Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000169347
Ethics application status
Approved
Date submitted
8/09/2016
Date registered
1/02/2017
Date last updated
1/02/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of the Eating4Two smartphone application for the prevention of excessive gestational weight gain.
Scientific title
Efficacy of the Eating4Two smartphone application for the prevention of excessive gestational weight gain: a randomised controlled trial.
Secondary ID [1] 290121 0
Nil known
Universal Trial Number (UTN)
U1111-1187-4314
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Excessive gestational weight gain 300224 0
Maternal obesity 300225 0
Condition category
Condition code
Reproductive Health and Childbirth 300101 300101 0 0
Antenatal care
Diet and Nutrition 300102 300102 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will receive usual care and will also be provided access to the Eating4Two smartphone application at no cost. Women in the intervention group will enter their weight into the App on a weekly basis and be weighed by maternity caregivers at approximately 38 weeks gestation and the commencement of labour (or prior to elective caesarean section).

The Eating4Two App provides women with advice on how to “eat for two” by increasing nutrient density rather than energy. Women are provided with information about food safety, nutrients, and their value in pregnancy, the nutrients provided in various foods and recommended daily serves. Sample meal plans demonstrate ways that nutrient needs in pregnancy can be met. In addition, the App provides information on managing common pregnancy related symptoms such as heartburn. The App calculates women’s BMI and prompts them to enter their weight weekly. The “weight tracker” graphs their weight gain, showing the weight gain range recommended by the Institute of Medicine (IOM) for their BMI category. When weight gain is above or below the recommended range, women are prompted to discuss the issue with their maternity caregiver so that individual advice can be provided. The App also sends regular messages to the participant (specific to their gestation) with information about their baby’s growth, development and nutritional needs, motivational messages, tips on weight management and physical activity in pregnancy and reminders to discuss weight gain with their maternity caregivers. These are sent approximately weekly. These messages are tailored to the woman’s BMI and gestation. The aim of the App is to augment usual care by providing timely and tailored information, motivation, encouraging lifestyle changes and discussions with caregivers. Women will have access to the App from enrolment in the study to birth. The only requirement is for women to use the weight tracker weekly and they may access other parts of the App as desired.
Intervention code [1] 295871 0
Prevention
Intervention code [2] 295872 0
Lifestyle
Comparator / control treatment
The control group will receive usual antenatal maternity care with the addition of a written nutrition and weight gain booklet: “Good nutrition in pregnancy”, published by the ACT Government (modified with local contacts for other sites). Usual care for women includes attendance at antenatal appointments in accordance with the following schedule; 12-14 weeks (booking visit), 16, 20, 26, 30, 33, 36, 38, 40, 41 weeks. Women choosing a shared care model receive alternate visits with their GP and with hospital clinic staff. While women’s BMI is calculated at their first hospital-booking visit, weighing is not routinely attended at subsequent antenatal clinic appointments or at labour commencement. Advice on weight gain is ad hoc and diet advice focuses on food safety in pregnancy. Women with a BMI > 35kg/m2 are referred to a community dietitian. Their usual maternity care provider will weigh women in the control group at approximately 38 weeks gestation. A maternity staff member will also weigh women in this group at the commencement of labour (or prior to elective caesarean section).
Control group
Active

Outcomes
Primary outcome [1] 299578 0
Excessive gestational weight gain.
Defined as GWG of >18, 16, 11.5 and 9kg for underweight, normal, overweight and obese women respectively. Calculated by subtracting first weight (< 15 weeks gestation from weight at term labour or planned term C/S)
Timepoint [1] 299578 0
Birth
Secondary outcome [1] 327587 0
Gestational weight gain
Total weight gain from first weight (<15 weeks gestation to term labour or planned C/S)
Timepoint [1] 327587 0
Birth
Secondary outcome [2] 327588 0
Weight change in the postpartum
Weight change from first weight (<15 weeks gestation) to 6 months postpartum (self reported) and from last weight in term labour or planned C/S to 6 months postpartum (self reported)

Timepoint [2] 327588 0
6 months post partum
Secondary outcome [3] 327589 0
Food intake
Food intake will be compared using the ASA24 diet recall instrument developed by the National Cancer Institute in the USA.
Timepoint [3] 327589 0
38 weeks gestation and 6 months postpartum
Secondary outcome [4] 327590 0
Physical activity
Physical activity will be compared using the International Physical Activity Questionnaire (IPAQ) (self-administered, long version), developed by an international consensus group.
Timepoint [4] 327590 0
38 weeks gestation and 6 months postpartum
Secondary outcome [5] 327591 0
Satisfaction with antenatal care
Satisfaction with antenatal care will be measured using the modified Quality Prenatal Care Questionnaire (QPCQ).
Timepoint [5] 327591 0
8-12 weeks postprtum
Secondary outcome [6] 327592 0
Neonatal macrosomia
Defined as neonatal birth weight > 4000g


Timepoint [6] 327592 0
Birth
Secondary outcome [7] 327593 0
Large for gestational age
Defined as neonatal birth weight > 90th centile for gestational age and infant sex.
Timepoint [7] 327593 0
Birth
Secondary outcome [8] 327594 0
Complications arising in pregnancy
Including hypertension and gestational diabetes as documented in medical records.
Timepoint [8] 327594 0
Birth
Secondary outcome [9] 327595 0
Labour interventions
Including induction or augmentation of labour as documented in medical records.
Timepoint [9] 327595 0
Birth
Secondary outcome [10] 327596 0
Mode of birth as documented in medical records.
Timepoint [10] 327596 0
Birth
Secondary outcome [11] 327597 0
Birth complications
Including shoulder dystocia and primary postpartum haemorrhage as documented in medical records.
Timepoint [11] 327597 0
Birth
Secondary outcome [12] 327598 0
Neonatal birth weight
Timepoint [12] 327598 0
Birth. As documented in medical record.
Secondary outcome [13] 327599 0
Qualitative experience
Timepoint [13] 327599 0
8-12 weeks postpartum. Data collected via focus group and individual semi-structured interviews with participants.
Secondary outcome [14] 327631 0
Admission to neontal nursery
Timepoint [14] 327631 0
At birth or within 7 days of birth. As documented in the maternal and/or neonatal medical record.
Secondary outcome [15] 327632 0
Gestation at birth
Timepoint [15] 327632 0
Birth. As identified in medical record.
Secondary outcome [16] 327633 0
Apgar score
Timepoint [16] 327633 0
Birth (one and five minutes) as described in medical record.

Eligibility
Key inclusion criteria
(1) at least 18 years of age (2) ability to provide informed consent (3) fluent in written and oral English language (4) less than 15 weeks gestation (5) personal ownership of a smartphone device (6) access to weighing scales (7) a valid email address and access to Internet.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
(1) planning to give birth in a non-participating hospital (2) multiple pregnancy (3) insulin or diet controlled diabetes prior to pregnancy (4) limitations to using a smartphone device (5) healthcare provider considers use of the App or GWG in accordance with IOM recommendations detrimental to the potential participant.

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)
A remote randomisation service will be used.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will proceed via stratified (by BMI) block allocation, by compouter sorftware.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample Size: This trial is designed to detect a clinically significant decrease in the proportion of women who have excessive GWG (according to current IOM recommendations) from 38% to 30%. A recent prospective study in Australia with 664 participants (of all BMI categories) found that 38% of the cohort experienced excessive GWG according to IOM recommendations (de Jersey, Nicholson, Callaway & Daniels, 2012). This is less than the proportion found in the control group of the LIMIT trial (42%) though this trial included only overweight and obese women (Dodd et al., 2014) who are known to be more at risk of excessive weight gain. A total sample size of 1156 (578 in each group) will allow detection of statistical significance with 80% power and two-sided 5% significance level (Dean, Sullivan & Soe, 2015). The follow-up period is short in studies focusing on GWG as the primary outcome, as the end point is delivery. However there is wide variation in reported attrition, which ranges from 3% to 20% (Bogaerts et al., 2013; Dodd et al., 2014). These are comprised largely of women experiencing miscarriage, fetal loss and moving out of area. Taking a conservative approach we have allowed for 15% attrition, which gives a total recruitment target of 1330 women.
Data Analysis: An intention to treat analysis will be conducted including withdrawals and losses to follow up. Even distribution of baseline characteristics between the intervention and the control groups is assumed by randomisation and will be further assessed by Chi squared test and Student t-test for categorical and continuous variables respectively. Descriptive statistics for the primary and secondary outcome variables will be calculated. Continuous outcome variables will be evaluated for normality and transformations will be applied as necessary. Regression analysis with adjustments for confounding variables (pre-pregnancy BMI, smoking, IRSAD, parity, age) will be used to evaluate the primary outcome and relative risk and 95% confidence intervals will be calculated. The multiple imputation method will be used to generate possible values for missing values. This is considered gold standard for dealing with missing data. Significance will be set at 0.05. Data will be analysed in Statistical Package for the Social Sciences (SPSS). All qualitative data will be combined for the purposes of analysis. Qualitative data analysis will follow a simple qualitative descriptive approach. Qualitative descriptive analysis is a low inference analysis that uses an inductive approach to develop descriptive themes. All transcripts will be coded by first attaching a descriptive label to each meaning unit (a sentence or group of sentences conveying a message or concept relevant to the study). Descriptive labels will be examined and grouped with other labels conveying a similar idea to create descriptive themes.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
22/12/2016
Date of last participant enrolment
Anticipated
31/12/2018
Actual
Date of last data collection
Anticipated
31/08/2019
Actual
Sample size
Target
1330
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW
Recruitment hospital [1] 6638 0
The Canberra Hospital - Garran
Recruitment hospital [2] 6639 0
Calvary Public Hospital ACT - Bruce
Recruitment hospital [3] 6640 0
John Hunter Hospital Royal Newcastle Centre - New Lambton
Recruitment hospital [4] 6641 0
The Maitland Hospital - Maitland
Recruitment hospital [5] 6642 0
Port Macquarie Base Hospital - Port Macquarie
Recruitment postcode(s) [1] 14259 0
2605 - Garran
Recruitment postcode(s) [2] 14260 0
2617 - Bruce
Recruitment postcode(s) [3] 14261 0
2305 - New Lambton
Recruitment postcode(s) [4] 14262 0
2320 - Maitland
Recruitment postcode(s) [5] 14263 0
2444 - Port Macquarie

Funding & Sponsors
Funding source category [1] 294496 0
Charities/Societies/Foundations
Name [1] 294496 0
Diabetes Australia
Country [1] 294496 0
Australia
Primary sponsor type
University
Name
University of Canberra
Address
University of Canberra, Bruce ACT, 2601
Country
Australia
Secondary sponsor category [1] 293360 0
None
Name [1] 293360 0
Address [1] 293360 0
Country [1] 293360 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295930 0
ACT Health Human Research Ethics Committee
Ethics committee address [1] 295930 0
Ethics committee country [1] 295930 0
Australia
Date submitted for ethics approval [1] 295930 0
13/05/2016
Approval date [1] 295930 0
01/08/2016
Ethics approval number [1] 295930 0
ETH 5.16.064

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

Contacts
Principal investigator
Name 68938 0
Prof Deborah Davis
Address 68938 0
University of Canberra, Bruce ACT, 2601
Country 68938 0
Australia
Phone 68938 0
+61 2 6206 3869
Fax 68938 0
Email 68938 0
[email protected]
Contact person for public queries
Name 68939 0
Deborah Davis
Address 68939 0
University of Canberra, Bruce ACT, 2601
Country 68939 0
Australia
Phone 68939 0
+61 2 6206 3869
Fax 68939 0
Email 68939 0
[email protected]
Contact person for scientific queries
Name 68940 0
Deborah Davis
Address 68940 0
University of Canberra, Bruce ACT, 2601
Country 68940 0
Australia
Phone 68940 0
+61 2 6206 3869
Fax 68940 0
Email 68940 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.