Pregnant women Community-based Activity and Nutrition programme (CAN)
| ISRCTN | ISRCTN90532350 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN90532350 |
| Secondary identifying numbers | RJ109/N215 |
- 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
Scientific
Women's Health
10th Floor, North Wing
St Thomas' Hospital
London
SE 1 7EH
United Kingdom
Study information
| Study design | Randomised controlled single-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/02/2010 |
| Completion date | 31/01/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 200 obese pregnant women |
| 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
SE 1 7EH
United Kingdom
Sponsor information
Guy's and St Thomas' Charity (UK)
Charity
Charity
First Floor, Counting House
Guy's Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom
| Website | http://www.gsttcharity.org.uk/ |
|---|---|
"ROR" |
https://ror.org/02p7svq74 |
Funders
Funder type
Charity
Guy's and St Thomas' Charity (UK) (ref: G081008)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Guy's and St Thomas' Charity, Guy's and St Thomas' Foundation, GSTTFoundation
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
12/04/2017: No publications found in PubMed, verifying study status with principal investigator.
