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 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 trial start date
01/09/2009
Overall trial end date
01/08/2012
Reason abandoned (if study stopped)
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
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research-governance@manchester.ac.uk
Sponsor type
University/education
Website
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
Basic results (scientific)
Publication list
2010 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/20507580
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25575860
Publication citations
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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.
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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.