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
Secondary identifying numbers N/A
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

Study designPilot randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use contact details below to request a patient information sheet
Scientific titleA 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 acronymTLC
Study objectivesThis 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) studiedMaternal obesity
InterventionThe 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 hospital’s 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 typeOther
Primary outcome measureThe 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 measuresNo secondary outcome measures
Overall study start date01/06/2011
Completion date01/05/2013

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participants72
Key inclusion criteria1. 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 criteria1. 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 enrolment01/06/2011
Date of final enrolment01/05/2013

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University of Manchester
Manchester
M13 9PL
United Kingdom

Sponsor information

University of Manchester (UK)
University/education

Simon Building
Brunswick Street
Manchester
M13 9PL
England
United Kingdom

ROR logo "ROR" https://ror.org/027m9bs27

Funders

Funder type

Government

Department of Health (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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

Editorial Notes

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