Maternal obesity Pregnancy and Childbirth Maternal obesity
Conditions
Interventions
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
Sponsors
University of Manchester (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
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)
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
United Kingdom
Outcome results
None listed