Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RJ109/N215
Study information
Scientific title
Piloting and evaluating a community-based programme for obese pregnant women: a single-centre randomised controlled trial
Acronym
CAN
Study hypothesis
A combined community-based intervention with dietary and physical advice combined with behavioural support will alter dietary and exercise behaviour in obese pregnant women which will result in improved glucose homeostasis.
Ethics approval
National Research Ethics Service King's College Hospital Research Ethics Committee, 19/09/2009, ref: 09/H0808/49
Study design
Randomised controlled single-centre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Maternal obesity
Intervention
The programme will commence at 16-20 weeks and last for approximately 20 weeks. The total duration of follow-up will be up to 6 months post-delivery.
The components are as follows:
At the group sessions healthy eating topics will include:
1. Low glycaemic index food which is patient and culturally focused
2. Fruits and vegetables
3. Reduced saturated fat intake
4. Food label reading
5. Portion sizes
6. More often rather than three big meals a day
7. Reduced sugar intake (especially sugar-rich beverages)
8. Supermarket tour
9. Basic cooking skills and recipe try-outs
Physical activity:
A menu of exercise choices, based on the participant's wishes and local availability will be offered. A participant will be able to choose, for example, weekly exercise sessions (land-based low impact exercise such as cycling and dancing and water-based exercise such as swimming and aqua-aerobics) which are provided in Lambeth by such organizations as Aqua_Natal and Sport England. Group exercise sessions will be fun, structured and non-competitive. For those that prefer exercising alone, walking is one of the menu options as the means to achieving agreed personal goals.
Postnatal women will be referred onto existing and well-established resources in the Children's Centres including breastfeeding cafés, mother and baby exercise classes and baby massage courses.
Behavioural change:
This psychology-based component will help women to change lifestyle through both one-to-one and group-based motivational sessions using a solution and problem-solving approach.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Glucose tolerance test at 28 weeks gestation
Secondary outcome measures
1. Total daily physical activity at 28 and 36 weeks measured by accelerometry and by self-reported duration of strenuous, moderate and mild physical activity and sedentary daily hours at 28 and 36 weeks
2. Diet at 28 and 36 weeks as assessed by structured questionnaire and 4-day diary at recruitment, 28 and 36 weeks
3. Attitudes towards diet and physical activity in pregnancy (the ADAPT questionnaire) will assess knowledge, perceived benefits and barriers, self-efficacy, motivation, social norms and attitudes
4. Other outcomes include: gestational diabetes, pre-eclampsia and severe pre-eclampsia, caesarean section (elective, emergency) and reasons for section, induction of labour, blood loss at delivery (ml), birth weight, prematurity, death (stillbirths and neonatal deaths up to 28 days), gestational age at delivery, placental weight, inpatient nights (antenatal and total), breastfeeding initiation rates and smoking cessation rates
5. 36-item short form health survey (SF-36) health status measure for assessment of costs per quality assured life years (QALYs), depression/anxiety score by Hospital Anxiety and Depression Scale, questionnaire and medical record data for evaluation of costs of intervention and healthcare costs
6. We shall also obtain the follow information at 6 months of age in the child:
6.1. Breastfeeding history questionnaire
6.2. Age at weaning
6.3. Weight gain at 28 weeks, 36 weeks and 6 months post-delivery
Overall trial start date
01/02/2010
Overall trial end date
31/01/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. Pregnant women with a singleton pregnancy (14-16 weeks' gestation; 16 - 45 years)
2. Attending participating centre
3. Booking body mass index (BMI) greater than 30 kg/m^2
4. No previous history of diabetes*
5. Currently not receiving anti-hypertensive medication
6. Fraser competence has been sought for those less than 18 years
*Women in whom Gestational Diabetes Mellitus (GDM) is diagnosed in the course of routine clinical care will remain in the study
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
200 obese pregnant women
Participant exclusion criteria
1. Inability and unwilling to provide informed consent
2. Multiple pregnancy
3. Women currently receiving treatment for diabetes (including dietary control) or hypertension
4. Chronic underlying renal disease, lupus, antiphospholipid syndrome (APS)
5. Confirmed abnormal foetal karyotype
Recruitment start date
01/02/2010
Recruitment end date
31/01/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Women's Health
London
SE 1 7EH
United Kingdom
Sponsor information
Organisation
Guy's and St Thomas' Charity (UK)
Sponsor details
First Floor
Counting House
Guy's Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Guy's and St Thomas' Charity (UK) (ref: G081008)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
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