Condition category
Pregnancy and Childbirth
Date applied
19/12/2006
Date assigned
21/02/2007
Last edited
03/02/2009
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.abdn.ac.uk/BIG/

Contact information

Type

Scientific

Primary contact

Dr Pat Hoddinott

ORCID ID

Contact details

Centre for Rural Health
University of Aberdeen
The Green House
Beechwood Business Park
Inverness
IV2 3BL
United Kingdom
+44 (0)1463 667322
p.hoddinott@abdn.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CZH/4/156

Study information

Scientific title

Acronym

The BIG Trial

Study hypothesis

1. To compare clinical and cost effectiveness of a policy to provide breastfeeding support groups with usual care (internal control) and non-participating areas of Scotland (external control)
2. To compare before and after breastfeeding rates at six to eight weeks between intervention and control
3. To compare women’s breastfeeding satisfaction between intervention and control
4. To measure the costs of the intervention to the health service and parents of each additional percentage point change in breastfeeding prevalence at six to eight weeks
5. To examine implementation processes using a qualitative case study approach

Ethics approval

Metropolitan MREC approval gained on the 26th July 2004 (ref: 04/MRE11/28)

Study design

Randomised controlled trial and qualitative case-studies

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Quality of life

Patient information sheet

Condition

Breastfeeding

Intervention

14 clusters of GP practices will be randomised to intervention or control. Intervention areas will be asked to double their existing number of breastfeeding groups and set up a minimum of two new breastfeeding groups. Groups will:
1. Be for women and their children
2. Be held weekly
3. Invite pregnant women and breastfeeding mothers
4. Have a health professional group facilitator
5. Be woman-centred with at least 50% of time social and interactive.

Area group facilitators will meet with women and voluntary organisation representatives every six to eight weeks for support and reflective practice. A group resource pack and a training day will be provided.

Control areas will provide usual care with no new breastfeeding group activity.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Any breastfeeding (exclusive or partial) at six to eight weeks for two years pre-study and two study years (National Child Health Surveillance Programme data).

Secondary outcome measures

1. Any breastfeeding at birth (National Child Health Surveillance Programme data).
2. Any breastfeeding at seven days (Guthrie data).
3. Any breastfeeding at eigh to nine months (National Child Health Surveillance Programme data).
4. Womens' satisfaction using the Maternal Breastfeeding Evaluation Scale.
5. Social support using The Duke-UNC Functional Social Support Questionnaire.
6. Knowledge of and attendance at any birth related groups.
7. Qualitative case studies to examine variations and implementation processes.
8. NHS costs and the costs and benefits to women.

Overall trial start date

01/10/2004

Overall trial end date

30/09/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Clusters of General Practitioner (GP) practices collecting National Child Health Surveillance Programme data
2. Any pregnant women or breastfeeding mothers with babies less than eight months old can participate in breastfeeding groups set up by intervention areas

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

14 clusters of GP practices

Participant exclusion criteria

1. Clusters of GP practices that do not collect National Child Health Surveillance Programme data
2. Any woman identified by health professionals as having a severe medical or mental health problem which could be detrimental to other group participants and/or their babies

Recruitment start date

01/10/2004

Recruitment end date

30/09/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Centre for Rural Health
Inverness
IV2 3BL
United Kingdom

Sponsor information

Organisation

University of Aberdeen (UK)

Sponsor details

c/o Professor David J Godden
The Centre for Rural Health
The Green House
Beechwood Business Park
Inverness
IV2 3BL
United Kingdom
+44 (0)1463 667322
d.godden@abdn.ac.uk

Sponsor type

Not defined

Website

http://www.abdn.ac.uk/crh/

Funders

Funder type

Government

Funder name

Scottish Executive Health Department, Chief Scientist Office (UK) (ref: CZH/4/156)

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

1. 2007 recruitment results in http://www.ncbi.nlm.nih.gov/pubmed/16996320
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19181729

Publication citations

  1. Recruitment results

    Hoddinott P, Britten J, Harrild K, Godden DJ, Recruitment issues when primary care population clusters are used in randomised controlled clinical trials: climbing mountains or pushing boulders uphill?, Contemp Clin Trials, 2007, 28, 3, 232-241, doi: 10.1016/j.cct.2006.08.004.

  2. Results

    Hoddinott P, Britten J, Prescott GJ, Tappin D, Ludbrook A, Godden DJ, Effectiveness of policy to provide breastfeeding groups (BIG) for pregnant and breastfeeding mothers in primary care: cluster randomised controlled trial., BMJ, 2009, 338, a3026.

Additional files

Editorial Notes