Skip to content

Healthy Eating and Lifestyle in Pregnancy (HELP)

Healthy Eating and Lifestyle in Pregnancy (HELP): a cluster randomised trial to evaluate the effectiveness of a weight management intervention in pregnancy on weight at 12 months following birth, gestational weight gain and pregnancy and birth outcomes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN25260464
Enrollment
570
Registered
2010-04-16
Start date
2011-02-28
Completion date
Unknown
Last updated
2021-06-07

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

Conditions

Obesity Nutritional, Metabolic, Endocrine Obesity

Interventions

Women will be invited to attend a weekly 1.5 hour group run jointly by NHS midwives and 'Slimming World' (SW) consultants. These groups differ from usual SW sessions because in addition to the diet an

Sponsors

Cardiff University (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Women will be included in the trial if they: 1. Are 18 years or over 2. Have a BMI of greater than or equal to 30 kg/m^2 3. Are at the earliest hospital contact (around 12 weeks) up to 20 weeks (and 6 days)

Exclusion criteria

Exclusion criteria: Women will not be eligible for the trial if: 1. They are greater than 20 weeks gestation 2. They are unable to understand the intervention, e.g. insufficient understanding of spoken English 3. They have antenatal maternal or foetal complications; serious physical or psychological disorders and previous surgery for weight problems

Design outcomes

Primary

MeasureTime frame
Maternal BMI at one year from birth

Secondary

MeasureTime frame
Current secondary outcome measures as of 19/03/2020: 1. General mental health measured at 36 weeks during pregnancy, 6 weeks post-birth, 6 months and 1 year from birth 2. Breastfeeding intentions, measured at 36 weeks during the pregnancy and breastfeeding behaviour and weaning (6 weeks, 6 months and 1 year) 3. Child weight centile, collected at birth, 6 weeks, 6 months and 1 year 4. Pregnancy and birth outcomes known to be related to obesity, collected at birth 5. Health service costs, measured at 36 weeks during pregnancy, 6 weeks post-birth, 6 months and 1 year from birth 6. Pregnancy weight gain (36 weeks) 7. Waist circumference and waist-hip ratio (12 months) 8. Self-report physical activity (36 weeks while pregnant, 6 weeks post-birth, 6 months and 12 months) 9. Self-report diet (36 weeks while pregnant, 6 weeks post-birth, 6 months and 12 months) 10. Self-report alcohol and smoking (36 weeks while pregnant, 6 weeks post-birth, 6 months and 12 months) 11. Health-related quality of life 36 weeks while pregnant, 6 weeks post-birth, 6 months and 12 months) _____ Previous secondary outcome measures: 1. Psychological factors, measured at 36 weeks during pregnancy, 6 weeks post-birth, 6 months and one year from birth 2. Breast feeding intentions, measured at 36 weeks during the pregnancy 3. Child weight centile, collected at birth, 6 weeks, 6 months and one year 4. Pregnancy and birth outcomes known to be related to obesity, collected at birth 5. Health service costs, measured at 36 weeks during pregnancy, 6 weeks post-birth, 6 months and one year from birth

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 20, 2026