ANZCTR - Registration

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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 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]

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

Condition category

Condition code

Reproductive Health and Childbirth

Normal pregnancy

Diet and Nutrition

Obesity

Metabolic and Endocrine

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]

Prevention

Intervention code [2]

Lifestyle

Intervention code [3]

Behaviour

Comparator / control treatment

receiving standard maternal care only (standard treatment)

Control group

Active

Outcomes

Primary outcome [1]

maternal weight gain in pregnancy

Timepoint [1]

at 6 weeks postpartum

Secondary outcome [1]

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]

26-28 weeks gestation

Secondary outcome [2]

Physical activity measured subjectively (International Physical Activity Questionnaire) and objectively (pedometer; steps/day)

Self-efficacy (Chronic Disease Self-efficacy Scale)

Timepoint [2]

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?

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]

Monash Medical Centre - Clayton campus - Clayton

Recruitment hospital [2]

Casey Hospital - Berwick

Recruitment hospital [3]

Dandenong Hospital - Dandenong

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Jack Brockhoff Foundation

Address [1]

PO BOX 1580
Doncaster East
Victoria 3109

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

International Diabetes Federation

Address [2]

Chauss?e de la Hulpe 166
B-1170 Brussels, Belgium

Country [2]

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]

Individual

Name [1]

Dr Caroyln Allen

Address [1]

Prince Henry's Institute
PO BOX 5152
Clayton
Victoria
3168

Country [1]

Australia

Other collaborator category [1]

Individual

Name [1]

Cheryce Harrison

Address [1]

MIHSR
Locked Bag 29
Clayton
Victoria
3168

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Southern Health Human Research Ethics Committee

Ethics committee address [1]

Human Research Ethics
Locked Bag 29 
Clayton 
Victoria 
3168

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

01/04/2008

Ethics approval number [1]

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

Prof Helena Teede

Address

Monash University
Monash Centre for Health Research and Implementation
Locked Bag 29
Clayton
VIC
3168

Country

Australia

Phone

+61385722662

Fax

helena.teede@monash.edu

Contact person for public queries

Name

Cheryce Harrison

Address

Monash University Monash Centre for Health Research and Implementation Locked Bag 29 Clayton VIC 3168

Country

Australia

Phone

+61385722662

Fax

cheryce.harrison@monash.edu

Contact person for scientific queries

Name

Professor Helena Teede

Address

Monash University Monash Centre for Health Research and Implementation Locked Bag 29 Clayton VIC 3168

Country

Australia

Phone

+61 3 85722662

Fax

helena.teede@monash.edu

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Limiting postpartum weight retention through early antenatal intervention: The HeLP-her randomised controlled trial.	2014	https://dx.doi.org/10.1186/s12966-014-0134-8
Embase	Risk stratification in early pregnancy for women at increased risk of gestational diabetes.	2015	https://dx.doi.org/10.1016/j.diabres.2014.09.006
Embase	Limiting Postpartum Weight Retention in Culturally and Linguistically Diverse Women: Secondary Analysis of the HeLP-her Randomized Controlled Trial.	2022	https://dx.doi.org/10.3390/nu14142988

N.B. These documents automatically identified may not have been verified by the study sponsor.

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