Well-Being and Physical Activity Study
Condition: Health Promotion
Study type: Interventional

Summary: 
      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).
    

Detailed description: 
      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:

        1. The FFW intervention will exert a positive direct effect on well-being self-efficacy.

        2. The FFW intervention will exert a positive direct effect on subjective well-being.

        3. The FFW intervention will exert a positive direct effect on well-being actions.

      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:

        1. The FFW intervention will exert a positive direct effect on well-being actions
           self-efficacy.

        2. The FFW intervention will exert a positive direct effect on physical activity
           self-efficacy.

        3. The FFW intervention will exert a positive direct effect on self-efficacy to regulate
           physical activity.

        4. The FFW intervention will exert a positive direct effect on physical activity.

      Exploratory analyses will be conducted to examine possible relationships between the FFW
      intervention and health-related quality of life.
    

Intervention name(s): Fun For Wellness (FFW)
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The intervention group will be compared to a usual care (UC) control group on outcomes of self-efficacy, physical activity, and well-being. The intervention group will participate in online activities for 30 days while UC control group participants will be asked to conduct their lives as usual for the same 30 day period. Both groups will complete assessments during this time period. The UC group will be given access to the intervention for 30 days after all study participants have completed the three survey battery administrations.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: e-Health; self-efficacy theory; mixture modeling; mobile health; complier average causal effect estimation