Promoting physical activity in regional and remote cancer survivors (PPARCS) using wearables and health coaching: randomised controlled trial protocol

IntroductionPhysically active cancer survivors have substantially less cancer recurrence and improved survival compared with those who are inactive. However, the majority of survivors (70%–90%) are not meeting the physical activity (PA) guidelines. There are also significant geographic inequalities in cancer survival with poorer survival rates for the third of Australians who live in non-metropolitan areas compared with those living in major cities. The primary objective of the trial is to increase moderate-to-vigorous PA (MVPA) among cancer survivors living in regional and remote Western Australia. Secondary objectives are to reduce sedentary behaviour and in conjunction with increased PA, improve quality of life (QoL) in non-metropolitan survivors. Tertiary objectives are to assess the effectiveness of the health action process approach (HAPA) model variables, on which the intervention is based, to predict change in MVPA.Methods and analysisEighty-six cancer survivors will be randomised into either the intervention or control group. Intervention group participants will receive a Fitbit and up to six telephone health-coaching sessions. MVPA (using Actigraph), QoL and psychological variables (based on the HAPA model via questionnaire) will be assessed at baseline, 12 weeks (end of intervention) and 24 weeks (end of follow-up). A general linear mixed model will be used to assess the effectiveness of the intervention.Ethics and disseminationEthics approval has been obtained from St John of God Hospital Subiaco (HREC/#1201). We plan to submit a manuscript of the results to a peer-reviewed journal. Results will be presented at conferences, community and consumer forums and hospital research conferences.Trial registration numberACTRN12618001743257; pre-results, U1111-1222-5698

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The Use of Telehealth Technology in Assessing the Accuracy of Self-Reported Weight and the Impact of a Daily Immediate-Feedback Intervention among Obese Employees

International Journal of Telemedicine and Applications ◽

10.1155/2011/909248 ◽

2011 ◽

Vol 2011 ◽

pp. 1-6 ◽

Cited By ~ 4

Author(s):

Nicolaas P. Pronk ◽

A. Lauren Crain ◽

Jeffrey J. VanWormer ◽

Brian C. Martinson ◽

Jackie L. Boucher ◽

...

Keyword(s):

Body Weight ◽

Mixed Model ◽

Linear Mixed Model ◽

Controlled Trial ◽

Intervention Group ◽

Study Groups ◽

Outcome Variable ◽

Control Group ◽

Immediate Feedback ◽

The Impact

Objective.To determine the accuracy of self-reported body weight prior to and following a weight loss intervention including daily self-weighing among obese employees.Methods.As part of a 6-month randomized controlled trial including a no-treatment control group, an intervention group received a series of coaching calls, daily self-weighing, and interactive telemonitoring. The primary outcome variable was the absolute discrepancy between self-reported and measured body weight at baseline and at 6 months. We used general linear mixed model regression to estimate changes and differences between study groups over time.Results.At baseline, study participants underreported their weight by an average of 2.06 (se=0.33) lbs. The intervention group self-reported a smaller absolute body weight discrepancy at followup than the control group.Conclusions.The discrepancy between self-reported and measured body weight appears to be relatively small, may be improved through daily self-monitoring using immediate-feedback telehealth technology, and negligibly impacts change in body weight.

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Increasing physical activity in cancer survivors at cardiovascular risk using Fitbits: Randomized controlled trial.

Journal of Clinical Oncology ◽

10.1200/jco.2018.36.7_suppl.93 ◽

2018 ◽

Vol 36 (7_suppl) ◽

pp. 93-93

Author(s):

Chloe Marie Maxwell-Smith ◽

Paul Andrew Cohen ◽

Cameron Platell ◽

Patrick Tan ◽

Jason Tan ◽

...

Keyword(s):

Physical Activity ◽

Cardiovascular Risk ◽

Cancer Survivors ◽

Mixed Model ◽

Linear Mixed Model ◽

Controlled Trial ◽

Behavioural Change ◽

Action Planning ◽

Phone Call ◽

Accelerometer Data

93 Background: Efforts to increase physical activity in cancer survivors have typically been facility-based, and results have generally not been durable. Home-based interventions provide a more feasible option, and are likely to produce longer-lasting benefits. Wearable trackers present a novel opportunity for monitoring physical activity in a practical way. The Health Action Process Approach model suggests that strategies such as action-planning and overcoming barriers may be effective for transitioning individuals from intention to behavioural change. This trial aims to increase physical activity in cancer survivors at cardiovascular risk, by implementing a 24-week self-monitoring and action-planning intervention using Fitbits. Methods: Sixty-eight cancer survivors were recruited to participate in the trial. Eligibility criteria included: insufficiently physically active, presence of cardiovascular risk factors, and completion of active cancer treatment in the five years prior to recruitment. Trial assessments are performed at baseline, 12-weeks, and 24-weeks, and measure physical activity (using 7-day accelerometer data), BMI, blood pressure, physical activity attitudes, barriers and perceived outcomes. Participants were randomly allocated to treatment and control groups, following the baseline assessment. Each participant in the treatment group was given a Fitbit Alta to monitor activity for the 24-week trial, attended two 2-hour group sessions involving goal-setting and action-planning activities, and a follow-up phone call to ensure program adherence. Results: Data collection is currently underway. Data analysis will use the Group x Time interaction from a General Linear Mixed Model analysis. Conclusions: As the population of cancer survivors is largely inactive and at cardiovascular risk, interventions are warranted. Specifically, physical activity interventions that are feasible, have robust theoretical underpinnings, and suit the preferences of cancer survivors post-treatment, show promise as a long-term solution. Clinical trial information: 2617000131358.

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The Effects of a Comprehensive, Integrated Obesity Prevention Intervention Approach (SuperFIT) on Children’s Physical Activity, Sedentary Behavior, and BMI Z-Score

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph16245016 ◽

2019 ◽

Vol 16 (24) ◽

pp. 5016 ◽

Cited By ~ 2

Author(s):

Ilona van de Kolk ◽

Sanne M. P. L. Gerards ◽

Lisa S. E. Harms ◽

Stef P. J. Kremers ◽

Jessica S. Gubbels

Keyword(s):

Physical Activity ◽

Sedentary Behavior ◽

Mixed Model ◽

Linear Mixed Model ◽

Intervention Group ◽

Integrated Approach ◽

Control Group ◽

Z Score ◽

Intervention Approach

SuperFIT is a comprehensive, integrated intervention approach aimed at promoting healthy energy balance-related behaviors in 2- to 4-year-old children in the preschool and home settings. A quasi-experimental research design was adopted to evaluate the effects of SuperFIT on physical activity (PA), sedentary behavior (SB) and Body Mass Index (BMI) z-score. Children could participate in the preschool-based and family-based component (full intervention) or only in the preschool-based component (partial intervention). Children’s PA levels and SB were assessed with accelerometers and observations, and height and weight were measured for the BMI z-score. Measurements were performed at baseline and two follow-up time points. Effectiveness was evaluated using linear mixed-model analyses, correcting for relevant covariates. Healthy changes in PA levels occurred within all study groups over time. No significant differences were found in overall PA levels between the intervention groups and control group at both follow-ups. Nevertheless, sedentary behavior decreased more in the full intervention group (effect size (ES): −0.62), and moderate-to-vigorous PA (ES: 0.85) and counts per minute (ES: 0.45) increased more compared to the control group on preschool days at the first follow-up. No effects were found for BMI z-score. The integrated approach of SuperFIT may induce changes in PA of young children, although the effects were small.

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Investigating the Impact of Cognitive Training for Individuals With Bothersome Tinnitus: A Randomized Controlled Trial

Otolaryngology ◽

10.1177/0194599821994742 ◽

2021 ◽

pp. 019459982199474

Author(s):

Maggie Xing ◽

Dorina Kallogjeri ◽

Jay F. Piccirillo

Keyword(s):

Randomized Controlled Trial ◽

Cognitive Training ◽

Mixed Model ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Functional Index ◽

Open Label ◽

Randomized Controlled ◽

The Impact

Objective To evaluate the effectiveness of cognitive training in improving tinnitus bother and to identify predictors of patient response. Study Design Prospective open-label randomized controlled trial. Setting Online. Methods Participants were adults with subjective idiopathic nonpulsatile tinnitus causing significant tinnitus-related distress. The intervention group trained by using auditory-intensive exercises for 20 minutes per day, 5 days per week, for 8 weeks. The active control group trained on the same schedule with non–auditory intensive games. Surveys were completed at baseline, 8 weeks, and 12 weeks. Results A total of 64 participants completed the study. The median age was 63 years (range, 25-69) in the intervention group and 61 years (34-68) in the control group. Mixed model analysis revealed that within-subject change in Tinnitus Functional Index in the intervention group was not different than the control group, with marginal mean differences (95% CI): 0.24 (–11.20 to 10.7) and 2.17 (–8.50 to 12.83) at 8 weeks and 2.33 (–8.6 to 13.3) and 3.36 (–7.91 to 14.6) at 12 weeks, respectively. When the 2 study groups were compared, the control group had higher Tinnitus Functional Index scores than the intervention group by 10.5 points at baseline (95% CI, –0.92 to 29.89), 8.1 at 8 weeks (95% CI, –3.27 to 19.42), and 9.4 at 12 weeks (95% CI, –2.45 to 21.34). Conclusion Auditory-intensive cognitive training was not associated with changes in self-reported tinnitus bother. Given the potential for neuroplasticity to affect tinnitus, we believe that future studies on cognitive training for tinnitus remain relevant.

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A Randomized Controlled Trial Evaluating Integrative Psychotherapeutic Group Treatment Compared to Self-Help Groups in Functional Vertigo/Dizziness

Journal of Clinical Medicine ◽

10.3390/jcm10102215 ◽

2021 ◽

Vol 10 (10) ◽

pp. 2215

Author(s):

Karina Limburg ◽

Katharina Radziej ◽

Heribert Sattel ◽

Peter Henningsen ◽

Marianne Dieterich ◽

...

Keyword(s):

Group Treatment ◽

Mixed Model ◽

Linear Mixed Model ◽

Controlled Trial ◽

Clinical Psychologist ◽

Control Group ◽

Attrition Rates ◽

Randomized Controlled ◽

Self Help ◽

Self Help Groups

We tested the efficacy of an integrative psychotherapeutic group treatment (IPGT) in reducing vertigo/dizziness-related impairment along with depression, anxiety, and somatization by conducting a randomized controlled superiority trial comparing IPGT to self-help groups moderated by a clinical psychologist (SHG). Adult patients with functional vertigo and dizziness symptoms were randomly allocated to either the IPGT or SHG as active control group. Outcomes were assessed at baseline (t0), after treatment lasting 16 weeks (t1), and 12 months after treatment (t2). A total of 81 patients were assigned to IPGT and 78 patients were assigned to SHG. Vertigo-related impairment was reduced in both conditions (IPGT: t0–t1: d = 1.10, t0–t2: d = 1.06; SHG: t0–t1: d = 0.86, t0–t2: d = 1.29), showing the efficiency of both IPGT and SHG. Clinically relevant improvements were also obtained for depression in both groups. Linear mixed model analyses revealed no differences between groups for all outcomes (effect of group for the primary outcome: b = −1.15, SE = 2.13, t = −0.54, p = 0.59). Attrition rates were higher in SHG (52.6%) than in IPGT (28.4%). Both conditions improved primary and secondary outcomes while IPGT was better accepted by patients than SHG. Trial registration: ClinicalTrials.gov, Identifier: NCT02320851.

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Influence of physical activity on periodontal health in patients with type 2 diabetes mellitus. A blinded, randomized, controlled trial

Clinical Oral Investigations ◽

10.1007/s00784-021-03908-6 ◽

2021 ◽

Author(s):

K. Wernicke ◽

J. Grischke ◽

M. Stiesch ◽

S. Zeissler ◽

K. Krüger ◽

...

Keyword(s):

Physical Activity ◽

Diabetes Mellitus ◽

Type 2 Diabetes ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Periodontal Health ◽

Randomized Controlled ◽

Hba1c Levels

Abstract Objectives The aim was to investigate the effect of physical activity on periodontal health and HbA1c levels in patients with type 2 diabetes mellitus (T2DM) over a period of 6 months. Materials and methods Thirty-seven patients with non-insulin-dependent T2DM were included in the study. The intervention group (n=20) performed physical activity over a period of 6 months. The control group (n=17) did not receive any intervention. Baseline and final examinations included dental parameters and concentrations of glycosylated hemoglobin (HbA1c) and high-sensitivity C-reactive protein (hsCRP). Results Physical activity showed a positive effect on periodontal health. Both the BOP (p= 0.005) and the severity of periodontitis (p= 0.001) were significantly reduced in the intervention group compared to the control group. Furthermore, HbA1c levels were reduced (p= 0.010) significantly in the intervention group while hsCRP levels significantly increased in the control group (p= 0.04). Conclusions Within the limitations of this randomized, controlled trial, physical activity over a period of 6 months is a health-promoting measure for patients with T2DM and improves both periodontal health and HbA1c concentrations.

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A randomised feasibility trial of an employer-based intervention for enhancing successful return to work of cancer survivors (MiLES intervention)

BMC Public Health ◽

10.1186/s12889-021-11357-9 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

M. A. Greidanus ◽

A. E. de Rijk ◽

A. G. E. M. de Boer ◽

M. E. M. M. Bos ◽

P. W. Plaisier ◽

...

Keyword(s):

Return To Work ◽

Cancer Survivors ◽

Controlled Trial ◽

Intervention Group ◽

Work Outcomes ◽

Feasibility Trial ◽

Control Group ◽

Secondary Effect ◽

Quality Of Working Life ◽

Randomised Controlled

Abstract Background Employers express a need for support during sickness absence and return to work (RTW) of cancer survivors. Therefore, a web-based intervention (MiLES) targeted at employers with the objective of enhancing cancer survivors’ successful RTW has been developed. This study aimed to assess feasibility of a future definitive randomised controlled trial (RCT) on the effectiveness of the MiLES intervention. Also preliminary results on the effectiveness of the MiLES intervention were obtained. Methods A randomised feasibility trial of 6 months was undertaken with cancer survivors aged 18–63 years, diagnosed with cancer < 2 years earlier, currently in paid employment, and sick-listed < 1 year. Participants were randomised to an intervention group, with their employer receiving the MiLES intervention, or to a waiting-list control group (2:1). Feasibility of a future definitive RCT was determined on the basis of predefined criteria related to method and protocol-related uncertainties (e.g. reach, retention, appropriateness). The primary effect measure (i.e. successful RTW) and secondary effect measures (e.g. quality of working life) were assessed at baseline and 3 and 6 months thereafter. Results Thirty-five cancer survivors were included via medical specialists (4% of the initially invited group) and open invitations, and thereafter randomised to the intervention (n = 24) or control group (n = 11). Most participants were female (97%) with breast cancer (80%) and a permanent employment contract (94%). All predefined criteria for feasibility of a future definitive RCT were achieved, except that concerning the study’s reach (90 participants). After 6 months, 92% of the intervention group and 100% of the control group returned to work (RR: 0.92, 95% CI: 0.81–1.03); no difference were found with regard to secondary effect measures. Conclusions With the current design a future definitive RCT on the effectiveness of the MiLES intervention on successful RTW of cancer survivors is not feasible, since recruitment of survivors fell short of the predefined minimum for feasibility. There was selection bias towards survivors at low risk of adverse work outcomes, which reduced generalisability of the outcomes. An alternative study design is needed to study effectiveness of the MiLES intervention. Trial registration The study has been registered in the Dutch Trial Register (NL6758/NTR7627).

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Effects of exercise in breast cancer patients: implications of the trials within cohorts (TwiCs) design in the UMBRELLA Fit trial

Breast Cancer Research and Treatment ◽

10.1007/s10549-021-06363-9 ◽

2021 ◽

Author(s):

Roxanne Gal ◽

Evelyn M. Monninkhof ◽

Carla H. van Gils ◽

Rolf H. H. Groenwold ◽

Sjoerd G. Elias ◽

...

Keyword(s):

Breast Cancer ◽

Physical Activity ◽

Beneficial Effect ◽

Cancer Survivors ◽

Breast Cancer Survivors ◽

Exercise Intervention ◽

Intervention Group ◽

Control Group ◽

Physical Fatigue ◽

Trials Within Cohorts

Abstract Purpose The Trials within Cohorts (TwiCs) design aims to overcome problems faced in conventional RCTs. We evaluated the TwiCs design when estimating the effect of exercise on quality of life (QoL) and fatigue in inactive breast cancer survivors. Methods UMBRELLA Fit was conducted within the prospective UMBRELLA breast cancer cohort. Patients provided consent for future randomization at cohort entry. We randomized inactive patients 12–18 months after cohort enrollment. The intervention group (n = 130) was offered a 12-week supervised exercise intervention. The control group (n = 130) was not informed and received usual care. Six-month exercise effects on QoL and fatigue as measured in the cohort were analyzed with intention-to-treat (ITT), instrumental variable (IV), and propensity scores (PS) analyses. Results Fifty-two percent (n = 68) of inactive patients accepted the intervention. Physical activity increased in patients in the intervention group, but not in the control group. We found no benefit of exercise for dimensions of QoL (ITT difference global QoL: 0.8, 95% CI = − 2.2; 3.8) and fatigue, except for a small beneficial effect on physical fatigue (ITT difference: − 1.1, 95% CI = − 1.8; − 0.3; IV: − 1.9, 95% CI = − 3.3; − 0.5, PS: − 1.2, 95% CI = − 2.3; − 0.2). Conclusion TwiCs gave insight into exercise intervention acceptance: about half of inactive breast cancer survivors accepted the offer and increased physical activity levels. The offer resulted in no improvement on QoL, and a small beneficial effect on physical fatigue. Trial registration Netherlands Trial Register (NTR5482/NL.52062.041.15), date of registration: December 07, 2015.

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How COVID-19 lockdown and reopening affected daily steps: evidence based on 164,630 person-days of prospectively collected data from Shanghai, China

International Journal of Behavioral Nutrition and Physical Activity ◽

10.1186/s12966-021-01106-x ◽

2021 ◽

Vol 18 (1) ◽

Author(s):

Ding Ding ◽

Minna Cheng ◽

Borja del Pozo Cruz ◽

Tao Lin ◽

Shuangyuan Sun ◽

...

Keyword(s):

Physical Activity ◽

At Risk ◽

Body Composition ◽

Mixed Model ◽

Linear Mixed Model ◽

University Education ◽

Control Group ◽

Daily Step ◽

Step Counts ◽

Reduced Physical Activity

Abstract Background COVID-19 lockdowns may lead to physical inactivity, a major risk factor for non-communicable diseases. This study aims to determine: 1) the trajectory in daily step counts before, during and after the lockdown in China, and 2) the characteristics associated with the trajectories. Methods From December 2019 to July 2020, smartphone-based step counts were continuously collected in 815 Chinese adults residing in Shanghai over 202 days across three phases: before, during, and after the lockdown. Participant characteristics were reported, and height, weight and body composition measured before the lockdown. A ‘sharp’ regression discontinuity design with cluster robust standard errors was used to test the effect of the lockdown and reopening on daily steps and a linear mixed model was used to examine the characteristics associated with trajectories during the observed period. Results Based on 164,630 person-days of data, we found a sharp decline in daily step counts upon the lockdown (24/01/2020) by an average of 3796 (SE = 88) steps, followed by a significant trend of increase by 34 steps/day (SE = 2.5; p < .001) until the end of the lockdown (22/03/2020). This increasing trend continued into the reopening phase at a slower rate of 5 steps per day (SE = 2.3; p = 0.029). Those who were older, married, university educated, insufficiently active, had an ‘at risk’ body composition, and those in the control group, were slower at recovering step counts during the lockdown, and those who were older, married, without university education and with an ‘at risk’ body composition recovered step counts at a slower pace after the reopening. Conclusions Despite later increases in step counts, COVID-19 lockdown led to a sustained period of reduced physical activity, which may have adverse health implications. Governments and health professionals around the world should continue to encourage and facilitate physical activity during the pandemic.

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Effectiveness of a psychological online training to promote physical activity among students: protocol of a randomized-controlled trial

Trials ◽

10.1186/s13063-021-05333-2 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Lena Violetta Krämer ◽

Nadine Eschrig ◽

Lena Keinhorst ◽

Luisa Schöchlin ◽

Lisa Stephan ◽

...

Keyword(s):

Physical Activity ◽

Randomized Controlled Trial ◽

Mixed Model ◽

Controlled Trial ◽

Control Group ◽

Web Based ◽

Intention To Treat ◽

Randomized Controlled ◽

Link Type

Abstract Background Many students in Germany do not meet recommended amounts of physical activity. In order to promote physical activity in students, web-based interventions are increasingly implemented. Yet, data on effectiveness of web-based interventions in university students is low. Our study aims at investigating a web-based intervention for students. The intervention is based on the Health Action Process Approach (HAPA), which discriminates between processes of intention formation (motivational processes) and processes of intention implementation (volitional processes). Primary outcome is change in physical activity; secondary outcomes are motivational and volitional variables as proposed by the HAPA as well as quality of life and depressive symptoms. Methods A two-armed randomized controlled trial (RCT) of parallel design is conducted. Participants are recruited via the internet platform StudiCare (www.studicare.com). After the baseline assessment (t1), participants are randomized to either intervention group (immediate access to web-based intervention) or control group (access only after follow-up assessment). Four weeks later, post-assessment (t2) is performed in both groups followed by a follow-up assessment (t3) 3 months later. Assessments take place online. Main outcome analyses will follow an intention-to-treat principle by including all randomized participants into the analyses. Outcomes will be analysed using a linear mixed model, assuming data are missing at random. The mixed model will include group, time, and the interaction of group and time as fixed effects and participant and university as random effect. Discussion This study is a high-quality RCT with three assessment points and intention-to-treat analysis meeting the state-of-the-art of effectiveness studies. Recruitment covers almost 20 universities in three countries, leading to high external validity. The results of this study will be of great relevance for student health campaigns, as they reflect the effectiveness of self-help interventions for young adults with regard to behaviour change as well as motivational and volitional determinants. From a lifespan perspective, it is important to help students find their way into regular physical activity. Trial registration The German clinical trials register (DRKS) DRKS00016889. Registered on 28 February 2019

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