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

ISRCTN	ISRCTN09432573
DOI	https://doi.org/10.1186/ISRCTN09432573
Protocol serial number	N/A
Sponsor	University of Manchester (UK)
Funder	Department of Health (UK)

Submission date: 28/04/2011
Registration date: 17/06/2011
Last edited: 29/08/2018

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Tina Lavender
Scientific

Room 4.323
Jean McFarlane Building
University Place
Oxford Road
Manchester
M13 9PL
United Kingdom

Email	tina.lavender@manchester.ac.uk

Study information

Primary study design	Interventional
Study design	Pilot randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	TLC
Study objectives	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(s)	NHS and University of Manchester approval pending as of 04/05/2011
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	01/05/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	72
Key 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)
Key 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
Date of first enrolment	01/06/2011
Date of final enrolment	01/05/2013

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University of Manchester

Manchester
M13 9PL
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

29/08/2018: No publications found, verifying study status with principal investigator.