Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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
ACTRN12613001202752
Ethics application status
Approved
Date submitted
23/07/2013
Date registered
1/11/2013
Date last updated
24/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigating predictors of excess weight gain during pregnancy
Scientific title
Investigating predictors of excess weight gain during pregnancy:a prospective observational cohort study.
Secondary ID [1] 282888 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
ewip
Linked study record

Health condition
Health condition(s) or problem(s) studied:
weight gain in pregnancy 289705 0
Condition category
Condition code
Reproductive Health and Childbirth 290030 290030 0 0
Antenatal care

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
56
Target follow-up type
Weeks
Description of intervention(s) / exposure
Observational cohort study of weight gain in pregnancy from 12-15 weeks of pregnancy to 6 months post-partum.
Intervention code [1] 287590 0
Not applicable
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290077 0
To investigate the relationship between gestational weight gain and Intuitive Eating Scale scores

Timepoint [1] 290077 0
weight gain to 37 weeks (term) pregnancy
The Intuitive eating scale will be assessed at four time pionts during pregnancy (11-14, 18-21, 26-28 and 37 weeks and 6 months post-partum)
Secondary outcome [1] 303900 0
To investigate the relationship between gestational weight gain and sleep using the o Pittsburgh sleep score
Timepoint [1] 303900 0
Weight gain to 37 weeks (term) pregnancy
Pittsburgh sleep score will be performed at 12-14 w/ 18-21w, 25-29 w, 35-37 w
Secondary outcome [2] 303902 0
To investigate the test retest reliability of the Intuitive eating Scale (IES) in pregnancy
Timepoint [2] 303902 0
Comparison between Intuitive eating scores at 11-14 weeks and 18 -21 weeks of pregnancy
Secondary outcome [3] 303903 0
To investigate the relationship between weight gain from 12 weeks of pregnancy till 6 months post- partum with sleep using the Pittsburgh sleep score
Timepoint [3] 303903 0
at 6 months post-partum
Secondary outcome [4] 305306 0
To investigate the relationship between gestational weight gain and mood using the Edinburgh depression score
Timepoint [4] 305306 0
37 weeks pregnant
Edinburgh depression score will be performed at 12-14 w/ 18-21w, 25-29 w, 35-37 w
Secondary outcome [5] 305307 0
To investigate the relationship between gestational weight gain and activity at 12-14 w/ 18-21w, 25-29 w, 35-37 w using the Pregnancy Physical Activity Questionnaire
Timepoint [5] 305307 0
at 37 weeks pregnant
Secondary outcome [6] 305308 0
To investigate the relationship between gestational weight gain and anthropomorphic measurements (Height and weight measurement ,Waist measurement and Upper arm measurement) early in pregnancy
Timepoint [6] 305308 0
at 37 weeks of pregnancy
Secondary outcome [7] 305309 0
To investigate the relationship between weight gain from 12 weeks of pregnancy till 6 months post- partum with Intuitive Eating Scale scores
Timepoint [7] 305309 0
at 6 months Postpartum
Secondary outcome [8] 305310 0
To investigate the relationship between weight gain from 12 weeks of pregnancy till 6 months post- partum with mood using the Edinburgh depression score
Timepoint [8] 305310 0
at 6 months postpartum
Secondary outcome [9] 305312 0
To investigate the relationship between weight gain from 12 weeks of pregnancy till 6 months post- partum with activity using the Pregnancy Physical Activity Questionnaire
Timepoint [9] 305312 0
at 6 months postpartum
Secondary outcome [10] 305313 0
To investigate the relationship between weight gain from 12 weeks of pregnancy till 6 months post- partum with anthropomorphic measurements (Height and weight measurement ,Waist measurement and Upper arm measurement) early in pregnancy
Timepoint [10] 305313 0
at 6 months postpartum

Eligibility
Key inclusion criteria
Pregnant with an on-going wanted singleton pregnancy at the time of a Nuchal translucency ultrasound (11-14weeks)
English speaking / reading skills
Consents to take part
Aged 18-45
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Home address outside of metropolitan Dunedin

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Regression modeling for hypothesis generation about the relationship between gestational weight gain and sleep, mood and activity; anthropomorphic measurements early in pregnancy

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/03/2013
Actual
18/03/2013
Date of last participant enrolment
Anticipated
1/05/2014
Actual
4/05/2015
Date of last data collection
Anticipated
Actual
24/05/2016
Sample size
Target
300
Accrual to date
Final
260
Recruitment outside Australia
Country [1] 5241 0
New Zealand
State/province [1] 5241 0
Otago

Funding & Sponsors
Funding source category [1] 287671 0
University
Name [1] 287671 0
Womens and Childrens Health Department
Dunedin School of Medicine
University of Otago
Country [1] 287671 0
New Zealand
Primary sponsor type
Individual
Name
Dr Helen Paterson
Address
Senior Lecturer / Obstetrician and Gynaecologist

Department of Women’s and Children's Health
Dunedin School of Medicine
University of Otago
PO Box 913
Dunedin
9058
Country
New Zealand
Secondary sponsor category [1] 286407 0
Individual
Name [1] 286407 0
Dr Jean Hay Smith
Address [1] 286407 0
Department of Women’s and Children's Health
Dunedin School of Medicine
University of Otago
PO Box 913
Dunedin
9058
Country [1] 286407 0
New Zealand
Secondary sponsor category [2] 286408 0
Individual
Name [2] 286408 0
Dr Gareth Treharne
Address [2] 286408 0
Department of Psycology
University of Otago
PO Box 913
Dunedin
9058
Country [2] 286408 0
New Zealand
Other collaborator category [1] 277534 0
Individual
Name [1] 277534 0
Prof. Peter Herbison
Address [1] 277534 0
Department of Preventive and Social Medicine
Dunedin School of Medicine
University of Otago
PO Box 913
Dunedin
9058
Country [1] 277534 0
New Zealand
Other collaborator category [2] 277535 0
Individual
Name [2] 277535 0
Dr Caroline Howarth
Address [2] 277535 0
Department of Nutrition
University of Otago
PO Box 913
Dunedin
9058
Country [2] 277535 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289635 0
University of Otago Human Ethics Committee
Ethics committee address [1] 289635 0
University of Otago
PO Box 913
Dunedin
9058
Ethics committee country [1] 289635 0
New Zealand
Date submitted for ethics approval [1] 289635 0
Approval date [1] 289635 0
23/11/2012
Ethics approval number [1] 289635 0
12/308.

Summary
Brief summary
Excess weight gain during pregnancy is associated with negative outcomes for mother and child. Interventions to reduce excess gestational weight gain can be costly and have not been effective to date. Our aim is to establish a simple way of identifying those women who are likely to gain excess weight during pregnancy in order to enable midwives and obstetricians to direct interventions towards women most at risk. Helping those women at risk of excess weight gain during pregnancy should make interventions work better and thus be cost-effective.
Trial website
NA
Trial related presentations / publications
NA
Public notes
Please email [email protected] for further information

Contacts
Principal investigator
Name 41674 0
Dr Helen Paterson
Address 41674 0
Senior Lecturer / Obstetrician and Gynaecologist

Department of Women’s and Children's Health
Dunedin School of Medicine
University of Otago
PO Box 913
Dunedin
9058
Country 41674 0
New Zealand
Phone 41674 0
+64 3 4747007 ext 8933
Fax 41674 0
+64 3 474 7620
Email 41674 0
[email protected]
Contact person for public queries
Name 41675 0
Gaye Ellis
Address 41675 0
Department of Women’s and Children's Health
Dunedin School of Medicine
University of Otago
PO Box 913
Dunedin
9058
Country 41675 0
New Zealand
Phone 41675 0
+64 3 4740999
Fax 41675 0
Email 41675 0
[email protected]
Contact person for scientific queries
Name 41676 0
Helen Paterson
Address 41676 0
Department of Women’s and Children's Health
Dunedin School of Medicine
University of Otago
PO Box 913
Dunedin
9058
Country 41676 0
New Zealand
Phone 41676 0
+64 3 4740999
Fax 41676 0
Email 41676 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
SourceTitleYear of PublicationDOI
EmbaseIntuitive eating and gestational weight gain.2019https://dx.doi.org/10.1016/j.eatbeh.2019.101311
N.B. These documents automatically identified may not have been verified by the study sponsor.