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Trial registered on ANZCTR


Registration number
ACTRN12613000125729
Ethics application status
Approved
Date submitted
30/01/2013
Date registered
1/02/2013
Date last updated
2/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Primary prevention of gestational diabetes for women who are overweight and obese: a randomised controlled trial
Scientific title
A randomised controlled trial comparing the effectiveness of a telephone based behavioural change program to usual care in reducing the incidence of gestational diabetes in overweight and obese women.
Secondary ID [1] 281863 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gestational Diabetes 288238 0
Gestational weight gain 288239 0
Large for gestational age infants 288240 0
Self efficacy 288241 0
Anxiety 288242 0
Depression 288243 0
Overweight/obesity 288265 0
Condition category
Condition code
Metabolic and Endocrine 288597 288597 0 0
Diabetes
Reproductive Health and Childbirth 288598 288598 0 0
Antenatal care
Diet and Nutrition 288619 288619 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
From recruitment in the first trimester until childbirth, women in the intervention group will receive a telephone based program informed by the Theory of Self-efficacy and employing Motivational Interviewing. Brief ( less than 5 minute) phone contact will alternate each week with a text message/email and this contact will involve goal setting, behaviour change reinforcement with weekly self weighing and charting, and the provision of health information. The intervention does not involve clinical care.
Intervention code [1] 286424 0
Prevention
Intervention code [2] 286425 0
Lifestyle
Intervention code [3] 286426 0
Behaviour
Comparator / control treatment
Usual pregnancy care will vary with respect to advice provided to women on lifestyle modifications and referrals to other health professionals such as dieticians. Women in both the intervention and control group will receive two commonly available information booklets one following recruitment and on at 36 weeks.
Control group
Active

Outcomes
Primary outcome [1] 288748 0
Proportion of women diagnosed with Gestation Diabetes on Oral Glucose Tolerance Test. Both the criteria for the Australian Diabetes in Pregnancy Society management guidelines and the International Association of Diabetes and Pregnancy Study Groups criteria will be used and reported separately.
Timepoint [1] 288748 0
24 - 28 weeks gestation
Secondary outcome [1] 300898 0
Proportion of women with a gestational weight gain within the Institute of Medicine's guidelines. Measured as the difference between the woman's booking in weight and the last recorded weight in her pregnancy record.
Timepoint [1] 300898 0
From 36 weeks gestation
Secondary outcome [2] 300899 0
Large for gestational age infants
The differences in the proportions of babies that are LGA will be compared. LGA infants will be defined as a birth weight > /=90th centile for gender and gestation, as well as a birth weight > 4000 grams. These data will be obtained from a review of medical records and will be reported using both criteria.
Timepoint [2] 300899 0
Birth
Secondary outcome [3] 300900 0
Self-efficacy related to healthy lifestyle changes in diet and exercise will be measured and the mean differences between groups will be compared. The Weight Efficacy Life-Style Questionnaire and the Self-Efficacy for Exercise Scale will be used.
Timepoint [3] 300900 0
Self reported using questionnaire at 36 weeks
Secondary outcome [4] 300901 0
Anxiety will be measured using the short version of the Speilberger State-Trait anxiety inventory (STAI-State). Mean scores will compared.
Timepoint [4] 300901 0
Self reported using questionnaire at 36 weeks
Secondary outcome [5] 300902 0
Depression will be measured using the Beck Depression Inventory II. The mean differences between groups will be compared.
Timepoint [5] 300902 0
Self reported using questionnaire at 36 weeks

Eligibility
Key inclusion criteria
Pregnant with gestation less than 14 weeks
Singelton pregnancy
Body Mass Index =/> 25
Able to give informed consent in English
Minimum age
18 Years
Maximum age
50 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Pre-exisiting diabetes
History of gestational diabetes

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)
Women who meet the selection criteria will be offered information on the study by their General Practitioner or Practice Nurse.Women interersted in participating will provide written informed consent and an enrolment form will be completed. The attending clinicians are not part of the research team.
The consent and enrolment form will be faxed/emailed to the research office. Women will be randomly allocated to the intervention or control group by an individual who is independent to the study team, drawing a sealed numbered opaque envelope indicating "intervention" or "control". Envelopes are numbered and will be drawn consecutively.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated randomisation sequence will be used to achieve block randomisation by recruitment site.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
Initial analysis will examine baseline characteristics of all women, as an indication that the treatment groups were comparable for selected variables including, age, parity and BMI category. Primary and secondary outcomes will be analysed on an "intention to treat" basis. Differences between trial arms will use the Chi-squared statistic for categorical outcomes and Student’s t-test for continuous outcomes and 95% confidence intervals will be reported. Appropriate regression models will be employed controlling for co-variates. The fidelity of the intervention will be assessed and reported and the feasibility of the intervention will be considered in the process evaluation that will include the experience of participants and General Practioners /Practice Nurses.

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 6259 0
3220 - Geelong
Recruitment postcode(s) [2] 6260 0
3250 - Colac
Recruitment postcode(s) [3] 6261 0
3280 - Warrnambool

Funding & Sponsors
Funding source category [1] 286647 0
University
Name [1] 286647 0
Deakin University
Address [1] 286647 0
PO Box 20000
School of Nursing and Midwifery
Geelong
Victoria
3220
Country [1] 286647 0
Australia
Primary sponsor type
Individual
Name
Dr Cate Nagle
Address
PO Box 20000
School of Nursing and Midwifery
Waterfront campus
Geelong
Victoria
3220
Country
Australia
Secondary sponsor category [1] 285430 0
None
Name [1] 285430 0
Address [1] 285430 0
Country [1] 285430 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288724 0
Barwon Health
Ethics committee address [1] 288724 0
Office of Research
P0 Box 281
Ryrie St
Geelong
Vic
3220
Ethics committee country [1] 288724 0
Australia
Date submitted for ethics approval [1] 288724 0
Approval date [1] 288724 0
05/09/2012
Ethics approval number [1] 288724 0
12/108

Summary
Brief summary
Gestational Diabetes Mellitus (GDM) has well recognised adverse health implications for the mother and her newborn that are both short and long term. Obesity is a significant risk factor for developing GDM and the prevalence of obesity is increasing globally. It is a matter of public health importance that clinicians have evidence based strategies to inform practice and currently there is insufficient evidence regarding the impact of dietary and lifestyle interventions on improving maternal and newborn outcomes. The primary aim of this study is to measure the impact of a telephone based intervention that promotes positive lifestyle modifications on the incidence of GDM. Secondary aims include: the impact on gestational weight gain; large for gestational age babies; differences in blood glucose levels taken at the Oral Glucose Tolerance Test (OGTT) and selected factors relating to self-efficacy and psychological wellbeing.
A randomised controlled trial (RCT) will be conducted involving pregnant women who are overweight (BMI >25 to 29.9 kg/m^2) or obese (BMI >30kg/m^2), less than 14 weeks gestation and recruited from the Barwon South West region of Victoria, Australia. From recruitment until birth, women in the intervention group will receive a program informed by the Theory of Self-efficacy and employing Motivational Interviewing. Brief (less than 5 minute) phone contact will alternate each week with a text message/email and will involve goal setting, behaviour change reinforcement with weekly weighing and charting, and the provision of health information. Those in the control group will receive usual care. Data for primary and secondary outcomes will be collected from medical record review and a questionnaire at 36 weeks gestation.
Evidence based strategies that reduce the incidence of GDM are a priority for contemporary maternity care. Changing health behaviours is a complex undertaking and trialling a composite intervention that can be adopted in various primary health settings is required so women can be accessed as early in pregnancy as possible. Using a sound theoretical base to inform such an intervention will add depth to our understanding of this approach and to the interpretation of results, contributing to the evidence base for practice and policy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37458 0
Dr Cate Nagle
Address 37458 0
Deakin University
School of Nursing and Midwifery
Waterfont Campus
1 Gheringhap St
Geelong
Victoria
3220
Country 37458 0
Australia
Phone 37458 0
+61 3 5227 8401
Fax 37458 0
+61 3 5227 8411
Email 37458 0
cate.nagle@deakin.edu.au
Contact person for public queries
Name 37459 0
Dr Cate Nagle
Address 37459 0
Deakin University
School of Nursing and Midwifery
Waterfont Campus
1 Gheringhap St
Geelong
Victoria
3220
Country 37459 0
Australia
Phone 37459 0
+61 3 5227 8401
Fax 37459 0
+61 3 5227 8411
Email 37459 0
cate.nagle@deakin.edu.au
Contact person for scientific queries
Name 37460 0
Dr Cate Nagle
Address 37460 0
Deakin University
School of Nursing and Midwifery
Waterfont Campus
1 Gheringhap St
Geelong
Victoria
3220
Country 37460 0
Australia
Phone 37460 0
+61 3 5227 8401
Fax 37460 0
+61 3 5227 8411
Email 37460 0
cate.nagle@deakin.edu.au

No information has been provided regarding IPD availability
Summary results
No Results