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.

scholarly journals Efficacy of a Multi-Component m-Health Diet, Physical Activity, and Sleep Intervention on Dietary Intake in Adults with Overweight and Obesity: A Randomised Controlled Trial

Nutrients ◽  
2021 ◽  
Vol 13 (7) ◽  
pp. 2468
Author(s):  
Sasha Fenton ◽  
Tracy L. Burrows ◽  
Clare E. Collins ◽  
Anna T. Rayward ◽  
Beatrice Murawski ◽  
...  
Keyword(s):  
Physical Activity ◽  
Weight Loss ◽  
Randomised Controlled Trial ◽  
Dietary Intake ◽  
Controlled Trial ◽  
Intervention Group ◽  
Weight Loss Intervention ◽  
Traditional Group ◽  
Traditional Diet ◽  
Randomised Controlled

This three-arm randomised controlled trial evaluated whether (1) a multi-component weight loss intervention targeting diet, physical activity (PA), and sleep was effective at improving dietary intake over six months and 12 months, compared with a control, and (2) the enhanced diet, PA, and sleep intervention was more effective at improving dietary intake than the traditional diet and PA intervention. A total of 116 adults (70% female, 44.5 years, BMI 31.7 kg/m2) were randomised to either traditional diet and PA intervention; enhanced diet, PA, and sleep intervention; or wait-list control. To examine between-group differences, intervention groups were pooled and compared with the control. Then, the two intervention groups were compared. At six months, the pooled intervention group consumed 1011 fewer kilojoules/day (95% CI −1922, −101), less sodium (−313.2 mg/day; 95% CI −591.3, −35.0), and higher %EI from fruit (+2.1%EI; 95% CI 0.1, 4.1) than the controls. There were no differences in intake between the enhanced and traditional groups at six months. At 12 months, the pooled intervention and control groups reported no significant differences. However, compared to the traditional group, the enhanced reported higher %EI from nutrient-dense foods (+7.4%EI; 95% CI 1.3, 13.5) and protein (+2.4%EI; 95% CI 0.1, 4.6), and reduced %EI from fried/takeaway foods (−3.6%EI; 95% CI −6.5, −0.7), baked sweet products (−2.0%EI; 95% CI −3.6, −0.4), and packaged snacks (−1.1%EI; 95% CI −2.2, −0.3). This weight loss intervention reduced total energy and sodium intakes as well as increased fruit intake in adults at six months. The enhanced intervention group reported improved dietary intake relative to the traditional group at 12 months.

scholarly journals Targeted, structured text messaging to improve dietary and lifestyle behaviours for people on maintenance haemodialysis (KIDNEYTEXT): study protocol for a randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. e023545 ◽  
Author(s):  
Jessica Stevenson ◽  
Katrina L Campbell ◽  
Mark Brown ◽  
Jonathan Craig ◽  
Kirsten Howard ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Text Messaging ◽  
Controlled Trial ◽  
Intervention Group ◽  
Text Messages ◽  
Dietary Guidelines ◽  
Drop Out ◽  
Local Health ◽  
Lifestyle Behaviours ◽  
Randomised Controlled

IntroductionManaging nutrition is critical for reducing morbidity and mortality in patients on haemodialysis but adherence to the complex dietary restrictions remains problematic. Innovative interventions to enhance the delivery of nutritional care are needed. The aim of this phase II trial is to evaluate the feasibility and effectiveness of a targeted mobile phone text messaging system to improve dietary and lifestyle behaviours in patients on long-term haemodialysis.Methods and analysisSingle-blinded randomised controlled trial with 6 months of follow-up in 130 patients on haemodialysis who will be randomised to either standard care or KIDNEYTEXT. The KIDNEYTEXT intervention group will receive three text messages per week for 6 months. The text messages provide customised dietary information and advice based on renal dietary guidelines and general healthy eating dietary guidelines, and motivation and support to improve behaviours. The primary outcome is feasibility including recruitment rate, drop-out rate, adherence to renal dietary recommendations, participant satisfaction and a process evaluation using semistructured interviews with a subset of purposively sampled participants. Secondary and exploratory outcomes include a range of clinical and behavioural outcomes and a healthcare utilisation cost analysis will be undertaken.Ethics and disseminationThe study has been approved by the Western Sydney Local Health District Human Research Ethics Committee—Westmead. Results will be presented at scientific meetings and published in peer-reviewed publications.Trial registration numberACTRN12617001084370; Pre-results.

scholarly journals A new model of exercise referral scheme in primary care: is the effect on adherence to physical activity sustainable in the long term? A 15-month randomised controlled trial

BMJ Open ◽  
2018 ◽  
Vol 8 (3) ◽  
pp. e017211 ◽  
Author(s):  
Carme Martín-Borràs ◽  
Maria Giné-Garriga ◽  
Anna Puig-Ribera ◽  
Carlos Martín ◽  
Mercè Solà ◽  
...  
Keyword(s):  
Physical Activity ◽  
Social Support ◽  
Primary Care ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Community Resources ◽  
Randomised Controlled ◽  
Exercise Referral ◽  
Exercise Referral Scheme

IntroductionStudies had not yet overcome the most relevant barriers to physical activity (PA) adherence. An exercise referral scheme (ERS) with mechanisms to promote social support might enhance adherence to PA in the long term.SettingA randomised controlled trial in 10 primary care centres in Spain.ObjectiveTo assess the effectiveness of a primary care-based ERS linked to municipal resources and enhancing social support and social participation in establishing adherence to PA among adults over a 15-month period.Participants422 insufficiently active participants suffering from at least one chronic condition were included. 220 patients (69.5 (8.4) years; 136 women) were randomly allocated to the intervention group (IG) and 202 (68.2 (8.9) years; 121 women) to the control group (CG).InterventionsThe IG went through a 12-week standardised ERS linked to community resources and with inclusion of mechanisms to enhance social support. The CG received usual care from their primary care practice.OutcomesThe main outcome measure was self-report PA with the International Physical Activity Questionnaire and secondary outcomes included stages of change and social support to PA practice.Data collectionParticipant-level data were collected via questionnaires at baseline, and at months 3, 9 and 15.BlindingThe study statistician and research assessors were blinded to group allocation.ResultsCompared with usual care, follow-up data at month 15 for the ERS group showed a significant increase of self-reported PA (IG: 1373±1845 metabolic equivalents (MET) min/week, n=195; CG: 919±1454 MET min/week, n=144; P=0.009). Higher adherence (in terms of a more active stage of change) was associated with higher PA level at baseline and with social support.ConclusionsPrescription from ordinary primary care centres staff yielded adherence to PA practice in the long term. An innovative ERS linked to community resources and enhancing social support had shown to be sustainable in the long term.Trial registration numberNCT00714831; Results.

scholarly journals Long-term efficacy and effectiveness of a behavioural and community-based exercise intervention (Urban Training) to increase physical activity in patients with COPD: a randomised controlled trial

2018 ◽  
Vol 52 (4) ◽  
pp. 1800063 ◽  
Author(s):  
Ane Arbillaga-Etxarri ◽  
Elena Gimeno-Santos ◽  
Anael Barberan-Garcia ◽  
Eva Balcells ◽  
Marta Benet ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Exercise Intervention ◽  
Controlled Trial ◽  
Text Messages ◽  
Chronic Obstructive ◽  
Efficacy Analysis ◽  
Copd Patients ◽  
Randomised Controlled

There is a need to increase and maintain physical activity in patients with chronic obstructive pulmonary disease (COPD). We assessed 12-month efficacy and effectiveness of the Urban Training intervention on physical activity in COPD patients.This randomised controlled trial (NCT01897298) allocated 407 COPD patients from primary and hospital settings 1:1 to usual care (n=205) or Urban Training (n=202). Urban Training consisted of a baseline motivational interview, advice to walk on urban trails designed for COPD patients in outdoor public spaces and other optional components for feedback, motivation, information and support (pedometer, calendar, physical activity brochure, website, phone text messages, walking groups and a phone number). The primary outcome was 12-month change in steps·day−1 measured by accelerometer.Efficacy analysis (with per-protocol analysis set, n=233 classified as adherent to the assigned intervention) showed adjusted (95% CI) 12-month difference +957 (184–1731) steps·day−1 between Urban Training and usual care. Effectiveness analysis (with intention-to-treat analysis set, n=280 patients completing the study at 12 months including unwilling and self-reported non-adherent patients) showed no differences between groups. Leg muscle pain during walks was more frequently reported in Urban Training than usual care, without differences in any of the other adverse events.Urban Training, combining behavioural strategies with unsupervised outdoor walking, was efficacious in increasing physical activity after 12 months in COPD patients, with few safety concerns. However, it was ineffective in the full population including unwilling and self-reported non-adherent patients.

scholarly journals A medical peer-delivered intervention comprising brief motivational interviewing via instant-messaging interaction to reduce drug misuse among youth in Hong Kong: A protocol for a randomised controlled trial

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
William Ho Cheung Li ◽  
Wei Xia ◽  
Laurie Long Kwan Ho ◽  
Ankie Tan Cheung ◽  
Queenie Kuai I. Leong ◽  
...  
Keyword(s):  
Hong Kong ◽  
Randomised Controlled Trial ◽  
Motivational Interviewing ◽  
Instant Messaging ◽  
Controlled Trial ◽  
Text Messages ◽  
Drug Consumption ◽  
Drug Misuse ◽  
Treatment Needs ◽  
Randomised Controlled

Abstract Aims Youth are frequently exposed to drugs, and most youth who misuse drugs are reluctant to seek help from services due to the worry of others being judgmental, lacking expertise, exposing their personal information, or informing their parents. Considering these concerns, we propose to evaluate the effectiveness of a medical peer-delivered intervention comprising brief motivational interviewing via instant-messaging interaction in reducing drug misuse among youth in Hong Kong. Methods A two-group single-blind, randomised controlled trial will be conducted. Multiple approaches, including online and face-to-face methods, will be used to recruit the participants. The participants, aged 25 years or younger and reporting any drugs that they have taken within the past 30 days, will be recruited and randomised to receive either brief motivational interviewing via interactive instant-messaging (the intervention) or general health text-messages (comparator). The primary outcome will be the change in the participants’ reductions in self-reported drug consumption at 12 months compared to that at baseline. The secondary outcomes will be the changes in the drug-abusing participants’ reductions in self-reported drug consumption at 6 months, the changes in the drug-quitting participants’ 6- and 12-month contemplation stages and relapse risk compared to that at baseline, 30 days’ self-reported drug abstinence at 6 and 12 months, and the treatment needs and motivation at 6 and 12 months compared to that at baseline. The effectiveness of the proposed intervention will be examined with adjusted regression models, with adjustment for baseline characteristics and the use of an intention-to‐treat approach. Discussion This proposed study will be the first randomised controlled trial to assess the effectiveness of a medical peer-delivered interactive intervention to reduce drug misuse among youth in Hong Kong. The proposed intervention has the potential to increase the help-seeking behaviour and intention to quit among youth who misuse drugs. As a result, more youth misusing drugs may be helped to abstain from drugs. This proposed study will inform decisions on whether it is worthwhile to invest resources in large-scale implementation of such an intervention.

scholarly journals Text messages for primary prevention of cardiovascular disease: the TextMe2 randomised controlled trial protocol

BMJ Open ◽  
2020 ◽  
Vol 10 (4) ◽  
pp. e036767
Author(s):  
Harry Klimis ◽  
Aravinda Thiagalingam ◽  
Clara K Chow
Keyword(s):  
Physical Activity ◽  
Risk Factors ◽  
Cardiovascular Disease ◽  
Medication Adherence ◽  
Primary Prevention ◽  
Randomised Controlled Trial ◽  
Cardiovascular Health ◽  
Controlled Trial ◽  
Text Messages ◽  
Randomised Controlled

IntroductionMobile health may be an effective means of delivering customised individually directed health promotion interventions for cardiovascular disease (CVD) primary prevention. The aim of this study is to evaluate the effectiveness of a lifestyle-focused text messaging programme for primary CVD prevention.Methods and analysisSingle-blind randomised controlled trial with 6 months’ follow-up in 246 patients with moderate-high absolute cardiovascular risk and without coronary heart disease recruited from a rapid access cardiology clinic. Participants will be randomised to receive either usual care or TextMe2 (text message-based prevention programme). The TextMe2 programme provides support, motivation and education on five topics: diet, physical activity, smoking, general cardiovascular health and medication adherence, and is delivered in four text messages per week over 6 months. The primary outcome is change in the proportion of patients who have three or more of five key modifiable risk factors that are uncontrolled (low-density lipoprotein >2.0 mmol/L, systolic blood pressure >140 mm Hg, body mass index >24.9 kg/m2, physical activity (less than the equivalent of 150 min of moderate intensity each week), current smoker). Secondary outcomes are changes in single biomedical risk factors, behavioural risk factors, quality of life, depression/anxiety scores, medication adherence, cardiovascular health literacy and hospital readmissions/representations. Analysis will be according to the intention-to-treat principle and full statistical analysis plan developed prior to data lock.Ethics and disseminationThis study has been approved by the Western Sydney Local Health District Human Research Ethics Committee at Westmead (AU/RED/HREC/17/WMEAD/186). Results will be presented at scientific meetings and published in peer-reviewed publications.Trial registration numberACTRN12618001153202.

scholarly journals Financial Incentives for Preventing Postpartum return to Smoking (FIPPS): study protocol for a three-arm randomised controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
M. Ussher ◽  
C. Best ◽  
S. Lewis ◽  
J. McKell ◽  
T. Coleman ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Financial Incentives ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Significant Other ◽  
Smoking Relapse ◽  
Stop Smoking ◽  
Randomised Controlled

Abstract Background Financial incentives are an effective way of helping women to stop smoking during pregnancy. Unfortunately, most women who stop smoking at this time return to smoking within 12 months of the infant’s birth. There is no evidence for interventions that are effective at preventing postpartum smoking relapse. Financial incentives provided after the birth may help women to sustain cessation. This randomised controlled trial will assess the effectiveness and cost-effectiveness of financial incentives to help women who are abstinent from smoking at end-of-pregnancy to avoid return to smoking up to 12 months postpartum. Methods This is a UK-based, multi-centre, three-arm, superiority, parallel group, individually randomised controlled trial, with 1:1:1 allocation. It will compare the effectiveness of two financial incentive interventions with each other (one intervention for up to 3 months postpartum offering up to £120 of incentives (£60 for the participant and £60 for a significant other support); the other for up to 12 months postpartum with up to £300 of incentives (£240 for the participant and £60 for a significant other support) and with a no incentives/usual care control group. Eligible women will be between 34 weeks gestation and 2 weeks postpartum, abstinent from smoking for at least 4 weeks, have an expired carbon monoxide (CO) reading < 4 parts per million (ppm), aged at least 16 years, intend remaining abstinent from smoking after the birth and able to speak and read English. The primary outcome is self-reported, lapse-free, smoking abstinence from the last quit attempt in pregnancy until 12 months postpartum, biochemically validated by expired CO and/or salivary cotinine or anabasine. Outcomes will be analysed by intention-to-treat and regression models used to compare the proportion of abstinent women between the two intervention groups and between each intervention group and the control group. An economic evaluation will assess the cost-effectiveness of offering incentives and a qualitative process evaluation will examine barriers and facilitators to trial retention, effectiveness and implementation. Discussion This pragmatic randomised controlled trial will test whether offering financial incentives is effective and cost-effective for helping women to avoid smoking relapse during the 12 months after the birth of their baby. Trial registration International Standard Randomised Controlled Trial Number 55218215. Registered retrospectively on 5th June 2019

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 SSHeW study protocol: does slip resistant footwear reduce slips among healthcare workers? A randomised controlled trial

BMJ Open ◽  
2018 ◽  
Vol 8 (11) ◽  
pp. e026023 ◽  
Author(s):  
Sarah Cockayne ◽  
Caroline Fairhurst ◽  
Gillian Frost ◽  
Catherine Hewitt ◽  
Mark Liddle ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Incidence Rate ◽  
Controlled Trial ◽  
Intervention Group ◽  
Text Messages ◽  
Hospital Environment ◽  
Control Group ◽  
Dress Code ◽  
Randomised Controlled

IntroductionSlips, trips and falls are common causes of injuries in the workplace. It is estimated that in Great Britain, nearly 1 million days are taken off work due to these injuries. There is some evidence to suggest this accident burden could be reduced by the use of slip resistant footwear. This protocol describes a multicentre trial investigating the effectiveness and cost-effectiveness of slip resistant footwear to prevent slips in National Health Service (NHS) staff working in clinical, general or catering environments.Methods and analysisA two-arm, randomised controlled trial conducted within England, with 4400 NHS staff, aged 18 years and above, who adhere to a dress code policy and work in a clinical, catering or general hospital environment. Participants will be randomised 1:1 to the intervention or waiting list control group. The intervention group will be offered a pair of 5-star GRIP rated slip resistant footwear. The control group will be offered the footwear at the end of the trial. The primary outcome is the incidence rate of self-reported slips in the workplace over a 14-week period, as reported via weekly text messages. Secondary outcomes include: time to first slip/fall, proportion of participants who slip and fall over 14 weeks and incidence rate of falls resulting from and not resulting from a slip in the workplace over 14 weeks. An economic evaluation will assess cost-effectiveness, in terms of cost per quality-adjusted life year gained. A nested qualitative study will explore the acceptability of the footwear and compliance.Ethics and disseminationThis protocol received a favourable ethical opinion from the University of York, Department of Health Sciences Research Governance Committee. The trial results will be published in peer-reviewed journals and at conferences. A summary of the findings will be made available to participants.Trial registration numberISRCTN33051393; Pre results.

scholarly journals Barriers and facilitators of loaded self-managed exercises and physical activity in people with patellofemoral pain: understanding the feasibility of delivering a multicentred randomised controlled trial, a UK qualitative study

BMJ Open ◽  
2019 ◽  
Vol 9 (6) ◽  
pp. e023805 ◽  
Author(s):  
Benjamin E Smith ◽  
Fiona Moffatt ◽  
Paul Hendrick ◽  
Marcus Bateman ◽  
James Selfe ◽  
...  
Keyword(s):  
Physical Activity ◽  
Locus Of Control ◽  
Randomised Controlled Trial ◽  
Qualitative Study ◽  
Self Efficacy ◽  
Controlled Trial ◽  
Intervention Group ◽  
Patellofemoral Pain ◽  
Barriers And Facilitators ◽  
Randomised Controlled

ObjectivesThere is an emergent body of evidence supporting exercise therapy and physical activity in the management of musculoskeletal pain. The purpose of this study was to explore potential barriers and facilitators with patients and physiotherapists with patellofemoral pain involved in a feasibility randomised controlled trial (RCT) study. The trial investigated a loaded self-managed exercise intervention, which included education and advice on physical activity versus usual physiotherapy as the control.DesignQualitative study, embedded within a mixed-methods design, using semi-structured interviews.SettingA UK National Health Service physiotherapy clinic in a large teaching hospital.ParticipantsPurposively sampled 20 participants within a feasibility RCT study; 10 patients with a diagnosis of patellofemoral pain, aged between 18 and 40 years, and 10 physiotherapists delivering the interventions.ResultsIn respect to barriers and facilitators, the five overlapping themes that emerged from the data were: (1) locus of control; (2) belief and attitude to pain; (3) treatment expectations and preference; (4) participants’ engagement with the loaded self-managed exercises and (5) physiotherapists’ clinical development. Locus of control was one overarching theme that was evident throughout. Contrary to popular concerns relating to painful exercises, all participants in the intervention group reported positive engagement. Both physiotherapists and patients, in the intervention group, viewed the single exercise approach in a positive manner. Participants within the intervention group described narratives demonstrating self-efficacy, with greater internal locus of control compared with those who received usual physiotherapy, particularly in relation to physical activity.ConclusionsImplementation, delivery and evaluation of the intervention in clinical settings may be challenging, but feasible with the appropriate training for physiotherapists. Participants’ improvements in pain and function may have been mediated, in some part, by greater self-efficacy and locus of control.Trial registration numberISRCTN35272486; Pre-results.

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