Plain English Summary
Background and study aims
Many women struggle to lose weight after pregnancy and talk about pregnancy as a time when their weight started to ‘creep up’. We need to find ways to help women lose weight after having a baby. Life becomes much busier for women when caring for a baby and going to weight loss groups may not work well for new mums. We have thought about other ways to help women after they have a baby that are more flexible. Nearly everyone has a mobile phone and uses their phone to send and receive text messages. Text messages have been used to help people lose weight so we carried out a small study to see if this might be a useful way to support weight loss after pregnancy.
Women who recently had a baby helped us design our text messages. We recruited one hundred mums from Northern Ireland and they received our weight management messages, or messages about child health and development, for 12 months. More than 4 out of 5 women completed the study. Women rated the messages very highly and felt they were supportive and motivating. Women receiving the weight loss messages lost more weight compared to those receiving the child health messages. The small numbers in our initial study mean we do not know for sure how well the messages work for everyone. We need to test this in a larger study with women from all parts of the United Kingdom.
For this bigger study, we will tell women about the study through social media, mother and baby groups and when they visit the GP for their postnatal check-up or baby immunisations. If women are interested in taking part they will contact the study team through text message, Email or telephone. Women who have had a baby in the last two years will be able to take part. We want to recruit women from a wide range of backgrounds which is why we are doing the study in all parts of the UK (England, Scotland, Wales and Northern Ireland).
Who can participate?
People aged 18 years or above who have recently given birth and are overweight (have a BMI greater than 25 kg/m²)
What does the study involve?
In total, 888 women with excess weight will be entered into the study. Women will be assigned by chance either to receive our weight loss text messages or to receive our text messages about child health and development for 12 months. As it is often difficult to travel to appointments with a baby, researchers will offer to visit the women in their home (or they can come to a research centre if they prefer) to measure weight and waist circumference and ask mums to complete a questionnaire. These visits will happen at the start of the study, at 6 months, 12 months (when the messages end) and at 24 months (12 months after women stop receiving the messages). When attempts to arrange a visit between the researcher and participant at 12 and 24 months have been unsuccessful, as a last resort we will ask women to measure and report their own weight. We will also speak to some women when they have received the messages for 6 months and when they have been receiving the messages for 12 months to see what they think of them. Women will receive a token of appreciation at each visit for the time they have given to the research.
Women have already helped us to write our text messages and chose the name of the study (Supporting MumS). For this bigger study, women will help us to review and edit the messages so they are relevant to women across the UK. We will invite two women to be part of our study team to help us with all aspects of the study.
If the text messages are shown to help women manage their weight after having a baby, they could be made widely available to all women. We will share our findings with a wide variety of audiences including mums, health professionals, politicians, and government departments that could provide the text message service to women.
What are the possible benefits and risks of participating?
By taking part in this research, participants will be helping us find the best ways to support new mums. Some of the messages participants receive may be helpful for the individual and/or their baby by helping them to lose weight or by providing information about child health and development. We do not anticipate any risks from taking part in this study.
Where is the study run from?
Queen's University Belfast (UK)
When is the study starting and how long is it expected to run for?
July 2021 to April 2025
Who is funding the study?
National Institute for Health Research (NIHR) (UK).
Who is the main contact?
Prof McKinley, m.mckinley@qub.ac.uk
Study website
Contact information
Type
Scientific
Contact name
Prof Michelle McKinley
ORCID ID
http://orcid.org/0000-0003-3386-1504
Contact details
Centre for Public Health
Institute Clinical Science A
Grosvenor Road
Belfast
BT12 6BJ
United Kingdom
+44 2890978936
m.mckinley@qub.ac.uk
Additional identifiers
EudraCT/CTIS number
Nil known
IRAS number
305557
ClinicalTrials.gov number
Nil known
Protocol/serial number
IRAS 305557, NIHR131509, CPMS 51568
Study information
Scientific title
Effectiveness and cost effectiveness of an automated text message intervention for weight management in postpartum women with overweight or obesity: the Supporting MumS Randomised Controlled Trial
Acronym
SMS
Study hypothesis
Women randomised to receive the intervention text messages (messages about weight management) will lose significantly more weight compared to women randomised to the active control (messages about child health and development).
Ethics approval(s)
Approved 24/02/2022, West of Scotland REC 4 (West of Scotland Research Ethics Service, Ward 11, Dykebar Hospital, Grahamston Road, Paisley, PA2 7DE, United Kingdom; +44 (0)141 3140213; WoSREC4@ggc.scot.nhs.uk), ref: 22/WS/0003
Study design
Multi-site parallel two-arm interventional randomized controlled trial with embedded process evaluation and cost-effectiveness analysis
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Community, GP practice, Hospital
Study type
Treatment
Patient information sheet
A copy of the participant sheet can be requested by emailing supportingmums@qub.ac.uk
Condition
Overweight and obesity in postpartum women
Intervention
Women will be recruited from all four countries in the UK using community based recruitment as well as signposting via routine contact with health professionals. Written informed consent will be obtained, baseline data collected and then participants will be randomised. Participants will be block randomised and randomisation will be stratified by site. The randomisation sequence will be developed in STATA by a statistician who is independent of the study team. The randomisation will be implemented via the London School of Hygiene and Tropical Medicine secure remote web-based system which will link directly with the text message database and will deliver the intervention or control content according to the random allocation sequence. Participants will become aware of their group allocation when they start to receive the messages. Participants will receive the text messages for one year.
The intervention group will receive automated text messages about weight loss and maintenance of weight loss for 12 months. The text messages will focus on diet and physical activity with embedded behaviour change techniques known to be positively associated with weight management.
The control group will receive automated text messages about child health and development for 12 months.
Study assessments will be conducted at baseline, 6 months, 12 months (end of intervention period) and 24 months (12 months after the intervention has ceased) for all participants.
Intervention type
Behavioural
Primary outcome measure
Current primary outcome measure as of 24/02/2024:
Between-group difference in mean weight change (kg) measured using calibrated scales from baseline to 12 months
Previous primary outcome measure:
Weight change from baseline to 12 months (kg), measured using calibrated scales
Secondary outcome measures
Current secondary outcome measures as of 24/02/2024:
1. Between-group difference in mean weight change (kg) from baseline to 24 months.
2. Between-group difference in mean waist circumference (cm) measured by a flexible measuring tape at baseline, 6, 12 and 24 months.
3. Between-group difference in mean BMI (kg/m2) measured at baseline, 6, 12 and 24 months.
4. Health behaviours are measured by: Fat and Fibre Barometer; self-report questionnaire on sugar and alcohol intake; International Physical Activity Questionnaire (IPAQ) - Short form; and self-report questionnaire on infant feeding practices (Infant Feeding Survey) measured at baseline, 6, 12 and 24 months
5. Study acceptability is measured by: recruitment; retention; engagement with the two-way text messages during 12 months; self-reported questionnaire on participant satisfaction with SMS messages (at 6 and 12 months) and rating of intervention (at 12 months); and qualitative interviews (at 6 and 12 months),
6. Economic evaluation outcomes are measured by: self-report questionnaire on health service resources use, prescribed and over-the counter medication usage and lifestyle-related costs; the EuroQol 5-dimension (EQ-5D-5L with visual analogue scale) quality of life questionnaire; and the ICEpop Capability Measure for Adults (ICECAP-A) at baseline, 6, 12 and 24 months
7. Moderators of intervention effect are measured by: Edinburgh Postnatal Depression Scale (EPDS); Generalised Anxiety Disorder (GAD-7); Pittsburgh Sleep Quality Index; and self-report questionnaire on confidence and desire for weight loss and maintenance at baseline, 6, 12 and 24 months
8. Mediators of intervention effect are measured by: Health Action Process Approach (HAPA) for diet and exercise; Self-Report Behavioural Automaticity Index for diet and exercise; Self-regulation of eating behaviour questionnaire; self-report questionnaire on monitoring and goal setting for diet and exercise; Motivation for weight loss scale; Social support for eating & exercise questionnaire; and Rosenberg Self-Esteem Scale at baseline, 6, 12 and 24 months
Previous secondary outcome measure:
1. Waist circumference measured by a flexible measuring tape at baseline, 6, 12 and 24 months
2. Health behaviours are measured by: Fat and Fibre Barometer; self-report questionnaire on sugar and alcohol intake; International Physical Activity Questionnaire (IPAQ) - Short form; and self-report questionnaire on infant feeding practices at baseline, 6, 12 and 24 months
3. Study acceptability is measured by: recruitment; retention; engagement with the two-way text messages during 12 months; self-reported questionnaire on participant satisfaction with SMS messages (at 6 and 12 months) and rating of intervention (at 12 months); and qualitative interviews (at 6 and 12 months),
4. Economic evaluation outcomes are measured by: self-report questionnaire on health service resources use, medication usage and lifestyle-related costs; the EuroQol 5-dimension (EQ-5D) quality of life questionnaire; and the ICEpop Capability Measure for Adults (ICECAP-A) at baseline, 6, 12 and 24 months
5. Moderators of intervention effect are measured by: Edinburgh Postnatal Depression Scale (EPDS); Generalised Anxiety Disorder (GAD-7); Pittsburgh Sleep Quality Index; and self-report questionnaire on confidence and desire for weight loss and maintenance at baseline, 6, 12 and 24 months
6. Mediators of intervention effect are measured by: Health Action Process Approach (HAPA) for diet and exercise; Self-Report Behavioural Automaticity Index for diet and exercise; Self-regulation of eating behaviour questionnaire; self-report questionnaire on monitoring and goal setting for diet and exercise; Motivation for weight loss scale; Social support for eating & exercise questionnaire; and Rosenberg Self-Esteem Scale at baseline, 6, 12 and 24 months
Overall study start date
01/07/2021
Overall study end date
30/04/2025
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Women (as per NICE Postnatal care guideline NG1941, for this trial, the term 'woman' is taken to include people who do not identify as women but are pregnant or have given birth)
2. Aged >18 years old
3. BMI ≥25 kg/m²
4. Have had a baby within the last two years
Participant type(s)
Healthy volunteer
Age group
Adult
Lower age limit
18 Years
Sex
Female
Target number of participants
888
Total final enrolment
892
Participant exclusion criteria
Current participant exclusion criteria as of 24/02/204:
1. Baby less than 6 weeks old
2. No access to a mobile phone to receive personal messages
3. Insufficient English to understand short written messages
4. Currently pregnant
5. Recent or planned bariatric surgery
6. Diagnosis of anorexia nervosa or bulimia by a doctor
7. On a specialist diet and receiving dietetic care
8. Taking part in another weight management research study/programme currently, or in the last 3 months
Previous participant exclusion criteria:
1. Baby less than 6 weeks old
2. No access to a mobile phone to receive personal messages
3. Insufficient English to understand short written messages
4. Currently pregnant
5. Recent or planned bariatric surgery
6. Eating disorder
7. On a specialist diet and receiving dietetic care
8. Taking part in another weight management research study currently, or in the last 3 months
Recruitment start date
20/04/2022
Recruitment end date
02/05/2023
Locations
Countries of recruitment
England, Northern Ireland, Scotland, United Kingdom, Wales
Study participating centre
Queen's University Belfast
Centre for Public Health
ICS A, School of Medicine, Dentistry & Biomedical Science
Grosvenor Road
Belfast
BT12 6BJ
United Kingdom
Study participating centre
University of Stirling
NMAHP Research Unit
Pathfoot Building
Stirling
FK9 4NF
United Kingdom
Study participating centre
London School of Hygiene and Tropical Medicine
Department of Population Health
Keppel Street
London
WC1E 7HT
United Kingdom
Study participating centre
Bradford Teaching Hospitals NHS Foundation Trust
Better Start Bradford Innovation Hub
Bradford
BD9 6RJ
United Kingdom
Study participating centre
Cardiff University
Centre for Trials Research
Cardiff
CF10 3FT
United Kingdom
Sponsor information
Organisation
Queen's University Belfast
Sponsor details
University Road
Belfast
BT7 1NN
Northern Ireland
United Kingdom
+44 2890973861
p.tighe@qub.ac.uk
Sponsor type
University/education
Website
ROR
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal
Intention to publish date
30/04/2026
Individual participant data (IPD) sharing plan
Current IPD sharing plan as of 24/02/2024:
Following publication of the results, the anonymised participant-level datasets generated during and/or analysed during the current study, along with the statistical code used for generating the results, will be available upon request from the Chief Investigator on reasonable request, as assessed by the Chief Investigator and Project Management Team and subject to any necessary data sharing agreements. Formal requests to be made in writing to the Chief Investigator (Prof M McKinley; m.mckinley@qub.ac.uk). Data availability will be consistent with timelines for storage of research data.
Previous IPD sharing plan:
Available on request. Formal requests to be made in writing to the CI (Prof M McKinley; m.mckinley@qub.ac.uk).
IPD sharing plan summary
Available on request
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1.0 | 30/11/2021 | 10/01/2022 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol file | version 2.0 | 07/03/2022 | 28/11/2023 | No | No |
| Protocol file | version 3.0 | 10/05/2023 | 29/11/2023 | No | No |
| Protocol file | version 4.0 | 12/04/2024 | 07/05/2024 | No | No |
| Protocol article | 06/05/2024 | 09/05/2024 | Yes | No |