Title: ‘Helpmedoit!’ a web and text based intervention to facilitate social support to achieve and maintain health related behaviour change
Funder: Chief Scientist Office, Scotland

Abstract: DESIGN: Stage 1 Development and piloting Stage 2 Exploratory trial with process evaluation. POPULATION: Adults (BMI 30+) trying to lose weight recruited via advertising, exercise on referral and primary care. STAGE 1: DEVELOPMENT During the development stage, health behaviour change experts and an IT company will work with user representatives to establish the optimal usability and acceptability of the app, website and SMS aspect. It will explore how to engage helpers and what support to helpers might be effective. This essential development and modelling work, and feasibility testing, follows the MRC guidance for the development and evaluation of complex interventions. The Helpmedoit! intervention will have multiple elements: support for goal setting and planning; nominate your helper to identify goal-specific social support group; obtain agreement from nominated helper(s) to provide support; helper-specific advice on providing effective support; track your progress for monitoring behaviour; specific information (including tips and case stories); the SMS, goal updates, support element of the intervention. Participants will be reminded to access the app and website which will provide guidance in setting goals, planning and nominating one or more helpers. The Helpmedoit! programme will contact these helpers via SMS, and invite them to help the individual. Participants will be able to choose not to share certain potentially sensitive bits of information (e.g. weight) with helpers. They will also be able to deselect helpers as well as nominate new helpers. Participants will be able to update their goals, plans and monitoring pages via SMS and smart phones. Helpers will receive guidance via SMS and the option to log onto the website which will give more detail on helping people to achieve health goals. These will be tailored to participants according to age and gender. They will be sent reminders to provide encouragement or commiseration and further support, depending upon progress towards goals. How this support is given is up to the helpers: it could be via SMS, phone call or face-to-face. SMS reminders will be sent to participants and helpers by the system when the goal date is close. Outgoing text messages will be designed to be engaging, according to best practice and will be based on consultation with the development panel. Data collection: We will recruit 10 user representatives to a development panel to provide input into the design and content of the app and website and how it will link with SMS messaging. The developing intervention will then be tested with up to 30 participants in focus groups or interviews. Outcomes in this stage will be analysis of qualitative data using thematic analysis. A report will be produced and submitted to an independent Trial steering Committee (TSC) who will decide whether the study should continue onto the exploratory trial. We will agree progression criteria in advance with the TSC; however, we suggest the following: Criterion 1: Was the software and associated SMS facility developed to a good standard in the timescale available? Did the software company produce the intervention as specified in the detailed design document? (This document will be produced during the development process in collaboration with the company and based on the findings from the focus groups and interviews). Did the software include the appropriate intervention elements to facilitate social support and behaviour change? This will be assessed by tabulating the logic model elements and the software will be compared to this to ensure it includes the key elements and addresses the aims and objectives of the logic model. Criterion 2: Was it feasible to implement the HelpMeDoIt! intervention via the web-based platform, app and SMS? If there were issues with the app, the website or other technical problems were the company responsive and able to provide solutions to any issues? This will be evidenced by the qualitative findings, page usage statistics, records of ‘bug’ reporting on the website and other measures of adherence. Criterion 3: Was the intervention acceptable and did the majority of the development group members find the intervention usable and acceptable? This will be assessed using the results from the usability questionnaire (which assesses ease of use and usefulness), the think-aloud results, the interview and focus group data and an expert heuristic evaluation. At this point, the study will either be terminated, to end at month 12 after a brief write-up period, or the SSC will agree to the progression to stage 2 feasibility testing. In months 9 and 10, the software company will proceed with further development of the programming in anticipation of proceeding to stage 2. STAGE 2: EXPLORATORY TRIAL This phase will test the app, website and SMS service developed in phase 1 and explore how the intervention works and whether it is worth testing in a full trial. The data collection methods will also be assessed for use in a full trial. 120 participants will be recruited and randomised to either complete the Helpmedoit! intervention or to receive a leaflet with information on healthy diet and physical activity. The active phase of the intervention will run for 6 months where we will remind participants/helpers to use the system, after this period they will still be able to access the program. Demographic information will be collected at baseline. Measures collected at baseline and 12 months include physical activity, diet, height, weight, waist circumference, mental health, self-esteem quality of life, NHS resource use and participant borne costs will be assessed. Potential mediators will be assessed including motivation, self-efficacy and social support. At 6 months, we will conduct a brief interview with up to 30 participants and 20 helpers to collect data on: acceptability; patterns of use; help received; barriers and suggested improvements to each of the interventions. We will also explore among the Helpmedoit! group their perception of the helpers experiences and the value of the helpers support as well as data on both positive and negative social support. Participants will be sampled on the basis of age, gender, socio-economic status, intervention usage and we will specifically seek to interview those who did not take up the intervention and reasons for this. We will collect in-depth qualitative data, on social support and on the ways that positive behaviour among helpers can be supported and encouraged. Qualitative data will be analysed using thematic analysis. Quantitative analyses will include descriptive analyses of recruitment rates, intervention use and response rates. Analyses of diet, physical activity and BMI will be carried out using ANCOVA with baseline scores as covariates to explore estimates of likely effect sizes for a larger trial. Secondary analyses will compare intervention and control groups in terms of weight lost, waist circumference, % weight lost, quality of life, self-esteem and mental health. We will conduct exploratory sub-group and mediation analyses. We will obtain estimates of key cost drivers to inform the design of a future cost effectiveness analysis. The Scottish Primary Care Research Network will cover service support costs.

Lay abstract: The internet and social media can be effective in influencing behaviour, and can reach large numbers of people. Previous research shows that setting goals, making plans and monitoring how well you are doing is important to facilitate behaviour change. The support of family, friends and others is also crucial in helping people to achieve and sustain behaviour change and healthier lifestyles. Helpmedoit! will be an app and website that will help people set a behaviour change goal and sign up friends or family as helpers to help them do it . These helpers will then be prompted by text messaging to enthuse, support or commiserate and help the person to achieve their goal. The programme will allow monitoring of progress and celebration of goals achieved. The active phase of the intervention will run for 6 months where we will send reminders by text to use the app and website, after this the program will still be accessible but we won't send reminders. So rather than using a predefined organised social group, like a club or church, or appointing a 'peer mentor' or 'community champion', to provide or facilitate social support, we are facilitating the individual to self-identify one or more helpers from their existing social contacts whom they believe will be best placed to provide the support they need to help achieve their goal. The helpers will either individually or as a loosely organised collective mobilise themselves to help support the participant to change their behaviour. The pair or group may be a sustainable entity that will both achieve and maintain behaviour change either through temporary use of the app and website and then sustained behaviour-related social support or through sustained and long term use of Helpmedoit! The study will be completed in two stages. Stage 1 will focus on the development and design of the intervention and stage 2 will test whether this intervention helps people to improve their diet, increase their physical activity or lose weight. STAGE 1: In stage 1, a development panel will be recruited and will include ten members of the public, IT specialists and behaviour change experts. They will work together to ensure the website and SMS aspect are usable and acceptable and they will explore how to engage helpers and what type of support to helpers might be effective. The app, website and texting will then be tested by additional members of the public. Focus groups and interviews will be completed with up to 30 participants to gather feedback. The intervention will have multiple elements, including: support for goal setting and planning; nominate your helper to identify goal-specific social support group; obtain agreement from nominated helper(s) to provide support; helper-specific advice on how to provide effective support; track your progress for monitoring behaviour; specific information (including tips and case stories); the SMS, goal updates, and support element of the intervention. The participants will be reminded to access the app and website, which will provide support and guidance for all parts of the intervention. Once helpers have been chosen, they will be sent a text inviting them to take part and to help their friend/family member/colleague. Helpers will be given the option to log on to the website and will be given information by text about how to provide support. Participants will be able to choose not to share certain potentially sensitive bits of information (e.g. body weight) with helpers. They will also be able to deselect helpers as well as nominate new helpers. Helpers can choose how they provide support: it could be via SMS, phone call or face to face. Texts sent to participants and helpers will be designed to be engaging and accessible. Participants can update how close they are to meeting their goals via the app and website. The results of this stage will be measured by analysing the focus group and interviews. At the end of stage 1, we will produce a report which will be reviewed by an independent steering group which will include members of the public and they will decide whether to progress to the next stage. STAGE 2: In stage 2, if the service seems promising it will then be tested in a group of 120 obese adults. We will recruit participants for this stage from the exercise on referral scheme, primary care and from the community via advertising. This second stage will assess whether and how the intervention has any impact on people’s diet and physical activity habits as well as their weight. Measuring diet and physical activity accurately is challenging. We will therefore test out the feasibility and acceptability of different ways of measuring physical activity and diet. Finally, we will explore how people use the intervention, whether participants and helpers like it and whether it mobilises helpers to provide effective support. Participants will be randomly put into two groups. The intervention group will complete the Helpmedoit! intervention for 6 months and the control group will receive a leaflet on healthy diet and physical activity. The control group will, however, be able to access the website after follow-up is complete. The results of this stage will be used to decide whether it is worth testing the intervention in a large-scale study. At baseline and 12 month follow-up physical activity, diet, height, weight, waist circumference, health related quality of life, social support, self-efficacy, motivation, mental health, NHS resource use and participant borne costs will be assessed. Up to 30 participants and 20 helpers will be interviewed about their experience of the intervention at 6 months. Interviews and focus groups will be analysed using appropriate methods and statistics will be used to analyse behaviour change. We will also measure whether the intervention is likely to provide good value for money as it has the potential to reach a lot of people at a low cost. We will apply for ethical approval for the study. Procedures for data storage, processing and management will comply with the Data Protection Act

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