scholarly journals Effect of Increasing Levels of Web-Based Behavioral Support on Changes in Physical Activity, Diet, and Symptoms in Men With Prostate Cancer: Protocol for a Randomized Controlled Trial

10.2196/11257 ◽  
2018 ◽  
Vol 7 (11) ◽  
pp. e11257 ◽  
Author(s):  
Kerri M Winters-Stone ◽  
Stacey A Kenfield ◽  
Erin L Van Blarigan ◽  
Esther L Moe ◽  
Justin W Ramsdill ◽  
...  
2018 ◽  
Author(s):  
Kerri M Winters-Stone ◽  
Stacey A Kenfield ◽  
Erin L Van Blarigan ◽  
Esther L Moe ◽  
Justin W Ramsdill ◽  
...  

BACKGROUND More than 3.1 million men in the United States are prostate cancer survivors. These men may improve their physical function, quality of life, and potentially their prognosis by adopting healthier lifestyle habits. The internet provides a scalable mechanism to deliver advice and support about improving physical activity and dietary habits, but the feasibility and acceptability of a Web-based lifestyle intervention and the dose of support necessary to improve health behaviors are not yet known. OBJECTIVES The Community of Wellness is a Web-based intervention focused on supporting exercise and healthy dietary practices for men with prostate cancer. The objectives of this study were to determine the feasibility, acceptability, and preliminary efficacy of the Community of Wellness Web portal among prostate cancer survivors by conducting a randomized controlled trial (RCT) comparing 4 levels of additive Web-based content and interaction with participants: Level 1 (Teaching; Control), Level 2 (Teaching + Tailoring), Level 3 (Teaching + Tailoring + Technology), and Level 4 (Teaching + Tailoring + Technology + Touch). METHODS This is a single-blinded RCT comparing 3 levels of behavioral support within the Community of Wellness Web portal intervention (Levels 2 to 4) with each other and with the control condition (Level 1). The control condition receives general static Web-based educational information only on physical activity and dietary habits, self-efficacy for behavior change, motivation for physical activity, and changes in anxiety and treatment-related side effects. We will enroll and randomize 200 men with prostate cancer equally to 4 levels of the Community of Wellness Web-based intervention for 3 months (50 men per level). Surveys will be completed by self-report at baseline, 3 months (immediately postintervention), and 6 months (3 months postintervention). Feasibility and acceptability will be assessed by enrollment statistics, Web-based usage metrics, and surveys at the 3-month time point. We will also conduct focus groups after the postintervention follow-up assessment in a sample of enrolled participants to evaluate elements of usability and acceptability that cannot be obtained via surveys. RESULTS Enrollment is ongoing, with 124 enrolled. Study completion (6-month follow-up) is expected by July 2019. CONCLUSIONS The goal of the study is to identify the level of support that is feasible, acceptable, promotes behavior change, and improves health in men with prostate cancer to inform future efforts to scale the program for broader reach. CLINICALTRIAL ClinicalTrials.gov NCT03406013; https://clinicaltrials.gov/ct2/show/NCT03406013 (Archived by WebCite at http://www.webcitation.org/73YpDIoTX). INTERNATIONAL REGISTERED REPOR PRR1-10.2196/11257


2021 ◽  
Author(s):  
Erin K. Tagai ◽  
Suzanne M. Miller ◽  
Shawna V. Hudson ◽  
Michael A. Diefenbach ◽  
Elizabeth Handorf ◽  
...  

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Lena Violetta Krämer ◽  
Nadine Eschrig ◽  
Lena Keinhorst ◽  
Luisa Schöchlin ◽  
Lisa Stephan ◽  
...  

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


10.2196/15024 ◽  
2020 ◽  
Vol 22 (7) ◽  
pp. e15024
Author(s):  
Juul M J Coumans ◽  
Catherine A W Bolman ◽  
Anke Oenema ◽  
Lilian Lechner

Background Tailoring an online intervention to participant preferences (eg, by giving participants a choice which modules to follow) may increase engagement in the intervention, motivation for behavioral change, and possibly intervention effects. So far, little is known about what characteristics predict these module choices. Filling this knowledge gap is useful for optimizing program engagement. Objective We investigated participant choice for a dietary and/or physical activity (PA) promotion module in our web-based computer-tailored intervention based on self-determination theory (SDT) and motivational interviewing (MI). Furthermore, we investigated which demographic characteristics, current behavior, psychosocial constructs and constructs from SDT and MI, and program-related variables such as advice on which module to follow were associated with these choices. Methods Observational data were used from the randomized controlled trial MyLifestyleCoach of participants who were randomized into the intervention condition, completed the baseline questionnaire, and made a module choice in the opening session of the intervention. Here, they received advice on their own dietary and PA behavior. At the session’s end, they chose which lifestyle modules they would like to follow (both, diet, PA, or no module). Measurements included demographic information; self-reported diet and PA; and several psychosocial, SDT, and MI constructs. In total, data from 619 Dutch adults (59.6% women; mean age was 51.9 [SD 13.5] years) were analyzed. A stepwise multinomial logistic regression analysis was conducted to investigate which characteristics are related to module choice; the diet module served as reference category as almost everyone was advised to follow this module. Results Of this sample, 54.8% (339/619) chose to do both the diet and PA module, 25.4% (157/619) chose to follow the diet module, 17.8% (110/619) preferred to follow no module, and 2.1% (13/619) chose to do the PA module only. Furthermore, it was found that older people, those who consumed more fruit, and those who scored lower on importance to change their current diet were more likely to choose no module compared to the diet module. People who had more motivation to change their current PA and those who received strong advice compared with slight advice to follow the diet module were more likely to choose both modules compared with the diet module only. Conclusions The results show that more than half of the sample was interested in following both the diet and PA module in this online lifestyle intervention. Several characteristics were found to be related to module choice. A future challenge is to examine how this knowledge can be used to improve future interventions, such as tailoring (messages or content) on specific groups or examining where and how MI could be used to motivate people to make a certain module choice. Trial Registration Netherlands Trial Register NL7333; https://www.trialregister.nl/trial/7333


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