Condition category
Pregnancy and Childbirth
Date applied
28/04/2011
Date assigned
17/06/2011
Last edited
17/06/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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
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 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 type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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

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

Room 4.323
Manchester
M13 9PL
United Kingdom

Sponsor information

Organisation

University of Manchester (UK)

Sponsor details

Simon Building
Brunswick Street
Manchester
M13 9PL
United Kingdom

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

2010 study protocol in http://www.ncbi.nlm.nih.gov/pubmed/20507580

Publication citations

  1. Study 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.

Additional files

Editorial Notes