Condition category
Nutritional, Metabolic, Endocrine
Date applied
02/02/2017
Date assigned
24/02/2017
Last edited
14/02/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Many women are overweight or obese from the start of pregnancy and this puts the mother’s and baby’s health at risk. If a woman is overweight or obese in pregnancy she is at greater risk of developing gestational diabetes (a type of diabetes that occurs during pregnancy) or pre-eclampsia (a serious condition where blood flow between the baby and placenta is reduced so the baby doesn’t get enough nutrients to develop properly). Women are also more likely to need a caesarean section and there is a greater risk of stillbirth and infant death. As well as starting pregnancy too heavy, some women gain too much weight during pregnancy. Many women struggle to lose weight after pregnancy and at the moment the best way to help these women is unknown. The period when women have a baby is a very unique time. On the one hand, it may be a time when women become very aware of the importance of good health and so might be open to changing their diet. On the other hand, women’s lives change completely. Their attention becomes focused on caring for the baby rather than themselves. This means that any support provided to women to help them lose weight after pregnancy needs to fit in with their busy and constantly changing lives. Many women are unable to attend scheduled classes or meetings and so it is important to a way to provide support. Text messages have been used to help people stop smoking and some research has shown that they may also help people to lose weight. The aim of this study is to find out whether a weight management programme delivered via text messages can help women lose weight after pregnancy.

Who can participate?
Adult women who have had a baby in the last two years.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive regular text messages on weight loss and how to keep weight off (weight loss maintainance) for 12 months. Those in the second group receive regular text messages about child health and development for 12 months. Women in both groups are visited every three months by study researchers. At each study visit, participants complete some questionnaires about health and lifestyle, have their weight and blood pressure measured and are asked to wear a pedometer (step counter) for seven days. They are also asked to take part in a short telephone interview twice during the study (at the three and twelve months) to gather views on the text message program.

What are the possible benefits and risks of participating?
Participants may benefit by finding the messages they receive to be helpful and supported. There are no anticipated risks involved with 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?
February 2017 to June 2018

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr Michelle McKinley
m.mckinley@qub.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Michelle McKinley

ORCID ID

http://orcid.org/0000-0003-3386-1504

Contact details

Centre for Public Health
School of Medicine
Dentistry & Biomedical Sciences
Queen's University Belfast
Institute of Clinical Science Block B (1st floor)
Grosvenor Road
Belfast
BT12 6BJ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Project: 14/67/20

Study information

Scientific title

A woman-centred, tailored SMS-delivered multi-component intervention for weight loss and maintenance of weight loss in the postpartum period: a pilot RCT (The SMS Study)

Acronym

The SMS Study

Study hypothesis

The SMS intervention shows promise as a way to support weight loss and weight loss maintenance in the post-partum period and should be tested in a full trial.

Ethics approval

Research Ethics Committee, School of Medicine, Dentistry & Biomedical Science, Queen's University Belfast

Study design

Single-centre pilot randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Home

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Weight loss and maintenance of weight loss

Intervention

Participants are randomised to one of two groups using the LSHTM’s secure remote web-based system which will link directly with the SMS database and will deliver the intervention or control content according to group allocation.

Interventions group: Participants will receive messages about weight loss and maintenance of weight loss for 12 months.

Control group: Participants will receive messages related to child health and development for 12 months.

In both groups, message delivery will be automated. Messages will be sent out using the London School of Hygiene and Tropical Medicine’s (LSHTM) existing messaging technology, via a secure server, as tried and tested in the txt2stop trial.

Study assessments will be carried out at baseline, 3, 6, 9 and 12 months.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Acceptability of the intervention and active control is measured using a satisfaction rating and qualitative views
2. Feasibility of recruitment is measured using study records at the end of the recruitment period
3. Retention rate is measured using study records at 3, 6, 9 and 12 months
4. Attrition rate is measured using study records at 3, 6, 9 and 12 months

Secondary outcome measures

Evidence of positive indicative effects is measured using change in weight and waist circumference at 3, 6, 9 and 12 months.

Overall trial start date

22/12/2014

Overall trial end date

30/06/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Had a baby in previous two years
2. Aged over 18 years
3. Postpartum BMI over 25kg/m2
4. Primiparous or multiparous

Participant type

Healthy volunteer

Age group

Adult

Gender

Female

Target number of participants

100

Participant exclusion criteria

1. No access to a mobile phone to receive personal messages
2. Insufficient English to understand messages
3. Pregnancy
4. On a specialist diet
5. Psychiatric disorders
6. Eating disorder
7. Previous/ planned bariatric surgery
8. Type 1 diabetes mellitus

Recruitment start date

10/02/2017

Recruitment end date

30/06/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Queen's University Belfast
University Road
Belfast
BT7 1NN
United Kingdom

Sponsor information

Organisation

Queen's University Belfast

Sponsor details

University Road
Belfast
BT7 1NN
United Kingdom

Sponsor type

University/education

Website

www.qub.ac.uk

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from m.mckinley:qub.ac.uk

Intention to publish date

31/08/2019

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes