Condition category
Pregnancy and Childbirth
Date applied
23/09/2013
Date assigned
07/11/2013
Last edited
22/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The aim of this study is to investigate if an individually tailored physical activity (PA) intervention can help women who are pregnant for the first time to achieve optimal levels of PA. PA in pregnancy has been linked to a number of psychological, biological and social benefits for mothers. Despite these benefits, PA in pregnancy is even lower than PA in the general population, with only between 3-15% of pregnant women meeting published PA guidelines. Furthermore, PA is seen to decline throughout the course of pregnancy. There is a lack of evidence regarding interventions based solely on promoting PA throughout pregnancy. Existing interventions often incorporate a range of lifestyle factors which make it difficult to measure determinants of PA in the short and long term. This study investigates whether an individually tailored intervention can help pregnant women become physically active or maintain physical activity throughout pregnancy.

Who can participate?
We aim to recruit 200 women who are pregnant for the first time.

What does the study involve?
Following a routine antenatal appointment, if the midwife deems the woman eligible to participate, they will give them a brief description of the study and ask if they are interested. If so, the researcher will be invited in to explain the research in more detail. If interested, the woman will be given an information sheet and consent form and asked to attend an information session. At this session, more information will be provided and participants who provide consent will be randomly allocated to either the intervention or the control group. Those in the intervention group will receive three individual consultations with the researcher and be invited to attend a weekly walking group. Those in the control group will receive usual care. All participants will be asked to wear an accelerometer (physical activity monitor) for one week in each trimester. They will also be asked to complete a questionnaire once in each trimester and once postpartum.

What are the possible benefits and risks of participating?
It is unknown whether the individually tailored intervention will produce any benefits for patients. There is a possibility that women who attend the meetings with the researcher and attend the weekly walking meetings will feel better supported to engage in physical activity and engage in greater physical activity than those in the control group. There are no known risks when taking part in this study. All decisions made regarding physical activity will be made jointly between the researcher and participant.

Where is the study run from?
The study will be run in the Ulster Hospital Maternity Unit, South Eastern Health and Social Care Trust, Northern Ireland.

When is the study starting and how long is it expected to run for?
Recruitment started in September 2012 and will finish in July 2013. Participants will be enrolled for the length of their pregnancy. The intervention will continue until the last participant gives birth, around January 2014. Data collection will subsequently be completed by March 2014.

Who is funding the study?
Department of Education and Learning (DEL), Northern Ireland.

Who is the main contact?
Prof. Marlene Sinclair, Professor of Midwifery Research, M.Sinclair1@ulster.ac.uk
Dr Elaine Madden, Head of Midwifery & Gynaecology at South Eastern Health & Social Care Trust, elaine.madden@setrust.hscni.net
Miss Sinead Currie, Currie-S4@email.ulster.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Marlene Sinclair

ORCID ID

Contact details

University of Ulster
Shore Road
Newtownabbey
BT37 0QB
United Kingdom
-
M.Sinclair1@ulster.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

What effects does an individually tailored intervention have on the physical activity of primigravida pregnant women?

Acronym

APP

Study hypothesis

It is hypothesised that physical activity participation will be higher in the intervention group than control/usual care group. Women who receive the tailored physical activity intervention will self-report more positive psychological outcomes than controls.

The null hypothesis is that there will be no difference in physical activity or psychological outcomes between groups.

Ethics approval

Office for Research Ethics Committees Northern Ireland (ORECNI), 14/05/2012, ref: 12/NI/0036

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Patient information can be found at: http://www.doctoralmidwiferysociety.org/Portals/c8d3e3f8-9c01-4bf5-abd9-3fd6b4c510ae/Participant%20Information%20Sheet%20version%209%2019%20June%20no%20footer.docx

Condition

Physical activity in pregnancy

Intervention

1. The intervention group will receive three face-to-face individual consultations with the researcher, one per trimester. After they reach 20 weeks gestation, they will be invited to attend a weekly walking group held in the hospital.
2. The control group will receive usual care.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Physical activity measured using an accelerometer and a self-report 7-day physical activity diary

Secondary outcome measures

1. Psychological wellbeing
2. Social support
3. Quality of life
4. Gestational weight gain
5. Mode of delivery
6. Gestational age

All of these were measured using a questionnaire.

Overall trial start date

15/09/2012

Overall trial end date

11/03/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Primigravida (pregnant with first child)
2. Viability scan confirming ongoing pregnancy between 8 and 18 weeks gestation
3. Singleton pregnancy
4. Speak and understand English
5. 18 years or over
6. Volunteers who are able to give full written consent

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

200

Participant exclusion criteria

1. Women with medical or obstetric complications or risks such as hypertension requiring medication, heart conditions, history of more than two miscarriages, metabolic disorders, existing diabetes (decided by midwife)
2. Any existing conditions which may contraindicate regular PA (physical activity)
3. Multiple pregnancies: twins, triplets or any other multiple gestation
4. Under 18 years of age
5. Gestation over 18 weeks at recruitment

Recruitment start date

15/09/2012

Recruitment end date

01/07/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Ulster
Newtownabbey
BT37 0QB
United Kingdom

Sponsor information

Organisation

South Eastern Health and Social Care Trust (UK)

Sponsor details

c/o Mr Paul Carlin
Ulster Hospital
Upper Newtownards Road
Dundonald
BT16 1RH
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Department of Employment and Learning (DEL) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in http://www.ncbi.nlm.nih.gov/pubmed/26686681

Publication citations

Additional files

Editorial Notes

22/12/2015: Publication reference added.