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Hockey Fans in Training: A Pilot Pragmatic Randomized Controlled Trial.

ABSTRACT: Hockey Fans in Training (Hockey FIT) is a gender-sensitized weight loss and healthy lifestyle program. We investigated 1) feasibility of recruiting and retaining overweight and obese men into a pilot pragmatic randomized controlled trial and 2) potential for Hockey FIT to lead to weight loss and improvements in other outcomes at 12 wk and 12 months.Male fans of two ice hockey teams (35-65 yr; body mass index ?28 kg·m) located in Ontario (Canada) were randomized to intervention (Hockey FIT) or comparator (wait-list control). Hockey FIT includes a 12-wk active phase (weekly, coach-led group meetings including provision of dietary information, practice of behavior change techniques, and safe exercise sessions plus incremental pedometer walking) and a 40-wk minimally supported phase (smartphone app for sustaining physical activity, private online social network, standardized e-mails, booster session/reunion). Measurement at baseline and 12 wk (both groups) and 12 months (intervention group only) included clinical outcomes (e.g., weight) and self-reported physical activity, diet, and self-rated health.Eighty men were recruited in 4 wk; trial retention was >80% at 12 wk and >75% at 12 months. At 12 wk, the intervention group lost 3.6 kg (95% confidence interval, -5.26 to -1.90 kg) more than the comparator group (P < 0.001) and maintained this weight loss to 12 months. The intervention group also demonstrated greater improvements in other clinical measures, physical activity, diet, and self-rated health at 12 wk; most sustained to 12 months.Results suggest feasible recruitment/retention of overweight and obese men in the Hockey FIT program. Results provide evidence for the potential effectiveness of Hockey FIT for weight loss and improved health in at-risk men and, thus, evidence to proceed with a definitive trial.

SUBMITTER: Petrella RJ

PROVIDER: S-EPMC5704649 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature

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Hockey Fans in Training: A Pilot Pragmatic Randomized Controlled Trial.

Petrella Robert J RJ Gill Dawn P DP Zou Guangyong G DE Cruz Ashleigh A Riggin Brendan B Bartol Cassandra C Danylchuk Karen K Hunt Kate K Wyke Sally S Gray Cindy M CM Bunn Christopher C Zwarenstein Merrick M

Medicine and science in sports and exercise 20171201 12

<h4>Introduction</h4>Hockey Fans in Training (Hockey FIT) is a gender-sensitized weight loss and healthy lifestyle program. We investigated 1) feasibility of recruiting and retaining overweight and obese men into a pilot pragmatic randomized controlled trial and 2) potential for Hockey FIT to lead to weight loss and improvements in other outcomes at 12 wk and 12 months.<h4>Methods</h4>Male fans of two ice hockey teams (35-65 yr; body mass index ≥28 kg·m) located in Ontario (Canada) were randomiz ...[more]

PMID: 28719494

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Project description:BACKGROUND:Effective approaches that engage men in weight loss and lifestyle change are important because of worldwide increases, including in Canada, in obesity and chronic diseases. Football Fans in Training (FFIT), developed in Scotland, successfully tackled these problems by engaging overweight/obese male football fans in sustained weight loss and positive health behaviours, through program deliveries at professional football stadia. METHODS:Aims: 1) Adapt FFIT to hockey within the Canadian context and integrate with HealtheSteps™ (evidence-based lifestyle program) to develop Hockey Fans in Training (Hockey FIT); 2) Explore potential for Hockey FIT to help overweight/obese men lose weight and improve other outcomes by 12 weeks, and retain these improvements to 12 months; 3) Evaluate feasibility of recruiting and retaining overweight/obese men; 4) Evaluate acceptability of Hockey FIT; and 5) Conduct program optimization via a process evaluation. We conducted a two-arm pilot pragmatic randomized controlled trial (pRCT) whereby 80 overweight/obese male hockey fans (35-65 years; body-mass index ?28 kg/m2) were recruited through their connection to two junior A hockey teams (London and Sarnia, ON) and randomized to Intervention (Hockey FIT) or Comparator (Wait-List Control). Hockey FIT includes a 12-week Active Phase (classroom instruction and exercise sessions delivered weekly by trained coaches) and a 40-week Maintenance Phase. Data collected at baseline and 12 weeks (both groups), and 12 months (Intervention only), will inform evaluation of the potential of Hockey FIT to help men lose weight and improve other health outcomes. Feasibility and acceptability will be assessed using data from self-reports at screening and baseline, program fidelity (program observations and coach reflections), participant focus group discussions, coach interviews, as well as program questionnaires and interviews with participants. This information will be analyzed to inform program optimization. DISCUSSION:Hockey FIT is a gender-sensitive program designed to engage overweight/obese male hockey fans to improve physical activity and healthy eating choices, thereby leading to weight loss and other positive changes in health outcomes. We expect this study to provide evidence for a full-scale confirmatory pRCT. TRIAL REGISTRATION:NCT02396524 (Clinicaltrials.gov). Date of registration: Feb 26, 2015.

Project description:The health outcomes of men continue to be poorer than women globally. Challenges in addressing this problem include difficulties engaging men in weight loss programs as they tend to view these programs as contrary to the masculine narrative of independence and self-reliance. Researchers have been turning towards sports fans to engage men in health promotion programs as sports fans are typically male, and tend to have poor health habits.Developed from the highly successful gender-sensitized Football Fans in Training program, Hockey Fans in Training (Hockey FIT) recruited 80 male hockey fans of the London Knights and Sarnia Sting who were overweight or obese into a weekly, 90-minute classroom education and group exercise program held over 12 weeks; a 40-week minimally-supported phase followed. A process evaluation of the Hockey FIT program was completed alongside a pragmatic randomized controlled trial and outcome evaluation in order to fully explore the acceptability of the Hockey FIT program from the perspectives of coaches delivering and participants engaged in the program. Data sources included attendance records, participant focus groups, coach interviews, assessment of fidelity (program observations and post-session coach reflections), and 12-month participant interviews.Coaches enjoyed delivering the program and found it simple to deliver. Men valued being among others of similar body shape and similar weight loss goals, and found the knowledge they gained through the program helped them to make and maintain health behaviour changes. Suggested improvements include having more hockey-related information and activities, greater flexibility with timing of program delivery, and greater promotion of technology support tools.We confirmed Hockey FIT was an acceptable "gender-sensitized" health promotion program for male hockey fans who were overweight or obese. Minor changes were required for optimization, which will be evaluated in a future definitive trial.NCT02396524 (Clinicaltrials.gov). Date of registration: Feb 26, 2015.

Project description:BACKGROUND:The Cochrane review on the effectiveness of speech and language therapy for aphasia following stroke suggests intensity of therapy is a key predictor for outcome. Current aphasia services cannot provide intervention at the intensity observed within trial contexts because of resource limitations. Telerehabilitation could widen access to speech-language pathologists (SLPs) in geographically remote contexts and reduce the time spent on travel by the therapist and patient. The current academic literature within this field is in its infancy, with few trials of speech and language therapy (SLT) delivered by videoconference. Our pilot randomized controlled trial (RCT) will explore feasibility aspects and effectiveness of telerehabilitation for aphasia in addition to standard SLT. METHOD/DESIGN:Our study is a pragmatic, exploratory, pilot randomized controlled trial, where participants will be randomized to a telerehabilitation group or a control group. Both groups receive standard SLT (usual care) but the telerehabilitation group receives an additional 5 h of telerehabilitation per week over 4 weeks through videoconference. This additional telerehabilitation focuses on spoken language with an emphasis on word naming. We aim to include 40 patients in each group, with inclusion criteria being aphasia any time post stroke. Participants will be assessed blindly at pre-randomization (baseline), and 4 weeks and 4 months after randomization. The primary endpoint is naming ability 3 months after the completed intervention, measured by the Norwegian Basic Aphasia Assessment (NGA) naming subtest. Secondary endpoints include other subtests of the NGA, the VAST (Verb and Sentence Test) subtest sentence production, Communicative Effectiveness Index (CETI) and the Stroke and Aphasia Quality of Life scale (SAQOL-39). Experiences of patients and SLPs with telerehabilitation are assessed using questionnaires and semi-structured interviews. Statistical between group comparisons will be in line with an intention-to-treat analysis. DISCUSSION:This pilot RCT of intensive language training by videoconference will contribute new scientific evidence to the field of aphasia telerehabilitation. Here, we describe our trial which will explore the feasibility of telerehabilitation for aphasia as an intervention, our choice of primary and secondary outcome measures and proposed analyses. Our trial will provide information for the development and delivery of future definitive RCTs. TRIAL REGISTRATION:ClinicalTrials.gov, ID: NCT02768922 . Registered on 11 May 2016. Last updated on 17 November 2017.

Project description:BackgroundFalls are the leading cause of injuries among older adults, and trips and slips are major contributors to falls.ObjectiveThe authors sought to compare the effectiveness of adding a component of surface perturbation training to usual gait/balance training for reducing falls and fall-related injury in high-risk older adults referred to physical therapy.DesignThis was a multi-center, pragmatic, randomized, comparative effectiveness trial.SettingTreatment took place within 8 outpatient physical therapy clinics.PatientsThis study included 506 patients 65+ years of age at high fall risk referred for gait/balance training.InterventionThis trial evaluated surface perturbation treadmill training integrated into usual multimodal exercise-based balance training at the therapist's discretion versus usual multimodal exercise-based balance training alone.MeasurementsFalls and injurious falls were assessed with a prospective daily fall diary, which was reviewed via telephone interview every 3 months for 1 year.A total of 211/253 (83%) patients randomized to perturbation training and 210/253 (83%) randomized to usual treatment provided data at 3-month follow-up. At 3 months, the perturbation training group had a significantly reduced chance of fall-related injury (5.7% versus 13.3%; relative risk 0.43) but no significant reduction in the risk of any fall (28% versus 37%, relative risk 0.78) compared with usual treatment. Time to first injurious fall showed reduced hazard in the first 3 months but no significant reduction when viewed over the entire first year.LimitationsThe limitations of this trial included lack of blinding and variable application of interventions across patients based on pragmatic study design.ConclusionThe addition of some surface perturbation training to usual physical therapy significantly reduced injurious falls up to 3 months posttreatment. Further study is warranted to determine the optimal frequency, dose, progression, and duration of surface perturbation aimed at training postural responses for this population.

Project description:Few randomized controlled trials (RCTs) report interventions targeting improvement of frailty status as an outcome.This RCT enrolled 117 older adults (65-79?years of age) in Toufen, Taiwan who scored 3-6 on The Chinese Canadian Study of Health and Aging Clinical Frailty Scale Telephone Version and then score ?1 on the Cardiovascular Health Study Phenotypic Classification of Frailty (CHS_PCF). With a two by two factorial design, subjects were randomly assigned to interventions (Exercise and nutrition, EN, n?=?55 or problem solving therapy, PST, n?=?57) or controls (non-EN, n?=?62 or non-PST, n?=?60). Educational booklets were provided to all. EN group subjects received nutrition consultation and a thrice-weekly exercise-training program while PST group subjects received 6 sessions in 3?month. Subjects were followed at 3, 6, and 12?months. Primary outcome was improvement of the CHS_PCF by at least one category (from pre-frail to robust, or from frail to pre-frail or robust) from baseline assessments. One hundred and one completed final assessments. Intention-to-treat analysis with the generalized estimating equation model was applied with adjustment for time and treatment-by-time interactions.Mean age was 71.4?±?3.7?years, with 59% females. Baseline characteristic were generally comparable between groups. EN group subjects had a higher improvement rate on the primary outcome than non-EN group subjects (45% vs 27%, adjusted p?=?0.008) at 3?months, but not 6 or 12?months. They also had more increase of serum 25(OH) vitamin D level (4.9?±?7.7 vs 1.2?±?5.4, p?=?0.006) and lower percentage of osteopenia (74% vs 89% p?=?0.042) at 12?months. PST group subjects had better improvement (2.7?±?6.1 vs 0.2?±?6.7, p?=?0.035, 6-month) and less deterioration (-3.5?±?9.7 vs -7.1?±?8.7, p?=?0.036, 12-month) of dominant leg extension power than non-PST subjects. Some secondary outcomes were also improved in control groups (non-EN or non-PST). No adverse effects were reported.The three-month EN intervention resulted in short-term (3-month) frailty status improvement and long-term effect on bone mineral density and serum vitamin D (12-month) among Taiwanese community-dwelling elders. The effect of PST was less pronounced.ClinicalTrials.gov: EC0970301

Project description:BackgroundClinical guidelines recommend non-pharmacological interventions as the first line of treatment for agitation in dementia. One intervention that shows some promise as a treatment for agitation is essential oils. The objective of this study was to provide preliminary evidence of the effectiveness and feasibility of using topically-administered, individualized essential oil preparations for the alleviation of agitation in persons with dementia.MethodsWe conducted a 10-week pragmatic, cluster-randomized, placebo-controlled, pilot feasibility trial to compare the effectiveness of topically-administered, individualized essential oil preparations to control (placebo) preparations. Outcomes included frequency and severity of agitation, quality of life, frequency of antipsychotic medication use and physical restraint, incidence of adverse events, and trial feasibility. Participants with dementia and clinically significant agitation were recruited from five residential aged-care facilities across regional South Australia.ResultsThirty-eight participants were randomized from five sites. Accounting for random effects, we found statistically significant differences between the intervention and control groups in Pittsburgh Agitation Scale (PAS) aberrant vocalization sub score, Cohen Mansfield Agitation Inventory (CMAI) verbally agitated sub score and CMAI total score at week 4, but not at weeks 8 (post-intervention) or 10 (follow-up). No significant time-group interactions were observed for other PAS/CMAI scores or sub scores, quality of life - Alzheimer's disease total score, or frequency of physical restraint or as-needed antipsychotic medication. No adverse events were reported in any group.ConclusionsThe study findings highlight some promising effects of topically-administered, individualized essential oil preparations for agitation in dementia, and indicate that a large multi-center, cluster-randomized controlled trial of this treatment is feasible.Trial registrationAustralian New Zealand Clinical Trial Registry [ACTRN12617001159347].

Dataset Information

Hockey Fans in Training: A Pilot Pragmatic Randomized Controlled Trial.

Publications

Hockey Fans in Training: A Pilot Pragmatic Randomized Controlled Trial.

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