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
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
Contact information
Public
Primary Care Clinical Sciences
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
| Phone | +44 121 414 8166 |
|---|---|
| j.a.ferguson@bham.ac.uk |
Scientific
Primary Care Clinical Sciences
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
| Phone | 01214148166 |
|---|---|
| j.a.ferguson@bham.ac.uk |
Study information
| Study design | Single-centre cluster feasibility randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Feasibility and acceptability of a routine weight management intervention for postnatal women embedded within the national child immunisation programme |
| Study acronym | PIMMS |
| Study objectives | 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(s) | West Midlands- Black Country Research Ethics Committee, 17/02/2016, ref: 15/WM/0445 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/01/2016 |
| Completion date | 28/02/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 80 |
| Total final enrolment | 28 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2016 |
| Date of final enrolment | 01/07/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Edgbaston
Birmingham
B152TT
United Kingdom
Sponsor information
University/education
C block, Aston Webb Building, University of Birmingham, Edgbaston
Birmingham
B15 2TT
England
United Kingdom
"ROR" |
https://ror.org/03angcq70 |
|---|
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/12/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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. |
| IPD sharing plan | The 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.
