A community lifestyle programme to improve the well-being of pregnant women with a body mass index (BMI) of 30 kg/m^2 or more

ISRCTN	ISRCTN29860479
DOI	https://doi.org/10.1186/ISRCTN29860479
Secondary identifying numbers	N/A

Submission date: 09/03/2010
Registration date: 22/04/2010
Last edited: 28/07/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Debbie Smith
Scientific

Room 5.305, Jean McFarlane Building
University Place
University of Manchester
Oxford Road
Manchester
M13 9PL
United Kingdom

Email	debbie.smith-2@manchester.ac.uk

Study information

Study design	Feasibility study using mixed-methods of data collection
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Community
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A community lifestyle programme to improve the well-being of pregnant women with a body mass index (BMI) of 30 kg/m^2 or more: a feasibility study
Study objectives	The primary outcome of this study is to examine the feasibility of a 10-week lifestyle programme for pregnant women with a BMI of 30 kg/m^2 or more. Secondly, information will be provided regarding the influence of attendance at an antenatal 10-week lifestyle programme on women's physical, emotional and psychological wellbeing and weight gain.
Ethics approval(s)	1. South Manchester NHS Research Ethics Committee (REC), 10/08/2009, ref: 09/H1003/80 2. The University of Manchester Ethics Committee, 14/09/2009, ref: 09142
Health condition(s) or problem(s) studied	Weight gain during pregnancy
Intervention	Women will be recruited to the study as soon after their booking appointment as possible (after 12 weeks gestation). They will be invited to attend a 10-week community lifestyle programme before 30 weeks gestation. The programme will be provided as a supplement to standard antenatal care. The programme is multi-faceted (addresses physical activity, healthy eating and emotional well-being), aimed at equipping participants with the skills and knowledge needed to adopt healthy behaviours. The programme runs for one and a half hour a week for 10 weeks. The women are given questionnaires to complete at baseline, the start of the 10-week programme, the end of the 10-week programme and at 4 - 6 weeks post-partum. They are invited to a follow-up focus group at 4 - 6 weeks post-partum. The women are also asked to complete a daily diary from recruitment to the follow-up focus group.
Intervention type	Behavioural
Primary outcome measure	1. Weight gain during pregnancy, weighed at booking and at the end of the pregnancy 2. Pregnancy outcome data (e.g., birth weight and mode of delivery), measured at end of the pregnancy
Secondary outcome measures	1. Psychological outcomes including self-efficacy, well-being and goal attainment: measured at four timepoints in questionnaire (baseline, start of the 10-week programme, end of the 10-week programme and 4 - 6 week postpartum follow-up) 2. Women's experience of pregnancy and health care services: measured at four timepoints in questionnaire (baseline, start of the 10-week programme, end of the 10-week programme and 4 - 6 week postpartum follow-up) and daily diary from recruitment to 1 - 6 weeks postpartum 3. Amount of physical activity: measured at four timepoints in questionnaire (baseline, start of the 10-week programme, end of the 10-week programme and 4 - 6 week postpartum follow-up) and daily diary from recruitment to 1 - 6 weeks postpartum 4. Food intake: measured at four timepoints in questionnaire (baseline, start of the 10-week programme, end of the 10-week programme and 4 - 6 week postpartum follow-up) and daily diary from recruitment to 1 - 6 weeks postpartum 5. The suitability and acceptability of the intervention components: measured post-programme in the end of programme questionnaire and post-partum follow-up questionnaire and focus group
Overall study start date	01/09/2009
Completion date	01/08/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	400
Key inclusion criteria	1. Female aged 18 years or over 2. Pregnant 3. Booking BMI of 30 kg/m^2 or more 4. Patient at Royal Bolton or Royal Oldham Hospital
Key exclusion criteria	1. Booking BMI of less than 30 kg/m^2 2. Aged under 18 years 3. Intend to move in the next three months 4. Take weight control medication 5. Have been advised by a Health care professional to not take part in physical activity during their pregnancy 6. Have any cautions for starting exercise (using the Revised Physical Activity Readiness Questionnaire [PARQ]) and the Royal College of Obstetricians and Gynaecologists [RCOG])
Date of first enrolment	01/09/2009
Date of final enrolment	01/08/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Manchester

Manchester
M13 9PL
United Kingdom

Sponsor information

University of Manchester (UK)
University/education

Oxford Road
Manchester
M13 9PL
England
United Kingdom

Email	research-governance@manchester.ac.uk
Website	http://www.manchester.ac.uk/
"ROR"	https://ror.org/027m9bs27

Funders

Funder type

Government

Department of Health (UK) - Innovation, Excellence and Service Fund

No information available

Department for Children, Schools and Families (DCSF) (UK) - Children, Young People and Families Fund

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	27/05/2010		Yes	No
Results article	results	01/02/2015		Yes	No

Editorial Notes

28/07/2016: Publication reference added.