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Trial registered on ANZCTR


Registration number
ACTRN12614000288628
Ethics application status
Approved
Date submitted
12/03/2014
Date registered
19/03/2014
Date last updated
30/05/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
txt4two: Testing the feasibility of an intervention program to promote healthy nutrition, physical activity and weight gain in pregnant women
Scientific title
txt4two: Testing the feasibility of a mobile phone (m-health) intervention program to promote healthy nutrition, physical activity and gestational weight gain with pregnant women in a pilot randomised controlled trial
Secondary ID [1] 284247 0
Nil
Universal Trial Number (UTN)
U1111-1154-4397
Trial acronym
txt4two
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gestational weight gain 291366 0
Condition category
Condition code
Diet and Nutrition 291731 291731 0 0
Obesity
Reproductive Health and Childbirth 291732 291732 0 0
Normal pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group women will receive a tailored suite of intervention strategies focusing on healthy nutrition, physical activity and gestational weight gain (GWG) for 20 weeks from 16 weeks gestation. This includes: tailored mobile phone text and video messages; mobile phone texts promoting goal setting and self-monitoring; print and accessible website nutrition, physical activity and GWG information; and a private moderated Facebook (Registered Trademark) chat forum. The tailored text and video messages will be sent three times weekly and the self monitoring and goal setting messages one to two times weekly reflecting participants self monitoring frequency choice.

Women randomised to the control group will continue to receive standard antenatal care.
Intervention code [1] 288957 0
Prevention
Intervention code [2] 288988 0
Behaviour
Intervention code [3] 288989 0
Lifestyle
Comparator / control treatment
The control group will continue with usual clinical care with no additional treatment.
Control group
Active

Outcomes
Primary outcome [1] 291669 0
Relevance, applicability and feasibility of the txt4two intervention with pregnant women.

Participants in the intervention arm will complete a questionnaire at completion with Likehart Scale style questions related to the relevance, practicality and desirability of intervention components and overall program.


Process evaluation will include quantitative assessment of:
a) Engagement - frequency/nature of contacts; engagement with technology
b) Logistical research insights -how feasible to recruit women, sample size requirements for larger trial, cost.
Timepoint [1] 291669 0
36 weeks gestation / 20 weeks after randomisation.
Secondary outcome [1] 307260 0
Percentage of women with excess GWG as measure by weight gain excess in accordance with the IOM guidelines
Timepoint [1] 307260 0
36 weeks gestation
Secondary outcome [2] 307261 0
Quality of diet as measured by food frequency questionnaire from READI trial.

Ball K, Abbott G, Cleland V, Timperio A, Thornton L, Mishra G, et al. Resilience to obesity among socioeconomically disadvantaged women: the READI study. Int J Obes. 2012;36(6):855-65.
Timepoint [2] 307261 0
36 weeks gestation
Secondary outcome [3] 307262 0
Quality of physical activity as measured by the PPAQ.
Timepoint [3] 307262 0
36 weeks gestation

Eligibility
Key inclusion criteria
Women with a singleton, live gestation between 10+0-17+6 weeks at the first hospital antenatal visit who have a pre-pregnancy BMI>25kg/m2 and mobile phone ownership.
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
< 18 years of age; comorbidities requiring medical and dietary management eg type 1 and 2 diabetes; or insufficient English.

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)
The research midwife will assist in the regular height and weight measurement procedures in the antenatal clinics. On identifying an eligible participant from confidentially calculating BMI, the midwife will seek the woman’s participation in the study. The research midwife will check the “alert page” and “privacy consent” page of the medical record to determine that there are no prior expressed refusal to consider research participation and that the midwife does not anticipate requiring an interpreter to communicate with a potential participant. In the absence of prior documented refusal to participate in any research projects and anticipating English skills adequate for the project, the research midwife shall review the clinical notes to confirm absence of exclusionary factors. The midwife will then approach the patient in the waiting room to discuss the project, offer a Participant Information and Consent Form and, if appropriate obtain written informed consent. Please note that women will not be informed that they have been invited to participate due to their body mass.

Randomisation will occur using numbered cards allocating women to either the intervention or control group will be placed in opaque, sequentially numbered envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be obtained using a computer random number generator.
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
Completed
Date of first participant enrolment
Anticipated
28/03/2014
Actual
29/05/2014
Date of last participant enrolment
Anticipated
Actual
10/10/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2184 0
Mercy Hospital for Women - Heidelberg

Funding & Sponsors
Funding source category [1] 288879 0
Charities/Societies/Foundations
Name [1] 288879 0
Lord Mayors Charitable Foundation
Country [1] 288879 0
Australia
Primary sponsor type
University
Name
Centre for Physical Activity and Nutrition Research, Deakin University
Address
221 Burwood Highway
Burwood
Victoria
3125
Country
Australia
Secondary sponsor category [1] 287572 0
Hospital
Name [1] 287572 0
Mercy Hospital for Women
Address [1] 287572 0
163 Studley Rd, Heidelberg VIC 3084
Country [1] 287572 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290707 0
Mercy Health Human Research Committee
Ethics committee address [1] 290707 0
Ethics committee country [1] 290707 0
Australia
Date submitted for ethics approval [1] 290707 0
Approval date [1] 290707 0
30/01/2014
Ethics approval number [1] 290707 0
R13-64
Ethics committee name [2] 290708 0
Deakin University Human Research Ethics Committee
Ethics committee address [2] 290708 0
Ethics committee country [2] 290708 0
Australia
Date submitted for ethics approval [2] 290708 0
Approval date [2] 290708 0
20/02/2014
Ethics approval number [2] 290708 0
2014-026

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46882 0
A/Prof Karen Campbell
Address 46882 0
Centre for Physical Activity and Nutrition Research,
Deakin University,
Locked Bag 20000,
Geelong, VIC 3220
Country 46882 0
Australia
Phone 46882 0
+61 3 52278414
Fax 46882 0
Email 46882 0
karen.campbell@deakin.edu.au
Contact person for public queries
Name 46883 0
Jane Willcox
Address 46883 0
Centre for Physical Activity and Nutrition Research,
Deakin University,
221 Burwood Highway,
Burwood
Victoria
3125
Country 46883 0
Australia
Phone 46883 0
+61 3 9244 6343
Fax 46883 0
Email 46883 0
jwillcox@deakin.edu.au
Contact person for scientific queries
Name 46884 0
Jane Willcox
Address 46884 0
Centre for Physical Activity and Nutrition Research,
Deakin University,
221 Burwood Highway,
Burwood
Victoria
3125
Country 46884 0
Australia
Phone 46884 0
+61 3 9244 6343
Fax 46884 0
Email 46884 0
jwillcox@deakin.edu.au

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.