scholarly journals Recruiting men from across the socioeconomic spectrum via GP registers and community outreach to a weight management feasibility randomised controlled trial

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Matthew D. McDonald ◽  
◽  
Stephan U. Dombrowski ◽  
Rebecca Skinner ◽  
Eileen Calveley ◽  
...  

Abstract 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.

2020 ◽  
Vol 4 (Supplement_1) ◽  
Author(s):  
Zoe Rock ◽  
Juliana Chen ◽  
Joanna Jaques ◽  
Bernard L Champion ◽  
Reginald V Lord ◽  
...  

Abstract Over 2.5 billion people worldwide are overweight or obese. Multidisciplinary weight management interventions have evolved to address the complexity of weight loss for those with one or more chronic diseases, and the trend of weight regain. The aim of these interventions is to encourage sustainable lifestyle changes, resulting in weight loss and weight maintenance and improvements in comorbidities. While some prospective clinical trials have demonstrated efficacy, results are often not reported by real life practices. The aim of this study was to evaluate the effectiveness of a Sydney based multidisciplinary weight management clinic with endocrinology, dietetics, exercise physiology, psychology, and bariatric surgical domains. All patients who attended the clinic for weight loss purposes between March 2017 and April 2019 were included (n=220). A retrospective chart review was conducted. Patient data on weight, BMI, waist circumference, body composition measurements, and selected blood test results and co-morbidities were analysed. All patient therapy included endocrinological input for co-morbidity identification and management, lifestyle intervention (dietetic and exercise physiology input) with optional adjunct pharmacotherapy or psychological counselling. Of the 220 cohort, 20 of the patients had sleeve gastrectomy. Patient retention in the clinic after the first consultation was 85% (n=186), a high rate within the weight management community. 59% of patients achieved a minimum of 5% total body weight loss, including 18% who achieved greater than 10% total body weight loss. Additionally, 31% of patients lost enough weight to decrease their BMI class by up to 2 or more classes. Of the gastric sleeve cohort average excess body weight loss was 32kg (21-56kg) enhanced by multidisciplinary care in the lead up to surgery. Across the cohort some patients completely reversed co-morbidities; including dyslipidaemia (n=1), hypertension (n=3), NAFLD (n=1), pre-diabetes (n=8) and type 2 diabetes (n=3), OSA (n=1). These results demonstrate that obesity is a chronic condition that can be successfully managed. We have demonstrated significant durable weight loss and improvement in metabolic co-morbidities with holistic coordinated care. Future directions include translating this model of care into standard practice in Australia and other countries where obesity to date not received the same coordinated approach as other chronic conditions.


2019 ◽  
Vol 29 (1) ◽  
Author(s):  
Margaret Kelman ◽  
Victoria Hammersley ◽  
Marilyn Kendall ◽  
Mome Mukherjee ◽  
Lynn Morrice ◽  
...  

AbstractIn the United Kingdom, there are acknowledged short comings in allergy care provision for patients seen in primary care. There is a lack of allergy training for healthcare professionals and this leads to inappropriate referrals to the limited number of allergy specialists. The primary aims of this study are to assess the feasibility of delivering and evaluating a new nurse-led allergy service in primary care, measured by recruitment, retention and quality of life. This is a single arm feasibility trial in which up to 250 participants referred to the nurse-led allergy clinic will receive the intervention and complete 6–12 weeks follow-up before being referred back to their usual care. Primary outcomes for this study will be establishment of clinics, recruitment and retention rates, and estimates of change in disease-specific quality of life measures. Secondary outcomes will be acceptability of the new service to participants/carers and healthcare professionals. A sample of participants and professional stakeholders will take part in more in-depth semi-structured qualitative interviews. Data from this feasibility trial will be used to inform plans for a pilot randomised controlled trial of nurse-led allergy clinics.


BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e033534 ◽  
Author(s):  
Tania Griffin ◽  
Yongzhong Sun ◽  
Manbinder Sidhu ◽  
Peymane Adab ◽  
Adrienne Burgess ◽  
...  

ObjectiveTo assess (1) the feasibility of delivering a culturally adapted weight management programme, Healthy Dads, Healthy Kids United Kingdom (HDHK-UK), for fathers with overweight or obesity and their primary school-aged children, and (2) the feasibility of conducting a definitive randomised controlled trial (RCT).DesignA two-arm, randomised feasibility trial with a mixed-methods process evaluation.SettingSocioeconomically disadvantaged, ethnically diverse localities in West Midlands, UK.ParticipantsFathers with overweight or obesity and their children aged 4–11 years.InterventionParticipants were randomised in a 1:2 ratio to control (family voucher for a leisure centre) or intervention comprising 9 weekly healthy lifestyle group sessions.OutcomesFeasibility of the intervention and RCT was assessed according to prespecified progression criteria: study recruitment, consent and follow-up, ability to deliver intervention, intervention fidelity, adherence and acceptability, weight loss, using questionnaires and measurements at baseline, 3 and 6 months, and through qualitative interviews.ResultsThe study recruited 43 men, 48% of the target sample size; the mean body mass index was 30.2 kg/m2 (SD 5.1); 61% were from a minority ethnic group; and 54% were from communities in the most disadvantaged quintile for socioeconomic deprivation. Recruitment was challenging. Retention at follow-up of 3 and 6 months was 63%. Identifying delivery sites and appropriately skilled and trained programme facilitators proved difficult. Four programmes were delivered in leisure centres and community venues. Of the 29 intervention participants, 20 (69%) attended the intervention at least once, of whom 75% attended ≥5 sessions. Sessions were delivered with high fidelity. Participants rated sessions as ‘good/very good’ and reported lifestyle behavioural change. Weight loss at 6 months in the intervention group (n=17) was 2.9 kg (95% CI −5.1 to −0.6).ConclusionsThe intervention was well received, but there were significant challenges in recruitment, programme delivery and follow-up. The HDHK-UK study was not considered feasible for progression to a full RCT based on prespecified stop–go criteria.Trial registration numberISRCTN16724454.


2009 ◽  
Vol 59 (562) ◽  
pp. e157-e166 ◽  
Author(s):  
Kiran Nanchahal ◽  
Joy Townsend ◽  
Louise Letley ◽  
David Haslam ◽  
Kaye Wellings ◽  
...  

2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. 547-547
Author(s):  
LaShauna Connell ◽  
Augustine Boateng ◽  
Darina Petrovsky ◽  
Justine Sefcik ◽  
Nancy Hodgson ◽  
...  

Abstract Recruitment of diverse community-dwelling persons living with dementia (PLWD) and their caregivers (dyads) into randomized controlled trials (RCT) is challenging, time consuming and expensive. This presentation will describe community outreach efforts used over a one-year period to recruit dyads of PLWD and their caregivers in Healthy Patterns RCT. Community outreach yielded 296 inquiries, such that people expressed interest in joining the study. Of the 296 inquiries, almost all (95.6%) identified as African American, and 91(30.7%) consented to join the study. Presentations at senior centers yielded the highest number of inquiries (n=148), followed by staff presence at various community events such as health fairs and senior galas (n=145) and referrals (n=3). We found that community outreach was an effective recruitment strategy to generate inquiries among diverse PLWD and their caregivers to enroll in Healthy Patterns. We will discuss these strategies and provide suggestions for recruiting diverse dyads into clinical trials.


BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e032653 ◽  
Author(s):  
Stephan U Dombrowski ◽  
Matthew McDonald ◽  
Marjon van der Pol ◽  
Mark Grindle ◽  
Alison Avenell ◽  
...  

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.


BMJ Open ◽  
2017 ◽  
Vol 7 (10) ◽  
pp. e017159 ◽  
Author(s):  
Lynsay Matthews ◽  
Juliana Pugmire ◽  
Laurence Moore ◽  
Mark Kelson ◽  
Alex McConnachie ◽  
...  

IntroductionHelpMeDoIt! will test the feasibility of an innovative weight loss intervention using a smartphone app and website. Goal setting, self-monitoring and social support are three key facilitators of behaviour change. HelpMeDoIt! incorporates these features and encourages participants to invite ‘helpers’ from their social circle to help them achieve their goal(s).AimTo test the feasibility of the intervention in supporting adults with obesity to achieve weight loss goals.Methods and analysis12-month feasibility randomised controlled trial and accompanying process evaluation. Participants (n=120) will be adults interested in losing weight, body mass index (BMI)>30 kg/m2and smartphone users. The intervention group will use the app/website for 12 months. Participants will nominate one or more helpers to support them. Helpers have access to the app/website. The control group will receive a leaflet on healthy lifestyle and will have access to HelpMeDoIt! after follow-up. The key outcome of the study is whether prespecified progression criteria have been met in order to progress to a larger randomised controlled effectiveness trial. Data will be collected at baseline, 6 and 12 months. Outcomes focus on exploring the feasibility of delivering the intervention and include: (i) assessing three primary outcomes (BMI, physical activity and diet); (ii) secondary outcomes of waist/hip circumference, health-related quality of life, social support, self-efficacy, motivation and mental health; (iii) recruitment and retention; (iv) National Health Service (NHS) resource use and participant borne costs; (v) usability and acceptability of the app/website; and (vi) qualitative interviews with up to 50 participants and 20 helpers on their experiences of the intervention. Statistical analyses will focus on feasibility outcomes and provide initial estimates of intervention effects. Thematic analysis of qualitative interviews will assess implementation, acceptability, mechanisms of effect and contextual factors influencing the intervention.Ethics and disseminationThe protocol has been approved by the West of Scotland NHS Research Ethics Committee (Ref: 15/WS/0288) and the University of Glasgow MVLS College Ethics Committee (Ref: 200140108). Findings will be disseminated widely through peer-reviewed publication and conference presentations.Trial registration numberISRCTN85615983.


2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
G Warner ◽  
Z Baghdasaryan ◽  
F Osman ◽  
E Lampa ◽  
A Sarkadi

Abstract The purpose of this study was to pilot and methodologically appraise innovative patient and public involvement (PPI) evaluation tools and to describe a case study of refugee involvement in the development of mental health intervention research. 'Refugee Advisors' were involved in the development of a randomised controlled trial protocol evaluating a brief group intervention for refugee children experiencing symptoms of post-traumatic stress in Sweden. During an 8-hour research meeting, observation and questionnaire data were collected using the Active Involvement of Users in Research Observation Schedule and Questionnaire, followed by a focus group discussion. The multi-method approach demonstrated good feasibility. There were clear examples of how the advisors influenced research development e.g. recruitment strategy, cultural brokerage among study group participants, outcome measure validation. The advisors described a perceived impact on the research, equality and acceptance, and knowledge gain. A sense of appreciation and empowerment was also interpreted. However, potential issues relating to the relevance of contributions and use of an interpreter were identified.


2021 ◽  
Author(s):  
Jenny Ingram ◽  
Lucy Beasant ◽  
John Benson ◽  
Adrian Murray Brunt ◽  
Anthony Maxwell ◽  
...  

Abstract Background. A multicentre feasibility trial (MIAMI), comparing outcomes and quality of life of women with multiple ipsilateral breast cancer (MIBC) randomised to therapeutic mammoplasty or mastectomy, has been conducted. The MIAMI feasibility trial aimed to investigate recruitment of sufficient numbers of women to this surgical trial, however only four patients were recruited. A nested qualitative study sought to understand the reasons for this lack of recruitment.Methods. Interviews were conducted from November 2019 to September 2020 with 17 staff from eight hospital-based breast care centres that recruited and attempted to recruit to MIAMI; and seven patients from four centres, comprising all patients who were recruited to the trial and some who declined to take part. Interviews were audio-recorded, anonymised and analysed using thematic methods of building codes into themes and sub-themes using the process of constant comparison.Results. Overarching themes of 1) influences on equipoise and recruitment and 2) effects of a lack of equipoise were generated. Within these themes health professional themes described the barriers to recruitment in ‘the treatment landscape has changed’; staff preferences and beliefs’ which influenced equipoise and patient advice; and how different the treatments were for patients. Patient themes of ‘altruism and timing of trial approach’; ‘influences from consultants and others’; and ‘diagnostic journey doubts’ played a part in whether patients agreed to take part in the trial.Conclusions. Barriers to recruiting to breast cancer surgical trials can be significant, especially where there are substantial differences between the treatments being offered and a lack of equipoise communicated by healthcare professionals to patients. Patients can become overwhelmed by numerous requests for participation in research trials and inappropriate timing of trial discussions. Alternative study designs to the gold standard randomised control trial for surgical interventions may be required to provide the high-quality evidence on which to base practice.Trial registration numbers: ISRCTN (ISRCTN17987569) and ClinicalTrials.gov (NCT03514654).


2021 ◽  
Vol 7 ◽  
pp. 205520762110334
Author(s):  
Julia V Bailey ◽  
Kirsty F Bennett ◽  
Anasztazia Gubijev ◽  
Jill Shawe ◽  
Judith Stephenson

Background Online sexual health research can be convenient, efficient and low cost, but there are debates about the adequacy of online informed consent, privacy, and the acceptability of different methods of follow-up. Objectives To explore women's views and experiences of the Contraception Choices feasibility trial procedures and the place of digital interventions for contraception decision making. Methods We analysed data from two sources: (1) Qualitative interviews. Eighteen interviews were conducted with women who had taken part in the Contraception Choices pre-trial feasibility study, to evaluate recruitment and online trial procedures. (2) Free-text comments. Women in the main Contraception Choices randomised controlled trial were followed up at 3 and 6 months, and asked ‘Please tell us what you liked or disliked about the website’ and ‘Has being in the study had any good or bad effects on your life?’ A total of 387 and 414 comments were made at 3 and 6 months respectively. Data were analysed thematically. Results Participants liked being involved in a study about contraception, although recruitment from an abortion clinic was less acceptable than in other sexual health settings. Women found the trial procedures straightforward, and expressed no major concerns about online self-registration, informed consent or online data collection. Online survey questions about contraception and fertility were acceptable, and participants liked the convenience of being followed up by email or text. Conclusions Participants appreciated the advantages of the online research design and did not express concerns about consent or privacy. Women would welcome digital interventions for contraception in a variety of settings.


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