scholarly journals Buddy-motivational interviewing (buddy-MI) to Increase Physical Activity in Community Settings: Results of a Pragmatic Randomised Controlled Trial

2015 ◽  
Vol 1 (3) ◽  
pp. 31-37
Author(s):  
David Brinson ◽  
Mark Wallace-Bell ◽  
Ray Kirk ◽  
Andrew Hornblow
Keyword(s):  
Physical Activity ◽  
Randomised Controlled Trial ◽  
Motivational Interviewing ◽  
Repeated Measures ◽  
Controlled Trial ◽  
Control Group ◽  
Ripple Effects ◽  
Parallel Group ◽  
Development Evaluation ◽  
Randomised Controlled

This article describes the implementation and evaluation of a novel buddy-Motivational Interviewing intervention intended to help apparently healthy but relatively sedentary adults to adopt and maintain regular physical activity for health and fitness. This intervention is an adaptation of Motivational Interviewing which adds client-selected motivational-buddies who can provide in-session input as well as ongoing out-of-session support focused on strengthening client’s motivation for and movement toward their physical activity goals. A pragmatic parallel-group randomised controlled trial with 12-month follow-up was implemented to test the intervention. The trial demonstrated that buddy-MI was feasible and could be delivered with equivalent fidelity to standard MI and both groups demonstrated statistically significant changes across a range of behavioural and health-status outcomes. Moreover, the experimental group participants generally ‘outperformed’ the control group participants as shown by the consistent trends observed over three repeated measures out to 12-months (although these between-group differences were statistically non-significant). Qualitative data indicated participant acceptance of the programme as well as providing initial evidence of positive collateral health effects (‘ripple effects’ whereby buddies changed their behaviours also). Consideration for further development, evaluation and applications are also discussed.

scholarly journals Buddy-Motivational Interviewing (buddy-MI) to Increase Physical Activity in Community Settings: Study Protocol for a Pragmatic Randomised Controlled Trial

2013 ◽  
Vol 1 (2) ◽  
pp. 6-14 ◽  
Author(s):  
David Brinson ◽  
Mark Wallace-Bell ◽  
Ray Kirk ◽  
Andrew Hornblow
Keyword(s):  
Physical Activity ◽  
Randomised Controlled Trial ◽  
Motivational Interviewing ◽  
Controlled Trial ◽  
Clinical Effectiveness ◽  
Great Difficulty ◽  
Community Settings ◽  
Parallel Group ◽  
Randomised Controlled

This article describes the development and evaluation of a novel buddy-motivational interviewing intervention intended to help apparently healthy but relatively sedentary adults to adopt and maintain regular physical activity for health and fitness. Many people experience great difficulty in initiating physical activity (“the getting going problem”) and behavioural regression is common (“the keeping it going problem”). Typically there is a rather large gap between what people know to be healthy and what they actually do. This intervention is an adaptation of motivational interviewing in that it adds client-selected motivational-buddies who can provide in-session input as well as ongoing out-of-session support focused on strengthening clients’ motivation for and movement toward their physical activity goals. A pragmatic parallel group randomised controlled trial with 12-month follow-up aims to deliver and assess the effectiveness of the intervention in a format that could realistically be implemented within primary care, workplaces, schools or other similar setting. The study is due to report clinical effectiveness findings in 2014.

scholarly journals Effectiveness and cost-effectiveness of the PLAN-A intervention, a peer led physical activity program for adolescent girls: results of a cluster randomised controlled trial

2021 ◽  
Vol 18 (1) ◽  
Author(s):  
Russell Jago ◽  
Byron Tibbitts ◽  
Kathryn Willis ◽  
Emily Sanderson ◽  
Rebecca Kandiyali ◽  
...  
Keyword(s):  
Physical Activity ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Control Group ◽  
Cluster Randomised ◽  
Secondary Outcomes ◽  
Randomised Controlled

Abstract Background Physical activity is associated with improved health. Girls are less active than boys. Pilot work showed that a peer-led physical activity intervention called PLAN-A was a promising method of increasing physical activity in secondary school age girls. This study examined the effectiveness and cost-effectiveness of the PLAN-A intervention. Methods We conducted a cluster randomised controlled trial with Year 9 (13–14 year old) girls recruited from 20 secondary schools. Schools were randomly assigned to the PLAN-A intervention or a non-intervention control group after baseline data collection. Girls nominated students to be peer leaders. The top 18 % of girls nominated by their peers in intervention schools received three days of training designed to prepare them to support physical activity. Data were collected at two time points, baseline (T0) and 5–6 months post-intervention (T1). Participants wore an accelerometer for seven days to assess the primary outcome of mean weekday minutes of moderate-to-vigorous physical activity (MVPA). Multivariable mixed effects linear regression was used to estimate differences in the primary outcome between the two arms on an Intention-to-Treat (ITT) basis. Resource use and quality of life were measured and a within trial economic evaluation from a public sector perspective was conducted. Results A total of 1558 girls were recruited to the study. At T0, girls in both arms engaged in an average of 51 min of MVPA per weekday. The adjusted mean difference in weekday MVPA at T1 was − 2.84 min per day (95 % CI = -5.94 to 0.25) indicating a slightly larger decline in weekday MVPA in the intervention group. Results were broadly consistent when repeated using a multiple imputation approach and for pre-specified secondary outcomes and sub-groups. The mean cost of the PLAN-A intervention was £2817 per school, equivalent to £31 per girl. Economic analyses indicated that PLAN-A did not lead to demonstrable cost-effectiveness in terms of cost per unit change in QALY. Conclusions This study has shown that the PLAN-A intervention did not result in higher levels of weekday MVPA or associated secondary outcomes among Year 9 girls. The PLAN-A intervention should not be disseminated as a public health strategy. Trial registration ISRCTN14539759–31 May, 2018.

scholarly journals Community-based rehabilitation training after stroke: results of a pilot randomised controlled trial (ReTrain) investigating acceptability and feasibility

BMJ Open ◽  
2018 ◽  
Vol 8 (2) ◽  
pp. e018409 ◽  
Author(s):  
Sarah G Dean ◽  
Leon Poltawski ◽  
Anne Forster ◽  
Rod S Taylor ◽  
Anne Spencer ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Cognitive Capacity ◽  
Economic Evaluations ◽  
Control Group ◽  
Rehabilitation Training ◽  
One To One ◽  
Randomised Controlled

ObjectivesTo assess acceptability and feasibility of trial processes and the Rehabilitation Training (ReTrain) intervention including an assessment of intervention fidelity.DesignA two-group, assessor-blinded, randomised controlled trial with parallel mixed methods process and economic evaluations.SettingCommunity settings across two sites in Devon.ParticipantsEligible participants were: 18 years old or over, with a diagnosis of stroke and with self-reported mobility issues, no contraindications to physical activity, discharged from National Health Service or any other formal rehabilitation programme at least 1 month before, willing to be randomised to either control or ReTrain and attend the training venue, possessing cognitive capacity and communication ability sufficient to participate. Participants were individually randomised (1:1) via a computer-generated randomisation sequence minimised for time since stroke and level of functional disability. Only outcome assessors independent of the research team were blinded to group allocation.InterventionsReTrain comprised (1) an introductory one-to-one session; (2) ten, twice-weekly group classes with up to two trainers and eight clients; (3) a closing one-to-one session, followed by three drop-in sessions over the subsequent 3 months. Participants received a bespoke home-based training programme. All participants received treatment as usual. The control group received an exercise after stroke advice booklet.Outcome measuresCandidate primary outcomes included functional mobility and physical activity.ResultsForty-five participants were randomised (ReTrain=23; Control=22); data were available from 40 participants at 6 months of follow-up (ReTrain=21; Control=19) and 41 at 9 months of follow-up (ReTrain=21; Control=20). We demonstrated ability to recruit and retain participants. Participants were not burdened by the requirements of the study. We were able to calculate sample estimates for candidate primary outcomes and test procedures for process and health economic evaluations.ConclusionsAll objectives were fulfilled and indicated that a definitive trial of ReTrain is feasible and acceptable.Trial registration numberNCT02429180; Results.

A Randomised Controlled Trial of a Digital Therapy for Diabetes Prevention Among High Risk Individual: Study Protocol (the Mydipp Trial)

2020 ◽  
Author(s):  
Nurul Fatihah Mohd Fauzi ◽  
Sharifah Wajihah Wafa ◽  
Naresh Bhaskar Raj ◽  
Mohd Ibrahim Abdullah ◽  
Barakatun Nisak Mohd Yusof ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Type 2 Diabetes ◽  
Randomised Controlled Trial ◽  
Diabetes Prevention ◽  
Controlled Trial ◽  
Parallel Group ◽  
Randomised Controlled

Abstract Background: Approximately 37% of the individuals with prediabetes will have diabetes in four years if they do not change their lifestyle through any intervention. Lifestyle modification intervention has shown to be effective in reducing or delaying the onset of type 2 diabetes mellitus (T2DM) among high-risk individuals. Some intervention approaches integrate human coaching into technology using phone or email to enable wider reach, known as digital therapy. It is considered as a scalable method to reach a larger population who are at risk, convenient and accessible. This study aims to determine the feasibility and efficacy of lifestyle intervention to prevent type 2 diabetes among adults who are at risk of developing diabetes, an assessor-blinded, parallel-group, randomised controlled trial using the Malaysia Diabetes Prevention Programme (MyDiPP) app.Methods: ‘MyDiPP’ is a 12-month lifestyle intervention digital therapy with multiple approaches (weight loss, dietary modification, physical activity and quality of life). Eligible adults are aged 18-65 years, overweight/obese (BMI ≥ 23 kgm2) and athigh-risk for type2diabetes (American Diabetes Association(ADA) Diabetes Risk Score ≥ 5, or HbA1c of 5.6-6.2%). Each participant will be randomly assigned to one oftwo study groups in 1:1 ratio using simple randomisation to intervention or usual care control groups. The primary outcome is the change in weight at 6 months and 12 months, while the secondary outcomes are changes in HbA1c level, physical activity level, dietary intake and quality of life. The MyDiPP programme is an assessor-blinded, parallel-group, randomised controlled trial, in which the app consists of educational lessons, group, technology-enabled discussions, tools to track nutritional intake, physical activity, body weight and blood glucose level as well as platform to communicate with the health coaches. Discussion: This study is necessary to determine to what extent the intervention programme reduces risks of diabetes risk in comparison to the usual care.Trial registration details:This trial was prospectively registered with Clinical Trial Registry (CTR) on 21st June 2019 with trial registration number NCT03997656.

scholarly journals Adapting the ToyBox obesity prevention intervention for use in Scottish preschools: protocol for a feasibility cluster randomised controlled trial

BMJ Open ◽  
2018 ◽  
Vol 8 (10) ◽  
pp. e023707 ◽  
Author(s):  
Stephen Malden ◽  
Adrienne R Hughes ◽  
Ann-Marie Gibson ◽  
Farid Bardid ◽  
Odysseas Androutsos ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomised Controlled Trial ◽  
Sedentary Behaviour ◽  
Obesity Prevention ◽  
Water Consumption ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Control Group ◽  
Cluster Randomised ◽  
Randomised Controlled

IntroductionThere is an increasing need for the adoption of effective preschool obesity prevention interventions to combat the high levels of early-childhood obesity in the UK. This study will examine the feasibility and acceptability of the adapted version of the ToyBox intervention—a preschool obesity prevention programme—for use in Scotland (ToyBox-Scotland). This will inform the design of a full-scale cluster randomised controlled trial (RCT).Methods and analysisThe ToyBox-Scotland intervention will be evaluated using a feasibility cluster RCT, which involves children aged 3–5 years at six preschools in Glasgow, three randomly assigned to the intervention group and three to the usual-care control group. The original ToyBox intervention was adapted for the Scottish context using a coproduction approach. Within the 18-week intervention, physical activity and sedentary behaviour will be targeted in the preschool through environmental changes to the classroom, physical activity sessions and movement breaks. Parents will receive home activity packs every 3 weeks containing sticker incentives and interactive parent–child games that target sedentary behaviour, physical activity, eating/snacking and water consumption. As this is a feasibility study, parameters such as recruitment rates, attrition rates and SDs of outcome measures will be obtained which will inform a power calculation for a future RCT. Additional variables to be assessed include accelerometer-measured physical activity, sedentary behaviour and sleep, body mass index, home screen time, eating/snacking and water consumption. Outcomes will be assessed at baseline and 14–17 weeks later. Intervention fidelity will be assessed using questionnaires and interviews with parents and practitioners, observation and session delivery records.Ethics and disseminationThis study was granted ethical approval by the University of Strathclyde’s School of Psychological Sciences and Health Ethics Committee. Results will be disseminated through publication in peer-reviewed journals, presentation at conferences and in lay summaries provided to participants.Trial registration numberISRCTN12831555.

Enhancing physical activity in cardiac patients who report hopelessness: Feasibility testing of an intervention

2018 ◽  
Vol 78 (2) ◽  
pp. 226-237 ◽  
Author(s):  
Susan L Dunn ◽  
Lorraine B Robbins ◽  
Sandi W Smith ◽  
Rajiv Ranganathan ◽  
Holli A DeVon ◽  
...  
Keyword(s):  
Physical Activity ◽  
Social Support ◽  
Randomised Controlled Trial ◽  
Motivational Interviewing ◽  
Controlled Trial ◽  
Intervention Group ◽  
Text Messages ◽  
Medium Effect ◽  
Significant Other ◽  
Randomised Controlled

Objective: Hopelessness is present in 27% of patients with ischaemic heart disease (IHD), can persist for 12 months and is associated with lack of physical activity (PA). No interventions have been tested to increase PA in IHD patients who report hopelessness. This study evaluated the feasibility of conducting a randomised controlled trial to investigate the effectiveness of the Heart Up! intervention, designed to reduce hopelessness through enhanced PA in IHD patients. It was hypothesised that increased PA would be identified in the intervention group. Setting: Patients were recruited from a large teaching hospital in the Midwestern USA. Data collection occurred in the patient’s home at 1 and 8 weeks after hospital discharge. Methods: A three-group design was used. Eligible patients were randomised to (1) motivational social support (MSS) from a nurse, (2) MSS from a nurse with social support from a significant other support (SOS) or (3) control. MSS-only and MSS-SOS recipients received motivational interviewing followed by 6 weeks of social support text messages from a nurse. MSS-SOS participants additionally received social support text messages from a significant other. Control participants received the usual care. Feasibility outcomes included recruitment and retention rates, patient acceptability and patient satisfaction. An accelerometer measured PA. Results: Of the 156 patients screened for the study, 43 met the inclusion criteria. Of eligible patients, 69.8% ( n = 30) enrolled and 67% ( n = 20) completed the study. Patients in the MSS and MSS-SOS groups expressed satisfaction with the intervention components (86% with motivational interviewing, 77% with nurse texts and 100% with significant other texts). Although differences were not statistically significant, a medium effect size for change in PA was identified in the MSS-SOS group compared to the other two groups. Conclusion: Study findings demonstrate the feasibility of the Heart Up! intervention and support testing its efficacy in a randomised controlled trial.

Lifestyle integrated functional exercise for people with dementia: study protocol for a home-based randomised controlled trial

2020 ◽  
Vol 27 (5) ◽  
pp. 1-14
Author(s):  
Sara Almeida ◽  
Madalena Gomes da Silva ◽  
Alda Marques
Keyword(s):  
Physical Activity ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Primary Outcome Measure ◽  
Step Test ◽  
Control Group ◽  
People With Dementia ◽  
Home Based ◽  
Functional Exercise ◽  
Randomised Controlled

Background/Aims Physical activity is effective in people with dementia. Most people with dementia live at home, but few home-based physical activity programmes have been developed. The aim of this protocol is to determine the feasibility, effectiveness and cost-effectiveness of the Lifestyle Integrated Functional Exercise for People with Dementia (LiFE4D). Methods A randomised, controlled trial will be implemented. The experimental group will receive LiFE4D and the control group will maintain usual treatment. LiFE4D is a 3-month programme adjusted to daily routines and involving carers, with decreased face-to-face contact over time. The primary outcome measure is exercise capacity assessed with the 2-Minute Step Test. Secondary outcomes include cognitive function, physical activity, health-related physical fitness, respiratory function, functionality, quality of life, carers' burden and costs. Results Findings from this study will improve knowledge and provide guidance on home-based physical activity for people with dementia. Conclusions If effective, the trial will provide a model of home-based physical activity and inform international guidelines for dementia care.

scholarly journals Protocol for the PreventIT feasibility randomised controlled trial of a lifestyle-integrated exercise intervention in young older adults

BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e023526 ◽  
Author(s):  
Kristin Taraldsen ◽  
A Stefanie Mikolaizak ◽  
Andrea B Maier ◽  
Elisabeth Boulton ◽  
Kamiar Aminian ◽  
...  
Keyword(s):  
Physical Activity ◽  
Older Adults ◽  
Randomised Controlled Trial ◽  
Exercise Intervention ◽  
Controlled Trial ◽  
Functional Decline ◽  
Control Group ◽  
Feasibility Randomised Controlled Trial ◽  
Randomised Controlled ◽  
Life Function

IntroductionThe European population is rapidly ageing. In order to handle substantial future challenges in the healthcare system, we need to shift focus from treatment towards health promotion. The PreventIT project has adapted the Lifestyle-integrated Exercise (LiFE) programme and developed an intervention for healthy young older adults at risk of accelerated functional decline. The intervention targets balance, muscle strength and physical activity, and is delivered either via a smartphone application (enhanced LiFE, eLiFE) or by use of paper manuals (adapted LiFE, aLiFE).Methods and analysisThe PreventIT study is a multicentre, three-armed feasibility randomised controlled trial, comparing eLiFE and aLiFE against a control group that receives international guidelines of physical activity. It is performed in three European cities in Norway, Germany, and The Netherlands. The primary objective is to assess the feasibility and usability of the interventions, and to assess changes in daily life function as measured by the Late-Life Function and Disability Instrument scale and a physical behaviour complexity metric. Participants are assessed at baseline, after the 6 months intervention period and at 1 year after randomisation. Men and women between 61 and 70 years of age are randomly drawn from regional registries and respondents screened for risk of functional decline to recruit and randomise 180 participants (60 participants per study arm).Ethics and disseminationEthical approval was received at all three trial sites. Baseline results are intended to be published by late 2018, with final study findings expected in early 2019. Subgroup and further in-depth analyses will subsequently be published.Trial registration numberNCT03065088; Pre-results.

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