Plain English Summary
Background and study aims
It has been found that one year after giving birth up to 25% of women keep more than 4kg of the weight that they have gained during their pregnancy. This excess weight can increase the risk of developing diseases later in life. It has been suggested that additional interventions (i.e. programmes or treatments) can be included as part of existing public health appointments to tackle this issue for women after having a baby very cheaply. This study aims to include an intervention for women who have gained weight during their pregnancy into the national child immunisation programme, in order to test whether or not women feel this would be an appropriate measure to take and would help them to lose weight after having had their baby.
Who can participate?
Women who have given birth within the last four and eight weeks with a BMI of over 25kg/m2, and have not yet attended their first child immunisation visit.
What does the study involve?
Participants who have volunteered for the study are visited at home to measure their weight and gather personal information. They are then randomly allocated into one of two groups. All women are asked to weigh themselves weekly and record this on a record card attached the child’s ‘red book’ and aim for 0.5-1kg weight loss per week. Women in the first group are provided with a leaflet on healthy living, but otherwise no additional advice or assistance. For women in the second group, nurses make recommendations for healthier lifestyle choices and they are also advised to use an online weight loss programme. At each child immunisation (2, 3, 4 months old), nurses weigh the women to check their progress. A final weight measurement is then taken three months after women start the study. Women and nurses in the trial are then interviewed for feedback about what they think of the intervention.
What are the possible benefits and risks of participating?
The potential benefits of participating in the study include weight loss and improved self-management of weight. There are no potential risks of the intervention to individual participants. However, we will be monitoring immunisation and breastfeeding rates to investigate if the intervention has an impact on these behaviours.
Where is the study run from?
University of Birmingham (UK)
When is the study starting and how long is it expected to run for?
January 2016 to April 2018
Who is funding the study?
University of Birmingham (UK)
Who is the main contact?
Ms Janice Ferguson
j.a.ferguson@bham.ac.uk
Trial website
Contact information
Type
Public
Primary contact
Ms Janice Ferguson
ORCID ID
Contact details
Primary Care Clinical Sciences
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
+44 121 414 8166
j.a.ferguson@bham.ac.uk
Type
Scientific
Additional contact
Ms Janice Ferguson
ORCID ID
Contact details
Primary Care Clinical Sciences
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
01214148166
j.a.ferguson@bham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Feasibility and acceptability of a routine weight management intervention for postnatal women embedded within the national child immunisation programme
Acronym
PIMMS
Study hypothesis
A brief routine weight management intervention for women in the postnatal period that promotes self-management through self-monitoring and signposting to an online weight management programme and is embedded within the child immunisation programme may be feasible and acceptable both to patients and health care professionals.
Ethics approval
West Midlands- Black Country Research Ethics Committee, 17/02/2016, ref: 15/WM/0445
Study design
Single-centre cluster feasibility randomised controlled trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Condition
Postnatal weight gain and obesity
Intervention
Intervention Group: The intervention is embedded within pre-existing immunisation contacts, when babies are two, three and four months old. The intervention involves nurses encouraging women in the postnatal period to make healthier lifestyle choices though self-monitoring of weight and signposting to a female specific online weight management programme.
Comparison Group: Women will receive a healthy lifestyle leaflet and no other intervention.
Women will be asked to weigh themselves weekly and record this on a record card attached to the child’s red book, with a goal of losing 0.5kg per week. The practice nurse will weigh the women at each child immunisation to assess their progress against their weight loss goal. Follow-up of weight will be three months after randomisation. Semi-structured interviews with both participants and nurses will be carried out at the end of the trial to obtain their views of the intervention.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Feasibility and acceptability of the intervention
Secondary outcome measures
1. Mean difference in weight change between groups
2. Breastfeeding rates
3. Immunisation rates
4. Recruitment rate
5. Adherence to intervention
6. Self-reported physical activity
7. Contamination rate
8. Diet quality
9. Body image
10. Depression scores
Overall trial start date
01/01/2016
Overall trial end date
26/04/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Women who have given birth between four and eight weeks ago
2. Have not yet attend the first immunisation visit
3. Aged 18 or over
4. BMI 25kg/m2 or more
5. Considered suitable to participate by their GP
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
80
Participant exclusion criteria
1. Dependency on insulin
2. Using illicit drugs or alcohol
3. Experiencing serious mental health difficulties (e.g. postnatal psychosis) or known history of eating disorders
4. Mothers in contact with social services because of concerns relating to safeguarding and/or domestic violence
5. Mothers whose babies have been removed from their care at birth
6. Mothers whose babies have died
Recruitment start date
01/01/2016
Recruitment end date
01/07/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
School of Heath and Population Sciences
University of Birmingham
Edgbaston
Birmingham
B152TT
United Kingdom
Funders
Funder type
University/education
Funder name
University Of Birmingham
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
United Kingdom
Results and Publications
Publication and dissemination plan
We intend to publish the results in a peer reviewed journal such as the British Journal of General Practice and will also present the results at appropriate national and international conferences (such as the European Congress on Obesity or UK Society for Behavioural Medicine annual meeting) as well as to primary care and public health professionals.
Intention to publish date
01/12/2017
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list