Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000233325
Ethics application status
Approved
Date submitted
5/05/2008
Date registered
7/05/2008
Date last updated
13/11/2018
Date data sharing statement initially provided
13/11/2018
Date results information initially provided
13/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Healthier lifestyles: Preventing Gestational Diabetes in High Risk Pregnancies: A Research and Education Project
Scientific title
Preventing Excess Weight Gain and Gestational Diabetes in Overweight and Obese Pregnancies: A Research and Education Project
Secondary ID [1] 262167 0
Healthy Lifestyles in Pregnancy (HeLP-her in Pregnancy)
Universal Trial Number (UTN)
Trial acronym
HeLP-her in pregnancy
Linked study record

Health condition
Health condition(s) or problem(s) studied:
prevention of excess weight gain and gestational diabetes in pregnancy 3111 0
Condition category
Condition code
Reproductive Health and Childbirth 3271 3271 0 0
Normal pregnancy
Diet and Nutrition 3272 3272 0 0
Obesity
Metabolic and Endocrine 290696 290696 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Healthy lifestyle information (improved diet, exercise, behaviour modification) during duration of pregnancy. Information will delivered in the form of 4 interactive education modules that focus on healthy eating, regular moderate exercise, identifying and removing barriers to healthy lifestyle behaviours and improving self efficacy. Participants will also receive detailed written information on the content covered in the education modules. The 4 education modules will be delivered between 14-16 to 26-28 weeks gestation (i.e. 1 module every 2-3 weeks).
Intervention code [1] 2853 0
Prevention
Intervention code [2] 2854 0
Lifestyle
Intervention code [3] 2855 0
Behaviour
Comparator / control treatment
receiving standard maternal care only (standard treatment)
Control group
Active

Outcomes
Primary outcome [1] 4162 0
maternal weight gain in pregnancy
Timepoint [1] 4162 0
at 6 weeks postpartum
Secondary outcome [1] 7012 0
gestational diabetes. this outcome will be measured by an oral glucose tolerance test (OGTT) at 26-28 weeks gestation, which is part of routine maternal care.
Timepoint [1] 7012 0
26-28 weeks gestation
Secondary outcome [2] 305075 0
Physical activity measured subjectively (International Physical Activity Questionnaire) and objectively (pedometer; steps/day)

Self-efficacy (Chronic Disease Self-efficacy Scale)
Timepoint [2] 305075 0
28 weeks and 6 weeks postpartum

Eligibility
Key inclusion criteria
Women identified as high risk for developing GDM as indicated by the routine clinical risk screening tool at Southern Health within the first 12-14 weeks of pregnancy.
Body Mass Index of above 25 kg/m2 (high ethnic risk groups) and above 27kgm2 (caucasion)
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women who have Type 1 or Type 2 diabetes.
Women not carrying singleton pregnancies.
Women who have an existing chronic illness/disease or contra-indication that prevents or restricts their participation and/or exacerbates their condition when participating in moderate physical activity during pregnancy.
Women who have a Body Mass Index of ³ 40kg/m2.
Women who have an active psychiatric illness.
Women who do not speak English/are not literate or who cannot attend the information session/s.

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 opaque envelops will contain group allocation information.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation will be used to draw up an allocation schedule containing even numbers of control and intervention groups. The schedule will allow randomisation to control or intervention when recruitment occurs.
Masking / blinding
Blinded (masking 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
15/05/2008
Actual
11/06/2008
Date of last participant enrolment
Anticipated
14/10/2010
Actual
13/10/2010
Date of last data collection
Anticipated
Actual
2/04/2012
Sample size
Target
275
Accrual to date
Final
228
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 1589 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 1590 0
Casey Hospital - Berwick
Recruitment hospital [3] 1591 0
Dandenong Hospital - Dandenong

Funding & Sponsors
Funding source category [1] 3355 0
Charities/Societies/Foundations
Name [1] 3355 0
Jack Brockhoff Foundation
Country [1] 3355 0
Australia
Funding source category [2] 265073 0
Charities/Societies/Foundations
Name [2] 265073 0
International Diabetes Federation
Country [2] 265073 0
United States of America
Primary sponsor type
Individual
Name
Professor Helena Teede
Address
MIMR
Locked Bag 29
Clayton
Victoria
3168
Country
Australia
Secondary sponsor category [1] 3003 0
Individual
Name [1] 3003 0
Dr Caroyln Allen
Address [1] 3003 0
Prince Henry's Institute
PO BOX 5152
Clayton
Victoria
3168
Country [1] 3003 0
Australia
Other collaborator category [1] 279 0
Individual
Name [1] 279 0
Cheryce Harrison
Address [1] 279 0
MIHSR
Locked Bag 29
Clayton
Victoria
3168
Country [1] 279 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5381 0
Southern Health Human Research Ethics Committee
Ethics committee address [1] 5381 0
Human Research Ethics
Locked Bag 29
Clayton
Victoria
3168
Ethics committee country [1] 5381 0
Australia
Date submitted for ethics approval [1] 5381 0
Approval date [1] 5381 0
01/04/2008
Ethics approval number [1] 5381 0
07216C

Summary
Brief summary
The primary aim of this study is to investigate the efficacy of simple lifestyle modification (healthy food choices and increased physical activity) in preventing excess weight gain during pregnancy (assessed 6 weeks postpartum). Secondary aims are to prevent prevalence of Gestational Diabetes Mellitus (GDM), identify barriers to healthy lifestyle choices and to provide an evidence base to inform future interventions targeting education and prevention of excess weight gain in the prevention of long-term obesity and prevention or treatment of Gestational Diabetes. The expected outcomes for this study include; 1/ Weight gain that is equal to, or below, recommended weight gain in the intervention group in comparison to the controls. 2/ Reduced prevalence of Gestational Diabetes and/or reduced intensity of treatment if diagnosis does occur in the intervention group. 3/ Lower incidence of increased foetal birth weight or macrosomia in the intervention group. 4/ Improved biological markers of health in the intervention group. 5/ Enhanced self-efficacy, motivation, mood and quality of life in the intervention group that persists long-term (1 year postpartum).
Trial website
Trial related presentations / publications
Harrison CL, Lombard CB, Strauss BJ, Teede HJ. Erratum: Optimizing healthy gestational weight gain in women at high risk of gestational diabetes: A randomized controlled trial. Obesity, 2016. 24(1): 268.
Harrison CL, Lombard CB, East C, Boyle J, & Teede HJ. Risk stratification in early pregnancy for women at increased risk of gestational diabetes. Diabetes research and clinical practice, 2015. 107(1): 61 – 68.
49. HARRISON CL, Teede HJ & Lombard CB How effective is self-weighing in the setting of a lifestyle intervention to reduce gestational weight gain and postpartum weight retention? ANZJOG, 2014. 54(4):382-5.
Harrison CL, Lombard CB, & Teede HJ. Limiting postpartum weight retention through early antenatal intervention: the HeLP-her randomised controlled trial. IJBNPA, 2014. 11(1): 134
Harrison CL, Teede HJ & Lombard CB How effective is self-weighing in the setting of a lifestyle intervention to reduce gestational weight gain and postpartum weight retention? ANZJOG, 2014. 54(4):382-5.
Harrison CL, Lombard CB, & Teede HJ. Limiting postpartum weight retention through early antenatal intervention: the HeLP-her randomised controlled trial. IJBNPA, 2014. 11(1): 134
Public notes

Contacts
Principal investigator
Name 28567 0
Prof Helena Teede
Address 28567 0
Monash University
Monash Centre for Health Research and Implementation
Locked Bag 29
Clayton
VIC
3168
Country 28567 0
Australia
Phone 28567 0
+61385722662
Fax 28567 0
Email 28567 0
helena.teede@monash.edu
Contact person for public queries
Name 11724 0
Dr Cheryce Harrison
Address 11724 0
Monash University Monash Centre for Health Research and Implementation Locked Bag 29 Clayton VIC 3168
Country 11724 0
Australia
Phone 11724 0
+61385722662
Fax 11724 0
Email 11724 0
cheryce.harrison@monash.edu
Contact person for scientific queries
Name 2652 0
Prof Professor Helena Teede
Address 2652 0
Monash University Monash Centre for Health Research and Implementation Locked Bag 29 Clayton VIC 3168
Country 2652 0
Australia
Phone 2652 0
+61 3 85722662
Fax 2652 0
Email 2652 0
helena.teede@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data previously shared with the international Women in Pregnancy (iWIP) consortium.


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Please see outcome papers in previous section - al... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseRisk stratification in early pregnancy for women at increased risk of gestational diabetes.2015https://dx.doi.org/10.1016/j.diabres.2014.09.006
EmbaseLimiting postpartum weight retention through early antenatal intervention: The HeLP-her randomised controlled trial.2014https://dx.doi.org/10.1186/s12966-014-0134-8
EmbaseLimiting Postpartum Weight Retention in Culturally and Linguistically Diverse Women: Secondary Analysis of the HeLP-her Randomized Controlled Trial.2022https://dx.doi.org/10.3390/nu14142988
N.B. These documents automatically identified may not have been verified by the study sponsor.