Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611000867998
Ethics application status
Approved
Date submitted
9/08/2011
Date registered
15/08/2011
Date last updated
3/06/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Healthy Start to Pregnancy study - an evaluation of a new early antenatal health promotion model of care for improving maternal health behaviours.
Scientific title
Evaluation of an early antenatal health promotion model of care for improving maternal lifestyle health behaviours.
Secondary ID [1] 262808 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Antenatal health behaviours (dietary intake/diet quality, physical activity, gestational weight gain, smoking) 270514 0
Condition category
Condition code
Diet and Nutrition 270677 270677 0 0
Other diet and nutrition disorders
Reproductive Health and Childbirth 270678 270678 0 0
Antenatal care
Public Health 270679 270679 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Attendance at a one-hour early antenatal lifestyle behaviour change workshop + receipt of written health education material designed to facilitate behaviour change (booklet; received once, at the workshop). Women attend the workshop at any time in pregnancy, but it's recommended they attend before 20 weeks. Content covers diet, physical activity, healthy weight gain, smoking cessation, and breastfeeding, goal setting and self monitoring techniques, and contacts for further support.
Intervention code [1] 269157 0
Behaviour
Intervention code [2] 269177 0
Lifestyle
Comparator / control treatment
Receipt of written health education material designed to facilitate behaviour change. This is the same information that is distributed at the group and constitutes usual care.
Control group
Active

Outcomes
Primary outcome [1] 269397 0
1. an improvement in fruit and vegetable intake (an increase, by at least 5%, of women meeting the pregnancy guidelines for fruit and for vegetable intake and an increase of at least half a serve of fruit and half a serve of vegetables consumed each day)
Timepoint [1] 269397 0
Time 1: Baseline/service entry; Time 2:+3 months from recruitment (valid and reliable 'short questions' from teh National Nutrition Survey)
Primary outcome [2] 269422 0
2. an improvement in pregnancy weight status (improved weight gain guideline awareness and increased proportion of women gaining appropriate amounts of weight for pregnancy)
Timepoint [2] 269422 0
Time 1: Baseline/service entry; Time 2:+3 months from recruitment; Time 3: immediate postnatal period (self-report)
Primary outcome [3] 269423 0
3. an improvement in the diet quality index;
Timepoint [3] 269423 0
Time 1: Baseline/service entry; Time 2:+3 months from recruitment (valid and reliable 'fat and fibre' diet quality index)
Secondary outcome [1] 287550 0
4. an improvement in physical activity (an increase, by at least 5%, of women undertaking adequate levels of physical activity for health and an increase of at least 30 minutes of physical activity per week);
Timepoint [1] 287550 0
Time 1: Baseline/service entry; Time 2:+3 months from recruitment. (Active Australia Survey)
Secondary outcome [2] 287601 0
5. a decrease of at least 5% in the percentage of women who smoke during pregnancy;
Timepoint [2] 287601 0
Time 1: Baseline/service entry; Time 2:+3 months from recruitment. (valid and reliable smoking assessment tool- from Mullen, P., et al., Improving disclosure of smoking by pregnant women. American Journal of Obstetrics and Gynecology, 1991. 165: p. 409-413. & Melvin, C.L., P. Tucker, and Smoke- Free Families Common Evaluation Measures for Pregnancy and Smoking Cessation Projects Working Group, Measurement and definition for smoking cessation intervention research: the Smoke- Free Families experience. Tobacco Control, 2000. 9(Suppl3): p. iii87-iii90).
)
Secondary outcome [3] 287602 0
6. an increased proportion of maternal intention to breastfeed.
Timepoint [3] 287602 0
Time 1: Baseline/service entry; Time 2:+3 months from recruitment. (valid and reliable tool - from Manstead, A., C. Proffitt, and J. Smart, Predicting and understanding mother' infant-feeding intentions and behavior: testing the theory of reasoned action. Journal of Personality and Social Psychology, 1983. 44(4): p. 657-671.)

Eligibility
Key inclusion criteria
Women will be included if they are pregnant, attending the Mater Mothers' Hospital antenatal clinic for pregnancy care, and who are able to provide informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Women will be excluded if they are unable to read and speak English at a level that allows completion of pen-and-paper surveys.

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)
All eligible women will be identified and approached by the research officer at their MMH antenatal clinic booking visit appointment. Those who provide consent will be randomised to the usual care (UC) or intervention (HSP) group. Allocation was concealed using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation process will be managed by the Mater Medical Research Institute using a pre-existing computer program (random sequence generation).
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
31/08/2010
Actual
31/08/2010
Date of last participant enrolment
Anticipated
Actual
7/03/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
380
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 269631 0
Charities/Societies/Foundations
Name [1] 269631 0
Mater Health Services (JP Kelly Foundation)
Country [1] 269631 0
Australia
Primary sponsor type
Individual
Name
Dr Shelley Wilkinson
Address
Senior Research Dietitian
Raymond Terrace, South Brisbane, Queensland 4101
Country
Australia
Secondary sponsor category [1] 266661 0
Individual
Name [1] 266661 0
Prof H David McIntyre
Address [1] 266661 0
Director of Obstetric Medicine,
Raymond Terrace, South Brisbane, Queensland 4101
Country [1] 266661 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269575 0
Mater Human Research Ethics Committee
Ethics committee address [1] 269575 0
Mater Medical Research Institute, Aubigny Place, Raymond Tce, South Brisbane, Queensland 4101
Ethics committee country [1] 269575 0
Australia
Date submitted for ethics approval [1] 269575 0
Approval date [1] 269575 0
Ethics approval number [1] 269575 0
1465M

Summary
Brief summary
Women with a healthy lifestyle during their pregnancy have healthier pregnancies and healthier babies. Their long term health is also improved, resulting in a better quality of life for them and their family, as well as lower health system costs with fewer doctor and hospital visits required. Currently, we do not know the best way to support women to make lifestyle changes to ensure they have the healthiest start to their pregnancy. This study is looking at how effective a workshop that is delivered early in pregnancy, that covers important diet, exercise, and smoking cessation advice, support and referrals, is to improve the health of pregnant women attending a large maternity hospital in South East Queensland.
Trial website
Trial related presentations / publications
Wilkinson, SA & McIntyre, HD. (2012). Evaluation of the Healthy Start to Pregnancy early antenatal health promotion workshop: A randomized controlled trial. BMC Pregnancy & Childbirth. 12:131.

Wilkinson, SA. & McIntyre, HD. Evaluation of an early antenatal health promotion workshop for improving health behaviours: The healthy start to pregnancy workshop RCT. 16th International Congress of Dietetics. Sydney, Australia. 5-8 September, 2012.
Public notes

Contacts
Principal investigator
Name 32996 0
Dr Shelley Wilkinson
Address 32996 0
Dept of Dietetics
Mater Health Services
MCH, level 3 - Allied Health
Raymond Tce
South Brisbane, Queensland. 4101
Country 32996 0
Australia
Phone 32996 0
+ 61 7 3163 6000
Fax 32996 0
Email 32996 0
[email protected]
Contact person for public queries
Name 16243 0
Dr Dr Shelley Wilkinson
Address 16243 0
c/o- Dept of Nutrition and Dietetics,
Mater Health Services,
Level 3 MCH
Raymond Tce
South Brisbane
Queensland, 4101
Country 16243 0
Australia
Phone 16243 0
+61 7 3163 8585
Fax 16243 0
Email 16243 0
[email protected]
Contact person for scientific queries
Name 7171 0
Dr Dr Shelley Wilkinson
Address 7171 0
c/o- Dept of Nutrition and Dietetics,
Mater Health Services,
Level 3 MCH
Raymond Tce
South Brisbane
Queensland, 4101
Country 7171 0
Australia
Phone 7171 0
+61 7 3163 8585
Fax 7171 0
Email 7171 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.