Contact information
Type
Scientific
Primary contact
Prof Tina Lavender
ORCID ID
Contact details
Room 4.323
Jean McFarlane Building
University Place
Oxford Road
Manchester
M13 9PL
United Kingdom
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tina.lavender@manchester.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A pilot randomised controlled trial to evaluate the impact of attending The Lifestyle Course (TLC) on the health of pregnant women with a Body Mass Index (BMI) of 30kg/m2 or more and their babies
Acronym
TLC
Study hypothesis
This is a pilot study so there is no formal research hypothesis. Instead the suitability and acceptability of the study design is examined and a research hypothesis for the main trial will be generated.
Ethics approval
NHS and University of Manchester approval pending as of 04/05/2011
Study design
Pilot randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
Maternal obesity
Intervention
The Lifestyle Course (TLC) is innovative as it is a multi-component intervention that addresses a complete healthy lifestyle for the whole family and combines theory-based behaviour change techniques (social cognitive theory) with a healthy eating, physical activity and well-being intervention. TLC is informed by the findings of a feasibility study (N=259) highlighting what intervention aspects were acceptable and suitable to pregnant women with a BMI of 30kg/m2 or more. TLC runs for two hours per week for 10-weeks and women must be between 12 and 28 weeks gestation. A multi-disciplinary team and a range of experts designed the intervention and tested it for use in a feasibility study with pregnant women with a BMI of 30kg/m2 or more in Greater Manchester.
Control group - routine maternity care. The 36 women who are randomised to the control arm of the intervention will continue to receive standard maternity care within the NHS trust that they were recruited from (Royal Bolton Hospitals NHS Foundation Trust and The Pennine Acute Hospitals NHS Trust). Their care will follow the individual hospitals maternity care guidelines and care pathways according to their antenatal booking BMI.
TLC group - The women who are randomised to the intervention arm and are offered the opportunity to attend the 10-week TLC will receive the same maternity care within their NHS trust. Any contact made with the research team by control women will be noted, as will any non-research questions that they ask to the research midwives in the data collection sessions.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
The pilot study will inform the main randomised controlled trial by evaluating the suitability and feasibility of the study, design, including conformation of the most appropriate primary endpoint.
This main objective is to inform the main trial by evaluating and providing information on the validity of the study design, will focus specifically on:
1.The suitability of the recruitment strategy
2.The suitability of the inclusion criteria
3.Womens understanding of the study and their reasons for participating or not participating
4.The success and suitability of the randomisation method
5.The required sample size for the main trial to ensure adequate power
6. Intervention group adherence to the 10week programme, reasons for attending or nonattending and views towards taking part in the study
7. Control group retention rates, views towards the taking part in the study and possible contamination
8. The acceptability and suitability of the data collection followup period length
9. The appropriateness of the primary and secondary outcomes for the study objectives and main trial¡¯s research question
10.The acceptability and suitability of the data collection methods used to collect outcome measures data
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/06/2011
Overall trial end date
01/05/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Attending antenatal care in Bolton NHS Foundation Trust or Oldham (part of the Pennine Acute Hospital NHS Trust
2. A body mass index (BMI) of 30kg/m2 or greater
3. Aged 18 or older
4. Between 12 and 28 weeks gestation at the start of the 10 week course (10th October 2011)
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
72
Participant exclusion criteria
1. BMI less than 30
2. Aged under 18
3. If women have been advised by a Health care professional to not take part in physical activity during their pregnancy or if they have any cautions for starting exercise [using the Revised Physical Activity Readiness Questionnaire and the Royal College of Obstetricians and Gynaecologists (RCOG) recommendations] then the research midwife will assess the women's suitability and in unsure cases will ask their consultant obstetrician for approval.
4. Multiple gestation
5. Preexisting preeclampsia
6. Preexisting gestational diabetes
Recruitment start date
01/06/2011
Recruitment end date
01/05/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Manchester
Manchester
M13 9PL
United Kingdom
Funders
Funder type
Government
Funder name
Department of Health (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
Basic results (scientific)
Publication list
2010 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/20507580
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.