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Welcome
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11 February 2012
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| [ Print-friendly version ] |
| Pregnant women Community-based Activity and Nutrition programme (CAN) |
| ISRCTN | ISRCTN90532350 |
| ClinicalTrials.gov identifier | |
| Public title | Pregnant women Community-based Activity and Nutrition programme (CAN) |
| Scientific title | Piloting and evaluating a community-based programme for obese pregnant women: a single centre randomised controlled trial |
| Acronym | CAN |
| Serial number at source | RJ109/N215 |
| 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. |
| Lay summary | |
| Ethics approval | National Research Ethics Service King's College Hospital Research Ethics Committee approved on the 19th September 2009 (ref: 09/H0808/49) |
| Study design | Randomised controlled single centre trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Maternal obesity |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/02/2010 |
| Anticipated end date | 31/01/2012 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 200 obese pregnant women |
| Interventions |
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 life-style through both one-to-one and group based motivational sessions using a solution and problem solving approach. |
| Primary outcome measure(s) | Glucose tolerance test at 28 weeks gestation |
| 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 health care costs 6. We shall also obtain the follow information at 6 months of age in the child: 6.1. Breast feeding history questionnaire 6.2. Age at weaning 6.3. Weight gain at 28 weeks, 36 weeks and 6 months post-delivery |
| Sources of funding | Guy's and St Thomas' Charity (UK) (ref: G081008) |
| Trial website | |
| Publications | |
| Contact name | Dr Eugene Oteng-Ntim |
| Address |
Women's Health
10th Floor, North Wing St Thomas' Hospital |
| City/town | London |
| Zip/Postcode | SE 1 7EH |
| Country | United Kingdom |
| Sponsor | Guy's and St Thomas' Charity (UK) |
| Address |
First Floor, Counting House
Guy's Hospital Great Maze Pond |
| City/town | London |
| Zip/Postcode | SE1 9RT |
| Country | United Kingdom |
| Sponsor website: | http://www.gsttcharity.org.uk/ |
| Date applied | 10/12/2009 |
| Last edited | 05/02/2010 |
| Date ISRCTN assigned | 05/02/2010 |
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| © 2012 ISRCTN unless otherwise stated. | |
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