A real world feasibility trial of the PLAYshop: a brief intervention to facilitate parent engagement in developing their child’s physical literacy

Abstract Background: Development of physical literacy, defined as “the motivation, confidence, physical competence, knowledge and understanding to value and take responsibility for engagement in physical activities for life”, can support children’s physically active behaviors and consequent health benefits. Little research exploring interventions to improve children's physical literacy exist, although substantive evidence shows parents play a key role in children's physically active behaviors and development of fundamental movement skills. The purpose of this study is to explore a novel, physical literacy intervention designed to assist parents to engage with their child in purposeful play; play that facilitates the development of physical literacy. Methods: The PLAYshop was a 75-minute workshop to build parents' self-efficacy to support their child’s physical literacy through interactive activities and educational messages as well as educational resources focused on core physical literacy concepts. We collected quantitative pre- and post-workshop surveys of parents’ satisfaction, knowledge, confidence and intention to adopt practices as well as qualitative follow-up implementation focused interviews from both parents and facilitators. We used paired t-tests to examine changes in parents' self-reported physical literacy knowledge and confidence and thematic analysis of interviews to explore workshop feasibility.Results: Six workshops were delivered to 33 parents of young children (3-8 years of age). Twenty-three parents completed both pre- and post-workshop surveys. Follow-up interviews were completed with 11 parents and four workshop facilitators. Parents’ self-reported knowledge and confidence to support their child’s physical literacy development significantly increased after PLAYshop participation. Further, the majority of parents were satisfied with the workshop and motivated to apply workshop learnings at-home with their child. Workshop facilitators identified seven workshop strengths (e.g., workshop champions and skilled facilitators) and four challenges (e.g., recruitment and unfavorable spaces).Conclusions: The PLAYshop was perceived positively by parents and facilitators and appeared to improve parent self-efficacy and intention to promote physical literacy with their child. Recruitment and attendance were key implementation challenges. The findings from this real world trial address an important evidence gap, highlighting areas for adaptations to improve the intervention and recruitment and suggesting that the PLAYshop is ready for efficacy testing in a more rigorous randomized controlled trial.

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A real world feasibility trial of the PLAYshop: an intervention to facilitate parent engagement in developing their child’s physical literacy

10.21203/rs.3.rs-23520/v1 ◽

2020 ◽

Author(s):

Cassandra Lane ◽

Kendra Reno ◽

Madison Predy ◽

Valerie Carson ◽

Chris Wright ◽

...

Keyword(s):

Real World ◽

Self Efficacy ◽

Controlled Trial ◽

Literacy Intervention ◽

Feasibility Trial ◽

Physical Literacy ◽

Physical Competence ◽

Physically Active ◽

Implementation Challenges

Abstract Background Development of physical literacy, defined as “the motivation, confidence, physical competence, knowledge and understanding to value and take responsibility for engagement in physical activities for life”, can support children’s physically active behaviors and consequent health benefits. Little research exploring interventions to improve children's physical literacy exist, although substantive evidence shows parents play a key role in children's physically active behaviors and development of fundamental movement skills. The purpose of this study is to explore a novel, physical literacy intervention designed to assist parents to engage with their child in purposeful play; play that facilitates the development of physical literacy. Methods The PLAYshop was a 75-minute workshop to build parents' self-efficacy to support their child’s physical literacy through interactive activities and educational messages as well as educational resources focused on core physical literacy concepts. We collected quantitative pre- and post-workshop surveys of parents’ satisfaction, knowledge, confidence and intention to adopt practices as well as qualitative follow-up implementation focused interviews from both parents and facilitators. We used paired t-tests to examine changes in parents' self-reported physical literacy knowledge and confidence and thematic analysis of interviews to explore workshop feasibility. Results Six workshops were delivered to 33 parents of young children (3–8 years of age). 23 parents completed both pre- and post-workshop surveys. Follow-up interviews were completed with 11 parents and four workshop facilitators. Parents’ self-reported knowledge and confidence to support their child’s physical literacy development significantly increased after PLAYshop participation. Further, the majority of parents were satisfied with the workshop and motivated to apply workshop learnings at-home with their child. Workshop facilitators identified seven workshop strengths (e.g., workshop champions and skilled facilitators) and four challenges (e.g., recruitment and unfavorable spaces). Conclusions The PLAYshop was perceived positively by parents and facilitators and appeared to improve parent self-efficacy and intention to promote physical literacy with their child. Recruitment and attendance were key implementation challenges. The findings from this real world trial address an important evidence gap, highlighting areas for adaptations to improve the intervention and recruitment and suggesting that the PLAYshop is ready for efficacy testing in a more rigorous randomized controlled trial.

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A real-world feasibility study of the PLAYshop: a brief intervention to facilitate parent engagement in developing their child’s physical literacy

Pilot and Feasibility Studies ◽

10.1186/s40814-021-00849-5 ◽

2021 ◽

Vol 7 (1) ◽

Author(s):

Cassandra Lane ◽

Valerie Carson ◽

Kayla Morton ◽

Kendra Reno ◽

Chris Wright ◽

...

Keyword(s):

Real World ◽

Self Efficacy ◽

Control Group ◽

Physical Literacy ◽

Physical Competence ◽

Physically Active ◽

Implementation Challenges ◽

Intention To Adopt ◽

Recruitment Challenges

Abstract Background Development of physical literacy, defined as “the motivation, confidence, physical competence, knowledge and understanding to value and take responsibility for engagement in physical activities for life,” can support children’s physically active behaviors and consequent health benefits. Little research has explored interventions to improve children’s physical literacy, although substantive evidence shows parents play a key role in children’s physically active behaviors and development of fundamental movement skills. The purpose of this study was to explore the feasibility of a novel, physical literacy program (the PLAYshop) designed to build parents’ self-efficacy to support their child’s physical literacy. Methods A non-randomized, one-arm concurrent nested design was used. Thirty-five parents of young children (3–8 years of age) attended a 75-min workshop inclusive of interactive activities, educational messages, and the provision of resources focused on core physical literacy concepts. Pre- and post-workshop surveys used quantitative measures to assess parents’ satisfaction, knowledge, confidence, and intention to adopt practices. Follow-up interviews qualitatively explored the implementation experiences of both parents and facilitators. Paired t tests and thematic analysis were undertaken. Results Of the 33 eligible parents, 23 completed both pre- and post-workshop surveys. Follow-up interviews were completed with 11 parents and four workshop facilitators. Parents’ self-reported knowledge and confidence to support their child’s physical literacy development significantly increased after PLAYshop participation. The majority of parents were satisfied with the workshop and motivated to apply learnings at home with their child. Workshop facilitators identified seven workshop strengths (e.g., workshop champions and skilled facilitators) and four challenges (e.g., recruitment and unfavorable spaces). Limitations include the lack of control group and recruitment challenges. Conclusions The PLAYshop was perceived positively by parents and facilitators and appeared to improve parent self-efficacy and intention to promote physical literacy with their child. Recruitment and attendance were key implementation challenges. The findings from this real-world study support the preliminary feasibility of the PLAYshop intervention and highlight areas to improve the intervention and recruitment prior to efficacy testing in a more rigorous trial format.

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71 Ultrasound directed reduction of Colles’ type distal radial fractures in ED (UDiReCT): a feasibility randomized controlled trial

Emergency Medicine Journal ◽

10.1136/emj-2020-rcemabstracts.21 ◽

2020 ◽

Vol 37 (12) ◽

pp. 835.3-836

Author(s):

Hamza Malik ◽

Andrew Appelboam ◽

Gordon Taylor ◽

Daryl Wood ◽

Karen Knapp

Keyword(s):

Data Collection ◽

Controlled Trial ◽

Wrist Fracture ◽

Recruitment Rate ◽

Feasibility Trial ◽

Point Of Care Ultrasound ◽

Distal Radial Fractures ◽

Definitive Trial ◽

Randomised Controlled

Aims/Objectives/BackgroundWrist fractures are among the commonest injuries seen in the emergency department (ED). Around 25% of these injuries have Colles’ type fracture displacement and undergo manipulation in the ED. In the UK, these manipulations are typically done ‘blind’ without real time imaging and recent observational studies show that over 40% of the injuries go on to require surgical fixation (due to inadequate initial reduction or re-displacement). Point of care ultrasound has been used to guide and improve wrist fracture reductions but it’s effect on subsequent outcome is not established. We set up and ran the UK’s first randomised controlled feasibility trial comparing standard and ultrasound guided ED wrist fracture manipulations to test a definitive trial protocol, data collection and estimate recruitment rate towards a future definitive trial.Methods/DesignWe conducted a 1:1, single blind, parallel group, randomised controlled feasibility trial in two UK hospitals. Adults with Colles’ type distal radial fractures requiring manipulation in the ED were recruited by supervising emergency physicians supported by network research nurses. Participants were randomised to ultrasound directed fracture manipulation (intervention) or standard care with sham ultrasound (controls). The trial was run through Exeter Clinical Trials Unit and consent, randomisation and data collection conducted electronically in REDCap cloud. All participants were followed up at 6 weeks to record any surgical intervention and also underwent baseline and 3 month quality of life (EQ-5D-5L) and wrist function (Patient Rated Wrist Evaluation (PRWE) assessments.Results/ConclusionsWe recruited 47 patients in total, with 23 randomised to the interventional arm and 24 randomised to the control arm. We were able to follow up 100% of the patients for the 6 week follow up. Data analysis and results will be presented at the time of the conference.

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Real-world effectiveness of app-based treatment for urinary incontinence: a cohort study

BMJ Open ◽

10.1136/bmjopen-2020-040819 ◽

2021 ◽

Vol 11 (1) ◽

pp. e040819

Author(s):

Pontus Rygh ◽

Ina Asklund ◽

Eva Samuelsson

Keyword(s):

Urinary Incontinence ◽

Cohort Study ◽

Real World ◽

Short Form ◽

Pelvic Floor Muscle ◽

Controlled Trial ◽

Healthcare Services ◽

International Consultation ◽

The Mean

ObjectivesThe efficacy of app-based treatment for stress urinary incontinence (SUI) has been demonstrated in a randomised controlled trial (RCT). In this study, we investigate the user characteristics and the effectiveness of the same app when freely available, and compare these results with the RCT.DesignProspective cohort study.ParticipantsDuring a 17-month period, 24 602 non-pregnant, non-postpartum women older than 18 years downloaded the app and responded anonymously to a questionnaire. Of these, 2672 (11%) responded to the 3-month follow-up.InterventionThree months’ use of the app Tät, containing information, a pelvic floor muscle training programme and lifestyle advice.Main outcome measuresChange in symptom severity (International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)) and subjective improvement (Patient Global Impression of Improvement (PGI-I)).ResultsOf the respondents, 88% lived in Sweden and 75% (18 384/24 602) were incontinent with a mean age of 45.5 (SD 14.1) years. The UI types, based on symptoms, were SUI (53%), urgency UI (12%), mixed UI (31%) and undefined (4%). The mean ICIQ-UI SF score was 8.2 (SD 4.0) at baseline. The mean ICIQ-UI SF score reduction at follow-up was 1.31 (95% CI: 1.19 to 1.44) with a larger reduction in those with more severe incontinence at baseline (severe/very severe 3.23 (95% CI: 2.85 to 3.61), moderate 1.41 (95% CI: 1.24 to 1.59) and slight 0.24 (95% CI 0.06 to 0.42). When the results were weighted to match the distribution of severity in the RCT, the ICIQ-UI SF score reduction was 2.2 compared with 3.9 in the RCT. Regarding PGI-I, 65% experienced improvement compared with 92% in the RCT.ConclusionsThe app Tät was effective for self-management of UI even in the real world. Although the reduction in incontinence symptoms was less than in the RCT, two-thirds of the users improved. App-based treatment reaches many women without requiring resources from ordinary healthcare services.

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Effectiveness of one-to-one peer support for patients with severe mental illness – a randomised controlled trial

European Psychiatry ◽

10.1016/j.eurpsy.2016.12.007 ◽

2017 ◽

Vol 42 ◽

pp. 103-110 ◽

Cited By ~ 39

Author(s):

C.I. Mahlke ◽

S. Priebe ◽

K. Heumann ◽

A. Daubmann ◽

K. Wegscheider ◽

...

Keyword(s):

Mental Illness ◽

Peer Support ◽

Self Efficacy ◽

Controlled Trial ◽

Intervention Group ◽

Treatment As Usual ◽

Secondary Outcomes ◽

One To One ◽

Randomised Controlled

AbstractBackgroundOne-to-one peer support is a resource-oriented approach for patients with severe mental illness. Existing trials provided inconsistent results and commonly have methodological shortcomings, such as poor training and role definition of peer supporters, small sample sizes, and lack of blinded outcome assessments.MethodsThis is a randomised controlled trial comparing one-to-one peer support with treatment as usual. Eligible were patients with severe mental illnesses: psychosis, major depression, bipolar disorder or borderline personality disorder of more than two years’ duration. A total of 216 patients were recruited through in- and out-patient services from four hospitals in Hamburg, Germany, with 114 allocated to the intervention group and 102 to the control group. The intervention was one-to-one peer support, delivered by trained peers and according to a defined role specification, in addition to treatment as usual over the course of six months, as compared to treatment as usual alone. Primary outcome was self-efficacy measured on the General Self-Efficacy Scale at six-month follow-up. Secondary outcomes included quality of life, social functioning, and hospitalisations.ResultsPatients in the intervention group had significantly higher scores of self-efficacy at the six-month follow-up. There were no statistically significant differences on secondary outcomes in the intention to treat analyses.ConclusionsThe findings suggest that one-to-one peer support delivered by trained peer supporters can improve self-efficacy of patients with severe mental disorders over a one-year period. One-to-one peer support may be regarded as an effective intervention. Future research should explore the impact of improved self-efficacy on clinical and social outcomes.

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A novel brief treatment for methamphetamine use disorders in South Africa: a randomised feasibility trial

Addiction Science & Clinical Practice ◽

10.1186/s13722-020-00209-3 ◽

2021 ◽

Vol 16 (1) ◽

Author(s):

K. Sorsdahl ◽

D. J. Stein ◽

S. Pasche ◽

Y. Jacobs ◽

R. Kader ◽

...

Keyword(s):

South Africa ◽

Controlled Trial ◽

Adverse Outcomes ◽

Feasibility Trial ◽

Control Group ◽

Brief Treatment ◽

Middle Income ◽

Methamphetamine Use ◽

Intention To Treat

Abstract Background Effective brief treatments for methamphetamine use disorders (MAUD) are urgently needed to complement longer more intensive treatments in low and middle income countries, including South Africa. To address this gap, the purpose of this randomised feasibility trial was to determine the feasibility of delivering a six-session blended imaginal desensitisation, plus motivational interviewing (IDMI) intervention for adults with a MAUD. Methods We enrolled 60 adults with a MAUD and randomly assigned them 1:1 to the IDMI intervention delivered by clinical psychologists and a control group who we referred to usual care. Feasibility measures, such as rates of recruitment, consent to participate in the trial and retention, were calculated. Follow-up interviews were conducted at 6 weeks and 3 months post-enrollment. Results Over 9 months, 278 potential particiants initiated contact. Following initial screening 78 (28%) met inclusion criteria, and 60 (77%) were randomised. Thirteen of the 30 participants assigned to the treatment group completed the intervention. Both psychologists were highly adherent to the intervention, obtaining a fidelity rating of 91%. In total, 39 (65%) participants completed the 6-week follow-up and 40 (67%) completed the 3-month follow-up. The intervention shows potential effectiveness in the intention-to-treat analysis where frequency of methamphetamine use was significantly lower in the treatment than in the control group at both the 6 week and 3-month endpoints. No adverse outcomes were reported. Conclusions This feasibility trial suggests that the locally adapted IDMI intervention is an acceptable and safe intervention as a brief treatment for MAUD in South Africa. Modifications to the study design should be considered in a fully powered, definitive controlled trial to assess this potentially effective intervention. Trial registration The trial is registered with the Pan African Clinical Trials Registry (Trial ID: PACTR201310000589295)

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A randomised controlled trial to investigate the effectiveness of sustained photoprotective behaviour in xeroderma pigmentosum after intervention

BJPsych Open ◽

10.1192/bjo.2021.764 ◽

2021 ◽

Vol 7 (S1) ◽

pp. S287-S287

Author(s):

Tamara Searle ◽

Jessica Walburn ◽

Sam Norton

Keyword(s):

Randomised Controlled Trial ◽

Self Efficacy ◽

Xeroderma Pigmentosum ◽

Controlled Trial ◽

Premalignant Lesions ◽

Mental Wellbeing ◽

Group Effect ◽

Post Intervention ◽

Randomised Controlled

AimsThis study aimed to investigate whether an intervention designed to improve photoprotective behaviours is effective at changing behaviour and whether any change could be maintained.BackgroundXeroderma Pigmentosum (XP) is a rare condition in which patients are at risk of malignancies when exposed to ultra-violet radiation (UVR). Sufferers must take extra precautions to protect themselves from UVR. They must apply sunscreen to exposed skin, wear thick clothing, gloves, and a UVR-protective visor. Treatments include preventative photoprotective measures; the use of sunscreen and protective clothing. Additionally, frequent eye and skin examinations are required and swift removal of any premalignant lesions.MethodIn this randomised controlled trial, 16 participants with XP were given questionnaires at 4 time points; baseline, post-intervention, 5 months and 9 months post-intervention. The intervention involved 7 one-on-one counselling sessions, as well as telephone consultations. Counselling sessions encouraged photoprotection adherence, self-efficacy and discussions of any barriers to improving photoprotective behaviour. This study focused on psychosocial variables, attitudes and photoprotection. Questionnaires included the photoprotection self-efficacy questionnaire, Self-Reported Behavioural Automaticity Index, Short Warwick-Edinburgh Mental Wellbeing Scale, Quality of Life and Brief Photoprotection Adherence Questionnaire.ResultThe intervention was shown to have no significant effect on participants’ questionnaires scores. Univariate ANCOVA revealed a group effect between follow-up 1 (FU1) and follow-up 2 (FU2); η2 = 0.422 for self-efficacy in wearing photoprotective clothing. A group effect was identified from BL to FU1 and FU1 to FU2; η2 = 0.343 and η2 = 0.378 respectively in how often participants reapplied sunscreen to their face when outside for longer periods. Univariate ANCOVA revealed no group or time effect for the other outcome variables; for example, sunscreen self-efficacy.ConclusionThe intervention had no significant effect on photoprotective behaviour questionnaire scores. Future research could focus on recruiting more participants globally to generate more statistically powered results. Research should focus on producing a maintainable intervention so that any positive change would produce better long-term health outcomes. This study lays the foundations for future XP research, which will be vital to improve understanding and enhance photo protective behaviour.

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An Interactive Parent-Targeted Text Messaging Intervention to Improve Oral Health in Children Attending Urban Pediatric Clinics: Feasibility Randomized Controlled Trial (Preprint)

10.2196/preprints.14247 ◽

2019 ◽

Author(s):

Belinda Borrelli ◽

Michelle Henshaw ◽

Romano Endrighi ◽

William G Adams ◽

Timothy Heeren ◽

...

Keyword(s):

Oral Health ◽

Health Behaviors ◽

Self Efficacy ◽

Text Messaging ◽

Text Messages ◽

Feasibility Trial ◽

Randomized Controlled ◽

Oral Health Behaviors ◽

Scale Range

BACKGROUND Effective preventive treatments for dental decay exist, but caries experience among preschoolers has not changed, with marked disparities in untreated decay. Despite near-universal use of SMS text messaging, there are no studies using text messages to improve the oral health of vulnerable children. OBJECTIVE This randomized controlled feasibility trial aimed to test the effects of oral health text messages (OHT) versus a control (child wellness text messages or CWT). OHT was hypothesized to outperform CWT on improving pediatric oral health behaviors and parent attitudes. METHODS Parents with a child aged <7 years were recruited at urban clinics during pediatric appointments (79% [41/52] below poverty line; 66% [36/55] black) and randomized to OHT (text messages on brushing, dental visits, bottle and sippy cups, healthy eating and sugary beverages, and fluoride) or CWT (text messages on reading, safety, physical activity and development, secondhand smoke, and stress) groups. Automated text messages based on Social Cognitive Theory were sent twice each day for 8-weeks. Groups were equivalent on the basis of the number of text messages sent, personalization, interactivity, and opportunity to earn electronic badges and unlock animated characters. Assessments were conducted at baseline and 8 weeks later. Data were analyzed with linear mixed–effects models. RESULTS A total of 55 participants were randomized (28 OHT and 27 CWT). Only one participant dropped out during the text message program and 47 (24 OHT and 23 CWT) completed follow up surveys. Response rates exceeded 68.78% (1040/1512) and overall program satisfaction was high (OHT mean 6.3; CWT mean 6.2; 1-7 scale range). Of the OHT group participants, 84% (21/25) would recommend the program to others. Overall program likeability scores were high (OHT mean 5.90; CWT mean 6.0; 1-7 scale range). Participants reported high perceived impact of the OHT program on brushing their child’s teeth, motivation to address their child's oral health, and knowledge of their child's oral health needs (mean 4.7, 4.6, and 4.6, respectively; 1-5 scale range). At follow up, compared with CWT, OHT group participants were more likely to brush their children’s teeth twice per day (odds ratio [OR] 1.37, 95% CI 0.28-6.50) and demonstrated improved attitudes regarding the use of fluoride (OR 3.82, 95% CI 0.9-16.8) and toward getting regular dental checkups for their child (OR 4.68, 95% CI 0.24-91.4). There were modest, but not significant, changes in motivation (F1,53=0.60; <italic>P</italic>=.45) and self–efficacy (F1,53=0.24; <italic>P</italic>=.63) to engage in oral health behaviors, favoring OHT (<italic>d</italic>=0.28 and <italic>d</italic>=0.16 for motivation and self–efficacy, respectively). CONCLUSIONS The OHT program demonstrated feasibility was well utilized and appealing to the target population and showed promise for efficacy.

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Effect of Follow-up Telephone by Enterostomal Nurses on Patients with Permanent Colostomy: A Systematic Review

Bangladesh Journal of Medical Science ◽

10.3329/bjms.v21i1.56327 ◽

2022 ◽

Vol 21 (1) ◽

pp. 54-66

Author(s):

Herlina Semi ◽

Sitti Syahriani Sambari ◽

Yuliana Syam ◽

Andi Masyitha Irwan

Keyword(s):

Systematic Review ◽

Self Efficacy ◽

Controlled Trial ◽

Quality Care ◽

Medical Science ◽

Management Service ◽

Adjustment Problems ◽

Permanent Colostomy ◽

Care Services

Background: Patients with permanent colostomy experience quality of life (QoL) decrease, complications, and colostomy adjustment problems. Technology-based interventions can be provided with telephone follow-up (TFU) to provide health education and advice on managing symptoms, identifying complications, and providing quality care services. Objective: To systematically describe and assess the effect of TFU on permanent colostomy include population, model and duration, instruments used, and effect of TFU. Materials and Methods: A systematic review was carried out using the Randomized Controlled Trial (RCT) approach in eight databases, including PubMed, Proquest, ScienceDirect, EBSCOhost, CANCERLIT, Wiley, Gray literature, and Scopus, to identify studies reported in English, published in the last ten years, available full text, and about TFU in permanent colostomy patients. Results and Discussion: Based on the 11 RCT articles analyzed, it was found that the TFU duration ranged from 27 days to 3 years. The TFU improved self-efficacy, QoL, colostomy adjustment, self-care, self-management, service satisfaction, and complications. Conclusion: The TFU has more effect on self-efficacy, QoL, and complications in patients with a permanent colostomy, and effective TFU was performed for at least three months. Further research is needed on the frequency or duration of telephone calls. Bangladesh Journal of Medical Science Vol. 21(1) 2022 Page : 54-66

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Healthy Dads, Healthy Kids UK, a weight management programme for fathers: feasibility RCT

BMJ Open ◽

10.1136/bmjopen-2019-033534 ◽

2019 ◽

Vol 9 (12) ◽

pp. e033534 ◽

Cited By ~ 2

Author(s):

Tania Griffin ◽

Yongzhong Sun ◽

Manbinder Sidhu ◽

Peymane Adab ◽

Adrienne Burgess ◽

...

Keyword(s):

Weight Loss ◽

Weight Management ◽

Controlled Trial ◽

Intervention Group ◽

Management Programme ◽

Feasibility Trial ◽

Minority Ethnic Group ◽

Weight Management Programme ◽

Overweight Or Obesity

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.

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