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.: PACTR201903750173871 Date of Approval: 27/03/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Bukhali: Building knowledge, optimising physical and mental health, and setting up healthier life trajectories in South African women
Official scientific title A preconception individually randomised controlled trial, part of the Healthy Life Trajectories Initiative (HeLTI)
Brief summary describing the background and objectives of the trial Does a integrated continuum of care intervention (4-phases) starting pre-conception and continued across the lifecourse (pregnancy, infancy and childhood) reduce childhood adiposity and the risk for NCDs, as well as improve measures of child development?
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine,Obesity,Paediatrics,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/04/2019
Actual trial start date
Anticipated date of last follow up 31/12/2026
Actual Last follow-up date
Anticipated target sample size (number of participants) 1530
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 Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
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
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
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
(i) women age 18-28 years at baseline measurement (i) women with type-I diabetes, cancer or epilepsy (ii) intellectual disability (iii) who are not able or willing to provide consent Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 18 Year(s) 28 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 02/02/2019 University of the Witwatersrand Human Research Ethics Committee Medical
Ethics Committee Address
Street address City Postal code Country
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
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 23/06/2020 University of the Witwatersrand Human Research Ethics Committee Medical
Ethics Committee Address
Street address City Postal code Country
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
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 03/12/2021 University of the Witwatersrand Human Research Ethics Committee Medical
Ethics Committee Address
Street address City Postal code Country
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
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 06/12/2021 University of the Witwatersrand Human Research Ethics Committee Medical
Ethics Committee Address
Street address City Postal code Country
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
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Child - Dual-energy X-ray absorptiometry-derived fat mass index (fat mass/height2) of the index-child at age 5 years 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
Secondary Outcome Child - Cardiometabolic Outcomes: (systolic and diastolic blood pressure, lipid profile, glucose, insulin, insulin resistance) 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
Secondary Outcome Child - Developmental and Mental Health Outcomes: cognitive, motor skills, communication, behavioural 5 years old, index child
Secondary Outcome Mother - Anthropometric Outcomes: overweight and obesity (OWO), DXA-derived body composition, waist circumference 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
Secondary Outcome Mother - Mental Health Outcomes: depressive symptoms, anxiety 2 years postpartum
Secondary Outcome Nutrition - aneamia 2 years postpartum
Secondary Outcome Physical health - hypertension 2 years postpartum
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
South African Medical Research Council Developmental Pathways for Health Research Unit University of the Witwatersrand Chris Hani Baragwanath Hospital, 26 Chris Hani Road, Soweto Johannesburg 1864 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
South African Medical Research Council Francie van Zijl Drive, Parowvallei Cape Town 7505 South Africa
Canadian Institutes for Health Research 160 Elgin Street, 10th Floor Ottawa Canada
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor South African Medical Research Council Developmental Pathways for Health Research Unit University of the Witwatersrand Chris Hani Baragwanath Hospital, 26 Chris Hani Road, Soweto Johannesburg 1864 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Professor Stephen Lye Lunenfeld-Tanenbaum Research Institute, Sinai Health System, Toronto and Departments of Obstetrics and Gynecology, Physiology and Medicine, University of Toronto Toronto Canada
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Shane Norris shane.norris@wits.ac.za +829282381 Chris Hani Baragwanath Hospital, 26 Chris Hani Road, Soweto
City Postal code Country Position/Affiliation
Johannesburg 1864 South Africa Research Professor and Director
Role Name Email Phone Street address
Public Enquiries Lisa Micklesfield lisa.micklesfield@wits.ac.za +27119331122 DPHRU, Wits Medical School, York Road
City Postal code Country Position/Affiliation
Johannesburg 2198 South Africa Associate Professor and Deputy Director
Role Name Email Phone Street address
Scientific Enquiries Catherine Draper catherine.draper@wits.ac.za +27119331122 DPHRU, Wits Medical School, York Road
City Postal code Country Position/Affiliation
Johannesburg 2198 South Africa Senior Researcher and Associate Director
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes As the trial progresses through the four phases, data and samples will become available for analyses. Through the HeLTI Global Office in Toronto, data and biological sample requests from any or all of the trial sites can be made following the process as detailed on the HeLTI website. Informed Consent Form,Study Protocol TBC TBC
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
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