Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000547943
Ethics application status
Approved
Date submitted
30/03/2020
Date registered
8/05/2020
Date last updated
6/11/2020
Date data sharing statement initially provided
8/05/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Beyond the Bump: Lifestyle Behaviours for Healthy Mums
Scientific title
Postpartum Community Program for Lifestyle (Diet and Exercise) Changes for Healthy Mums
Secondary ID [1] 300871 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
postpartum <1 year post-delivery women 316793 0
type 2 diabetes 316794 0
gestational diabetes 316795 0
Condition category
Condition code
Reproductive Health and Childbirth 315008 315008 0 0
Childbirth and postnatal care
Metabolic and Endocrine 315012 315012 0 0
Other metabolic disorders
Metabolic and Endocrine 315157 315157 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention includes attending the 'Beyond the Bump' community walk and talk program at the local park in which participants (n=25 per group; 100 total) will be offered postnatal care advice from experts in their fields for 15-20 min before engaging in a 30-minute walk in the community (borg scale 9-13/20) once a week for 10 weeks. Topics given will include dietetics, women's health physiotherapy, exercise physiology, psychology, child CPR, and neonatal development given by dietitians, women's health physiotherapists, exercise physiologists, psychologists, neonatology nurses, and neonatal developmental specialists.
Attendance will be taken at the beginning of each session to assess adherence.
Non-randomised trial. Participants that attend the intervention will be eligible to join the 'intervention' group. Participants that do not attend the intervention are eligible to join the control group.
Intervention code [1] 317194 0
Prevention
Intervention code [2] 317195 0
Lifestyle
Comparator / control treatment
The control group will not attend the intervention but will complete the same measures 10-weeks apart. The control received standard-care advice alone, provided by ISLHD Antenatal clinic.
Control group
Active

Outcomes
Primary outcome [1] 323313 0
Changes in moderate-vigorous physical activity levels (MVPA: min.day-1 and min.wk-1) as measured through an accelerometer
Timepoint [1] 323313 0
before versus following 10-wks intervention/control
Primary outcome [2] 323327 0
Changes in sedentary time (min.day-1 and min.wk-1) as measured by an accelerometer
Timepoint [2] 323327 0
before versus following 10-wks intervention/control
Primary outcome [3] 323328 0
Changes in Diet quality, Nutrient Reference Values for Australia and New Zealand and recommended food group serving sizes based on the Australian Guide to Healthy Eating in Pregnancy to determine nutritional adequacy as measured through detailed 3-day diet records (analysed in Foodworks).
Timepoint [3] 323328 0
Before versus following 10-wks intervention/control
Secondary outcome [1] 381583 0
Changes in caloric intake as measured through detailed 3-day food record (analysed in Foodworks)
Timepoint [1] 381583 0
Before versus following 10-wks intervention/control
Secondary outcome [2] 381584 0
Changes in macronutrient requirements being met as measured through detailed 3-day food record (analysed in Foodworks)
Timepoint [2] 381584 0
Before versus following 10-wks intervention/control
Secondary outcome [3] 381585 0
Changes in supplementation use as measured through detailed 3-day food record (analysed in Foodworks)
Timepoint [3] 381585 0
Before versus following 10-wks intervention/control
Secondary outcome [4] 381586 0
changes in maternal well being as measured through the SF-36 questionnaire
Timepoint [4] 381586 0
Before versus following 10-wks intervention/control
Secondary outcome [5] 381587 0
Changes in maternal mental health (depression, anxiety, and stress) as measured through a DASS questionnaire
Timepoint [5] 381587 0
Before versus following 10-wks intervention/control
Secondary outcome [6] 381588 0
Changes in lifestyle intentions as measured through a 12 item outcome expectations questionnaire.
Timepoint [6] 381588 0
Before versus following 10-wks intervention/control
Secondary outcome [7] 381589 0
Changes in maternal body composition (% body fat) as measured with a DEXA scan
Timepoint [7] 381589 0
Before versus following 10-wks intervention/control
Secondary outcome [8] 381590 0
Incidence of chronic disease (ie. Type 2 Diabetes) through data linkage to medical records.
Timepoint [8] 381590 0
12mo. 24mo, 5y, 10y post delivery
Secondary outcome [9] 381591 0
Changes in maternal sleep duration (min.night-1, min.wk-1) measured with an Actigraph accelerometer
Timepoint [9] 381591 0
Before versus following 10-wks intervention/control
Secondary outcome [10] 381592 0
Changes in maternal sleep interruptions (interruptions.night-1, interruptions.wk-1) measured with an Actigraph accelerometer
Timepoint [10] 381592 0
Before versus following 10-wks intervention/control
Secondary outcome [11] 381596 0
Changes in physical activity patterns (min.day-1, min.wk-1) in the control group during isolation measures due to COVID-19 (Level 3 and 4) of 2020 to the control group of no isolation 2021 as measured with an Actigraph accelerometer.
Timepoint [11] 381596 0
Before versus following 10-wks intervention/control (2020 vs 2021).
Secondary outcome [12] 381598 0
macronutrient percentage of total energy as measured through detailed 3-day food record (analysed in Foodworks)
Timepoint [12] 381598 0
Before versus following 10-wks intervention/control
Secondary outcome [13] 382364 0
Incidence of chronic disease (ie. Gestational Diabetes) through data linkage to medical records.
Timepoint [13] 382364 0
12mo. 24mo, 5y, 10y post delivery
Secondary outcome [14] 382365 0
Incidence of chronic disease (ie. Pre-diabetes) through data linkage to medical records.
Timepoint [14] 382365 0
12mo. 24mo, 5y, 10y post delivery

Eligibility
Key inclusion criteria
• Delivered a baby in the last 12 months; and
• Any woman previously diagnosed with GDM
OR
• Women who have had any of the following risk factors for GDM:
- Overweight or Obese (Body Mass Index >25 kg/m2)
- aged 40 years or over
- a family history of type 2 diabetes or a first-degree relative (mother or sister) who has had gestational diabetes
- elevated blood glucose levels in the past
- Aboriginal and Torres Strait Islander backgrounds
- Melanesian, Polynesian, Chinese, Southeast Asian, Middle Eastern or Indian background
- Polycystic Ovary Syndrome 
- previously given birth to a large baby (weighing more than 4.5kg)
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria:
• < 18 years of age
• diagnosed Type 1 or 2 Diabetes
• Presence of any absolute contraindications to exercise/walking (including musculoskeletal and joint)

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2020
Actual
1/05/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
10
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 29698 0
2522 - University Of Wollongong

Funding & Sponsors
Funding source category [1] 305322 0
University
Name [1] 305322 0
University of Wollongong Community Engagement Grant (CEG)
Country [1] 305322 0
Australia
Primary sponsor type
University
Name
University of Wollongong
Address
Northfields Avenue,
Wollongong,
NSW,
2522
Country
Australia
Secondary sponsor category [1] 305690 0
None
Name [1] 305690 0
Address [1] 305690 0
Country [1] 305690 0
Other collaborator category [1] 281252 0
Government body
Name [1] 281252 0
Illawarra Shoalhaven Local Health District Diabetes Service
Address [1] 281252 0
Level 2,
304 Crown St
Wollongong
NSW
2500
Country [1] 281252 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305661 0
Joint UOW and ISLHD Health and Medical Human Research Ethics Committee
Ethics committee address [1] 305661 0
The University of Wollongong,
Northfields Avenue,
Wollongong,
NSW,
2522
Ethics committee country [1] 305661 0
Australia
Date submitted for ethics approval [1] 305661 0
16/01/2020
Approval date [1] 305661 0
24/03/2020
Ethics approval number [1] 305661 0
2019/ETH13571

Summary
Brief summary
To conduct a proof-of-concept trial to determine whether an ‘after delivery’ community care (education & physical activity) program impacts physical activity levels, diet quality, health behaviour and attitudes, and reduces risk factors for and incidence of Type 2 Diabetes in the 10 years post-delivery in mothers with a history of or risk factors for GDM, compared to control no=intervention.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101130 0
Dr Monique Francois
Address 101130 0
The University of Wollongong
Northfields Avenue,
Wollongong,
NSW,
2522
Country 101130 0
Australia
Phone 101130 0
+61 2 4221 5136
Fax 101130 0
Email 101130 0
[email protected]
Contact person for public queries
Name 101131 0
Dr Monique Francois
Address 101131 0
The University of Wollongong
Northfields Avenue,
Wollongong,
NSW,
2522
Country 101131 0
Australia
Phone 101131 0
+61 2 4221 5136
Fax 101131 0
Email 101131 0
[email protected]
Contact person for scientific queries
Name 101132 0
Dr Monique Francois
Address 101132 0
The University of Wollongong
Northfields Avenue,
Wollongong,
NSW,
2522
Country 101132 0
Australia
Phone 101132 0
+61 2 4221 5136
Fax 101132 0
Email 101132 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.