Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001528145p
Ethics application status
Submitted, not yet approved
Date submitted
5/09/2019
Date registered
5/11/2019
Date last updated
5/11/2019
Date data sharing statement initially provided
5/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
mater4newmums: A pilot randomised controlled trial investigating the effect of a mobile phone (m-health) intervention on healthy eating, physical activity and postnatal weight retention in women of prepregnancy BMI of 25 or greater
Scientific title
mater4newmums: A pilot RCT on effect of a mobile phone (m-health) intervention promoting healthy eating and physical activity on postnatal weight retention
Secondary ID [1] 297919 0
None
Universal Trial Number (UTN)
None
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gestational weight gain 312302 0
Condition category
Condition code
Diet and Nutrition 310864 310864 0 0
Obesity
Reproductive Health and Childbirth 313304 313304 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This randomised controlled trial is an evaluation of an intervention that is being designed/evaluated to target retention of excess weight retention post pregnancy, specifically targeting areas of diet, exercise and breastfeeding.
A total of 80 women will be recruited to this trial and will be randomised to two study groups: mater4newmums program (treatment), or standard care (control).
The mater4newmums program will be delivered by an automated text messaging system (Propelo, http://propelo.com.au/), designed to send individually tailored text messages which are interactive. Text message content will include links to short motivational video messages from experts in the health profession, customised texting alert system, weekly/fortnightly (as decided by participant) weight and goal self monitoring texts (interactive- participants can text back), and links to a website with detailed healthy eating and physical activity information. These messages will be received intensively over a 6 month period following the birth of their baby, plus tapered monthly texts to 12 months. This intervention/program is being developed by the principal investigator (Associate professor and dietitian) with input from other allied health staff at Mater Misericordiae Limited. Participants will be given the option to tailor the frequency of the text messages, and the goals (e.g. weight loss, eating more vegetables) and rewards (e.g. bubble bath) referred to in the text messages. The messages will also be tailored to refer to the participant and the investigator of the study by name. This program is content and text message delivery schedules of different text message types is presently under development in consultation with mothers from the hospital, thus the maximum and minimum text messages received is not yet defined.
Participants randomised to the intervention group will receive this in addition to standard clinical care (30 minute goal setting and counselling session at 34-36 weeks pregnancy), Mater Mothers Hospital 'nutrition for new mums' handout', direction to access 'nutrition for new mums' 8 minute video (matermothers.org.au) and additional dietetic resources as requested.
Standard clinical care aspects of the intervention will be delivered by dietitians at the Mater Mothers Hospital, while mater4newmums program specific components will be delivered solely by text message.
Engagement with the study text messages, and linked resources is measured and analysed.
Intervention code [1] 314138 0
Lifestyle
Intervention code [2] 314141 0
Prevention
Intervention code [3] 315899 0
Treatment: Other
Comparator / control treatment
Study 2 participants randomised to the control/usual care group will receive standard clinical care (30 minute goal setting and counselling session at 34-36 weeks pregnancy), Mater Mothers Hospital 'nutrition for new mums' handout', direction to access 'nutrition for new mums' 8 minute video (matermothers.org.au) and additional dietetic resources as requested. They will also be offered a 6-12 week postnatal telephone review (or reviews) as required.
Standard clinical care aspects of the intervention will be delivered by dietitians at the Mater Mothers Hospital.
Control group
Active

Outcomes
Primary outcome [1] 319694 0
Calculated weight loss between intervention group (mater4newmums program) and control group (usual care) based on self reported weight on study specific survey questions.
Timepoint [1] 319694 0
Baseline: 6 weeks and 6 months postpartum
Secondary outcome [1] 369199 0
Change in weight from prepregnancy to 6 months postpartum based on self reported weight on study specific survey questions.
Timepoint [1] 369199 0
6 months postpartum
Secondary outcome [2] 370705 0
Change in self reported weight from prepregnancy to 12 months postpartum based on self reported weight on study specific survey questions.
Timepoint [2] 370705 0
12 months postpartum
Secondary outcome [3] 370706 0
Calculated fruit intake (serves/d) as self reported by participants on the Fat and Fibre Behavioural Questionnaire
Timepoint [3] 370706 0
6 weeks postpartum, 6 months postpartum, 12 months postpartum
Secondary outcome [4] 370734 0
Calculated physical activity levels (minutes/week) as self-reported by participants on the Active Australia Survey.
Timepoint [4] 370734 0
6 weeks postpartum, 6 months postpartum, 12 months postpartum
Secondary outcome [5] 370735 0
Proportion of women meeting physical activity guidelines defined by the Australian Government physical activity and sedentary behaviour guidelines. Physical activity levels self reported by participants on the Active Australia Survey.
Timepoint [5] 370735 0
6 weeks postpartum, 6 months postpartum, 12 months postpartum
Secondary outcome [6] 374514 0
‘Breastfeeding Intention’ classifying women’s intention to breastfeed to 6-months based from a valid algorithm calculated from responses from five questions about breastfeeding behaviours rated from 0 (no intention to breastfeed) to 16 (very strong intentions to fully breastfeed for 6 months). Breastfeeding status scores will be descriptively documented.
Timepoint [6] 374514 0
6 weeks postpartum, 6 months postpartum, 12 months postpartum
Secondary outcome [7] 375433 0
Calculated vegetable intake (serves/d) on the Fat and Fibre Behavioural Questionnaire
Timepoint [7] 375433 0
6 weeks postpartum, 6 months postpartum, 12 months postpartum
Secondary outcome [8] 375434 0
Proportion of women meeting fruit (2/d) and vegetable (5+/d) guidelines (%) on the Fat and Fibre Behavioural Questionnaire
Timepoint [8] 375434 0
6 weeks postpartum, 6 months postpartum, 12 months postpartum
Secondary outcome [9] 375435 0
Proportion of women meeting guidelines on three diet quality scores (fat intake; fibre intake and diet quality overall) (%) on the Fat and Fibre Behavioural Questionnaire. The total index, fat index and fibre index will each be calculated as the average of the relevant non-missing items, yielding scores from 1 (least healthy) to 5 (most healthy).
Timepoint [9] 375435 0
6 weeks postpartum, 6 months postpartum, 12 months postpartum
Secondary outcome [10] 375436 0
Proportion of women meeting physical activity guidelines as self-reported by participants on the Active Australia Survey. . Minutes of physical activity per week will be assessed against Australia’s physical activity and sedentary behaviour guidelines which recommend at least half an hour of moderate exercise on most, if not all days during pregnancy (equating to 150 minutes per week).
Timepoint [10] 375436 0
6 weeks postpartum, 6 months postpartum, 12 months postpartum
Secondary outcome [11] 375437 0
Recruitment rates (women engaged in program/women offered enrolment)
Timepoint [11] 375437 0
From initiation of randomised controlled trial recruitment to end of randomised controlled trial recruitment
Secondary outcome [12] 375438 0
Number of messages sent (median and IQR OR mean and SD) as recorded by the automated text messaging software.
Timepoint [12] 375438 0
From initiation of randomised controlled trial recruitment to end of randomised controlled trial recruitment
Secondary outcome [13] 375439 0
Web analytics (website hits on specific pages promoted through program)
Timepoint [13] 375439 0
From initiation of randomised controlled trial recruitment to end of randomised controlled trial recruitment
Secondary outcome [14] 375440 0
Number of replies to messages sent by the texting program, as recorded by the automated text messaging software.
Timepoint [14] 375440 0
From initiation of randomised controlled trial recruitment to end of randomised controlled trial recruitment
Secondary outcome [15] 375452 0
Length of time breastfeeding (days) as reported on study specific survey questions
Timepoint [15] 375452 0
6 weeks postpartum, 6 months postpartum, 12 months postpartum

Eligibility
Key inclusion criteria
Women with pre-pregnancy BMI > 25kg/m2 and/or diagnosis of GDM; can read and speak English to a level that allows completion of the intervention, 24-28 weeks gestation, and >18 years.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women will be ineligible if they have a pre-pregnancy diagnosis of type 1 diabetes mellitus, have a history of substance use, a severe medical or psychological diagnosis that would prevent participation within the intervention or plan to participate in a commercial weight loss program.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes will be used to conceal randomsations
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2020
Actual
Date of last participant enrolment
Anticipated
31/07/2020
Actual
Date of last data collection
Anticipated
31/08/2021
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 302435 0
Hospital
Name [1] 302435 0
Mater Misericordiae Limited
Country [1] 302435 0
Australia
Primary sponsor type
Hospital
Name
Mater Misericordiae limited
Address
Level 3 Aubigny Place,
Raymond Terrace,
South Brisbane,
QLD 4101
Country
Australia
Secondary sponsor category [1] 302337 0
Individual
Name [1] 302337 0
Dr Shelley Wilkinson
Address [1] 302337 0
Mater Misericordiae Limited
Level 3, Allied Health,
Salmon Building
41 Raymond Terrace,
South Brisbane, QLD, 4101
Country [1] 302337 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 303104 0
Mater Misericoridiae Limited Human Research Ethics Committee
Ethics committee address [1] 303104 0
Level 2, Aubigny Place
Raymond Terrace South Brisbane
QLD, 4101
Ethics committee country [1] 303104 0
Australia
Date submitted for ethics approval [1] 303104 0
04/02/2019
Approval date [1] 303104 0
Ethics approval number [1] 303104 0

Summary
Brief summary
Up to 50% of women gain more than the recommended amount of weight during pregnancy. Retention of weight gained during pregnancy contributes to becoming overweight and obese and subsequent chronic disease risk, with the associated personal, financial and public health burdens. This study is a randomised-controlled trial to evaluate a consumer co-created text-message-based intervention to support women to improve diet quality and decrease postpartum weight retention.
Trial website
Trial related presentations / publications
Public notes
The mater4newmums program being evaluated in this randomised controlled trial is presently under development in consultation with women who have recently had babies at the Mater Mothers' Hospital. Development of this program involves an interview based study to inform the content of the text message based intervention. From interview content, a preliminary version of the intervention will be produced and evaluated through participant testing and feedback in a smaller group of 15 women. The program will be refined through this feedback.

Contacts
Principal investigator
Name 92486 0
A/Prof Shelley Wilkinson
Address 92486 0
Mater Misericordiae Limited
Level 3, Allied Health, Salmon Building
Raymond Terrace
South Brisbane,
QLD 4101
Country 92486 0
Australia
Phone 92486 0
+617 3163 7072
Fax 92486 0
Email 92486 0
[email protected]
Contact person for public queries
Name 92487 0
Shelley Wilkinson
Address 92487 0
Mater Misericordiae Limited
Level 3, Allied Health, Salmon Building
Raymond Terrace
South Brisbane,
QLD 4101
Country 92487 0
Australia
Phone 92487 0
+617 3163 7072
Fax 92487 0
Email 92487 0
[email protected]
Contact person for scientific queries
Name 92488 0
Shelley Wilkinson
Address 92488 0
Mater Misericordiae Limited
Level 3, Allied Health, Salmon Building
Raymond Terrace
South Brisbane,
QLD 4101
Country 92488 0
Australia
Phone 92488 0
+617 3163 7072
Fax 92488 0
Email 92488 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
Data will be only be presented in summary format due to assurances given at participant recruitment/consent.


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.