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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 10.1186/ISRCTN29860479
ClinicalTrials.gov identifier
EudraCT number
Public 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
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 N/A
Serial number at source N/A
Study hypothesis The primary outcome of this study is to examine the feasibility of a 10-week style 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.
Lay summary Not provided at time of registration
Ethics approval 1. South Manchester NHS Research Ethics Committee (REC) approved on the 10th August 2009 (ref: 09/H1003/80)
2. The University of Manchester Ethics Committee approved on the 14th September 2009 (ref: 09142)
Study design Feasibility study using mixed-methods of data collection
Countries of recruitment United Kingdom
Disease/condition/study domain Weight gain during pregnancy
Participants - 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
Participants - 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])
Anticipated start date 01/09/2009
Anticipated end date 01/08/2012
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 400
Interventions 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.
Primary outcome measure(s) 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 measure(s) 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
Sources of funding 1. Department of Health (UK) - Innovation, Excellence and Service Fund
2. Department for Children, Schools and Families (DCSF) (UK) - Children, Young People and Families Fund
Trial website
Publications 1. 2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20507580
Contact name Dr  Debbie  Smith
  Address Room 5.305, Jean McFarlane Building
University Place
University of Manchester
Oxford Road
  City/town Manchester
  Zip/Postcode M13 9PL
  Country United Kingdom
  Email debbie.smith-2@manchester.ac.uk
Sponsor University of Manchester (UK)
  Address Oxford Road
  City/town Manchester
  Zip/Postcode M13 9PL
  Country United Kingdom
  Email research-governance@manchester.ac.uk
  Sponsor website: http://www.manchester.ac.uk/
Date applied 09/03/2010
Last edited 13/08/2012
Date ISRCTN assigned 22/04/2010
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