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Trial registered on ANZCTR


Registration number
ACTRN12616001011471
Ethics application status
Approved
Date submitted
6/07/2016
Date registered
1/08/2016
Date last updated
1/08/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of a health coaching program for improving wellness and pregnancy outcomes in women with gestational Diabetes Mellitus (GDM): a pilot study
Scientific title
Gestational Diabetes Mellitus (GDM) Wellness project: a pilot study investigating the efficacy of a health coaching program for improving wellness and pregnancy outcomes in women with gestational diabetes mellitus (GDM)
Secondary ID [1] 289467 0
nil
Universal Trial Number (UTN)
U1111-1184-3222
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gestational Diabetes Mellitus 299149 0
Condition category
Condition code
Metabolic and Endocrine 299164 299164 0 0
Diabetes
Reproductive Health and Childbirth 299603 299603 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Health coaching of high risk women diagnosed with GDM is delivered by midwifes who have undergone training in health coaching (Health Change Australia; health change.com, Core Training Part 1 and Part 2 ). The initial meeting is face-to-face at a routine antenatal clinic appointment. Subsequent follow-up is by weekly telephone call or email (according to participant preference), or at scheduled antenatal clinic visits (one-to-one interview), until delivery. The Coach’s role is to encourage and monitor the woman’s adherence to the GDM diet and exercise program (as prescribed by the Diabetes in Pregnancy Service), to monitor weight, to encourage breastfeeding, and to carry out follow-up post-partum (OGTT results at 6-12 weeks post-partum and 12 months postpartum, weight at 6 and 12 months postpartum). Women in the Intervention group also attend a one-on-one appointment (45 min-1 hr duration) with an exercise physiologist during pregnancy (usually within the first month after enrolment in the study) to set out specific individualized goals for regular physical activity pre- and post-partum. The number of contacts with health coaches is recorded and is a secondary outcome of the trial.
Intervention code [1] 295050 0
Lifestyle
Intervention code [2] 295430 0
Behaviour
Comparator / control treatment
Usual outpatient care for women with GDM consists of attendance at a multidisciplinary seminar (diabetes nurse educator, dietitian, social worker, exercise physiologist), followed by 2-3 weekly multidisciplinary antenatal clinic visits. Women are encouraged to contact diabetes nurse educator weekly by telephone or email.
Control group
Active

Outcomes
Primary outcome [1] 298649 0
Oral Glucose tolerance test
Timepoint [1] 298649 0
6-12 weeks postpartum and 12 months postpartum
Secondary outcome [1] 324847 0
gestational weight gain i.e. using clinic mechanical scale at booking and after 37 weeks gestation.
Timepoint [1] 324847 0
at term i.e. after 37 weeks gestation
Secondary outcome [2] 324849 0
infant weight i.e. routine weight of neonate using digital scales, as recorded in the medical record.
Timepoint [2] 324849 0
birth
Secondary outcome [3] 324850 0
maternal requirement for insulin to treat GDM: assessed by patient report and review of medical records,
Timepoint [3] 324850 0
term i.e. after 37 weeks gestation
Secondary outcome [4] 324851 0
number of contacts with healthcare providers: assessed from records of contact with Health Coaches (intervention group) as well as digital medical record (all participants)
Timepoint [4] 324851 0
term i.e. after 37 weeks gestation
Secondary outcome [5] 324852 0
depression: assessed by Edinburgh Depression Scale
Timepoint [5] 324852 0
36 weeks gestation
Secondary outcome [6] 326073 0
anxiety assessed by STAI short form
Timepoint [6] 326073 0
36 weeks gestation
Secondary outcome [7] 326158 0
infant birth weight centile (www,gestation.net)
Timepoint [7] 326158 0
birth

Eligibility
Key inclusion criteria
1. diagnosis of GDM according to ADIPS criteria 2012: gestation 30 weeks or less
2. Age 18 years or above
3. Singleton pregnancy
4. English speaker
5. BMI 30 kg/m2 or above at booking
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-singleton pregnancy

Other major pregnancy complications or chronic health problems.

pre-existing type 1 or type 2 DM – pre-existing impaired glucose tolerance (IGT) or impaired fasting glucose (IFG) is allowed

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)
sealed envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
block randomization (sealedenvelope.com)
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
All data will be analysed by intention to treat. Comparisons between Usual Care and Intervention groups will be made using unpaired t –tests or Mann Whitney U tests (e.g. post-partum OGTT results, pregnancy weight gain). Categorical variables will be compared using the Fisher exact test. Questionnaire scores collected at several time points will be analysed by repeated measures ANOVA: scores will be adjusted for age and parity.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
18/11/2014
Date of last participant enrolment
Anticipated
22/11/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment hospital [1] 5987 0
Launceston General Hospital - Launceston
Recruitment postcode(s) [1] 13409 0
7250 - Launceston

Funding & Sponsors
Funding source category [1] 293833 0
Charities/Societies/Foundations
Name [1] 293833 0
Clifford Craig Medical Research Trust
Country [1] 293833 0
Australia
Primary sponsor type
Individual
Name
Dr Anne Corbould
Address
Level 5, Launceston General Hospital, Charles Street, Launceston, TAS 7250
Country
Australia
Secondary sponsor category [1] 292662 0
None
Name [1] 292662 0
Address [1] 292662 0
Country [1] 292662 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295260 0
University of Tasmania Health and Medical Human Research and Ethics Committee
Ethics committee address [1] 295260 0
Office of Research Services
Private Bag 01
Hobart, TAS 7001
Ethics committee country [1] 295260 0
Australia
Date submitted for ethics approval [1] 295260 0
Approval date [1] 295260 0
27/08/2013
Ethics approval number [1] 295260 0

Summary
Brief summary
Elevated blood glucose levels developing for the first time in pregnancy (Gestational Diabetes Mellitus; GDM) is a common complication of pregnancy in our local community. In most cases, the diabetes will resolve after the baby is delivered, although it may return years later (type 2 diabetes). However, we have found that in certain women there is a high chance that the blood glucose levels will remain elevated after pregnancy, with adverse effects on the health of the woman in the long-term, and potentially also on the baby during a subsequent pregnancy. There is strong evidence that diabetes in individuals at high risk can be prevented through lifestyle intervention with diet and exercise. Our study will determine whether in high-risk women with GDM, we can prevent elevated blood glucose levels in the first year after their pregnancy by offering them one-on-one advice about a healthy lifestyle by a health coach (a nurse or other allied health professional) during their pregnancy and for the first year after giving birth. The women who participate in this trial will mostly see their health coach during routine antenatal visits so that inconvenience to the patient will be minimized. We will compare high risk women who had a health coach to those who did not i.e. outcomes during pregnancy and in the first year after giving birth. If our trial is successful, we believe our program could easily be incorporated into routine clinical care in our antenatal clinics..
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66702 0
Dr Anne Corbould
Address 66702 0
Department of Medicine
Launceston General Hospital
Charles St
Launceston TAS 7250
Country 66702 0
Australia
Phone 66702 0
+61 3 67776777
Fax 66702 0
Email 66702 0
[email protected]
Contact person for public queries
Name 66703 0
Anne Corbould
Address 66703 0
Department of Medicine
Launceston General Hospital
Charles St
Launceston TAS 7250
Country 66703 0
Australia
Phone 66703 0
+61 3 67776777
Fax 66703 0
Email 66703 0
[email protected]
Contact person for scientific queries
Name 66704 0
Anne Corbould
Address 66704 0
Department of Medicine
Launceston General Hospital
Charles St
Launceston TAS 7250
Country 66704 0
Australia
Phone 66704 0
+61 3 67776777
Fax 66704 0
Email 66704 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

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