Changes to trial information |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Study Design |
Block size |
29/03/2019 |
Based on the response rate of the first 4 clusters, 4 additional clusters have been added so that the target of 6000 participants can be reached. |
Block was 6 for first 6 clusters and block size was 24 for the remaining 24 clusters 30 clusters in total. |
Block was 6 for first 6 clusters and block size was 24 for the remaining 30 clusters 34 clusters in total. |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Study Design |
Allocation sequence |
22/07/2019 |
Since the trial changed from cluster to individual randomisation, the method for randomisation needed to be changed. |
Permuted block randomization |
Simple randomization using a randomization table created by a computer software program |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Intervention |
Intervention List |
22/07/2019 |
Due to difficulties with recruitment, peer group sessions with young women were not found to be feasible. |
Experimental Group, Bukhali, 1 monthly peer group session, plus 1 monthly one-on-one session with a community health worker, 18 months, Peer group sessions: topic experts and a specialised CHW curriculum developer integrated the behaviour change theory and approach and designed a facilitator’s manual for the CHWs. The peer group sessions cover 9 modules (women’s health, chronic diseases, diet, sleep, physical activity and fitness, sitting, body size and image, emotional awareness, and caregiving) in 6 sessions, and these modules repeat with new content every 6 sessions. A resource book has been developed for young women, which contains some of the essential content, as well as, space for participants to engage with the material through the use of checklists, diaries and reflections.
Individual (private) sessions: are designed to provide feedback to young women (for example, Hb status, nutritional status, blood pressure), offer services (home-based HIV and pregnancy testing), engage through Healthy Conversations to identify aspects of behaviour change, set goals and monitor, provide support to the family as needed and directed by the young women, and provide access to a healthcare referral network.
Multi-micronutrient supplement: the CHW will dispense and monitor the micronutrient supplement use. The MMN supplement is based on WHO recommendations with 27mg of Fe. Participants that are determined to be anaemic will take daily supplements. Participants that have normal Hb levels will take the supplement twice a week. All participants will have their Hb concentrations assessed every 6months. The micronutrient breakdown is stipulated in the information sheet.
, 3000, |
Experimental Group, Bukhali, 1 monthly one-on-one session with a community health worker, either delivered in person, or telephonically., 18 months, Individual (private) sessions: are designed to provide feedback to young women (for example, Hb status, nutritional status, blood pressure), offer services (home-based HIV and pregnancy testing), engage through Healthy Conversations to identify aspects of behaviour change, set goals and monitor, provide support to the family as needed and directed by the young women, and provide access to a healthcare referral network.
Participants receive a resource book that was developed by topic experts and a specialised CHW curriculum developer, which integrate behaviour change theory and approach. A similar facilitator’s manual is available for the CHWs. The resource book and facilitator's manual cover 8 modules (women’s health, chronic diseases, diet, sleep, physical activity and fitness, sitting, body size and image, and emotional awareness) in 18 sessions. The resource book contains essential content, as well as space for participants to engage with the material through the use of checklists, diaries and reflections.
Multi-micronutrient supplement: the CHW will dispense and monitor the micronutrient supplement use. The MMN supplement is based on WHO recommendations with 27mg of Fe. Participants that are determined to be anaemic will take daily supplements. Participants that have normal Hb levels will take the supplement twice a week. All participants will have their Hb concentrations assessed every 6months. The micronutrient breakdown is stipulated in the information sheet., 3000, |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Official scientific title |
12/11/2021 |
Cluster randomisation proved not to be feasible. |
A preconception cluster randomised controlled trial, part of the Healthy Life Trajectories Initiative (HeLTI) |
A preconception individually randomised controlled trial, part of the Healthy Life Trajectories Initiative (HeLTI) |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Anticipated date of last follow up |
12/11/2021 |
Follow up of offspring will be at 60 months, and recruitment of pregnant participants is ongoing. |
31 Dec 2021 |
31 Dec 2026 |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Intervention |
Intervention List |
12/11/2021 |
Further details have become available about the pregnancy and postnatal intervention, as these have been developed. |
Experimental Group, Bukhali, 1 monthly one-on-one session with a community health worker, either delivered in person, or telephonically., 18 months, Individual (private) sessions: are designed to provide feedback to young women (for example, Hb status, nutritional status, blood pressure), offer services (home-based HIV and pregnancy testing), engage through Healthy Conversations to identify aspects of behaviour change, set goals and monitor, provide support to the family as needed and directed by the young women, and provide access to a healthcare referral network.
Participants receive a resource book that was developed by topic experts and a specialised CHW curriculum developer, which integrate behaviour change theory and approach. A similar facilitator’s manual is available for the CHWs. The resource book and facilitator's manual cover 8 modules (women’s health, chronic diseases, diet, sleep, physical activity and fitness, sitting, body size and image, and emotional awareness) in 18 sessions. The resource book contains essential content, as well as space for participants to engage with the material through the use of checklists, diaries and reflections.
Multi-micronutrient supplement: the CHW will dispense and monitor the micronutrient supplement use. The MMN supplement is based on WHO recommendations with 27mg of Fe. Participants that are determined to be anaemic will take daily supplements. Participants that have normal Hb levels will take the supplement twice a week. All participants will have their Hb concentrations assessed every 6months. The micronutrient breakdown is stipulated in the information sheet., 3000, |
Experimental Group, Bukhali, 1 monthly one-on-one session with a community health worker, either delivered in person, or telephonically., 18 months, if no pregnancy. If participant becomes pregnant, the duration will be 60 months (to correspond with age of offspring)., Individual (private) sessions: are designed to provide feedback to young women (for example, Hb status, nutritional status, blood pressure), offer services (home-based HIV and pregnancy testing), engage through Healthy Conversations to identify aspects of behaviour change, set goals and monitor, provide support to the family as needed and directed by the young women, and provide access to a healthcare referral network.
Participants receive a resource book that was developed by topic experts and a specialised CHW curriculum developer, which integrate behaviour change theory and approach. A similar facilitator’s manual is available for the CHWs. The resource book and facilitator's manual cover 8 modules (women’s health, chronic diseases, diet, sleep, physical activity and fitness, sitting, body size and image, and emotional awareness) in 18 sessions. The resource book contains essential content, as well as space for participants to engage with the material through the use of checklists, diaries and reflections.
For the pregnancy and postnatal period, the South African Department of Health Road to Health book provides the framework for the intervention, and the CHWs use a facilitator manual to guide their monthly contact sessions. In the infancy and early childhood period, participants receive a facilitator manual to guide monthly contact sessions, drawing on content to promote early childhood development and the prevention of early childhood obesity.
Multi-micronutrient supplement: the CHW will dispense and monitor the micronutrient supplement use. The MMN supplement is based on WHO recommendations with 27mg of Fe. Participants that are determined to be anaemic will take daily supplements. Participants that have normal Hb levels will take the supplement twice a week. All participants will have their Hb concentrations assessed every 6months. The micronutrient breakdown is stipulated in the information sheet., 3000, |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Intervention |
Intervention List |
12/11/2021 |
Further details have become available about the pregnancy and postnatal intervention, as these have been developed. |
Control Group, Bukhali Call Centre, 1 call per month, follow-up email or WhatsApp communication, 18 months, Control arm (standard of care plus): materials are developed for a call centre intervention that covers practical life skills. Information will be provided via email, SMS and telephonic conversation. The call centre team will offer centre-based HIV and pregnancy testing and counselling. , 3000, Active-Treatment of Control Group |
Control Group, Bukhali Call Centre, 1 call per month, follow-up email or WhatsApp communication, 18 months, if no pregnancy. If participant becomes pregnant, the duration will be 60 months (to correspond with age of offspring).
, Control arm (standard of care plus): materials are developed for a call centre intervention that covers practical life skills. Information will be provided via email, SMS and telephonic conversation. The call centre team will offer centre-based HIV and pregnancy testing and counselling. , 3000, Active-Treatment of Control Group |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Eligibility |
Inclusion criteria |
12/11/2021 |
Expanded age range to boost recruitment. |
(i) women age 18-25 years at baseline measurement |
(i) women age 18-28 years at baseline measurement |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Eligibility |
Maximum age |
12/11/2021 |
Expanded age range to boost recruitment. |
25 Year(s) |
28 Year(s) |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Ethics |
Ethics List |
06/12/2021 |
Approval for additional measures |
|
TRUE, University of the Witwatersrand Human Research Ethics Committee Medical, Research Office, Faculty of Health Sciences, Phillip Tobias Building, Offices 301-304, 3rd Floor, Cnr York Road and 29 Princess of Wales Terrace, Parktown, Johannesburg, 2193, South Africa, , 23 Jun 2020, +27117171252, HREC-Medical.ResearchOffice@wits.ac.za, 6015_15726_4737.pdf |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Ethics |
Ethics List |
06/12/2021 |
Approval for amendment to participant information sheet |
|
TRUE, University of the Witwatersrand Human Research Ethics Committee Medical, Research Office, Faculty of Health Sciences, Phillip Tobias Building, Offices 301-304, 3rd Floor, Cnr York Road and 29 Princess of Wales Terrace, Parktown, Johannesburg, 2193, South Africa, , 03 Dec 2021, +27117171252, HREC-Medical.ResearchOffice@wits.ac.za, 6015_15727_4737.pdf |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Ethics |
Ethics List |
06/12/2021 |
Data governance framework |
|
TRUE, University of the Witwatersrand Human Research Ethics Committee Medical, Research Office, Faculty of Health Sciences, Phillip Tobias Building, Offices 301-304, 3rd Floor, Cnr York Road and 29 Princess of Wales Terrace, Parktown, Johannesburg, 2193, South Africa, , 06 Dec 2021, +27117171252, HREC-Medical.ResearchOffice@wits.ac.za, 6015_15728_4737.pdf |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Ethics |
Ethics List |
06/12/2021 |
Updated email address |
TRUE, University of the Witwatersrand Human Research Ethics Committee Medical, Research Office, Faculty of Health Sciences, Phillip Tobias Building, Offices 301-304, 3rd Floor, Cnr York Road and 29 Princess of Wales Terrace, Parktown, Johannesburg, 2193, South Africa, , 02 Feb 2019, +27117171252, zanele.ndlovu@wits.ac.za, 6015_5297_4737.pdf |
TRUE, University of the Witwatersrand Human Research Ethics Committee Medical, Research Office, Faculty of Health Sciences, Phillip Tobias Building, Offices 301-304, 3rd Floor, Cnr York Road and 29 Princess of Wales Terrace, Parktown, Johannesburg, 2193, South Africa, , 02 Feb 2019, +27117171252, HREC-Medical.ResearchOffice@wits.ac.za, 6015_5297_4737.pdf |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Public title |
08/02/2022 |
To be more specific in the title |
Bukhali: Building knowledge, optimising physical and mental health, and setting up healthier life trajectories in South Africa |
Bukhali: Building knowledge, optimising physical and mental health, and setting up healthier life trajectories in South African women |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Target no of participants |
08/02/2022 |
No change |
6000 |
6800 |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Outcome |
OutCome List |
08/02/2022 |
Slight editing of wording to be more precise. |
Secondary Outcome, Child - Anthropometric Outcomes: (a) age- and sex-standardized continuous BMI-z score, (b) BMI growth trajectories, (c) continuous waist circumference z- score, (d) upper arm circumference, (e) head circumference., 5 years old, index child |
Secondary Outcome, Child - 1. Anthropometry (age- and sex-standardized continuous BMI-z score, BMI growth trajectories, continuous waist circumference z- score, upper arm circumference, head circumference), 5 years old, index child |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Outcome |
OutCome List |
08/02/2022 |
Removed numbering |
Secondary Outcome, Child - 1. Anthropometry (age- and sex-standardized continuous BMI-z score, BMI growth trajectories, continuous waist circumference z- score, upper arm circumference, head circumference), 5 years old, index child |
Secondary Outcome, Child - Anthropometry (age- and sex-standardized continuous BMI-z score, BMI growth trajectories, continuous waist circumference z- score, upper arm circumference, head circumference), 5 years old, index child |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Outcome |
OutCome List |
08/02/2022 |
Slight editing of wording to be more precise. |
Secondary Outcome, Child - Cardiometabolic Outcomes: (a) cardiometabolic risk score, (b) systolic and diastolic blood pressure, (c) total, non-HDL, LDL, triglyceride and HDL cholesterol, glucose, insulin, HOMA-IR, hsCRP, HbA1C, 5 years old, index child |
Secondary Outcome, Child - Cardiometabolic Outcomes: (systolic and diastolic blood pressure, lipid profile, glucose, insulin, insulin resistance), 5 years old, index child |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Outcome |
OutCome List |
08/02/2022 |
Slight editing of wording to be more precise. |
Secondary Outcome, Child - Health Behaviour Outcomes: (a) nutrition, (b) physical activity, (c) screen time, (d) sleep time, 5 years old, index child |
Secondary Outcome, Child - Health Behaviour Outcomes: dietary intake, physical activity, screen time, sedentary behaviour, sleep time, 5 years old, index child |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Outcome |
OutCome List |
08/02/2022 |
Slight editing of wording to be more precise. |
Secondary Outcome, Child - Developmental and Mental Health Outcomes: (a) cognitive, (b) behavioural, (c) emotional, 5 years old, index child |
Secondary Outcome, Child - Developmental and Mental Health Outcomes: cognitive, motor skills, communication, behavioural, 5 years old, index child |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Outcome |
OutCome List |
08/02/2022 |
Changed due to update in protocol. |
Secondary Outcome, Child - School Readiness Outcomes, 5 years old, index child |
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Outcome |
OutCome List |
08/02/2022 |
Changed due to update in protocol. |
Secondary Outcome, Child - Health Care Utilisation Outcomes: (a) unplanned hospital admissions, (b) emergency department visits, (c) routine and non-routine use of services, 5 years old, index child |
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Outcome |
OutCome List |
08/02/2022 |
Slight editing of wording to be more precise. |
Secondary Outcome, Mother - Anthropometric Outcomes: (a) overweight and obesity (OWO), (b) body composition, (c) waist circumference, 2 years postpartum |
Secondary Outcome, Mother - Anthropometric Outcomes: overweight and obesity (OWO), DXA-derived body composition, waist circumference, 2 years postpartum |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Outcome |
OutCome List |
08/02/2022 |
Slight editing of wording to be more precise. |
Secondary Outcome, Mother - Health Behaviour Outcomes: (a) nutrition, (b) physical activity, (c) screen time, (d) sleep time , 2 years postpartum |
Secondary Outcome, Mother - Health Behaviour Outcomes: dietary patterns, physical activity, screen time, sedentary behaviour, sleep time, tobacco and alcohol use, 2 years postpartum |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Outcome |
OutCome List |
08/02/2022 |
Slight editing of wording to be more precise. |
Secondary Outcome, Mother - Mental Health Outcomes: (a) depressive symptoms, (b) anxiety, (c) life stress, 2 years postpartum |
Secondary Outcome, Mother - Mental Health Outcomes: depressive symptoms, anxiety, 2 years postpartum |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Outcome |
OutCome List |
08/02/2022 |
Update to protocol |
Secondary Outcome, Mother - Relationship Outcomes: (a) relationship satisfaction, (b) social support, 2 years postpartum |
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Outcome |
OutCome List |
08/02/2022 |
Update to protocol. |
Secondary Outcome, Mother - Parenting Behaviour Outcomes: (a) co-parenting, (b) parenting style, (c) parenting self-efficacy, (d) parenting stress, 2 years postpartum |
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Outcome |
OutCome List |
08/02/2022 |
Update to protocol. |
Secondary Outcome, Mother - Health Service Utilisation Outcomes. (a) unplanned hospital admissions, (b) emergency department visits, (c) routine and non-routine use of physician services, 2 years postpartum |
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Outcome |
OutCome List |
08/02/2022 |
Edited to be more specific. |
|
Secondary Outcome, Nutrition - aneamia, 2 years postpartum |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Outcome |
OutCome List |
08/02/2022 |
Edited to be more specific. |
|
Secondary Outcome, Physical health - hypertension, 2 years postpartum |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Final no of participants |
16/02/2022 |
We will recruit approximately 6800 women so reach a target of 1530 pregnancies |
|
1530 |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Final no of participants |
16/02/2022 |
We will recruit approximately 6800 women to reach a target of 1530 pregnancies |
1530 |
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Target no of participants |
16/02/2022 |
No change |
6800 |
0 |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Target no of participants |
16/02/2022 |
No change |
0 |
6800 |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Target no of participants |
25/02/2022 |
Target number of pregnant participants |
6800 |
1530 |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Final no of participants |
25/02/2022 |
Still to be established |
1530 |
|