Feasibility of a brief weight loss intervention for women following childbirth, delivered within the national child immunisation programme

ISRCTN ISRCTN10460064
DOI https://doi.org/10.1186/ISRCTN10460064
Secondary identifying numbers N/A
Submission date
05/08/2015
Registration date
28/08/2015
Last edited
08/06/2021
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

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 February 2019 (as of 22/10/2018)

Who is funding the study?
University of Birmingham (UK)

Who is the main contact?
Ms Janice Ferguson
j.a.ferguson@bham.ac.uk

Study website

Contact information

Ms Janice Ferguson
Public

Primary Care Clinical Sciences
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom

Phone +44 121 414 8166
Email j.a.ferguson@bham.ac.uk
Ms Janice Ferguson
Scientific

Primary Care Clinical Sciences
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom

Phone 01214148166
Email j.a.ferguson@bham.ac.uk

Study information

Study designSingle-centre cluster feasibility randomised controlled trial
Primary study designInterventional
Secondary study designCluster randomised trial
Study setting(s)GP practice
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet.
Scientific titleFeasibility and acceptability of a routine weight management intervention for postnatal women embedded within the national child immunisation programme
Study acronymPIMMS
Study objectivesA 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(s)West Midlands- Black Country Research Ethics Committee, 17/02/2016, ref: 15/WM/0445
Health condition(s) or problem(s) studiedPostnatal weight gain and obesity
InterventionIntervention 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 typeBehavioural
Primary outcome measureFeasibility and acceptability of the intervention
Secondary outcome measures1. 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 study start date01/01/2016
Completion date28/02/2019

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participants80
Total final enrolment28
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/01/2016
Date of final enrolment01/07/2016

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

School of Heath and Population Sciences
University of Birmingham
Edgbaston
Birmingham
B152TT
United Kingdom

Sponsor information

University of Birmingham
University/education

C block, Aston Webb Building, University of Birmingham, Edgbaston
Birmingham
B15 2TT
England
United Kingdom

ROR logo "ROR" https://ror.org/03angcq70

Funders

Funder type

University/education

University Of Birmingham
Private sector organisation / Universities (academic only)
Location
United Kingdom

Results and Publications

Intention to publish date01/12/2017
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planWe 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.
IPD sharing planThe datasets generated during and analysed during the current study are available upon request from Professor Amanda Daley, A.Daley@lboro.ac.uk, on reasonable request. Access to anonymised data may be granted following review of the request. Exclusive use will be retained until the publication of major outputs.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article 16/02/2020 08/06/2021 Yes No
Results article 01/12/2020 08/06/2021 Yes No
HRA research summary 28/06/2023 No No

Editorial Notes

08/06/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
3. The participant level data was added.
4. The trial website was added.
22/10/2018: The following changes have been made to the trial record:
1. The overall trial end date has been changed from 26/04/2018 to 28/02/2019
2. The plain English summary has been updated to reflect the new trial end date
24/08/2018: The overall trial end date was changed from 01/07/2017 to 26/04/2018.
07/04/2016: Ethics approval information added.