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

Piloting and evaluating a community-based programme for obese pregnant women: a single-centre randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN90532350
Enrollment
200
Registered
2010-02-05
Start date
2010-02-01
Completion date
Unknown
Last updated
2017-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maternal obesity Nutritional, Metabolic, Endocrine Obesity

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 sessi

Sponsors

Guy's and St Thomas' Charity (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Glucose tolerance test at 28 weeks gestation

Secondary

MeasureTime frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026