ObjectivesTo examine the acceptability and feasibility of narrative text messages with or without financial incentives to support weight loss for men.DesignIndividually randomised three-arm feasibility trial with 12 months’ follow-up.SettingTwo sites in Scotland with high levels of disadvantage according to Scottish Index for Multiple Deprivation (SIMD).ParticipantsMen with obesity (n=105) recruited through community outreach and general practitioner registers.InterventionsParticipants randomised to: (A) narrative text messages plus financial incentive for 12 months (short message service (SMS)+I), (B) narrative text messages for 12 months (SMS only), or (C) waiting list control.OutcomesAcceptability and feasibility of recruitment, retention, intervention components and trial procedures assessed by analysing quantitative and qualitative data at 3, 6 and 12 months.Results105 men were recruited, 60% from more disadvantaged areas (SIMD quintiles 1 or 2). Retention at 12 months was 74%. Fewer SMS+I participants (64%) completed 12-month assessments compared with SMS only (79%) and control (83%). Narrative texts were acceptable to many men, but some reported negative reactions. No evidence emerged that level of disadvantage was related to acceptability of narrative texts. Eleven SMS+I participants (31%) successfully met or partially met weight loss targets. The cost of the incentive per participant was £81.94 (95% CI £34.59 to £129.30). Incentives were acceptable, but improving health was reported as the key motivator for weight loss. All groups lost weight (SMS+I: −2.51 kg (SD=4.94); SMS only: −1.29 kg (SD=5.03); control: −0.86 kg (SD=5.64) at 12 months).ConclusionsThis three-arm weight management feasibility trial recruited and retained men from across the socioeconomic spectrum, with the majority from areas of disadvantage, was broadly acceptable to most participants and feasible to deliver.Trial registration numberNCT03040518.

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Short Message Service (SMS)-delivered behaviour change interventions are frequently used to support weight management. This systematic review examines the effectiveness of SMS-delivered behaviour change interventions for weight management. Electronic databases were searched for randomised controlled trials (RCTs) comparing SMS-delivered adult weight management interventions to control groups, published between 1990 and 2018. Weight change was examined using random effects meta-analyses at intervention cessation and postintervention follow-up. Subgroup analyses examined intervention duration, SMS frequency, theory use, SMS interactivity, and SMS tailoring. Fifteen studies met inclusion criteria (2705 participants). For weight loss interventions (n = 12, 1977 participants), the mean difference in weight change was −2.28 kg (95% confidence interval [CI] −3.17 to −1.36 kg). No studies reported postintervention follow-up. For weight loss maintenance interventions (n = 3, 728 participants), the mean difference in weight change was −0.68 kg (95% CI, −1.31 to −0.05 kg), and postintervention follow-up (n = 2, 498 participants) effects were −0.57 kg (95% CI, −1.67 to 0.53 kg). No subgroup differences were found. SMS-delivered behaviour change interventions for weight loss led to significant small to moderate weight loss and weight loss maintenance compared with control groups. Evidence on long-term effects is limited. SMS-delivered behaviour change interventions are a potentially effective and scalable intervention option for obesity treatment.

Background In 2016, 26% of UK men were estimated to be obese. Systematic reviews suggest that few men engage in formal weight loss interventions that support weight reduction and improve health. Objective To co-produce, with patient and public involvement, an acceptable and feasible randomised controlled trial design to test a men-only weight management intervention. Design This was a two-phase feasibility study. Phase 1 was the development of intervention components, study procedures and materials including a discrete choice experiment with survey questions. Phase 2 was an individually randomised three-arm feasibility trial over 12 months. Qualitative interviews were conducted at 3 and 12 months. Setting The setting was two sites in Scotland that had disadvantaged urban and rural areas and differed in employment levels and ethnic groups. Participants In phase 1, 1045 men with obesity were recruited by Ipsos MORI (London, UK; www.ipsos.com/ipsos-mori/en-uk) to represent the UK population. In phase 2, 105 men with obesity were recruited in the community or through general practice obesity registers. Qualitative interviews were conducted with 50 men at 3 months and with 33 men at 12 months. Interventions The trial arms were narrative short message service (SMS) for 12 months (SMS only), financial endowment incentive informed by loss aversion and linked to achievement of weight loss targets plus narrative SMS for 12 months (SMS + I), and waiting list control group for 12 months followed by 3 months of an alternative SMS style developed based on feedback from men who had received the narrative SMS (control). Main outcome measures The main outcome measures were acceptability and feasibility of recruitment, retention, engagement, intervention components and trial procedures. Outcomes were assessed by examining procedural, quantitative and qualitative data at 3, 6 and 12 months. Results The most acceptable incentive strategy, based on the discrete choice experiment results, was to verify weight loss of 5% at 3 months, verify weight loss of 10% at 6 months and maintain weight loss of 10% at 12 months. Overall, 105 men with obesity from across the socioeconomic spectrum were successfully recruited to target, 59% of whom lived in more disadvantaged areas. Retention at 12 months was acceptable (74%) and was higher among individuals from disadvantaged areas. Narrative SMS were acceptable to many men, with a minority reporting negative reactions. Incentives were acceptable but were not the primary motivation for behaviour change. Twelve men in the incentive arm (33%) secured at least some money and three (8%) secured the full amount. Both intervention arms lost some weight, with greater weight loss in the arm that received SMS and incentives. The alternative SMS based on men’s feedback received no strong negative reactions. Limitations Fewer participants from the SMS + I arm (64%) completed the study at 12 months than did those in the SMS-only (79%) and control (83%) arms. The reasons for this difference were complex. Conclusions The men-only weight management intervention consisting of narrative SMS and financial incentives was acceptable and feasible, meeting the progression criteria for a full trial. Tailoring of SMS may improve acceptability and retention. Future work Minor refinements to the intervention components based on the study findings will be made prior to testing in a multisite definitive randomised controlled trial. Trial registration ClinicalTrials.gov NCT03040518. Funding This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 8, No. 11. See the NIHR Journals Library website for further project information.

Background Men, particularly those living in disadvantaged areas, are less likely to participate in weight management programmes than women despite similar levels of excess weight. Little is known about how best to recruit men to weight management interventions. This paper describes patient and public involvement in pre-trial decisions relevant to recruitment and aims to report on recruitment to the subsequent men-only weight management feasibility trial, including the: i) acceptability and feasibility of recruitment; and ii) baseline sample characteristics by recruitment strategy. Methods Men with BMI ≥30 kg/m2 and/or waist circumference ≥ 40 in. were recruited to the feasibility trial via two strategies; community outreach (venue information stands and word of mouth) and GP letters, targeting disadvantaged areas. Recruitment activities (e.g. letters sent, researcher venue hours) were recorded systematically, and baseline characteristics questionnaire data collated. Qualitative interviews (n = 50) were conducted three months post-recruitment. Analyses and reporting followed a complementary mixed methods approach. Results 105 men were recruited within four months (community n = 60, GP letter n = 45). Community outreach took 2.3 recruiter hours per participant and GP letters had an opt-in rate of 10.2% (n = 90/879). More men were interested than could be accommodated. Most participants (60%) lived in more disadvantaged areas. Compared to community outreach, men recruited via GP letters were older (mean = 57 vs 48 years); more likely to report an obesity-related co-morbidity (87% vs 44%); and less educated (no formal qualifications, 32% vs 10%, degree educated 11% vs 41%). Recruitment strategies were acceptable, a sensitive approach and trusting relationships with recruiters valued, and the ‘catchy’ study name drew attention. Conclusions Targeted community outreach and GP letters were acceptable strategies that successfully recruited participants to a men-only weight management feasibility trial. Both strategies engaged men from disadvantaged areas, a typically underserved population. Using two recruitment strategies produced samples with different health risk profiles, which could add value to research where either primary or secondary prevention is of interest. Further work is required to examine how these strategies could be implemented and sustained in practice. Trial registration ClinicalTrials.gov: NCT03040518, 2nd February 2017.

Aim Designing financial incentives for health behaviour change requires choices across several domains, including value (the size of the incentive), frequency of incentives, and direction (gain or loss). However, the rationale underlying complex incentive design is infrequently reported. Transparent reporting is important if we want to understand and improve the incentive development process. This paper describes a mixed methods approach for designing financial incentives for health behaviour change which involves stakeholders throughout the design process. Subject and methods The mixed methods approach focuses on incentives for weight loss for men with obesity living in areas with high levels of disadvantage. The approach involves: (a) using an existing framework to identify all domains of a financial incentive scheme for which choices need to be made, deciding what criteria are relevant (such as effectiveness, acceptability and uptake) and making choices on each domain on the basis of the criteria; (b) conducting a survey of target population preferences to inform choices for domains and to design the incentive scheme; and (c) making final decisions at a stakeholder consensus workshop. Results The approach was implemented and an incentive scheme for weight loss for men living with obesity was developed. Qualitative interview data from men receiving the incentives in a feasibility trial endorses our approach. Conclusion This paper demonstrates that a mixed methods approach with stakeholder involvement can be used to design financial incentives for health behaviour change such as weight loss. Trial registration number NCT03040518. Date: 2 February 2017.

Background Obesity increases the risk of type 2 diabetes, heart disease, stroke, mobility problems and some cancers, and its prevalence is rising. Men engage less than women in existing weight loss interventions. Game of Stones builds on a successful feasibility study and aims to find out if automated text messages with or without endowment incentives are effective and cost-effective for weight loss at 12 months compared to a waiting list comparator arm in men with obesity. Methods A 3-arm, parallel group, assessor-blind superiority randomised controlled trial with process evaluation will recruit 585 adult men with body mass index of 30 kg/m2 or more living in and around three UK centres (Belfast, Bristol, Glasgow), purposively targeting disadvantaged areas. Intervention groups: (i) automated, theory-informed text messages daily for 12 months plus endowment incentives linked to verified weight loss targets at 3, 6 and 12 months; (ii) the same text messages and weight loss assessment protocol; (iii) comparator group: 12 month waiting list, then text messages for 3 months. The primary outcome is percentage weight change at 12 months from baseline. Secondary outcomes at 12 months are as follows: quality of life, wellbeing, mental health, weight stigma, behaviours, satisfaction and confidence. Follow-up includes weight at 24 months. A health economic evaluation will measure cost-effectiveness over the trial and over modelled lifetime: including health service resource-use and quality-adjusted life years. The cost-utility analysis will report incremental cost per quality-adjusted life years gained. Participant and service provider perspectives will be explored via telephone interviews, and exploratory mixed methods process evaluation analyses will focus on mental health, multiple long-term conditions, health inequalities and implementation strategies. Discussion The trial will report whether text messages (with and without cash incentives) can help men to lose weight over 1 year and maintain this for another year compared to a comparator group; the costs and benefits to the health service; and men’s experiences of the interventions. Process analyses with public involvement and service commissioner input will ensure that this open-source digital self-care intervention could be sustainable and scalable by a range of NHS or public services. Trial registration ISRCTN 91974895. Registered on 14/04/2021.

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