Condition category
Pregnancy and Childbirth
Date applied
09/03/2010
Date assigned
22/04/2010
Last edited
28/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Debbie Smith

ORCID ID

Contact details

Room 5.305
Jean McFarlane Building
University Place
University of Manchester
Oxford Road
Manchester
M13 9PL
United Kingdom
-
debbie.smith-2@manchester.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

Acronym

Study hypothesis

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

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

Study design

Feasibility study using mixed-methods of data collection

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Community

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/09/2009

Overall trial end date

01/08/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

400

Participant 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])

Recruitment start date

01/09/2009

Recruitment end date

01/08/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Manchester
Manchester
M13 9PL
United Kingdom

Sponsor information

Organisation

University of Manchester (UK)

Sponsor details

Oxford Road
Manchester
M13 9PL
United Kingdom
-
research-governance@manchester.ac.uk

Sponsor type

University/education

Website

http://www.manchester.ac.uk/

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

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

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

2010 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/20507580
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25575860

Publication citations

  1. Protocol

    Smith DM, Whitworth M, Sibley C, Taylor W, Gething J, Chmiel C, Lavender T, The design of a community lifestyle programme to improve the physical and psychological well-being of pregnant women with a BMI of 30 kg/m2 or more., BMC Public Health, 2010, 10, 284, doi: 10.1186/1471-2458-10-284.

  2. Results

    Smith DM, Taylor W, Whitworth MK, Roberts S, Sibley C, Lavender T, The feasibility phase of a community antenatal lifestyle programme [The Lifestyle Course (TLC)] for women with a body mass index (BMI)≥ 30 kg/m(2.), Midwifery, 2015 , 31, 2, 280-287, doi: 10.1016/j.midw.2014.10.002.

Additional files

Editorial Notes

28/07/2016: Publication reference added.