Pregnant women Community-based Activity and Nutrition programme (CAN)

ISRCTN	ISRCTN90532350
DOI	https://doi.org/10.1186/ISRCTN90532350
Protocol serial number	RJ109/N215
Sponsor	Guy's and St Thomas' Charity (UK)
Funder	Guy's and St Thomas' Charity (UK) (ref: G081008)

Submission date: 10/12/2009
Registration date: 05/02/2010
Last edited: 13/04/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

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

Dr Eugene Oteng-Ntim
Scientific

Women's Health
10th Floor, North Wing
St Thomas' Hospital
London
SE 1 7EH
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised controlled single-centre trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Piloting and evaluating a community-based programme for obese pregnant women: a single-centre randomised controlled trial
Study acronym	CAN
Study objectives	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(s)	National Research Ethics Service King's College Hospital Research Ethics Committee, 19/09/2009, ref: 09/H0808/49
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Glucose tolerance test at 28 weeks gestation
Key secondary outcome measure(s)	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
Completion date	31/01/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	200
Key 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
Key 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
Date of first enrolment	01/02/2010
Date of final enrolment	31/01/2012

Locations

Countries of recruitment

United Kingdom

Study participating centre

Women's Health

London
SE 1 7EH
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?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

12/04/2017: No publications found in PubMed, verifying study status with principal investigator.