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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
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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
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Secondary ID [1]
284247
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Nil
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Universal Trial Number (UTN)
U1111-1154-4397
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Trial acronym
txt4two
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Gestational weight gain
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Condition category
Condition code
Diet and Nutrition
291731
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0
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Obesity
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Reproductive Health and Childbirth
291732
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0
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Normal pregnancy
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
288957
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Prevention
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Intervention code [2]
288988
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Behaviour
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Intervention code [3]
288989
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Lifestyle
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Comparator / control treatment
The control group will continue with usual clinical care with no additional treatment.
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Control group
Active
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
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Timepoint [1]
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36 weeks gestation / 20 weeks after randomisation.
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Secondary outcome [1]
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Percentage of women with excess GWG as measure by weight gain excess in accordance with the IOM guidelines
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Assessment method [1]
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Timepoint [1]
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36 weeks gestation
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Secondary outcome [2]
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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.
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Assessment method [2]
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Timepoint [2]
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36 weeks gestation
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Secondary outcome [3]
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Quality of physical activity as measured by the PPAQ.
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Assessment method [3]
307262
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Timepoint [3]
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36 weeks gestation
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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.
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Minimum age
18
Years
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Maximum age
45
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
< 18 years of age; comorbidities requiring medical and dietary management eg type 1 and 2 diabetes; or insufficient English.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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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.
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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.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
28/03/2014
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Actual
29/05/2014
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Date of last participant enrolment
Anticipated
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Actual
10/10/2014
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
100
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Accrual to date
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Final
100
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Mercy Hospital for Women - Heidelberg
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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Lord Mayors Charitable Foundation
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Address [1]
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Level 15, 1 Collins St, Melbourne VIC 3000
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Country [1]
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Australia
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Primary sponsor type
University
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Name
Centre for Physical Activity and Nutrition Research, Deakin University
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Address
221 Burwood Highway
Burwood
Victoria
3125
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Country
Australia
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Secondary sponsor category [1]
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Hospital
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Name [1]
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Mercy Hospital for Women
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Address [1]
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163 Studley Rd, Heidelberg VIC 3084
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Country [1]
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Mercy Health Human Research Committee
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Ethics committee address [1]
290707
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163 Studley Rd, Heidelberg VIC 3084
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
290707
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Approval date [1]
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30/01/2014
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Ethics approval number [1]
290707
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R13-64
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Ethics committee name [2]
290708
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Deakin University Human Research Ethics Committee
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Ethics committee address [2]
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221 Burwood Rd
Burwood
Victoria
3125
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Ethics committee country [2]
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Australia
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Date submitted for ethics approval [2]
290708
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Approval date [2]
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20/02/2014
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Ethics approval number [2]
290708
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2014-026
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Summary
Brief summary
Research shows women are struggling to eat well and exercise during pregnancy with up to 50% exceeding the weight gain guidelines for pregnancy. This excess gestational weight gain (GWG) puts the mother and infant at risk of negative health consequences (eg gestational diabetes, difficult deliveries and future obesity). Novel ways to extend our reach to all women is required.
This project aims to test a mobile phone (m-health) and internet delivered intervention promoting healthy eating, physical activity and pregnancy and GWG in pregnant women.
This study will trial the intervention with 50 pregnant women from MHW from recruitment to 36 weeks gestation and compare with 50 pregnant women in standard care. It will include: tailored text messages, video messages from health professionals and peers, weight and goal self-monitoring, detailed information on a website and a chat forum.
Findings will inform the development of larger-scale digitally based programs to improve the delivery of healthy pregnancy nutrition, physical activity and healthy GWG.
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Trial website
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Trial related presentations / publications
Willcox JC, Campbell KJ, McCarthy EA, Wilkinson SA, Lappas M, Ball K, et al. Testing the feasibility of a mobile technology intervention promoting healthy gestational weight gain in pregnant women (txt4two) - study protocol for a randomised controlled trial. Trials 2015;16(1):209-
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Karen Campbell
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Address
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Centre for Physical Activity and Nutrition Research,
Deakin University,
Locked Bag 20000,
Geelong, VIC 3220
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Country
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Australia
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Phone
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+61 3 52278414
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Ms Jane Willcox
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Address
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Centre for Physical Activity and Nutrition Research,
Deakin University,
221 Burwood Highway,
Burwood
Victoria
3125
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Country
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Australia
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Phone
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+61 3 9244 6343
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Ms Jane Willcox
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Address
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Centre for Physical Activity and Nutrition Research,
Deakin University,
221 Burwood Highway,
Burwood
Victoria
3125
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Country
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Australia
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Phone
46884
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+61 3 9244 6343
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Fax
46884
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Email
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[email protected]
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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.
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