ANZCTR - Registration

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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]

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

Condition category

Condition code

Reproductive Health and Childbirth

Antenatal care

Intervention/exposure

Study type

Observational

Patient registry

True

Target follow-up duration

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]

Not applicable

Comparator / control treatment

N/A

Control group

Uncontrolled

Outcomes

Primary outcome [1]

To investigate the relationship between gestational weight gain and Intuitive Eating Scale scores

Timepoint [1]

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]

To investigate the relationship between gestational weight gain and sleep using the o Pittsburgh sleep score

Timepoint [1]

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]

To investigate the test retest reliability of the Intuitive eating Scale (IES) in pregnancy

Timepoint [2]

Comparison between Intuitive eating scores at 11-14 weeks and 18 -21 weeks of pregnancy

Secondary outcome [3]

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]

at 6 months post-partum

Secondary outcome [4]

To investigate the relationship between gestational weight gain and mood using the Edinburgh depression score

Timepoint [4]

37 weeks pregnant
Edinburgh depression score will be performed at 12-14 w/ 18-21w, 25-29 w, 35-37 w

Secondary outcome [5]

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]

at 37 weeks pregnant

Secondary outcome [6]

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]

at 37 weeks of pregnancy

Secondary outcome [7]

To investigate the relationship between weight gain from 12 weeks of pregnancy till 6 months post- partum with Intuitive Eating Scale scores

Timepoint [7]

at 6 months Postpartum

Secondary outcome [8]

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]

at 6 months postpartum

Secondary outcome [9]

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]

at 6 months postpartum

Secondary outcome [10]

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]

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]

New Zealand

State/province [1]

Otago

Funding & Sponsors

Funding source category [1]

University

Name [1]

Womens and Childrens Health Department
Dunedin School of Medicine
University of Otago

Address [1]

PO Box 913
Dunedin
9058

Country [1]

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]

Individual

Name [1]

Dr Jean Hay Smith

Address [1]

Department of Women’s and Children's Health
Dunedin School of Medicine
University of Otago
PO Box 913
Dunedin
9058

Country [1]

New Zealand

Secondary sponsor category [2]

Individual

Name [2]

Dr Gareth Treharne

Address [2]

Department of Psycology
University of Otago
PO Box 913
Dunedin
9058

Country [2]

New Zealand

Other collaborator category [1]

Individual

Name [1]

Prof. Peter Herbison

Address [1]

Department of Preventive and Social Medicine
Dunedin School of Medicine
University of Otago
PO Box 913
Dunedin
9058

Country [1]

New Zealand

Other collaborator category [2]

Individual

Name [2]

Dr Caroline Howarth

Address [2]

Department of Nutrition
University of Otago
PO Box 913
Dunedin
9058

Country [2]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Otago Human Ethics Committee

Ethics committee address [1]

University of Otago 
PO Box 913
Dunedin
9058

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

Approval date [1]

23/11/2012

Ethics approval number [1]

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 pregnancy.weight@otago.ac.nz for further information

Contacts

Principal investigator

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

Phone

+64 3 4747007 ext 8933

Fax

+64 3 474 7620

helen.paterson@otago.ac.nz

Contact person for public queries

Name

Gaye Ellis

Address

Department of Women’s and Children's Health
Dunedin School of Medicine
University of Otago
PO Box 913
Dunedin
9058

Country

New Zealand

Phone

+64 3 4740999

Fax

gaye.ellis@otago.ac.nz

Contact person for scientific queries

Name

Helen Paterson

Address

Department of Women’s and Children's Health
Dunedin School of Medicine
University of Otago
PO Box 913
Dunedin
9058

Country

New Zealand

Phone

+64 3 4740999

Fax

helen.paterson@otago.ac.nz

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

Source	Title	Year of Publication	DOI
Embase	Intuitive eating and gestational weight gain.	2019	https://dx.doi.org/10.1016/j.eatbeh.2019.101311

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

Trial Review

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Documents added manually

Documents added automatically