Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000397516
Ethics application status
Approved
Date submitted
2/04/2015
Date registered
29/04/2015
Date last updated
29/04/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
A cluster randomised trial to evaluate the effectiveness of a telephone based coaching program in reducing excessive gestational weight gain amongst pregnant women
Scientific title
Evaluation of a telephone based information and coaching program to reduce excessive gestational weight gain amongst pregnant women
Secondary ID [1] 286471 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gestational weight gain 294658 0
Condition category
Condition code
Public Health 294959 294959 0 0
Health promotion/education
Reproductive Health and Childbirth 294960 294960 0 0
Antenatal care
Diet and Nutrition 295006 295006 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Women in the intervention group will be enrolled in a coaching program run by the Get Healthy Service which has been adapted specifically for pregnant women (the GWG module). The coaching program comprises up to 10 calls between 15 - 40 minutes in duration by university qualified coaches (8 during pregnancy and 2 after birth). The length is directed by the participant, and can be flexible. Similar to the standard GHS, the calls are aimed at healthy eating, physical activity and achieving healthy weight gain during pregnancy. Calls are based on behaviour change principles designed to help with goal setting, maintaining motivation, overcoming barriers and making sustainable life changes. The timing of calls is designed to be flexible based on participant preferences. Generally, the schedule for calls pre-delivery: 3 calls in the first 3 weeks, followed by a call every 2-3 weeks, unless requested otherwise from the participant. For post pregnancy calls: 1 call at 10 weeks, 1 call at 14 weeks post delivery, unless requested otherwise by the participant.

Participants in the coaching arm will receive 10 calls: 8 during pregnancy, 2 post pregnancy. Fewer calls may be conducted if the woman withdraws from the Service, or delivers before her 7th call.

Compliance to the study will be monitored by recording the number and dates of coaching calls received by a participant and recording reason for withdrawing from the Service in the case of withdrawals

Participants in the coaching program will also be provided with evidence based materials including pregnancy specific fact sheets, the Having a Baby Book published by NSW Health and the Get Healthy Information booklet which includes generic advice on healthy eating, physical activity and achieving and maintaining a healthy weight. All pregnancy specific content is developed based on nationally and internationally endorsed guidelines such as the Australian Dietary Guidelines and US Institute of Medicine Weight Gain during Pregnancy guidelines.
Intervention code [1] 291559 0
Lifestyle
Comparator / control treatment
In additional to usual care provided by the antenatal clinic, women in the control group will receive the evidence based package of materials described above, including advice on healthy eating, physical activity and achieving healthy weight gain during pregnancy. Usual care for this study is the routine care women receive as part of their antenatal appointments in the hospitals.
Participants will receive 1 coaching and information call from the Get Healthy Service coach in addition to their usual care, after referral from her midwife (at or before 22 weeks gestation). It is anticipated that the duration of the call will be between 30 to 40 minutes.
Control group
Active

Outcomes
Primary outcome [1] 294715 0
Weight, self reported by participants.
Timepoint [1] 294715 0
Baseline when intervention starts, 36 weeks of pregnancy and 12 months post birth
Secondary outcome [1] 313924 0
Overall fruit and vegetable intake, self-reported during telephone interview
Timepoint [1] 313924 0
Baseline when intervention starts, 36 weeks of gestation and 12 months post birth
Secondary outcome [2] 314001 0
Perception of the service by participants (continuing and non-continuing), midwives, nursing unit managers and medical practitioners. Interviews will be conducted with purposefully selected participants.

The composite outcomes from the interviews will be used to further enhance the program.
Timepoint [2] 314001 0
Ongoing as appropriate during the study period.

Eligibility
Key inclusion criteria
Pregnant women

Women with conditions that may potentially require minor adaptation of the standard dietary or physical activity to participate in the program safely will require clearance from a medical practitioner. All conditions are listed in the protocol.
Some examples of conditions that require medical clearance include:
Hypertension
Epilepsy
Asthma Moderate (women requiring daily bronchodilators and steroid inhalers)
Type 2 diabetes (diet controlled)
Musculo-skeletal problems
Previous pre-term birth
Recurrent miscarriage
(Note that this is not an exhaustive list)
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Pre-pregnancy BMI < 18.5 kg/m2;
2. Gestation of over 18 weeks;
3. Non English speaking;
4. Multiple pregnancy; and
5. Women with complex medical conditions

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)
This study will be a stratified cluster randomised trial, with stratification by pre-pregnancy BMI (normal and overweight/obese) and clustering by hospital. Pregnant women at each hospital recruited into the trial on their first booking visit in the relevant arms.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Hospitals within geographic classification (rural or metropolitan) will be randomised into either the control and intervention arm using excel random number generator function.
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
The sample size has been calculated based on the ability to detect a difference of 3 kgs in gestational weight gain between intervention and control groups, at 80% power and with expected attrition rate of 30%. Of the 640 women, approximately 165 in total would fall into the normal category and 475 into the overweight/obese category.

Differences between the two groups in mean weight gain will be tested using the independent samples t-test, and the proportion returning to their pre-pregnancy weight 12 months post birth will be analysed using the X2 test.
Multivariate regression models will be used to estimate odds ratios for gestational weight gain with age, pre-pregnancy BMI, dietary and physical activity scores, weight gain during pregnancy and the type of intervention as independent variables.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/09/2014
Actual
2/09/2014
Date of last participant enrolment
Anticipated
31/12/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
640
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 3650 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 3651 0
Dubbo Base Hospital - Dubbo
Recruitment hospital [3] 3652 0
Orange Health Service - Orange
Recruitment hospital [4] 3653 0
Lismore Base Hospital - Lismore
Recruitment hospital [5] 3654 0
Blacktown Hospital - Blacktown

Funding & Sponsors
Funding source category [1] 291039 0
Government body
Name [1] 291039 0
NSW Office of Preventive Health
Country [1] 291039 0
Australia
Primary sponsor type
Government body
Name
NSW Office of Preventive Health
Address
Liverpool Hospital, Don Everett Building.
Locked Bag 7103
Liverpool BC
1871 NSW
Country
Australia
Secondary sponsor category [1] 289722 0
None
Name [1] 289722 0
NA
Address [1] 289722 0
NA
Country [1] 289722 0
Other collaborator category [1] 278422 0
Government body
Name [1] 278422 0
NSW Kids and Families
Address [1] 278422 0
73 Miller Street
North Sydney
2060 NSW
Country [1] 278422 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292623 0
SWSLHD Human Research Ethics Committee
Ethics committee address [1] 292623 0
Ethics committee country [1] 292623 0
Australia
Date submitted for ethics approval [1] 292623 0
Approval date [1] 292623 0
26/06/2014
Ethics approval number [1] 292623 0
HREC/14/LPOOL/131

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

Contacts
Principal investigator
Name 56274 0
Ms Michelle Maxwell
Address 56274 0
Liverpool Hospital, Don Everett Building.
Locked Bag 7103
1871 NSW
Country 56274 0
Australia
Phone 56274 0
+61 2 8738 6503
Fax 56274 0
Email 56274 0
[email protected]
Contact person for public queries
Name 56275 0
Michelle Maxwell
Address 56275 0
Liverpool Hospital, Don Everett Building.
Locked Bag 7103
1871 NSW
Country 56275 0
Australia
Phone 56275 0
+61 2 8738 6503
Fax 56275 0
Email 56275 0
[email protected]
Contact person for scientific queries
Name 56276 0
Santosh Khanal
Address 56276 0
Liverpool Hospital, Don Everett Building.
Locked Bag 7103
1871 NSW
Country 56276 0
Australia
Phone 56276 0
+61 2 8738 7231
Fax 56276 0
Email 56276 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.