Title: A woman-centred, tailored SMS-delivered multi-component intervention for weight loss and maintenance of weight loss in the postpartum period: intervention adaptation and pilot RCT
Funder: Health and Social Care Research and Development Division (HSC R&D) of Public Health Agency, Northern Ireland

Abstract: THE NEED FOR THIS STUDY: Systematic review evidence and National Institute of Clinical Excellence (NICE) guidance highlight gaps in knowledge about effective and appropriate weight management interventions in women during the postpartum period. Such interventions must carefully consider the difficulties in reaching this population and the specific barriers to lifestyle behaviour change that come with having a new baby. Employing mobile technologies to change diet, weight and activity behaviours presents a promising and expanding area of behavioural research but one that has not been explored extensively, or trialled, with this group. SMS (short message service or text message) interventions have the advantage of unlimited reach, flexible scheduling and individual tailoring of content, thus making them an attractive proposition, with the potential to help address health inequalities. AIM: To adapt and pilot test an evidence and theory-based tailored SMS-delivered intervention supporting overweight or obese (OW/OB) women's behaviour change for weight loss and maintenance of weight loss in the postpartum period. DESIGN: This study will adapt an existing and effective SMS-Based intervention developed for smoking cessation (txt2stop) to support postpartum women to lose weight and maintain this weight loss. The adapted intervention will be piloted in a parallel group, single site (Northern Ireland) randomised controlled trial (RCT). SETTING: Intervention is based on mobile technology so setting is anytime, anyplace; outcomes will be measured at home or at a research centre according to participant preference. TARGET POPULATION: women who have had a baby in previous two years; aged over 18 years; postpartum BMI over 25 kg/m2. INTERVENTION: Tailored, multicomponent SMS-delivered intervention with two weight management phases: (i) weight loss and (ii) maintenance of weight loss. The SMS-delivered intervention will allow message tailoring according to women’s weight management progress; their social circumstances and eating triggers (gathered from women at baseline); other health-related behaviours (smoking, alcohol, breastfeeding); and individual preferences for time and frequency of messages (the latter will be explored in PPI). CONTROL: Active control - will receive SMS support related to general child care and development. MAIN RESEARCH QUESTIONS: Pilot RCT - The main research questions for the pilot RCT: Can all components of the trial be successfully delivered? What are the views of OW/OB postpartum women regarding the acceptability and perceived benefits of the SMS-delivered intervention? What are the views of OW/OB postpartum women regarding the acceptability of, and willingness to be randomised to, the active control? What fine-tuning of the intervention content or delivery is required for a full trial? Can data for the proposed endpoints be successfully collected? Is the recruitment strategy appropriate? Is the retention rate acceptable? What sample size would be required in a definitive trial? What are the indicative effects of the intervention on weight loss and weight loss maintenance? INTERVENTION DURATION AND MEASUREMENT OF OUTCOMES: Pilot RCT – one year; Data collection at 0,3,6, 9 and 12 months. Assessments: anthropometric measurements, blood pressure, questionnaires and interviews to gather feedback on the intervention and its acceptability. POTENTIAL IMPACT OF PROPOSED RESEARCH: An intervention that could be scaled up at low-cost for wide scale implementation, resulting in improvements in weight management after pregnancy.

Lay abstract: 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 or pre-eclampsia. She is 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 we don’t know enough about how to help them. 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 or becoming more active. 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. Some schemes have been set up for women to help them lose weight after pregnancy but most of these have involved women going to scheduled classes or group meetings. Although many women signed up for the sessions, women struggled to attend because of the demands of looking after the baby and other family members. Based on these approaches which have not worked so well, we have thought about other ways to help women after they have a baby, providing support in a flexible, non-intrusive way and so that women don’t have to be at a particular place at a particular time. Nearly everyone has a mobile phone and most people use it to send and receive text messages. Text messages have been used to help people stop smoking and some research has shown that they may also help people to lose weight. In the study we propose we could like to test a weight management programme delivered via text messages to help women lose weight after pregnancy. Our idea is that women would have easy access to support and the information received would be tailored to their needs. For example, if late night eating is a particular trigger for a women, she would receive supportive messages at this time of the day to encourage a change in this habit. We plan to work closely with women to develop the text messaging service as we want to make sure the messages are clear and easy to understand. Importantly, as well as helping women to lose weight, the text messaging service would also be used to help women keep the weight off. Sometimes this important part of weight management is overlooked but it may be the hardest part. We will invite women who are overweight or obese after pregnancy to take part in a pilot study (this means an small scale trial). Women would be assigned by chance to either receive weight management messages or to receive general messages about child health and development for one year. Researchers would visit the women in their home, or in a research centre (based on their preference), every 3 months to collect measurements like weight and waist circumference and to complete questionnaires. Women would receive a token of appreciation for their time commitment. This trial would tell us if our approach is acceptable to women and so would be worth trialling on a larger scale. If successful, this work could result in a weight management intervention that is made widely available to postpartum women.

Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: CANCER AND NEOPLASMS;CARDIOVASCULAR;METABOLIC AND ENDOCRINE;ORAL AND GASTROINTESTINAL;STROKE