Condition category
Nutritional, Metabolic, Endocrine
Date applied
10/12/2009
Date assigned
05/02/2010
Last edited
04/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Eugene Oteng-Ntim

ORCID ID

Contact details

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

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

http://www.gsttcharity.org.uk/

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

Publication citations

Additional files

Editorial Notes