Condition category
Nutritional, Metabolic, Endocrine
Date applied
11/01/2010
Date assigned
16/04/2010
Last edited
03/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.cf.ac.uk/medic/subsites/sewtu/

Contact information

Type

Scientific

Primary contact

Dr Sharon Simpson

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G0802038

Study information

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

Acronym

HELP

Study hypothesis

Is a weight management intervention for obese pregnant women, which targets physical activity and healthy eating, effective in reducing women’s body mass index (BMI) at 12 months from giving birth and at what cost?

Ethics approval

Research Ethics Committee for Wales approved on the 15th December 2009 (ref: 09/MRE09/58)

Study design

Cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Not Applicable

Drug names

Primary outcome measures

Maternal BMI at one year from birth

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 trial start date

01/02/2010

Overall trial end date

31/01/2014

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Female

Target number of participants

570

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

01/02/2010

Recruitment end date

31/01/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Primary Care and Public Health
Cardiff
CF14 4YS
United Kingdom

Sponsor information

Organisation

Cardiff University (UK)

Sponsor details

Research and Commercial Division
7th Floor
30 - 36 Newport Road
Cardiff
CF24 0DE
United Kingdom
+44 (0)29 2087 9274
davieskp2@cardiff.ac.uk

Sponsor type

University/education

Website

http://www.cardiff.ac.uk/

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK) - National Prevention Research Initiative (NPRI)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24886352

Publication citations

  1. Protocol

    John E, Cassidy DM, Playle R, Jewell K, Cohen D, Duncan D, Newcombe RG, Busse M, Owen-Jones E, Williams N, Longo M, Avery A, Simpson SA, Healthy eating and lifestyle in pregnancy (HELP): a protocol for a cluster randomised trial to evaluate the effectiveness of a weight management intervention in pregnancy., BMC Public Health, 2014, 14, 439, doi: 10.1186/1471-2458-14-439.

Additional files

Editorial Notes