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Trial registered on ANZCTR


Registration number
ACTRN12616000072415
Ethics application status
Approved
Date submitted
1/12/2015
Date registered
22/01/2016
Date last updated
22/01/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of the effectiveness of an infant and family health and wellbeing text message intervention (Connecting 2u) in supporting expectant and new parents
Scientific title
Effectiveness of the Connecting2u Text Messaging Intervention for expectant and new parents: evaluation of maternal self-efficacy, and parental attachment and practice
Secondary ID [1] 287985 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Evaluation of the C2u Project
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parental attachment 296860 0
Maternal Confidence 296861 0
Parental Health Behaviours 296862 0
Condition category
Condition code
Public Health 297095 297095 0 0
Health promotion/education
Reproductive Health and Childbirth 297157 297157 0 0
Antenatal care
Reproductive Health and Childbirth 297158 297158 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will involve the delivery of C2u text messages to participants in addition to standard practice. The content of the C2u text messages are based on antenatal and postnatal care, focusing on health behaviours (maternal nutrition and weight; physical activity; alcohol, tobacco, drugs, medication consumption; immunisation reminders; appointment reminders), mental health and wellbeing, communication, bonding and attachment, infant feeding, preparing for parenthood/ becoming a parent, and circle of security.

The intervention will commence at 16 weeks' gestation, with a duration period of around 12 months. The intervention will cease once the infant is six months of age.

For the first 12 weeks of the intervention, the participant will be sent two text messages a week. This will be reduced to one text message a week, after the first 12 weeks, and until birth. After birth, the participant will be sent two text messages a week for the first 12 weeks. This will be reduced to one text message for the remaining weeks of the intervention.
Intervention code [1] 293323 0
Behaviour
Comparator / control treatment
Standard practice of care

Standard practice of care is defined as routine antenatal midwifery and obstetric care and postnatal appointment scheduling, abiding by the Queensland Health's Pregnancy Health Record and Personal Health Record.
Control group
Active

Outcomes
Primary outcome [1] 296700 0
Change in Maternal self-efficacy (confidence) as a result of project implementation.
Timepoint [1] 296700 0
Tools: Maternal Confidence Questionnaire
Data Collection Points: Two weeks post birth, and six months post birth.
Participants Assessed: Mothers
Primary outcome [2] 296772 0
Change in parental attachment as a result of project implementation.
Timepoint [2] 296772 0
Tools: Maternal Antenatal Attachment Scale; Maternal Postnatal Attachment Scale; Paternal Antenatal Attachment Scale; Paternal Postnatal Attachment Scale.
Data Collection Points: Baseline; 37 weeks' gestation; two weeks post birth; and six months post birth.
Participants Assessed: Mothers and Fathers
Primary outcome [3] 296773 0
Change in infant feeding practices as a result of project implementation.
Timepoint [3] 296773 0
Antenatal Tools: Infant Feeding Intentions Scale
Data Collection Point: Baseline, and 37 weeks' gestation
Participants Assessed: Mothers

Postnatal Tools: 2010 Australian National Infant Feeding Questions
Data Collection Point: two weeks post birth; and six months post birth.
Participants Assessed: Mothers
Secondary outcome [1] 319140 0
Change in vegetable and fruit consumption as a result of project implementation.
Outcome is primary.
Timepoint [1] 319140 0
Tools: Self-Reported Adult Health Status - Queensland
Data Collection Point: Baseline; 37 weeks' gestation; two weeks post birth; and six months post birth.
Participants Assessed: Mothers and Fathers
Secondary outcome [2] 319563 0
Change in tobacco consumption as a result of project implementation.
Outcome is primary.
Timepoint [2] 319563 0
Tools: Recommended Questions for Prenatal Screening
Data Collection Point: Baseline and 37 weeks' gestation
Participants Assessed: Mothers (Antenatal)

Tools: Self-Reported Adult Health Status - Queensland
Data Collection Point: Two weeks post birth and six months post birth.
Participants Assessed: Mothers (Postnatal)

Tools: Self-Reported Adult Health Status - Queensland
Data Collection Point: Baseline; 37 weeks' gestation; two weeks post birth; and six months post birth.
Participants Assessed: Fathers
Secondary outcome [3] 319564 0
Change in alcohol consumption as a result of project implementation.
Outcome is primary.
Timepoint [3] 319564 0
Tools: Audit-C
Data Collection Point: Baseline; 37 weeks' gestation; two weeks post birth; and six months post birth.
Participants Assessed: Mothers and Fathers
Secondary outcome [4] 319565 0
Change in physical activity behaviours as a result of project implementation.
Outcome is primary.
Timepoint [4] 319565 0
Tools: Active Australian Survey
Data Collection Point: Baseline; 37 weeks' gestation; two weeks post birth; and six months post birth.
Participants Assessed: Mothers and Fathers
Secondary outcome [5] 319618 0
The effectiveness of text messages to disseminate health promoting messages' as a secondary outcome.
Timepoint [5] 319618 0
Tools: Process Evaluation Questions; Focus Groups
Data Collection: 37 weeks' gestation; post intervention completion
Participants Assessed: Mothers and Fathers within the intervention group.

Eligibility
Key inclusion criteria
Recruitment of Mothers:
Mothers are twelve weeks pregnant and over, has a mobile phone, is over 16 years of age, does not require interpreter services, does not suffer from psychosis, and does not plan to place infant in foster care or adoptive care.

Potential recruitment for postnatal analysis will occur in the late antenatal stage. As such, mothers can be recruited from 12 weeks' gestation until birth.

Recruitment of Fathers
Partner is at least 12 weeks' gestation and is over 16 years of age. Father is required to be over 16 years of age, owns his own mobile phone, does not require interpreter services, does not suffer from psychosis, and does not plan to place infant in foster care or adoptive care.

Potential recruitment for postnatal analysis will occur in the late antenatal stage. As such, fathers can be recruited from when partner is 12 weeks' gestation until birth.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria for mothers:
Mothers who are not yet 12 weeks pregnant and/or are under 16 years of age. Furthermore, mothers who do not own a mobile phone, suffer from psychosis, require interpreter services, and/or plan on placing infant in foster care or adoptive care will be excluded.

Exclusion criteria for fathers:
Partner is not at least 12 weeks' gestation and/or is not over 16 years of age. Furthermore, fathers who do not own a mobile phone, suffer from psychosis, require interpreter services, and/or plan on placing infant in foster care or adoptive care will be excluded.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Two sample situations were considered based on the presence or absence of intervention. It was hypothesized that the mean or proportion of the main outcomes of interests would be different among the participating mothers and fathers belonging to the intervention and control arms, after the antenatal (at T2) and early life interventions (T4).
For sample size calculation, it was assumed 5% level of significance and 80% power. Further, it was assumed 1:1 ratio for the number of participating mothers and fathers in intervention and control arms. STATA version 8 was used for sample size calculations.
Non-response and loss to follow up together (after enrollment) were expected to be 30% at T2 and 50% at T4, as compared to the enrolled numbers at T1, among the participating mothers and fathers belonging to the control arm. This rate is expected to be less among the intervention arm participants. But, it was assumed the same rate of non-response among the participants of both the arms in order to be on the safe side. Also targeting the same number of enrollments in both the arms was easier in terms of randomization.

SPSS will be used to evaluate and analyse the data gathered. A statistical analysis will be performed to compare control and intervention groups for:
- Data Collection 1 and 2 (pre and post antenatal group)
- Data Collection 3 and 4 (pre and post postnatal group)
- Data Collection 1 and 4 (pre and post of the entire group of participants).

To ensure both control and intervention groups will be comparable at baseline, a number of statistical analyses will be performed. In order to assess differences between control and intervention groups in variables measured at a categorical level, Chi square tests will be used.

To ensure that parental attachment, maternal confidence, infant feeding intentions/practices, and health behaviours are comparable at baseline across intervention and control groups, Independent samples t-tests will be performed.

Mann-whitney U test will be used in the case of non-normally distributed data.

Pearson and Spearman correlation tests will be performed to look at the correlations between parental attachment , and/or maternal confidence, and/or infant feeding intentions/practices, and health behaviours.

Independent samples t-test and Mann Whitney U tests will be used to examine the mean differences in parental attachment , and/or maternal confidence, and/or infant feeding intentions/practices, and health behaviours across independent variables.

ANOVA will be used to observe the mean differences between various demographics and parental attachment , and/or maternal confidence, and/or infant feeding intentions/practices, and health behaviours scores.

Furthermore, a Kruskal-Wallis test will be perfomed to determine significant differences between parental attachment, and/or maternal confidence, and variable demographics scores. Mann-Whitney U tests will be undertaken to determine where the significant differences occurred.

Wilcoxon signed rank tests will be used to examine mean differences between parental attachment pre and post of the intervention (DC1 and DC2; DC3 and DC4; DC1 and DC4) and maternal confidence pre and post of the intervention (DC3 and DC4) in both the control and intervention groups.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
4/01/2016
Date of last participant enrolment
Anticipated
14/03/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 4805 0
Redland Hospital - Cleveland
Recruitment hospital [2] 4806 0
Beaudesert Hospital - Beaudesert
Recruitment hospital [3] 4807 0
Logan Hospital - Meadowbrook
Recruitment hospital [4] 4808 0
Mater Mother's Hospital - South Brisbane
Recruitment postcode(s) [1] 12311 0
4163 - Cleveland
Recruitment postcode(s) [2] 12312 0
4285 - Beaudesert
Recruitment postcode(s) [3] 12313 0
4131 - Meadowbrook
Recruitment postcode(s) [4] 12314 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 292485 0
Government body
Name [1] 292485 0
Children's Health Queensland
Country [1] 292485 0
Australia
Primary sponsor type
Government body
Name
Children's Health Queensland
Address
199 Grey St, South Brisbane QLD 4101
Country
Australia
Secondary sponsor category [1] 291194 0
None
Name [1] 291194 0
Address [1] 291194 0
Country [1] 291194 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293950 0
National Health and Medical Research Council - Australian Health Ethics Committee
Ethics committee address [1] 293950 0
AHEC Secretariat
NHMRC
GPO Box 1421
Canberra ACT 2601
Ethics committee country [1] 293950 0
Australia
Date submitted for ethics approval [1] 293950 0
20/08/2015
Approval date [1] 293950 0
26/08/2015
Ethics approval number [1] 293950 0

Summary
Brief summary
The aim of this study is to examine the efficacy of an infant and family health and wellbeing short-term message service (SMS) intervention in supporting expectant and new parents both birthing at partnered Queensland Hospitals. The intervention period will be for 48 weeks from recruitment date and involves the provision of relevant and timely information on positive parenting strategies, attachment and health behaviours and support networks via an SMS program. Participants will be recruited in the antenatal period via antenatal clinics in partnered hospitals in late 2015 (600 intervention; 600 control).

This study will follow a mixed methods design involving qualitative and quantitative methodologies. The researchers aim to measure the effectiveness of the project by following a mixed methods design. Study procedures will involve face-to-face and web-based surveys pre-intervention and web based and telephone surveys for the last three data collection points in the evaluation, including post-intervention. Focus group interviews with a selection of participants post project intervention.

This trial follows on from the Connecting2u (C2u) pilot project conducted with families delivering at Logan Hospital between March and October 2014 which indicated the effectiveness of text messages in supporting parental confidence. Phase Two includes the dissemination of text messages in the antenatal period as research has indicated the importance of early intervention before birth in regards to health and wellbeing of the parents and child.
Trial website
Trial related presentations / publications
Public notes
Publication pending for Connecting2u Phase One.

Contacts
Principal investigator
Name 61790 0
Ms Cindy Dawson
Address 61790 0
Children's Health Queensland
199 Grey St,
South Brisbane QLD 4101
Country 61790 0
Australia
Phone 61790 0
+61 7 34122941
Fax 61790 0
Email 61790 0
[email protected]
Contact person for public queries
Name 61791 0
Cindy Dawson
Address 61791 0
Children's Health Queensland
199 Grey St,
South Brisbane QLD 4101
Country 61791 0
Australia
Phone 61791 0
+61 7 34122941
Fax 61791 0
Email 61791 0
[email protected]
Contact person for scientific queries
Name 61792 0
Neil Harris
Address 61792 0
School of Medicine,
Gold Coast campus,
Griffith University,
QLD 4222, Australia
Country 61792 0
Australia
Phone 61792 0
+61 7 555 27879
Fax 61792 0
Email 61792 0
[email protected]

No information has been provided regarding IPD availability


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.