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Accelerometer-based assessment of physical activity within the Fun For Wellness online behavioral intervention: protocol for a feasibility study.

ABSTRACT: Background:Fun For Wellness (FFW) is an online behavioral intervention designed to promote growth in well-being and physical activity by providing capability-enhancing learning opportunities to participants. The conceptual framework for the FFW intervention is guided by self-efficacy theory. Evidence has been provided for the efficacy of FFW to promote self-reported free-living physical well-being actions in adults who comply with the intervention. The objective of this manuscript is to describe the protocol for a feasibility study designed to address uncertainties regarding the inclusion of accelerometer-based assessment of free-living physical activity within the FFW online intervention among adults with obesity in the United States of America (USA). Method:The study design is a prospective, double-blind, parallel group randomized pilot trial. Thirty participants will be randomly assigned to the FFW or usual care (UC) group to achieve a 1:1 group (i.e., FFW:UC) assignment. Recruitment of participants is scheduled to begin on 29 April 2019 at a local bariatric services center within a major healthcare organization in the Midwest of the USA. There are five eligibility criteria for participation in this study: (1) between 18 and 64?years old, (2) a body mass index ??25.00?kg/m2, (3) ability to access the online intervention, (4) the absence of simultaneous enrollment in another intervention program promoting physical activity, and (5) willingness to comply with instructions for physical activity monitoring. Eligibility verification and data collection will be conducted online. Three waves of data will be collected over a 13-week period. Instruments designed to measure demographic information, anthropometric characteristics, acceptability and feasibility of accelerometer-based assessment of physical activity, self-efficacy, and well-being will be included in the study. Data will be analyzed using descriptive statistics (e.g., recruitment rates), Pearson's correlation coefficient, Bland-Altman analyses, and inferential statistical models under both an intent to treat approach and a complier average causal effect approach. Discussion:Results are intended to inform the preparation of a future definitive randomized controlled trial. Trial registration:ClinicalTrials.gov, NCT03906942, registered 8 April 2019. Trial funding:The Erwin and Barbara Mautner Charitable Foundation and the Michigan State University College of Education.

SUBMITTER: Myers ND

PROVIDER: S-EPMC6544927 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Accelerometer-based assessment of physical activity within the Fun For Wellness online behavioral intervention: protocol for a feasibility study.

Myers Nicholas D ND Lee Seungmin S Bateman André G AG Prilleltensky Isaac I Clevenger Kimberly A KA Pfeiffer Karin A KA Dietz Samantha S Prilleltensky Ora O McMahon Adam A Brincks Ahnalee M AM

Pilot and feasibility studies 20190531

<h4>Background</h4>Fun For Wellness (FFW) is an online behavioral intervention designed to promote growth in well-being and physical activity by providing capability-enhancing learning opportunities to participants. The conceptual framework for the FFW intervention is guided by self-efficacy theory. Evidence has been provided for the efficacy of FFW to promote self-reported free-living physical well-being actions in adults who comply with the intervention. The objective of this manuscript is to ...[more]

PMID: 31164990

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Project description:BackgroundFun For Wellness (FFW) is an online behavioral intervention developed to encourage growth in well-being by providing capability-enhancing learning opportunities to participants. Self-efficacy theory guides the conceptual model underlying the FFW intervention. Some initial evidence has been provided for the efficacy of FFW to promote: well-being self-efficacy; interpersonal, community, psychological and economic subjective well-being; and, interpersonal and physical well-being actions. The purpose of this paper is to describe the protocol for a new randomized controlled trial (RCT) designed to provide the first investigation of the effectiveness of FFW to increase well-being and physical activity in adults with obesity in the United States of America.MethodsThe study design is a large-scale, prospective, parallel group RCT. Approximately 9 hundred participants will be randomly assigned to the FFW or Usual Care (UC) group to achieve a 1:1 group (i.e., ffwUC) assignment. Participants will be recruited through an online panel recruitment company. Data collection, including determination of eligibility, will be conducted online and enrollment is scheduled to begin on 8 August 2018. Data collection will occur at baseline, 30 days and 60 days after baseline. Instruments to measure demographic information, anthropometric characteristics, self-efficacy, physical activity and well-being will be included in the battery. Data will be modeled under an intent to treat approach and/or a complier average causal effect approach depending on the level of observed engagement with the intervention.DiscussionThe effectiveness trial described in this paper builds upon the 2015 FFW efficacy trial and has the potential to be important for at least three reasons. The first reason is based upon a general scientific approach that the potential utility of interventions should be evaluated under both ideal (e.g., more controlled) and real-world (e.g., less controlled) conditions. The second reason is based upon the global need for readily scalable online behavioral interventions that effectively promote physical activity in adults. The third reason is based upon the troubling global trend toward obesity along with evidence for obesity as a risk factor for several major non-communicable diseases.Trial registrationClinicalTrials.gov, identifier: NCT03194854 , registered 21 June 2017.

Project description:BACKGROUND:Insufficient physical activity in the adult population is a global pandemic. Fun for Wellness (FFW) is a self-efficacy theory- and Web-based behavioral intervention developed to promote growth in well-being and physical activity by providing capability-enhancing opportunities to participants. OBJECTIVE:This study aimed to evaluate the effectiveness of FFW to increase physical activity in adults with obesity in the United States in a relatively uncontrolled setting. METHODS:This was a large-scale, prospective, double-blind, parallel-group randomized controlled trial. Participants were recruited through an online panel recruitment company. Adults with overweight were also eligible to participate, consistent with many physical activity-promoting interventions for adults with obesity. Also consistent with much of the relevant literature the intended population as simply adults with obesity. Eligible participants were randomly assigned to the intervention (ie, FFW) or the usual care (ie, UC) group via software code that was written to accomplish equal allocations to the FFW and UC groups. Data collection was Web based, fully automated, and occurred at three time points: baseline, 30 days after baseline (T2), and 60 days after baseline (T3). Participants (N=461) who were assigned to the FFW group (nFFW=219) were provided with 30 days of 24-hour access to the Web-based intervention. A path model was fit to the data consistent with the FFW conceptual model for the promotion of physical activity. RESULTS:There was evidence for a positive direct effect of FFW on transport-related physical activity self-efficacy (beta=.22, P=.02; d=0.23), domestic-related physical activity self-efficacy (beta=.22, P=.03; d=0.22), and self-efficacy to regulate physical activity (beta=.16, P=.01; d=0.25) at T2. Furthermore, there was evidence for a positive indirect effect of FFW on physical activity at T3 through self-efficacy to regulate physical activity at T2 (beta=.42, 95% CI 0.06 to 1.14). Finally, there was evidence for a null direct effect of FFW on physical activity (beta=1.04, P=.47; d=0.07) at T3. CONCLUSIONS:This study provides some initial evidence for both the effectiveness (eg, a positive indirect effect of FFW on physical activity through self-efficacy to regulate physical activity) and the ineffectiveness (eg, a null direct effect of FFW on physical activity) of the FFW Web-based behavioral intervention to increase physical activity in adults with obesity in the United States. More broadly, FFW is a scalable Web-based behavioral intervention that may effectively, although indirectly, promote physical activity in adults with obesity and therefore may be useful in responding to the global pandemic of insufficient physical activity in this at-risk population. Self-efficacy to regulate physical activity appears to be a mechanism by which FFW may indirectly promote physical activity in adults with obesity. TRIAL REGISTRATION:ClinicalTrials.gov, identifier: NCT03194854; https://clinicaltrials.gov/ct2/show/NCT03194854.

Project description:Background/Aims: Increasing concerns about cognitive decline and dementia in the aging populations of most westernized countries suggests the need for interventions that can preserve cognitive function, are cost-effective, and feasibly implemented on a large scale. Empirical evidence is accumulating that points to the potential beneficial effects of cardiovascular fitness, healthy diet, social integration and participation in cognitively stimulating activities in the maintenance of cognitive function. We have developed and pilot tested ?Passport,? a multi-component, cognitive-behavioral, phone and mail based intervention to promote such lifestyle changes in older adults.Methods: Cognitively intact (TICS ? 31), sedentary (<90 min physical activity[PA] per week) adults aged 61?80 years were recruited from among HealthPartners? members. Baseline assessments included cognitive function, biomarkers, lifestyle factors, and physical traits. In the first phase, 21 participants were recruited and all assigned (non-randomized) to receive a course book, pedometer, tool kit and 7 bi-weekly phone coaching calls. In the second phase, 42 participants were recruited and randomized to either the Guided Intervention (n=22) or a Self-Directed (n=20) group, who received the study materials but no coaching. We completed 6 month follow-up measures with 58 (92%) subjects, and report here on their PA and nutritional outcomes.Results: The 63 enrolled subjects were female (60%), 70 years old, highly educated (73% college or more), predominantly retired (81%), non-Hispanic White (71%;) and married (65%). On average, they were overweight, BMI M=29.8, normotensive, systolic BP M=122.8, and normocholesterolemic, total serum cholesterol M=189.3. Mixed-model analyses indicated a time*treatment group effect on objectively monitored MVPA (p<.05), with a significant increase in the guided group (7.3 to 16.5mins/day, p<.05). We observed a significant effect of time on saturated fat intake (p<.05), with a significant pre-post reduction among Guided participants (26.1 to 23.4 grams, p<.05). Similar patterns of effects were observed for intake of fruits, vegetables and dietary fiber. Finally, we observed a time effect on intake of fish high in omega-3 fatty acids, driven by an increase in the non-randomized group (p<.05).Conclusions: Passport shows promise for improving aspects of lifestyle behaviors hypothesized to be important for the primary prevention of cognitive decline in older adults.

Project description:Despite the extensive evidence on the benefits of physical activity (PA) in older adults, including reduced risk of disease, mortality, falls, and cognitive and functional decline, most do not attain sufficient PA levels. Theoretical work suggests that behavioral change interventions are most effective during life transitions, and as such, a theory-based, online intervention tailored for recently retired and empty nest individuals could lend support for increasing levels of PA. The aim of this study is to examine the feasibility of the intervention and study procedures for a future controlled trial. This study has a randomized controlled trial design with an embedded qualitative and quantitative process evaluation. Participants are randomized at 1:1 between the intervention and waitlist controls. Potential participants are within six months of their final child leaving the familial home or within six months of retiring (self-defined), currently not meeting the Canadian PA guidelines, have no serious contraindications to exercise, and are residing in Victoria, British Columbia, Canada. Participants are recruited by online and print flyers as well as in-person at community events. The study aims to recruit 40 empty nest and 40 retired participants; half of each group received the intervention during the study period. The internet-delivered intervention is delivered over a 10-week period, comprising 10 modules addressing behavior change techniques associated with PA. Primary outcomes relate to recruitment, attrition, data collection, intervention delivery, and acceptability. Secondary behavioral outcomes are measured at baseline and post-treatment (10 weeks). Intervention-selected participants are invited to an optional qualitative exit interview. The results of this feasibility study will inform the planning of a randomized effectiveness trial, that will examine the behavior change, health-related fitness, and well-being outcomes by exploring how reflexive processes of habit and identity may bridge adoption and maintenance in behavioral adherence.

Project description:BackgroundLow physical activity levels and poor physical functioning are strongly associated with poor clinical outcomes and mortality in adult kidney failure patients, regardless of treatment modality. Compared with the general population, individuals with chronic kidney disease are physically inactive, have reduced physical abilities and difficulties performing routine daily tasks, lower health-related quality of life, and higher cardiovascular morbidity and mortality. In addition, frail kidney failure patients have higher hospitalization and mortality rates as compared with other kidney failure patients. Evidence suggests that assessment and recommendations for physical activity should be part of standard care for kidney failure patients. Structured exercise can improve physical function and quality of life in frail older adults and may be used specifically for management of frailty in kidney failure. However, research is needed to determine best practices for implementation of physical function measurements and physical activity promotion in standard kidney failure care.ObjectiveThe proposed Move More study will assess the feasibility of a physical activity intervention offered to the kidney failure inpatients in Calgary, Alberta. Specifically, this study is designed to examine the effects of an early physical activity/mobility intervention led by a kinesiologist, and supported by the clinical care team including physiotherapists (PT) and nurse clinicians.MethodsThe Move More study is a single-arm pilot intervention examining feasibility and optimal improvement in real-world conditions. Kidney failure inpatients at the Foothills Medical Centre will be recruited to participate. Patients will receive an individualized in-hospital physical activity/mobility intervention. Frailty and physical function will be assessed at baseline and postintervention prior to hospital discharge. The goal is to recruit 24 to 36 patients.ConclusionsEvidence needed to support the inclusion of mobility and physical activity as part of standard care will be gathered, with knowledge gained used to help direct future physical activity programming for kidney failure inpatients.

Project description:BACKGROUND:Employees in an office setting are more likely to remain physically inactive. Physical inactivity has become one of the major barriers to overcoming the risk factors for anxiety, depression, coronary heart disease, certain cancers, and type 2 diabetes. Currently, there is a gap in mobile health (mHealth) apps to promote physical activity (PA) for workers in the workplace. Studies on behavior change theories have concluded that health apps generally lack the use of theoretical constructs. OBJECTIVE:The objective of this study was to study the feasibility of a persuasive app aimed at encouraging PA among employees and to understand the motivational aspects behind the implementation of mHealth apps among office workers. METHODS:A 4-week study using a mixed methods (quantitative and qualitative) design was conducted with office-based employees in cities in 4 countries: Oulu, Finland; Carlow, Ireland; London, United Kingdom; and Dhaka, Bangladesh. Of the 220 invited participants (experimental group, n=115; control group, n=105), 84 participated (experimental group, n=56; control group, n=28), consisting of working-age volunteers working in an office setting. Participants used 2 different interventions: The experimental group used an mHealth app for PA motivation, and the control group used a paper diary. The purpose was to motivate employees to engage in healthier behavior regarding the promotion of PA in the workplace. A user-centered design process was followed to design, develop, and evaluate the mHealth app, incorporating self-determination theory (SDT) and using game elements. The paper diary had no specific theory-driven approach, design technique, nor game elements. RESULTS:Compliance with app usage remained relatively low, with 27 participants (experimental group, n=20; control group, n=7) completing the study. The results support the original hypothesis that the mHealth app would help increase PA (ie, promoting daily walking in the workplace) in comparison to a paper diary (P=.033). The mHealth app supported 2 of the basic SDT psychological needs, namely autonomy (P=.004) and competence (P=.014), but not the needs of relatedness (P=.535). CONCLUSIONS:The SDT-based mHealth application motivated employees to increase their PA in the workplace. However, compliance with app usage remained low. Future research should further develop the app based on user feedback and test it in a larger sample.

Project description:Fun For Wellness (FFW) is a self-efficacy theory-based online behavioral intervention that aims to promote growth in physical activity and well-being. The FFW conceptual model for the promotion of subjective well-being posits that FFW exerts both a positive direct effect, and a positive indirect effect through well-being self-efficacy, on subjective well-being. Subjective well-being is defined in FFW as an individual's satisfaction with their status in seven key domains of their life. Well-being self-efficacy is defined in FFW as the degree to which an individual perceives that they have the capability to attain a positive status in seven key domains of their life. The objective of this study was to use baseline target moderation to assess variation in the impact of FFW on subjective well-being dimensions in adults with obesity. Data (N = 667) from the Well-Being and Physical Activity Study (ClinicalTrials.gov, identifier: NCT03194854) were reanalyzed. There was evidence that well-being self-efficacy at baseline moderated the direct effect of FFW on well-being self-efficacy at 30 days post-baseline for the occupational and psychological dimensions. Both of these findings suggest a "compensatory" effect. Similarly, there was evidence that well-being self-efficacy at baseline moderated the indirect effect of FFW on subjective well-being at 60 days post-baseline through well-being self-efficacy at 30 days post-baseline for the occupational and psychological dimensions. Both of these findings suggest a "compensatory" effect. Finally, there was evidence that well-being self-efficacy at baseline moderated the direct effect of FFW on subjective well-being at 60 days post-baseline for the community, occupational, and physical dimensions. Each of these three findings suggests some version of a "rich-get-richer" effect. In summary, results provide both supportive and unsupportive (i.e., interpersonal, economic, and overall dimensions) evidence regarding variation in the impact of the FFW intervention and should impact the design of future FFW trials.

Project description:BackgroundDiabetes mellitus is a major health problem among people with physical disabilities. Health coaching has been proven to be an effective approach in terms of behavioral changes, patient self-efficacy, adherence to treatment, health service use, and health outcomes. Telehealth systems combined with health coaching have the potential to improve the quality of health care by increasing access to services. Treatment fidelity is particularly important for behavior change studies; however, fidelity protocols are inadequately administered and reported in the literature.ObjectiveThe aim of this study is to outline all the intervention fidelity strategies and procedures of a telecoaching intervention-artificial intelligence for diabetes management (AI4DM)-which is a randomized controlled trial to evaluate the feasibility, acceptability, and preliminary efficacy of a telehealth platform in adults with type 2 diabetes and permanent impaired mobility. AI4DM aims to create a web-based disability-inclusive diabetes self-management program. We selected the National Institutes of Health Behavior Change Consortium (NIH BCC) fidelity framework to describe strategies to ensure intervention fidelity in our research.MethodsWe have developed fidelity strategies based on the five fidelity domains outlined by the NIH BCC-focusing on study design, provider training, treatment delivery, treatment receipt, and enactment of treatment skills. The design of the study is grounded in the social cognitive theory and is intended to ensure that both arms would receive the same amount of attention from the intervention. All providers will receive standardized training to deliver consistent health coaching to the participants. The intervention will be delivered through various controlling and monitoring strategies to reduce differences within and between treatment groups. The content and structure of the study are delivered to ensure comprehension and participation among individuals with low health literacy. By constantly reviewing and monitoring participant progress and protocol adherence, we intend to ensure that participants use cognitive and behavioral skills in real-world settings to engage in health behavior.ResultsEnrollment for AI4DM will begin in October 2021 and end in October 2022. The results of this study will be reported in late 2022.ConclusionsDeveloping and using fidelity protocols in behavior change studies is essential to ensure the internal and external validity of interventions. This study incorporates NIH BCC recommendations into an artificial intelligence embedded telecoaching platform for diabetes management designed for people with physical disabilities. The developed fidelity protocol can provide guidance for other researchers conducting telehealth interventions within behavioral health settings to present more consistent and reproducible research.Trial registrationClinicalTrials.gov NCT04927377; http://clinicaltrials.gov/ct2/show/NCT04927377.International registered report identifier (irrid)PRR1-10.2196/31695.

Dataset Information

Accelerometer-based assessment of physical activity within the Fun For Wellness online behavioral intervention: protocol for a feasibility study.

Publications

Accelerometer-based assessment of physical activity within the Fun For Wellness online behavioral intervention: protocol for a feasibility study.

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