Title: Effectiveness and cost effectiveness of an automated text message intervention for weight management in postpartum women with overweight or obesity: the Supporting MumS (SMS) Randomised Controlled Trial
Funder: Public Health Agency, NI

Abstract: 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. _x000D_ _x000D_ 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. _x000D_ _x000D_ 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). _x000D_ _x000D_ 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). 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. _x000D_ _x000D_ 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._x000D_ _x000D_ 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.

Lay abstract: RESEARCH QUESTION: Does a fully automated text message intervention support weight loss and maintenance of weight loss in women with overweight or obesity who have had a baby in the last two years? _x000D_ BACKGROUND: Women are at an increased risk for weight gain during the reproductive years. Weight loss interventions are needed to support postpartum women to improve their health before future pregnancies. Our NIHR-funded pilot RCT showed that a text message delivered intervention might work well for this group._x000D_ AIMS:_x000D_ 1.To adapt the text message library to ensure broad acceptability across different ethnic groups and the four countries in the UK. _x000D_ 2.To conduct a 2-arm parallel group RCT comparing weight change at 12 months for postpartum women with overweight or obesity who receive text messages about weight management or an active control._x000D_ 3.To assess differences between groups in secondary outcomes. _x000D_ 4. To assess the prevalence and trajectories of postnatal mental health in women across the UK, particularly those from marginalised groups, including assessment of the mother-child relationship._x000D_ 5.To assess the cost-effectiveness of the text message intervention._x000D_ 6. To conduct a process evaluation to explore women’s experiences of the intervention, the pathways through which the intervention effects are mediated and contextual factors affecting the outcomes or future implementation of the intervention, including the impact of postnatal mental health on intervention engagement and outcomes._x000D_ 7. To seek permission for linkage to routine data for long term health outcomes (mum and youngest baby)._x000D_ 8. To examine the effect of the 12 month intervention in the longer-term, at 24 months (i.e. 12 months after the intervention has ceased). _x000D_ 9. To conduct interviews with stakeholders to explore scale-up and implementation._x000D_ RESEARCH DESIGN: A UK-wide multi-site, 2-arm, parallel RCT, with embedded process evaluation and cost-effectiveness analysis. _x000D_ INTERVENTION: Fully automated 12 month text message intervention for weight loss and maintenance of weight loss. _x000D_ ACTIVE CONTROL: Text messages about child health and development for 12 months. _x000D_ POPULATION: Women with Body Mass Index greater than or equal to 25 kg/m2 who have had a baby in the last 2 years._x000D_ RECRUITMENT: n=888 women via community-based approaches, social media and routine contact with health professionals. _x000D_ SETTING: Five sites - Scotland, N.Ireland, Wales, England (Bradford, London)._x000D_ OUTCOME MEASURES: 0, 6, 12 & 24 months. Collected at home visits. Primary outcome: weight loss at 12 months. Secondary outcomes: Proportion of women gaining a substantial amount of weight (>5kg) during the 12 and 24 month follow-up, change in waist circumference, change in dietary intake, change in physical activity and infant feeding practices. Exploratory outcomes: As part of the process evaluation, a moderator (factors that influence response to intervention) and mediator (possible mechanisms that bring about behaviour change) analysis will be conducted._x000D_ PROCESS EVALUATION: Reach, acceptability, engagement, perceived benefits, perceived mechanisms of impact, factors important for implementation; from study records and interviews with women at 6 & 12 months (n=50)._x000D_ COST-EFFECTIVENESS: An economic evaluation will be will be conducted using a National Health Service and personal social services perspective with an additional societal perspective applied to capture the broader impact, adhering to guidance for conducting public health economic evaluations._x000D_ TIMELINE: M 0-6 - Set up, cultural adaptation of text message library with PPI; M 7-24 - Recruitment & 6 month follow-up; M 19-30 – 12M follow-up; M 31-42 – 24M follow-up; M 43-46 - Completion of data analysis, final report, dissemination (ongoing from M30)._x000D_ ANTICIPATED IMPACT & DISSEMINATION: If successful, this postpartum weight management intervention could be implemented throughout the UK to reduce lifelong excess weight in women. The findings will be disseminated widely to women, health professionals, policy makers, service commissioners and academics.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: CANCER AND NEOPLASMS;CARDIOVASCULAR;METABOLIC AND ENDOCRINE;ORAL AND GASTROINTESTINAL;STROKE