4. Community based intervention: Home visits in between the counselling sessions & 3 Peer support group sessions. 185
Control Group Control or usual care Brief lifestyle change advice during hospital stay 1 year Typically, GDM women receive some health education and advice on lifestyle from healthcare providers during routine antenatal care. 185 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Women who fulfil the following criteria will be eligible for initial inclusion: 1. Diagnosed with GDM using standard criteria (specify) defined by the research team. 2. Currently living in the community served by the clinics included in the study and planning to remain in the area for the next year 3. Participant is willing and able to give informed consent for participation in the study. 4. Able to communicate in one of the predominant official languages spoken in the Western Cape (Cape Town) and Gauteng (Johannesburg) provinces (e.g. English, Afrikaans, isiXhosa, isiZulu and Sesotho) Women with the following characteristics will not be included in the study: 1. Women who had T2DMM or type 1 diabetes prior to the index pregnancy 2. Post-delivery, women are diagnosed with diabetes at the postpartum OGTT 3. Post- delivery women who have stillbirths or infants who die before 6 weeks 18 Year(s) 60 Year(s) Female
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 21/11/2016 UCT HREC
Ethics Committee Address
Street address City Postal code Country
observatory Cape Town 7925 South Africa
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 27/03/2017 Human Research Ethics Committee Univ Witwatersrand
Ethics Committee Address
Street address City Postal code Country
York Road Johannesburg 2193 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Completion of the 6-weeks OGTT (yes/no variable) 6-8 weeks post pregnancy
Primary Outcome The change in diabetes risk at 12 months 12 months after delivery
Secondary Outcome weight change 12 months after delivery
Secondary Outcome Absolute waist circumference 12 months after delivery
Secondary Outcome f. T2DM and dysglycaemia measured using fasting and 2-hour OGTT blood glucose 12 months after pregnancy
Secondary Outcome g. Insulin resistance (HOMA-IR) and 2-hour OGTT insulin 12 months post delivery
Secondary Outcome Indicators of psychosocial health 12 months post delivery
Secondary Outcome diet intake 12 months post delivery
Secondary Outcome blood pressure 12 months post delivery
Secondary Outcome physical activity 12 months post delivery
Secondary Outcome breast feeding history 12 months post partum
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Chris Hani Baragwanath hospital Soweto Soweto 1864 South Africa
Tygerberg hospital Tygerberg Cape Town 7505 South Africa
Mowbray Maternity Hospital Mowbray Cape Town 7700 South Africa
Groote Schuur hospital Observatory Cape Town 7925 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
the International Development Research Centre (IDRC), grant number: 108002-001.
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Chronic Disease Initiative for Africa, J47, Old Main Building, Groote Schuur hospital, Observatory Cape Town 7925 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Tracey Naledi, South Africa Department of Health Room T20-06 Cape Town 8000 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Naomi Levitt naomi.levitt@uct.ac.za 0216506541 J47, CDIA, Old Main Building, Groote Schuur hospital, Observatory
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Director, Chronic Disease Initiative for Africa
Role Name Email Phone Street address
Public Enquiries Bee Williams bee.williams@uct.ac.za 0214066572 J47, CDIA, Old Main Building, Groote Schuur hospital, Observatory
City Postal code Country Position/Affiliation
Cape Town 7925 St. Helena Manager, Chronic Disease Initiative for Africa
Role Name Email Phone Street address
Scientific Enquiries Naomi Levitt naomi.levitt@uct.ac.za 0216506541 J47, CDIA, Old Main Building, Groote Schuur hospital, Observatory
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Director, Chronic Disease Initiative for Africa
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Please update Statistical Analysis Plan,Study Protocol Please update Please update
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 19/12/2023
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 19/12/2023
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information