scholarly journals Effect of text messaging on depression in patients with coronary heart disease: a substudy analysis from the TEXT ME randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e022637 ◽  
Author(s):  
Sheikh Mohammed Shariful Islam ◽  
Clara K Chow ◽  
Julie Redfern ◽  
Cindy Kok ◽  
Karin Rådholm ◽  
...  
Keyword(s):  
Physical Activity ◽  
Coronary Heart Disease ◽  
Text Messaging ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Support Programme ◽  
History Of ◽  
Randomised Controlled ◽  
History Of Depression

ObjectiveWe aimed to evaluate the effects on depression scores of a lifestyle-focused cardiac support programme delivered via mobile phone text messaging among patients with coronary heart disease (CHD).DesignSubstudy and secondary analysis of a parallel-group, single-blind randomised controlled trial of patients with CHD.SettingA tertiary hospital in Sydney, Australia.InterventionThe Tobacco, Exercise and dieT MEssages programme comprised four text messages per week for 6 months that provided education, motivation and support on diet, physical activity, general cardiac education and smoking, if relevant. The programme did not have any specific mental health component.OutcomesDepression scores at 6 months measured using the Patient Health Questionnaire-9 (PHQ-9). Treatment effect across subgroups was measured using log-binomial regression model for the binary outcome (depressed/not depressed, where depressed is any score of PHQ-9 ≥5) with treatment, subgroup and treatment by subgroup interaction as fixed effects.ResultsDepression scores at 6 months were lower in the intervention group compared with the control group, mean difference 1.9 (95% CI 1.5 to 2.4, p<0.0001). The frequency of mild or greater depressive symptoms (PHQ-9 scores≥5) at 6 months was 21/333 (6.3%) in the intervention group and 86/350 (24.6%) in the control group (relative risk (RR) 0.26, 95% CI 0.16 to 0.40, p<0.001). This proportional reduction in depressive symptoms was similar across groups defined by age, sex, education, body mass index, physical activity, current smoking, current drinking and history of depression, diabetes and hypertension. In particular, the rates of PHQ-9 ≥5 among people with a history of depression were 4/44 (9.1%) vs 29/62 (46.8%) in intervention vs control (RR 0.19, 95% CI 0.07 to 0.51, p<0.001), and were 17/289 (5.9%) vs 57/288 (19.8%) among others (RR 0.30, 95% CI 0.18 to 0.50, p<0.001).ConclusionsAmong people with CHD, a cardiac support programme delivered via mobile phone text messaging was associated with fewer symptoms of mild-to-moderate depression at 6 months in the treatment group compared with controls.Trial registration numberACTRN12611000161921.

P573Effects of mobile text messaging on glycemic control in patients with coronary heart disease and diabetes mellitus: a randomized controlled trial

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
X H Huo ◽  
H M K Krumholz ◽  
X B Bai ◽  
E S S Spatz ◽  
Q D Ding ◽  
...  
Keyword(s):  
Physical Activity ◽  
Diabetes Mellitus ◽  
Coronary Heart Disease ◽  
Text Messaging ◽  
Hba1c Level ◽  
Primary Outcome ◽  
Intervention Group ◽  
Control Group ◽  
Secondary Outcomes

Abstract Background Mobile health interventions hold the prospect to support risk factor and lifestyle modification and are readily scalable in healthcare systems. Purpose We aim to assess whether text messaging program can improve glycemic control in high-risk patients with coronary heart disease (CHD) and diabetes mellitus (DM). Methods The study was a multi-centre randomised clinical trial conducted at 34 clinics in China. 502 individuals with both CHD and DM were recruited and randomly assigned to either the text messaging intervention (n=251) or control group (n=251). The control group received 2 thank-you messages per month in addition to usual care. The intervention group received 6 messages per week for 6 months. Messages provided educational and motivational information related to glucose monitoring, BP control, physical activity and lifestyle recommendations. The primary outcome was change in glycemic hemoglobin (HbA1C) from baseline to 6 months. Results Follow-up rate was 99%. At 6 months, HbA1C was significantly lower in intervention group compared to control group (mean HbA1C 6.7% vs. 7.2%, P<0.001), with a mean change of −0.2% and 0.1% from baseline, respectively (mean absolute change −0.3% [95% CI −0.5 to 0.1]; P=0.003). Significantly more participants in intervention group achieved a HbA1c<7% (69.3% vs. 52.6%; P=0.004), and change in FBG was larger in intervention group (−0.5 vs. 0.1 mmol/L; P=0.011). No differences in SBP, LDL-C, BMI and physical activity were observed. Almost all patients reported messages to be easy to understand (97.1%) and useful (94.1%). Table 1. Primary and Secondary Outcomes Analyses at 6 Month Follow-up Parameter Intervention (N=251) Control (N=251) Mean Difference in Change P value for Baseline 6 Months Mean Change Baseline 6 Months Mean Change (95% CI) Difference in Change Primary Outcome HbA1C level, %, mean (SD) 6.9 (1.4) 6.7 (1.3) −0.2 (1.0) 7.1 (1.4) 7.2 (1.5) 0.1 (1.1) −0.3 (−0.5, −0.1) 0.003 Secondary Outcomes HbA1C level<7%, No. (%) 155 (62.0%) 174 (69.3%) – 139 (56.1%) 132 (52.6%) – 1.2 (1.1, 1.3)a 0.004   FBG, mmol/L, mean (SD) 8.1 (2.7) 7.5 (2.7) −0.5 (2.5) 8.5 (3.0) 8.6 (3.3) 0.1 (3.1) −0.6 (−1.1, −0.2) 0.011   SBP, mmHg, mean (SD) 135.9 (18.4) 134.7 (18.7) −1.4 (17.1) 135.9 (18.1) 132.2 (17.7) −3.5 (17.8) 2.4 (−0.8,5.5) 0.144   LDL-C, mmol/L, mean (SD) 2.6 (0.8) 2.5 (0.7) −0.1 (0.7) 2.6 (0.8) 2.5 (0.8) −0.1 (0.7) 0 (−0.1, 0.1) 0.828   BMI, mean (SD) 26.4 (3.2) 26.3 (3.5) −0.1 (2.1) 26.3 (3.2) 26.0 (3.4) −0.4 (2.5) 0.3 (−0.1, 0.7) 0.213   Physical activity (MET min/wk), 1386 1386 177 1386 1386 322 −70.7 0.784     median (IQR) (693–3066) (918–3612) (2840) (693–3066) (693–3002) (2635) (−574.9, 433.5) Conclusion Use of a simple, culturally sensitive mobile text-messaging program could be an effective and scalable way to improve disease self-management among patients with CHD and DM. Acknowledgement/Funding Research Special Fund for Public Welfare Industry of Health (201502009) from the National Health and Family Planning Commission of China

scholarly journals ITM support for patients with chronic respiratory and cardiovascular diseases: a protocol for a randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e023863
Author(s):  
Julie Redfern ◽  
Karice Hyun ◽  
Anna Singleton ◽  
Nashid Hafiz ◽  
Rebecca Raeside ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Respiratory Disease ◽  
Text Messaging ◽  
Controlled Trial ◽  
Text Message ◽  
Chronic Respiratory Disease ◽  
Control Group ◽  
Local Health ◽  
Support Programme ◽  
Randomised Controlled

IntroductionSimple and scalable strategies are needed to improve ‘out-of-hospital’ support and management for people living with cardiovascular disease (CVD) and respiratory disease. Text messaging via mobile phones has been shown to be effective in helping promote lifestyle change and is supported by quantitative and qualitative evidence. The aim of this study is to test the effectiveness and implementation of a 6-month text messaging support programme for people with CVD and respiratory disease as an addition to cardiac and pulmonary outpatient rehabilitation.Methods and analysisPragmatic randomised controlled trial (n=310) to test the effectiveness of a 6-month text message support programme on clinical outcomes in people with CVD and chronic respiratory disease who are attending outpatient cardiac and pulmonary rehabilitation. The study includes a nested process evaluation to inform scalability and implementation across settings. The intervention group will receive a text message support programme comprising five messages per week for 26 weeks and the control group will continue with standard care. The primary outcome is exercise capacity (6 min walk distance). Secondary outcomes include clinical measures (proportion of people meeting the Australian guideline-recommended blood pressure and cholesterol targets), lifestyle outcomes (smoking rates, achievement of national guidelines for nutrition and physical activity), quality of life, mood (Hospital Anxiety and Depression Scale), medication adherence and attendance at and completion of rehabilitation.Ethics and disseminationPrimary ethics approval was received from the Sydney Local Health District Hospital Human Research Ethics Committee and associated Governance committees at sites. Results will be disseminated via the usual scientific forums including peer-reviewed publications and presentations at international conferences. At its conclusion, the study will determine the effectiveness and implementation of a simple programme that aims to improve health outcomes and attendance at rehabilitation for people with CVD and chronic respiratory disease.Trial registration numberACTRN12616001167459

scholarly journals Children’s physical activity level and sedentary behaviour in Norwegian early childhood education and care: effects of a staff-led cluster-randomised controlled trial

2020 ◽  
Author(s):  
Eivind Andersen ◽  
Steinar Øvreås ◽  
Kari Anne Jørgensen ◽  
Janne Borch-Jenssen ◽  
Thomas Moser
Keyword(s):  
Physical Activity ◽  
Sedentary Time ◽  
Controlled Trial ◽  
Intervention Group ◽  
Activity Level ◽  
Control Group ◽  
Education And Care ◽  
Vigorous Intensity ◽  
Randomised Controlled ◽  
Children’S Physical Activity

Abstract Background: A growing body of evidence suggest that the children’s physical activity (PA) level in early childhood education and care (ECEC) settings are insufficient. Since most children attend ECEC settings for many hours on most days of the week, and these institutions reach children across the socioeconomic spectrum, the ECEC settings may serve as an ideal avenue for increasing physical activity level, reduce sedentary time and enhance the overall health of young children. This paper investigates the effectiveness of the “Active Kindergarten – Active Children” study to increase children’s PA level and reduce sedentary time within the ECEC setting. Methods: Accelerometers were used to asses PA and sedentary time. A total of 116 three to four-year olds took part in a randomised controlled trial in 11 ECEC settings. Participants were cluster-randomised, by ECEC setting, to either a 12 week staff-led and expert-supported intervention or a waiting list control group. Results: The intervention group increased time spent in moderate- and vigorous intensity PA by 10 min/day (95% CI = 3, 18; P=0.01), took 1909 more steps per day (95% CI = 1130, 2688; P˂0.01) and reduced sedentary time with 14min/day (95% CI = -27, -1; P=0.04) compared to the control group. The intervention group had a 2.4 higher odds (95% CI = 1.05, 5.7; P = 0.04) of meeting the PA recommendations compared to the control group at follow-up. Conclusions: Our results show that a flexible staff-led and expert-supported multicomponent PA intervention can increase total PA level, moderate- and vigorous intensity PA and reduce time spent sedentary in three to four-year old children during their stay in ECEC settings.Trial registration: The trial was retrospectively registered on September 19, 2020 and available online at ClinicalTrials.gov: No. NCT04555746

scholarly journals Children’s physical activity level and sedentary behaviour in Norwegian early childhood education and care: effects of a staff-led cluster-randomised controlled trial

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Eivind Andersen ◽  
Steinar Øvreås ◽  
Kari Anne Jørgensen ◽  
Janne Borch-Jenssen ◽  
Thomas Moser
Keyword(s):  
Physical Activity ◽  
Sedentary Time ◽  
Controlled Trial ◽  
Intervention Group ◽  
Activity Level ◽  
Control Group ◽  
Education And Care ◽  
Vigorous Intensity ◽  
Randomised Controlled ◽  
Children’S Physical Activity

Abstract Background A growing body of evidence suggest that the children’s physical activity (PA) level in early childhood education and care (ECEC) settings are insufficient. Since most children attend ECEC settings for many hours on most days of the week, and these institutions reach children across the socioeconomic spectrum, the ECEC settings may serve as an ideal avenue for increasing physical activity level, reduce sedentary time and enhance the overall health of young children. This paper investigates the effectiveness of the “Active Kindergarten – Active Children” study to increase children’s PA level and reduce sedentary time within the ECEC setting. Methods Accelerometers were used to asses PA and sedentary time. A total of 116 three to four-year olds took part in a randomised controlled trial in 11 ECEC settings. Participants were cluster-randomised, by ECEC setting, to either a 12 week staff-led and expert-supported intervention or a waiting list control group. Results The intervention group increased time spent in moderate- and vigorous intensity PA by 10 min/day (95% CI = 3, 18; P = 0.01), took 1909 more steps per day (95% CI = 1130, 2688; P < 0.01) and reduced sedentary time with 14 min/day (95% CI = − 27, − 1; P = 0.04) compared to the control group. The intervention group had a 2.4 higher odds (95% CI = 1.05, 5.7; P = 0.04) of meeting the PA recommendations compared to the control group at follow-up. Conclusions Our results show that a flexible staff-led and expert-supported multicomponent PA intervention can increase total PA level, moderate- and vigorous intensity PA and reduce time spent sedentary in three to four-year old children during their stay in ECEC settings. Trial registration The trial was retrospectively registered on September 19, 2020 and available online at ClinicalTrials.gov: No. NCT04555746.

scholarly journals Effects of a culturally tailored parenting support programme in Somali-born parents’ mental health and sense of competence in parenting: a randomised controlled trial

BMJ Open ◽  
2017 ◽  
Vol 7 (12) ◽  
pp. e017600 ◽  
Author(s):  
Fatumo Osman ◽  
Raziye Salari ◽  
Marie Klingberg-Allvin ◽  
Ulla-Karin Schön ◽  
Renée Flacking
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Parenting Support ◽  
Sense Of Competence ◽  
Support Programme ◽  
Culturally Tailored ◽  
Randomised Controlled

ObjectivesTo evaluate the effectiveness of a culturally tailored parenting support programme on Somali-born parents’ mental health and sense of competence in parenting.DesignRandomised controlled trial.SettingA city in the middle of Sweden.ParticipantsSomali-born parents (n=120) with children aged 11–16 years and self-perceived stress in their parenting were randomised to an intervention group (n=60) or a waiting-list control group (n=60).InterventionParents in the intervention group received culturally tailored societal information combined with the Connect parenting programme during 12 weeks for 1–2 hours per week. The intervention consisted of a standardised training programme delivered by nine group leaders of Somali background.OutcomeThe General Health Questionnaire 12 was used to measure parents’ mental health and the Parenting Sense of Competence scale to measure parent satisfaction and efficacy in the parent role. Analysis was conducted using intention-to-treat principles.ResultsThe results indicated that parents in the intervention group showed significant improvement in mental health compared with the parents in the control group at a 2-month follow-up: B=3.62, 95% CI 2.01 to 5.18, p<0.001. Further, significant improvement was found for efficacy (B=−6.72, 95% CI −8.15 to −5.28, p<0.001) and satisfaction (B=−4.48, 95% CI −6.27 to −2.69, p<0.001) for parents in the intervention group. Parents’ satisfaction mediated the intervention effect on parental mental health (β=−0.88, 95% CI −1.84 to −0.16, p=0.047).ConclusionThe culturally tailored parenting support programme led to improved mental health of Somali-born parents and their sense of competence in parenting 2 months after the intervention. The study underlines the importance of acknowledging immigrant parents’ need for societal information in parent support programmes and the importance of delivering these programmes in a culturally sensitive manner.Clinical trial registrationNCT02114593.

A novel model of home-based, patient-tailored and mobile application-guided cardiac telerehabilitation in patients with atrial fibrillation: A randomised controlled trial

2021 ◽  
pp. 026921552110323
Author(s):  
Cheng Cai ◽  
Zhipeng Bao ◽  
Nan Wu ◽  
Fengming Wu ◽  
Guozhen Sun ◽  
...  
Keyword(s):  
Physical Activity ◽  
Atrial Fibrillation ◽  
Cardiac Rehabilitation ◽  
Mobile Application ◽  
Controlled Trial ◽  
Intervention Group ◽  
Rehabilitation Program ◽  
Control Group ◽  
Cardiac Rehabilitation Program ◽  
Randomised Controlled

Objective: To assess the effectiveness of tele-monitored cardiac rehabilitation in patients who have undergone ablation for atrial fibrillation. Design: Single-centre, prospective, assessment-blinded, randomised controlled trial. Setting: Domiciliary rehabilitation with support from a tertiary care hospital. Subjects: One hundred patients who underwent ablation for atrial fibrillation were recruited. Interventions: Participants were randomly allocated to a 12-week standard rehabilitation treatment (control group) or a comprehensive, domiciliary, mobile application-guided and tele-monitored cardiac rehabilitation program (intervention group) in a 1:1 fashion. Main outcome measures: The primary endpoint was the improvement in VO2peak. The secondary outcomes included adherence, physical activity, beliefs related to cardiovascular disease and exercise self-efficacy. Results: Ninety-seven patients completed follow-up. The mean VO2peak increased significantly in both the intervention group ( n = 49) (baseline vs 12 weeks: 19.1 ± 4.7 vs 27.3 ± 5.6 ml/(min kg), P < 0.01) and the control group ( n = 48) (baseline vs 12 weeks: 18.7 ± 4.9 vs 22.9 ± 6.3 ml/(min kg), P < 0.01). The results of the between-group analysis of aerobic capacity were significantly in favour of the intervention group. During the 12-week program, patients in the intervention group exhibited better adherence than those in the control group. Moreover, self-reported physical activity improved more in the intervention group than in the control group, as did the beliefs related to cardiovascular disease and exercise self-efficacy (all P < 0.01). Conclusions: Our domiciliary, mobile application-guided and tele-monitored cardiac rehabilitation program could lead to a more significant improvements in physical fitness, adherence and health beliefs than standard cardiac rehabilitation in patients who have undergone ablation for atrial fibrillation.

scholarly journals Theory-based mobile phone text messaging intervention for blood pressure control (TEXT4BP) among hypertensive patients in Nepal: study protocol for a feasibility randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e040799
Author(s):  
Buna Bhandari ◽  
Padmanesan Narasimhan ◽  
Abhinav Vaidya ◽  
Rohan Jayasuriya
Keyword(s):  
Physical Activity ◽  
Blood Pressure ◽  
Randomised Controlled Trial ◽  
Text Messaging ◽  
Controlled Trial ◽  
Intervention Group ◽  
Pressure Control ◽  
Hypertensive Patients ◽  
Randomised Controlled ◽  
Text Messaging Intervention

IntroductionUncontrolled blood pressure is one of the main risk factors for cardiovascular disease and death in Low-income and middle-income countries. Improvements to medication adherence and lifestyle changes can be assisted by using mobile phone text messaging interventions. This study aims to test the feasibility and acceptability of a text messaging intervention for blood pressure control ‘(TEXT4BP)’, developed based on behavioural change theory to improve treatment adherence and lifestyle change among hypertensive patients in Nepal.Methods and analysisThe TEXT4BP intervention will be tested using a two-arm parallel-group, unblinded, individually randomised controlled trial. This feasibility study would recruit 200 clinically diagnosed hypertensive patients aged 18–69 years, currently receiving blood pressure-lowering medication for more than 3 months, visiting a tertiary healthcare facility in Kathmandu, Nepal. A nested qualitative study will assess the acceptability of the short message service intervention. The intervention group will receive text messages containing information on hypertension, diet, medication and physical activity three times a week for 3 months. The control group will receive standard care. At baseline and 3 months, measures of medication adherence, salt intake, physical activity and blood pressure will be collected. Feasibility measures, such as differential rates of recruitment and attrition rates, will be calculated. Acceptability of text message interventions will be studied using usability measures and in-depth interviews among intervention group participants. This pilot study is not funded.Ethics and disseminationThis study has received ethics approval from the University of New South Wales Human Research Ethics Committee B (HC190357), Nepal Health Research Council (302/2019) and Institutional Review Committee of Kathmandu Medical College and Teaching Hospital Kathmandu, Nepal (030520192). The findings of the study will be disseminated through peer-reviewed publications and conference presentations.Trial registration numberACTRN12619001213134.

scholarly journals Efficacy of a Multi-component m-Health Weight-loss Intervention in Overweight and Obese Adults: A Randomised Controlled Trial

2020 ◽  
Vol 17 (17) ◽  
pp. 6200
Author(s):  
Mitch Duncan ◽  
Sasha Fenton ◽  
Wendy Brown ◽  
Clare Collins ◽  
Nicholas Glozier ◽  
...  
Keyword(s):  
Physical Activity ◽  
Weight Loss ◽  
Body Weight ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Obese Adults ◽  
Secondary Outcomes ◽  
Randomised Controlled

Background: This study compared the efficacy of two multi-component m-health interventions with a wait-list control group on body weight (primary outcome), and secondary outcomes of cardiovascular risk factors, lifestyle behaviours, and mental health. Methods: Three-arm randomised controlled trial (Enhanced: physical activity, diet, sleep, Traditional: physical activity, diet, Control) with assessments conducted at baseline, 6 and 12 months. Participants (n = 116) were overweight or obese adults aged 19–65 (M = 44.5 [SD = 10.5]). The 6-month intervention was delivered via a smartphone app providing educational materials, goal-setting, self-monitoring and feedback, and also included one face-to-face dietary consultation, a Fitbit and scales. The trial was prospectively registered and conducted between May 2017 and September 2018. Group differences on primary and secondary outcomes were examined between the Pooled Intervention groups (Pooled Intervention = Enhanced and Traditional) and Control groups, and then between Enhanced and Traditional groups. Results: Nineteen participants (16.4%) formally withdrew from the trial. Compared with the Control group, average body weight of the Pooled Intervention group did not differ at 6 (between-group difference = −0.92, (95% CI −3.33, 1.48)) or 12 months (0.00, (95% CI −2.62, 2.62)). Compared with the Control group, the Pooled Intervention group significantly increased resistance training (OR = 7.83, (95% CI 1.08, 56.63)) and reduced energy intake at 6 months (−1037.03, (−2028.84, −45.22)), and improved insomnia symptoms at 12 months (−2.59, (−4.79, −0.39)). Compared with the Traditional group, the Enhanced group had increased waist circumferences (2.69, (0.20, 5.18)) and sedentary time at 6 months (105.66, (30.83, 180.48)), and improved bed time variability at 12 months (−1.08, (−1.86, −0.29)). No other significant differences were observed between groups. Conclusions: Relative to Controls, the Pooled Intervention groups did not differ on body weight but improved resistance training, and reduced energy intake and insomnia symptom severity. No additional weight loss was apparent when targeting improvements in physical activity, diet and sleep in combination compared with physical activity and diet.

scholarly journals Community-based weight loss programme targeting overweight Chinese adults with pre-diabetes: study protocol of a randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (4) ◽  
pp. e035196
Author(s):  
Mandy Ho ◽  
Pui Hing Chau ◽  
Esther Yee Tak Yu ◽  
Michael Tin-cheung Ying ◽  
Cindy Lo Kuen Lam
Keyword(s):  
Physical Activity ◽  
Weight Loss ◽  
Controlled Trial ◽  
Intervention Group ◽  
Text Messages ◽  
Control Group ◽  
Chinese Adults ◽  
Intervention Programme ◽  
Community Based ◽  
Randomised Controlled

IntroductionType 2 diabetes mellitus (T2DM) is one of the world’s fastest growing health problems. Asians have a strong ethnic predisposition for T2DM, developing T2DM at a lower degree of obesity and at younger ages than other ethnic groups. T2DM has a gradual onset, with most individuals progressing through a pre-diabetic state, providing an opportunity to prevent T2DM and its complications. This study aims to evaluate the effectiveness of a community-based lifestyle intervention programme on weight loss and improvements in insulin sensitivity and cardiometabolic profiles in Chinese adults with pre-diabetes.Methods and analysisThis study is a 12-month, assessor-blinded randomised controlled trial. Adults with pre-diabetes (aged 40–64 years, n=180) with pre-diabetes are randomised into either an intervention group (receiving group-based lifestyle interventions) or a control group (receiving text messages containing health information). The intervention programme targets a weight loss of 5% during the first 6 months by restricting caloric intake and increasing physical activity. Participants in the intervention group will attend six group sessions and two individual face-to-face diet counselling sessions during the first 6 months, followed by monthly telephone support during the 6-month maintenance phase. Participants in the control group will receive monthly text messages containing general health information only. The primary outcome is weight loss (%). Secondary outcomes include insulin sensitivity (assessed using fasting insulin level and homeostatic model assessment of insulin resistance), glycaemic control (assessed using glycated haemoglobin level), lipid profile, blood pressure, carotid artery thickness, dietary intake and level of physical activity. Intention-to-treat analysis will be conducted using a generalised linear mixed effects model with a logit link and linear mixed models.Ethics and disseminationThis study has been approved by the relevant research ethics committee. The results will be disseminated through peer-reviewed journals and scientific presentations.Trial registration numberNCT03609697.

scholarly journals Participatory health through behavioural engagement and disruptive digital technology for postoperative rehabilitation: protocol of the PATHway trial

BMJ Open ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e041328
Author(s):  
Xia Wang ◽  
David J Hunter ◽  
Sarah Robbins ◽  
Sarah Capistrano ◽  
Vicky Duong ◽  
...  
Keyword(s):  
Physical Activity ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Postoperative Rehabilitation ◽  
Randomised Controlled

IntroductionPostsurgical rehabilitation is critical for optimal recovery in people undergoing orthopaedic surgery. Currently, knee and lumbar spine postsurgical care is not standardised, economically sustainable, nor based on quality evidence, contributing to substantial clinical variation, poor outcomes and increasing healthcare costs. This protocol describes the design of a randomised controlled trial aiming to evaluate the effectiveness and cost-effectiveness of a postsurgical clinical pathway augmented by disruptive technology and compared with standardised rehabilitation alone, in decreasing pain and improving function after total knee replacement (TKR) or lumbar laminectomy (with or without fusion).MethodsAn assessor-blinded, parallel group, randomised controlled trial will be conducted to recruit 204 consenting participants (102 per arm) of whom 50% are undergoing TKR and 50% lumbar surgery. The intervention group will receive a 6-month technology-enabled rehabilitation package in addition to usual postsurgical care. The package includes (1) an exercise program delivered via the Physitrack app on the iPad, (2) a health-coaching program delivered via video calls and motivational messages, (3) use of physical activity tracker with goal setting and motivational reminders (Fitbit). For those undergoing TKR, the intervention will also include knee joint range of motion self-monitoring via the Goniometer app. The control group will receive usual postsurgical care. Participants will be followed up at 3, 6 and 12 months from the enrolment date. The primary outcome is pain measured with the Numerical Rating Scale at 3 months. Secondary outcomes include pain-related disability, quality of life, computer self-efficacy, physical activity participation and sedentary behaviour. Data analysis will be blinded and by intention-to-treat. A trial-based cost-effectiveness analysis will determine the potential incremental cost per quality-adjusted life-year gained.Ethics and disseminationThis protocol is approved by the human research ethics committee of the University of Sydney. Dissemination will occur through lay summary, infographics, conferences and journal publications.Trial registration numberACTRN12618001448235.

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