‘No one ever asked us’: a feasibility study assessing the co-creation of a physical activity programme with adolescent girls

2019 ◽  
Vol 27 (3) ◽  
pp. 34-43
Author(s):  
Méabh Corr ◽  
Elaine Murtagh
Keyword(s):  
Physical Activity ◽  
Data Collection ◽  
Behaviour Change ◽  
Adolescent Girls ◽  
Retention Rate ◽  
Controlled Trial ◽  
Activity Level ◽  
Health Concern ◽  
Post Intervention ◽  
Behaviour Change Wheel

Background: Globally, the poor activity level of adolescent girls is a public health concern. Little research has involved adolescents in the design of interventions. This study assessed the feasibility of involving girls in the co-creation of an activity programme. Methods: Thirty-one students (15–17 years old) were recruited from a post-primary school. The Behaviour Change Wheel guided intervention design, providing insights into participants’ capability, opportunity and motivation for change. Step counts and self-reported physical activity levels were recorded pre- and post-intervention. Feasibility benchmarks assessed recruitment, data collection, acceptability and adherence. Results: Activity and educational sessions were delivered for six weeks during physical education class. Average attendance was 87% (benchmark = 80%). Eligibility was 61% (benchmark = 60%). There was a 100% retention rate (benchmark = 90%). All participants ( n = 31) completed baseline measures and 71% ( n = 22) completed post-measures. 54% ( n = 17) of students completed pedometer measurements, with 32% ( n = 10) having complete data. Average daily steps were 13,121 pre-intervention and 14,128 post-intervention ( p > 0.05). Data collection was feasible, receiving a mean score > 4/5 (benchmark > 3.5/5). Conclusions: The Behaviour Change Wheel can be used to co-create an activity programme with adolescent girls. Predetermined benchmarks, except for pedometer recordings, were reached or exceeded, providing evidence for the need of a randomised controlled trial to test effectiveness.

A personalised smartphone-delivered just-in-time adaptive intervention (JITABug) to increase physical activity in older adults: A feasibility pilot study (Preprint)

2021 ◽  
Author(s):  
Jacqueline Louise Mair ◽  
Lawrence Hayes ◽  
Amy Campbell ◽  
Duncan Buchan ◽  
Chris Easton ◽  
...  
Keyword(s):  
Physical Activity ◽  
Older Adults ◽  
Data Collection ◽  
Real Time ◽  
Behaviour Change ◽  
Time Of Day ◽  
Activity Level ◽  
Just In Time ◽  
Activity Tracker ◽  
Wearable Activity Tracker

BACKGROUND Just-in-time-adaptive-interventions (JITAIs) provide real-time ‘in the moment’ behaviour change support to people when they need it most. JITAIs could be a viable way to provide personalised physical activity support to older adults in the community. However, it is unclear how feasible it is to remotely deliver a physical activity intervention via a smartphone to older adults, or how acceptable older adults would find a JITAI targeting physical activity in everyday life. OBJECTIVE (1) to describe the development of “JITABug”, a personalised smartphone and activity tracker delivered JITAI designed to support older adults to increase or maintain their physical activity level; (2) to explore the acceptability of JITABug in a free-living setting, and (3) to assess the feasibility of conducting an effectiveness trial of the JITABug intervention. METHODS The intervention development process was underpinned by the Behaviour Change Wheel. The intervention consisted of a wearable activity tracker (Fitbit) and a companion smartphone app (JITABug) which delivered goal setting, planning, reminders, and just-in-time adaptive messages to encourage achievement of personalised physical activity goals. Message delivery was tailored based on time of day, real-time physical activity tracker data, and weather conditions. We tested the feasibility of remotely delivering the JITAI with older adults in a 6-week trial using a mixed-methods approach. Data collection involved assessment of physical activity by accelerometery and activity tracker, self-reported mood and mental wellbeing via ecological momentary assessment, and contextual information on physical activity via voice memos. Feasibility and acceptability outcomes included: (1) recruitment capability and adherence to the intervention; (2) intervention delivery ‘in the wild’; (3) appropriateness of data collection methodology; (4) adverse events and; (5) participant satisfaction. RESULTS Of 46 recruited older adults (aged 56-72 years old), 65% completed the intervention. The intervention was successfully delivered as intended; 27 participants completed the intervention independently, 94% of physical activity messages were successfully delivered, and 99% of Fitbit and 100% of weather data calls were successful. Wrist-worn accelerometer data were obtained from 96% at baseline and 96% at follow up. On average, participants recorded 8/16 (50%) voice memos, 3/8 (38%) mood assessments, and 2/4 (50%) wellbeing assessments via the app. Overall acceptability of the intervention was very good (77% satisfaction). Participant feedback suggested that more diverse and tailored physical activity messages, app usage reminders, technical refinements regarding real-time data syncing, and an improved user interface could improve the intervention and make it more appealing. CONCLUSIONS This study suggests that a smartphone delivered JITAI utilizing a wearable activity tracker is an acceptable way to support physical activity in older adults in the community. Overall, the intervention is feasible, however based on user feedback, the JITABug app requires further technical refinements that may enhance usage, engagement, and user satisfaction before moving to effectiveness trials. CLINICALTRIAL Non-Applicable

scholarly journals Individualised behaviour change strategies for physical activity in multiple sclerosis (IPAC-MS): protocol for a randomised controlled trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Farren L. Goulding ◽  
Charity D. Evans ◽  
Katherine B. Knox ◽  
Hyun J. Lim ◽  
Michael C. Levin ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Multiple Sclerosis ◽  
Randomised Controlled Trial ◽  
Behaviour Change ◽  
Controlled Trial ◽  
Activity Level ◽  
Change Strategies ◽  
Randomised Controlled

Abstract Background Multiple sclerosis (MS) is a chronic, degenerative disease of the central nervous system. Because of the long-term and unpredictable nature of the disease, the burden of MS is significant from both a patient and societal perspective. Despite a recent influx of disease-modifying therapies to treat MS, many individuals continue to experience disability that negatively affects productivity and quality of life. Previous research indicates that physical activity has a positive impact on walking function in individuals with MS, in addition to the usual beneficial effects on overall health. However, most people with MS are not active enough to gain these benefits, and a lack of support to initiate and maintain physical activity has been identified as a major barrier. This study will evaluate the impact of a novel intervention involving individualised behaviour change strategies delivered by neurophysiotherapists on increasing physical activity levels in individuals with MS who are currently inactive. Methods/design This single-blind, parallel-group, randomised controlled trial will be conducted in Saskatchewan, Canada. Eligible participants include individuals with MS who are ambulatory but identified as currently inactive by the self-reported Godin Leisure-Time Exercise Questionnaire (GLTEQ). The intervention will be delivered by neurophysiotherapists and includes individualised behaviour change strategies aimed at increasing physical activity over a 12-month period. The control group will receive usual care during the 12-month study period. The primary outcome is the change in physical activity level, as measured by the change in the GLTEQ score from baseline to 12 months. Secondary outcomes include the change in patient-reported outcome measures assessing MS-specific symptoms, confidence and quality of life. Discussion Physical activity has been identified as a top research priority by the MS community. Findings from this novel study may result in new knowledge that could significantly impact the management and overall health of individuals with MS. Trial registration ClinicalTrials.gov, NCT04027114. Registered on 10 July 2019.

scholarly journals Parent BMI Increase 2 to 5 Years Post-study Related to Change in Age but Independent of Other Sociodemographics, Health Behavior, and Study Engagement (P16-001-19)

2019 ◽  
Vol 3 (Supplement_1) ◽  
Author(s):  
Brenda Abu ◽  
Barbara Lohse ◽  
Leslie Cunningham-Sabo
Keyword(s):  
Physical Activity ◽  
Health Behavior ◽  
Low Income ◽  
Repeated Measures ◽  
Controlled Trial ◽  
Family Intervention ◽  
Activity Level ◽  
Nutrition Intervention ◽  
Post Intervention ◽  
Age Change

Abstract Objectives Characterize parent (P) weight change 2–5 y post participation in Fuel for Fun (FFF) a controlled trial of a school and family intervention focused on culinary and physical activity experiences for 4th grade youth. Methods P who had participated with their 4th grader in FFF were recruited via email to enroll in a follow-up (FFF-FU) assessment. FFF-FU survey set included measures from the original study and new items pertinent to P of adolescents. Physical activity was measured with the IPAQ; low income was denoted as using an income-based program or worry about money for food. Height, weight, age in FFF and FFF-FU were self-reported. Perimenopausal age included 47 y within BL and FFF-FU. Youth in FFF cohorts 1 and 4 were controls and cohorts 2 and 3 included the multi-component intervention. P were enrolled in 1 of 4 treatments varying in type and intensity. FFF and FFF-FU data were collected online using the Qualtrics platform. FFF P completed surveys at baseline (BL), post-intervention, and 4 months post-study. FFF-FU data were collected spring 2018, about 2 to 5 years years post-BL. Data were analyzed with repeated measures controlling for BL or FFF-FU sociodemographics, engagement, health behaviors. Results Of the 418 FFF P, 127 completed FFF-FU surveys (mean age 42.5 6.0 y) with 115 providing weight and height. FFF-FU sample was female (88%), white (84%), active (44% high activity), educated (69% college degree or higher), but had lower BMI and fewer with low income than FFF P. Of FFF-FU providing heights/weights at the 4 assessments, mean (SE) BMIs were 24.2 (0.5), 24.4 (0.5), 24.6 (0.6) and 25.7 (0.6) respectively. Change in BMI was significant after controlling for age, stress, ethnicity, sex, physical activity level, P treatment and engagement, but not when BL to FFU-FU change in age or perimenopausal age were controlled. The significantly greater increase in BMI for P of intervention youth than controls persisted when controlling for sociodemographic and health behavior findings, but not when BL to FFF-FU age change, perimenopausal age or activity level were controlled. Conclusions Significant weight gain by P of youth in a nutrition intervention 2 to 5 years post-study was unrelated to stress, ethnicity, activity level, income, but was related to the FFF-FU age change from BL and perimenopausal age. Funding Sources NIFA.

scholarly journals Moving from intention to behaviour: a randomised controlled trial protocol for an app-based physical activity intervention (i2be)

BMJ Open ◽  
2022 ◽  
Vol 12 (1) ◽  
pp. e053711
Author(s):  
Lili L Kókai ◽  
Diarmaid T Ó Ceallaigh ◽  
Anne I Wijtzes ◽  
Jeanine E Roeters van Lennep ◽  
Martin S Hagger ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomised Controlled Trial ◽  
Behaviour Change ◽  
Controlled Trial ◽  
Vigorous Physical Activity ◽  
Well Being ◽  
Behaviour Change Techniques ◽  
Automatic Processes ◽  
Post Intervention ◽  
Randomised Controlled

IntroductionEfficacy tests of physical activity interventions indicate that many have limited or short-term efficacy, principally because they do not sufficiently build on theory-based processes that determine behaviour. The current study aims to address this limitation.Methods and analysisThe efficacy of the 8-week intervention will be tested using a three-condition randomised controlled trial delivered through an app, in women with a prior hypertensive pregnancy disorder. The intervention is based on the integrated behaviour change model, which outlines the motivational, volitional and automatic processes that lead to physical activity. The mechanisms by which the behaviour change techniques lead to physical activity will be tested.Following stratification on baseline factors, participants will be randomly allocated in-app to one of three conditions (1:1:1). The information condition will receive information, replicating usual care. Additionally to what the information condition receives, the motivation condition will receive content targeting motivational processes. Additionally to what the motivation condition receives, the action condition will receive content targeting volitional and automatic processes.The primary outcome is weekly minutes of moderate-to-vigorous physical activity, as measured by an activity tracker (Fitbit Inspire 2). Secondary outcomes include weekly average of Fitbit-measured daily resting heart rate, and self-reported body mass index, waist-hip ratio, cardiorespiratory fitness and subjective well-being. Tertiary outcomes include self-reported variables representing motivational, volitional, and automatic processes. Outcome measures will be assessed at baseline, immediately post-intervention, and at 3 and 12 months post-intervention. Physical activity will also be investigated at intervention midpoint. Efficacy will be determined by available case analysis. A process evaluation will be performed based on programme fidelity and acceptability measures.Ethics and disseminationThe Medical Ethics Committee of the Erasmus MC has approved this study (MEC-2020-0981). Results will be published in peer reviewed scientific journals and presented at scientific conferences.Trial registration numberNetherlands trial register, NL9329.

scholarly journals Fidelity of primary care nurses’ delivery of a behaviour change intervention to enhance physical activity in chronic patients

2020 ◽  
Author(s):  
Heleen Westland ◽  
Jaap CA Trappenburg ◽  
Marieke J Schuurmans ◽  
Michelle Zonneveld ◽  
Carin D Schröder
Keyword(s):  
Physical Activity ◽  
Primary Care ◽  
Behaviour Change ◽  
Controlled Trial ◽  
Activity Level ◽  
Behaviour Change Techniques ◽  
High Fidelity ◽  
Chronic Patients ◽  
Quality Of Delivery

Abstract Background The effectiveness of a nurse-led intervention to enhance physical activity, the Activate intervention, was evaluated in primary care patients at risk for cardiovascular diseases in a cluster-randomised controlled trial (n = 195 patients, 31 general practices). To contribute to an accurate interpretation of the trial results, understanding of how the intervention works and enabling reproducibility, this study aimed to evaluate the fidelity of delivery of the Activate intervention by assessing: 1. self-reported fidelity of delivery; 2. observed fidelity of delivery; 3. quality of nurses’ delivery of the Activate intervention and 4. nurses’ beliefs about their capability, motivation, confidence and effectiveness towards delivering the Activate intervention, including behaviour change techniques. Methods An observational study was conducted. Nurses’ self-reported fidelity was evaluated using checklists (n = 279), and the observed fidelity and quality of delivery were examined using audio-recordings of intervention consultations (n = 44). Nurses’ beliefs towards delivering the intervention were assessed using questionnaires (n = 72). Results The self-reported fidelity was 87.6% and observed fidelity was 85.6%, representing high fidelity. The observed fidelity of applied behaviour change techniques was moderate (76.8%). The observed quality of delivery was sufficient and varied among nurses (mean 2.9; SD 4.4; range 0–4). Nurses’ beliefs about their capability, motivation, confidence and effectiveness towards delivering the intervention increased during the trial. Conclusions Nurses delivered most intervention components as intended with sufficient quality. Nurses believed they were capable, motivated and confident to deliver the intervention. They believed the intervention was effective to increase patients’ physical activity level. Despite the high fidelity and moderate fidelity of applied behaviour change techniques, the varying quality of delivery within and across nurses might have diluted the effectiveness of the Activate intervention. Trial registration: ClinicalTrials.gov NCT02725203 registered 31 March, 2016, https://clinicaltrials.gov/ct2/show/NCT02725203.

Supporting behaviour change in sedentary adults via real-time multidimensional physical activity feedback: A mixed-methods randomized controlled trial (Preprint)

2020 ◽  
Author(s):  
Max James Western ◽  
Martyn Standage ◽  
Oliver James Peacock ◽  
Thomas Edward Nightingale ◽  
Dylan Thompson
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Mixed Methods ◽  
Real Time ◽  
Behaviour Change ◽  
Controlled Trial ◽  
Post Intervention ◽  
Self Monitoring ◽  
Randomized Controlled

BACKGROUND Increasing physical activity (PA) behaviour remains a public health priority and wearable technology is increasingly being used to support behaviour change efforts. Using wearables to capture and provide comprehensive, visually persuasive, multidimensional feedback with realtime support may be a promising way to increase PA in inactive individuals. OBJECTIVE To test whether a six-week self-monitoring intervention using composite web-based multidimensional PA feedback with real-time daily support increased PA in adults. METHODS A six-week, mixed-methods, two-armed pilot randomized controlled trial (RCT) with six-week follow-up was used, whereby fifty-one low to moderately active (physical activity Level (PAL)<2.0) adults (mean age = 51.3 years; %female = 55) were randomly assigned to receive the self-monitoring intervention (n=36) or waiting-list control (n=15). Assessment of PA across multiple health-harnessing PA dimensions (e.g. PAL, weekly moderate-to-vigorous intensity physical activity (MVPA), sedentary time, steps), psychosocial cognitions (e.g. behavioral regulation, barrier self-efficacy, habit strength) and health were made at pre-randomisation baseline, 6 and 12 weeks. An exploratory analysis of mean difference and confidence intervals was made using the ANCOVA model. After the 12-week assessment intervention participants were interviewed to explore their views on the programme. RESULTS There were no notable differences in any PA outcome immediately post-intervention, but at 12-weeks moderate-to-large effects were observed with a mean (95% CI) difference in PAL of 0.09 (0.02 – 0.15), effect size (Hedges’ g)=0.8; daily moderate-intensity PA of 24 minutes (0 – 45), g=0.6; weekly MVPA of 195 minutes (58 – 331), g=0.8; and steps of 1545 (581 – 2553), g=0.7. Descriptive analyses suggested the differences in PA at 12 weeks were more pronounced in females, and participants with lower baseline PA levels. Immediately post intervention there were favourable difference in autonomous motivation, controlled motivation, perceived competence for PA, and barrier self-efficacy, with the latter sustained at follow-up. Qualitative data implied that the intervention washighly informative for participants and that the realtime feedback element was particularly useful in providing tangible, daily, behavioural support. CONCLUSIONS Using wearable trackers to capture and present sophisticated multidimensional PA feedback combined with discrete realtime support may be a useful way to facilitate changes in behaviour. Further investigation into the ways to optimise the use of wearables in inactive participants and test the efficacy of this approach via a robust study design is warranted. CLINICALTRIAL www.clinicaltrials.gov REF: NCT02432924

scholarly journals The Girls Active Project: a school-based intervention to increase adolescent girls’ physical activity

2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
S Mc Quinn ◽  
S Belton ◽  
A Staines ◽  
M Sweeney
Keyword(s):  
Physical Activity ◽  
Behaviour Change ◽  
Adolescent Girls ◽  
Patient Involvement ◽  
Activity Levels ◽  
School Based Intervention ◽  
School Based ◽  
Behaviour Change Wheel ◽  
Recommended Guidelines ◽  
Public And Patient Involvement

Abstract Background National and international evidence indicate that adolescent's physical activity (PA) participation rates are low. In Ireland, 93% of adolescent girls (vs 86% boys) do not reach recommended PA guidelines for health. Literature indicates that socio-economic status is a predictor of PA participation. The aim of this study was to work with a socio-economically disadvantaged school in Dublin (Ireland) and, using the behaviour change wheel (BCW) framework, design the components of a school-based intervention to increase adolescent girls' PA levels. Methods A circular development process was undertaken to collectively design the intervention in accordance with the steps recommended by the BCW. One all-girl, socio-economically disadvantaged post-primary school was invited to take part. Public and Patient Involvement (PPI), alongside a cross-sectional, mixed-methods study design, was used to identify the barriers and facilitators to PA using both quantitative questionnaires, and three semi-structured focus groups. Results Girls (n = 287) felt they would be more active in school if they had 'more time to do it' and they 'developed a habit of doing it'. The qualitative data identified influence of their peers, beliefs about their capabilities, setting goals and lack of reinforcement as additional themes. Just 1.4% of students in this sample self-reported meeting the recommended PA guidelines. The BCW design process, informed by the data, PPI members and research team resulted in the selection of specific intervention functions and behaviour change techniques. Conclusions The PA levels of adolescent girls are far below recommended guidelines for optimum health. Helping schools to fulfil their PA promoting role should be a public health priority. The BCW provided a systematic framework for developing a PA school-based intervention. The feasibility and preliminary efficacy of the Girls Active Project will be examined. Key messages Physical activity levels of adolescent girls in Ireland are far below recommended guidelines for health. Using Public and Patient Involvement, and the Behaviour Change Wheel provided a well-founded framework with which to develop a school-based intervention to improve Physical Activity levels.

scholarly journals Effect of mindfulness on physical activity in primary healthcare patients: a randomised controlled trial pilot study

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Peter Nymberg ◽  
Susanna Calling ◽  
Emelie Stenman ◽  
Karolina Palmér ◽  
Eva Ekvall Hansson ◽  
...  
Keyword(s):  
Physical Activity ◽  
Study Design ◽  
Controlled Trial ◽  
Dropout Rate ◽  
Activity Monitor ◽  
Activity Level ◽  
Self Report ◽  
Ethical Review ◽  
Mixed Effect ◽  
Registration Number

Abstract Increased physical activity can have health benefits among inactive individuals. In Sweden, the healthcare system uses physical activity on prescription (PAP) to motivate patients to increase their physical activity level. Mindfulness may further heighten the internal motivation to engage in physical activity. However, previous research has not demonstrated clear evidence of such an association. Aim Examine the feasibility of the study design as a preparation for a full-scale study, and examine the differences, between three interventions, in change over time in physical activity levels and in related variables. Method Comparison between three different interventions in an ordinary primary health care setting: PAP, mindfulness, and a combination of PAP and mindfulness. Physical activity was measured with self-report and ACTi Graph GT1X activity monitor. Statistical analysis was performed with a mixed-effect model to account for repeated observations and estimate differences both within groups and between groups at 3- and 6-months follow-up. Results Between September 2016 and December 2018, a total of 88 participants were randomised into three groups. The total dropout rate was 20.4%, the attendance rate to the mindfulness courses (52% > 6 times) and the web-based mindfulness training (8% > 800 min) was low according to the stated feasibility criteria. Eleven participants were excluded from analysis due to low activity monitor wear time. Neither the activity monitor data nor self-reported physical activity showed any significant differences between the groups. Conclusion The study design needs adjustment for the mindfulness intervention design before a fully scaled study can be conducted. A combination of PAP and mindfulness may increase physical activity and self-rated health more than PAP or mindfulness alone. Trial registration ClinicalTrials.gov, registration number NCT02869854. Regional Ethical Review Board in Lund registration number 2016/404.

scholarly journals Ambulatory oxygen for treatment of exertional hypoxaemia in pulmonary fibrosis (PFOX trial): a randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e040798
Author(s):  
Anne E Holland ◽  
Tamera Corte ◽  
Daniel C Chambers ◽  
Andrew J Palmer ◽  
Magnus Per Ekström ◽  
...  
Keyword(s):  
Physical Activity ◽  
Cost Effectiveness ◽  
Interstitial Lung Disease ◽  
Randomised Controlled Trial ◽  
Lung Disease ◽  
Oxygen Therapy ◽  
Controlled Trial ◽  
Activity Level ◽  
Anxiety And Depression ◽  
Randomised Controlled

IntroductionInterstitial lung diseases are characterised by scarring of lung tissue that leads to reduced transfer of oxygen into the blood, decreased exercise capacity and premature death. Ambulatory oxygen therapy may be used to treat exertional oxyhaemoglobin desaturation, but there is little evidence to support its efficacy and there is wide variation in clinical practice. This study aims to compare the clinical efficacy and cost-effectiveness of ambulatory oxygen versus ambulatory air in people with fibrotic interstitial lung disease and exertional desaturation.Methods and analysisA randomised, controlled trial with blinding of participants, clinicians and researchers will be conducted at trial sites in Australia and Sweden. Eligible participants will be randomised 1:1 into two groups. Intervention participants will receive ambulatory oxygen therapy using a portable oxygen concentrator (POC) during daily activities and control participants will use an identical POC modified to deliver air. Outcomes will be assessed at baseline, 3 months and 6 months. The primary outcome is change in physical activity measured by number of steps per day using a physical activity monitor (StepWatch). Secondary outcomes are functional capacity (6-minute walk distance), health-related quality of life (St George Respiratory Questionnaire, EQ-5D-5L and King’s Brief Interstitial Lung Disease Questionnaire), breathlessness (Dyspnoea-12), fatigue (Fatigue Severity Scale), anxiety and depression (Hospital Anxiety and Depression Scale), physical activity level (GENEActive), oxygen saturation in daily life, POC usage, and plasma markers of skeletal muscle metabolism, systematic inflammation and oxidative stress. A cost-effectiveness evaluation will also be undertaken.Ethics and disseminationEthical approval has been granted in Australia by Alfred Hospital Human Research Ethics Committee (HREC/18/Alfred/42) with governance approval at all Australian sites, and in Sweden (Lund Dnr: 2019-02963). The results will be published in peer-reviewed scientific journals, presented at conferences and disseminated to consumers in publications for lay audiences.Trial registration numberClinicalTrials.gov Registry (NCT03737409).

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