Healthy Eating and Lifestyle in Pregnancy (HELP)

ISRCTN	ISRCTN25260464
DOI	https://doi.org/10.1186/ISRCTN25260464
Protocol serial number	G0802038
Sponsor	Cardiff University (UK)
Funder	Medical Research Council (MRC) (UK) - National Prevention Research Initiative (NPRI)

Submission date: 11/01/2010
Registration date: 16/04/2010
Last edited: 24/05/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Sharon Simpson
Scientific

Department of Primary Care and Public Health
South East Wales Trials Unit
7th floor Neuadd Meirionnydd
Cardiff University
Heath Park
Cardiff
CF14 4YS
United Kingdom

Phone	+44 (0)29 2068 7181
Email	SimpsonSA@cf.ac.uk

Study information

Primary study design	Interventional
Study design	Cluster randomised controlled trial
Secondary study design	Cluster randomised trial
Study type	Participant information sheet
Scientific title	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
Study acronym	HELP
Study objectives	Is a weight management intervention for obese pregnant women, which targets physical activity and healthy eating, effective in reducing womens body mass index (BMI) at 12 months from giving birth and at what cost?
Ethics approval(s)	Research Ethics Committee for Wales, 15/12/2009, ref: 09/MRE09/58
Health condition(s) or problem(s) studied	Obesity
Intervention	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 and lifestyle advice there is midwife input and additional exercise advice and monitoring. Women will be recruited at 12 - 20 weeks gestation and the intervention will run until 6 months post-partum. The treatment period will therefore vary dependent on what stage in pregnancy the woman was recruited and when she gives birth. However, it will be between 43 and 56 weeks (taking into account normal gestation is 37 - 42 weeks). Those in the control group will receive usual care from their midwife which includes between 7 and 10 antenatal consultations, as well as a leaflet on healthy eating and physical activity in pregnancy. The follow up is until one year from giving birth for both arms of the trial.
Intervention type	Other
Primary outcome measure(s)	Maternal BMI at one year from birth
Key secondary outcome measure(s)	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
Completion date	31/01/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	570
Total final enrolment	598
Key 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)
Key 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
Date of first enrolment	28/02/2011
Date of final enrolment	31/01/2014

Locations

Countries of recruitment

United Kingdom
Wales

Study participating centre

Cardiff University

Cardiff
CF14 4YS
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2014		Yes	No
Results article		01/08/2021	24/05/2021	Yes	No
Protocol article	protocol	10/05/2014		Yes	No
HRA research summary			28/06/2023	No	No
Other publications	process evaluation framework	01/07/2014		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

24/05/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
19/03/2020: The secondary outcome measures were changed.
12/03/2020: The recruitment start date was changed from 01/02/2010 to 28/02/2011.
04/10/2018: Publication references added.