Healthy Eating and Lifestyle in Pregnancy (HELP)
| ISRCTN | ISRCTN25260464 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25260464 |
| Secondary identifying numbers | G0802038 |
- 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
Not provided at time of registration
Contact information
Dr Sharon Simpson
Scientific
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 |
|---|---|
| SimpsonSA@cf.ac.uk |
Study information
| Study design | Cluster randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient 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 hypothesis | 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 |
| Condition | 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 | Maternal BMI at one year from birth |
| Secondary outcome measures | 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 |
| Overall study start date | 01/02/2010 |
| Overall study end date | 31/01/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 570 |
| Total final enrolment | 598 |
| Participant 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) |
| Participant 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 |
| Recruitment start date | 28/02/2011 |
| Recruitment end date | 31/01/2014 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
Cardiff University
Cardiff
CF14 4YS
United Kingdom
CF14 4YS
United Kingdom
Sponsor information
Cardiff University (UK)
University/education
University/education
Research and Commercial Division
7th Floor, 30 - 36 Newport Road
Cardiff
CF24 0DE
Wales
United Kingdom
| Phone | +44 (0)29 2087 9274 |
|---|---|
| davieskp2@cardiff.ac.uk | |
| Website | http://www.cardiff.ac.uk/ |
"ROR" |
https://ror.org/03kk7td41 |
Funders
Funder type
Research council
Medical Research Council (MRC) (UK) - National Prevention Research Initiative (NPRI)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 10/05/2014 | Yes | No | |
| Other publications | process evaluation framework | 01/07/2014 | Yes | No | |
| Results article | results | 01/07/2014 | Yes | No | |
| Results article | 01/08/2021 | 24/05/2021 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
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.
