Abstract
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.
Highlights
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 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)
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 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 intervention among adults with obesity in the USA
Summary
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 feasibility study described in this paper attempts to build an evidence-based foundation for a specific response to a global need for readily scalable online behavioral interventions that effectively promote physical activity in adults [16]. The feasibility study described in this paper proposes a physical activity intervention for adults with obesity (i.e., FFW) that includes activity monitors (i.e., accelerometers) and promotes physical activity within a more broadly focused weight management program where there is access to a health care provider (i.e., at a local bariatric service center within a major healthcare organization in the Midwest of the USA). For two eligibility criteria (i.e., age and the absence of simultaneous enrollment in another intervention program promoting either well-being or physical activity), this self-report-based limitation should be regarded as potentially more problematic due to the absence of a structural characteristic in the study design that guards against the provision of false information. Abbreviations BET I CAN: Behaviors, emotions, thoughts, interaction, context, awareness steps; BMI: Body mass index; CA: California; CACE: Complier average causal effect; FFW: Fun for Wellness; FL: Florida; I COPPE: Interpersonal, community, occupational, physical, psychological, economic; IPAQ: International physical activity questionnaire; ITT: Intent to treat; M: Mean; MVPA: Moderate to vigorous physical activity; NHANES: National Health and Nutritional Examination survey; PAMP: Physical activity monitoring package; PASE: Physical activity self-efficacy; RCT: Randomized controlled trial; REGARDS: Reasons for Geographic and Racial Differences in Stroke; SD: Standard deviation; SERPA: Self-efficacy to regulate physical activity; UC: Usual care; USA: United States of America; W1: Wave 1; W2: Wave 2; W3: Wave 3; WBASE: Well-being actions self-efficacy; WBSE: Wellbeing self-efficacy; WHO: World Health Organization
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