An interventional study of Fun For Wellness (FFW) in Health Promotion, sponsored by University of Miami. Completed at 1 site in United States. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-21.
Sponsored by University of Miami · Not applicable, Interventional, and Treatment
Fun For Wellness (FFW) is an online behavioral intervention designed to promote growth in well-being by providing capability-enhancing learning opportunities to participants. This study is a randomized controlled trial (RCT) designed to provide an initial evaluation of the effectiveness of FFW to increase well-being and physical activity in an obese adult population in the United States of America. The conceptual framework for the FFW intervention is guided by self-efficacy theory. The FFW intervention consists of participants engaging in BET I CAN challenges. BET I CAN is an acronym that stands for behaviors, emotions, thoughts, interactions, awareness, and next steps. The FFW intervention is conceptualized as exerting both a positive direct effect, and a positive indirect effect through self-efficacy (i.e., well-being self-efficacy), on well-being (i.e., subjective well-being and well-being actions).
The World Health Organization (WHO) estimates that 650 million adults are obese and that this number has tripled since 1975. To reduce adult obesity the WHO recommends that individuals limit energy intake from low quality food sources (e.g., highly processed foods high in fat), increase energy intake from high quality food sources (e.g., raw vegetables), and engage in regular physical activity (e.g., 150 minutes at moderate intensity per week). There is evidence, that well-designed cognitive-behavioral interventions can successfully promote physical activity in obese adults.
Insufficient physical activity in the general adult population is a global pandemic. At the individual-level, there is evidence that behavioral interventions designed to promote physical activity by focusing on personal psychological attributes (e.g., self-efficacy) can be effective. Delivering a physical activity intervention online has been shown to be an effective mode of delivery that also may allow for efficient scaling up of an intervention. Thus, a readily scalable online behavioral intervention that effectively promotes physical activity in obese adults may be useful in regard to responding to a global pandemic (i.e., physical inactivity) in an at-risk population (i.e., obese adults).
The conceptual framework for the Fun For Wellness intervention is based on self-efficacy theory. Over the past few decades, self-efficacy theory has been one of the most widely studied conceptual frameworks in sport and exercise psychology. FFW is an online behavioral intervention designed to promote growth in well-being by providing capability-enhancing learning opportunities to participants. For participants who comply with the 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.
A panel company will invite participants from their General Population member panel to go to the research webpage to be screened for the study. No more than six hundred obese adults (BMI ≥ 25.00 kg/m2) between 18 and 64 years old will be randomly assigned to the FFW or Usual Care (UC) group to achieve a 1:1 group (i.e. FFW:UC) assignment. Recruitment, eligibility verification and data collection will be conducted online. Data will be collected at baseline, 30 days and 60 days post-baseline. Instruments to measure demographic information, anthropometric characteristics, self-efficacy, physical activity, well-being, and health-related quality of life will be included in the battery. Data will be modeled under both an intent to treat approach and a complier average causal effect approach.
Primary outcomes are: well-being self-efficacy, subjective well-being and well-being actions.
Hypotheses for intervention compliers are:
Secondary outcomes are: well-being actions self-efficacy, physical activity self-efficacy, self-efficacy to regulate physical activity, and physical activity.
Hypotheses for intervention compliers are:
Exploratory analyses will be conducted to examine possible relationships between the FFW intervention and health-related quality of life.
University of Miami is the lead sponsor of 838 studies on the registry; 164 are open to participants now.
Of its 114 completed or terminated interventional studies of FDA-regulated products, 96 (84%) have results posted.
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There are seven eligibility criteria for participation in this study.
Inclusion Criteria:
Exclusion Criteria:
Intervention participants will: 1) watch original videos with vignettes performed by professional actors; 2) read and/or watch mini-lectures that teach skills for behavior change; 3) engage in self-reflection exercises, 4) play original interactive games related to vignettes and mini-lectures; 5) interact with other FFW users via chat room functions and; 6) watch funny narrated video clips about well-being.
Behavioral: Fun For Wellness (FFW)
The Usual Care (UC) group will conduct their lives as usual during the 30 day intervention period.
FFW consists of videos, games, and content teaching 14 skills to support seven drivers of change that promote well-being in I COPPE domains. The drivers form the acronym BET I CAN, which stands for: Behaviors, Emotions, Thoughts, Interactions, Context, Awareness, and Next Steps. B teaches basics of habit formation, including antecedents, behaviors, and consequences and techniques like goal setting, behavior tracking and rewards. E teaches how to build positive emotions and cope with negative ones. T teaches lessons from cognitive behavioral therapy. I builds communication skills such as empathy, listening and assertiveness. C teaches how to create healthier environmental contexts. A aims to increase insight. N emphasizes the need to make plans and anticipate barriers.
Change in overall Well-Being Self-Efficacy (WBSE) Scale scores between baseline and time 3.
The FFW intervention will exert a positive direct effect on well-being self-efficacy.
Time frame: baseline, 30 days, and 60 days
Change in subjective well-being I COPPE Scale scores between baseline and time 3.
The FFW intervention will exert a positive direct effect on subjective well-being.
Time frame: baseline, 30 days, and 60 days
Change in I COPPE Actions Scale scores between baseline and time 3.
The FFW intervention will exert a positive direct effect on well-being actions
Time frame: baseline, 30 days, and 60 days
Change in Well-Being Actions Self-Efficacy (WBASE) Scale scores between baseline and time 3.
The FFW intervention will exert a positive direct effect on well-being actions self-efficacy.
Time frame: baseline, 30 days, and 60 days
Change in Job-Related Physical Activity Self-Efficacy (J-R PASE) Scale scores between baseline and time 3.
The FFW intervention will exert a positive direct effect on job-related physical activity self-efficacy.
Time frame: baseline, 30 days, and 60 days
Change in Transportation-Related Physical Activity Self-Efficacy (T-R PASE) Scale scores between baseline and time 3.
The FFW intervention will exert a positive direct effect on transportation-related physical activity self-efficacy.
Time frame: baseline, 30 days, and 60 days
Change in Domestic-Related Physical Activity Self-Efficacy (D-R PASE) Scale scores between baseline and time 3.
The FFW intervention will exert a positive direct effect on domestic-related physical activity self-efficacy.
Time frame: baseline, 30 days, and 60 days
Change in Leisure-Related Physical Activity Self-Efficacy (L-R PASE) Scale scores between baseline and time 3.
The FFW intervention will exert a positive direct effect on leisure-related physical activity self-efficacy.
Time frame: baseline, 30 days, and 60 days
Change in Self-Efficacy to Regulate Physical Activity (SERPA) Scale scores between baseline and time 3.
The FFW intervention will exert a positive direct effect on self-efficacy to regulate physical activity.
Time frame: baseline, 30 days, and 60 days
Change in Long International Physical Activity Questionnaire (Long-IPAQ) scores between baseline and time 3
The FFW intervention will exert a positive direct effect on physical activity.
Time frame: baseline, 30 days, and 60 days
Relationships between FFW intervention and SF36v2 scores.
Exploratory analyses will be conducted to examine possible relationships between the FFW intervention and health-related quality of life.
Time frame: baseline, 30 days, and 60 days
Plan to share: No
Ran from Aug 2018 to primary completion in Nov 2018, 3 months.
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This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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