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Effectiveness of the fun for wellness online behavioral intervention to promote well-being and physical activity: protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:Fun 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. METHODS:The 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. , FFW:UC) 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. DISCUSSION:The 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 REGISTRATION:ClinicalTrials.gov, identifier: NCT03194854 , registered 21 June 2017.

SUBMITTER: Myers ND

PROVIDER: S-EPMC6567517 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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Effectiveness of the fun for wellness online behavioral intervention to promote well-being and physical activity: protocol for a randomized controlled trial.

Myers Nicholas D ND Prilleltensky Isaac I Lee Seungmin S Dietz Samantha S Prilleltensky Ora O McMahon Adam A Pfeiffer Karin A KA Ellithorpe Morgan E ME Brincks Ahnalee M AM

BMC public health 20190613 1

<h4>Background</h4>Fun 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 ...[more]

PMID: 31196052

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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:BackgroundFun 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).MethodThe 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.DiscussionResults are intended to inform the preparation of a future definitive randomized controlled trial.Trial registrationClinicalTrials.gov, NCT03906942, registered 8 April 2019.Trial fundingThe Erwin and Barbara Mautner Charitable Foundation and the Michigan State University College of Education.

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: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:BackgroundWhile benefiting from strong cultural ties to family, land and culture Native Americans residing on reservations experience psychological distress at rates 2.5 times that of the general population. Treatment utilization for psychological health in reservation-based communities is low with access to culturally appropriate care lacking. Evidence suggests that for mental health treatment, Native Americans prefer culturally informed care that respects Native perspectives on health and well-being.MethodsTo decrease stress and promote well-being in tribal Head Start teachers we adapted and implemented a culturally focused intervention within a community-based participatory research framework using mixed methods. Feasibility and acceptability of the adapted 5-session curriculum was tested in a single arm intervention study with a sample of 18 teachers on the Fort Peck Reservation. Participants completed surveys at baseline and upon completion of the intervention. Within session observations and two post-intervention focus groups (n = 8, n = 10) were conducted to elaborate and explain the quantitative results eliciting participant experience of intervention effectiveness and feasibility, acceptably and appropriateness. Implementation outcomes were assessed quantitatively using the Acceptability of Intervention, Intervention Appropriateness, and Feasibility of Intervention measures.ResultsQuantitively, attendance rate overall was 93% with no dropouts. Pretest/posttest surveys were analyzed using t-tests and Hedges g to measure effect size. Contrary to our hypothesis, self-perceived stress showed a small positive effect size, indicating that participants were more stressed post intervention. However, depression decreased, with tribal identity and resilience showing positive effect sizes. Content analysis for the qualitative data collected within session observations and post intervention focus groups revealed how lifetime traumas were affecting participants, providing some explanation for the increase in stress. Teachers reported that the sessions helped their psychological health and well-being, supporting feasibility of future interventions. Acceptability scored highest with a mean (SD) of 4.25 (.84) out of 5, appropriateness 4.18 (.86) and feasibility 4.06 (.96) supporting intervention to be acceptable, appropriate, and feasible.ConclusionUtilizing a culturally based intervention to buffer stress and support the well-being of reservation-based teachers showed promise in helping them recognize their cultural strengths, stress, and need for ongoing support. Implementation outcomes show that intervention scale-out is feasible.

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Effectiveness of the fun for wellness online behavioral intervention to promote well-being and physical activity: protocol for a randomized controlled trial.

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Effectiveness of the fun for wellness online behavioral intervention to promote well-being and physical activity: protocol for a randomized controlled trial.

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