Developing a Positive Psychology Intervention to Promote Health Behaviors in Metabolic Syndrome: Proof-of Concept Trial
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      Specific Aim #1 (Feasibility; primary aim): To assess the feasibility of the positive
      psychology (PP)-motivational interviewing (MI) group-based physical activity intervention and
      outcome assessments in patients with metabolic syndrome (MetS).

      Hypothesis: The PP exercises and MI-based goal-setting sessions will be feasible: most (≥50%)
      of participants will complete 6/8 exercises/sessions. Furthermore, we will be able to obtain
      objective physical activity measurement follow-up data from at least 80% of enrolled
      participants at 8 weeks.

      Specific Aim #2 (Acceptability): To assess whether the intervention is acceptable to
      participants, as measured by ratings provided after each PP and MI exercise.

      Hypothesis: The intervention will be acceptable: participants will rate each PP and MI
      exercise with a mean score of at least 7 out of 10 on ratings of ease of completion and
      helpfulness.

      Specific Aim #3 (Outcomes): To assess whether this preliminary intervention appears to result
      in improvement of physical activity, related health behaviors (sedentary time, diet quality),
      and psychological well-being (optimism, positive affect, anxiety, depression).

      Hypothesis: The intervention will lead to improvements in physical activity, related health
      behaviors, optimism and positive affect, and reductions in depression and anxiety at 8 weeks
      compared to baseline.
    

Detailed description: 
      In this proof-of-concept study, investigators will run two 8-week PP-MI groups (complete n=8
      each, n=16 total) for primary care patients with MetS. Investigators will use ratings of
      feasibility and acceptability for each of the sessions and obtain objective physical activity
      measures pre- and post- group. Investigators will also obtain questionnaire-based information
      related to health behavior adherence and psychological and physical health to ensure the
      feasibility of these methods prior to further testing. Investigators may gather exit
      interview data to assess participant liking, utility, and additional needs, to allow for
      further refinement of the intervention.

      Baseline information about enrolled participants will be obtained from the patients, care
      providers, and the electronic medical record as required for characterization of the
      population. This information will include medical data related to MetS (e.g., blood sugar,
      blood pressure, body mass index, triglycerides, cholesterol), current medications, and
      sociodemographic data (age, gender, race/ethnicity, education, marital status).

      Participants will attend 90-minute groups sessions that will be held at two primary care
      clinics (MGH Healthcare Centers). The overall structure of each session will be: 30 minutes
      for positive psychology exercise review/discussion, 30 minutes for physical activity goal
      setting, education, and discussion, and 30 minutes for a group walk or indoor exercises in
      inclement weather.

      Participants will be asked to wear an Actigraph GT3x+ accelerometer for 1 week at baseline
      and 1 week at follow-up to assess the feasibility of doing so. Accelerometers such as this
      one are considered to be the standard for measuring habitual physical activity. They are
      pedometer-size devices that attach to a belt and are worn at the waist. Participants will
      also be given a Fitbit Zip to keep, which they will be asked to wear daily for the duration
      of the study in order to track their activity (steps).

      Upon beginning the groups, participants will be provided with a treatment manual with weekly
      PP exercises, information about the importance of physical activity and related health
      behaviors, and how to set goals to improve these behaviors. The PI will lead all groups.

      For the first session, in the PP portion, participants will discuss and be assigned the first
      exercise- gratitude for positive events- and will be instructed to complete the PP exercise
      during the next week. Prior to completing the exercise, participants will be asked to rate
      their current levels of happiness and optimism. Immediately after completing the exercise,
      participants will rate the ease of exercise completion, overall utility of the exercise, and
      their current levels of happiness and optimism, all using 10-point Likert scales. In the
      first goal-setting session, we will discuss the importance of physical activity in MetS.
      Participants will be given a Fitbit Zip to keep, which they will use to track the number of
      steps they take each day, for the duration of the study. Investigators will review
      instructions for use and set a goal for monitoring their baseline physical activity over the
      next week. Fitbits will not be used as an outcome measure but as a tool that participants can
      use to monitor their activity and set goals. Finally, the last 30 minutes will be spent doing
      a group walk around the local clinic neighborhood. All group walks and exercises will be done
      at a pace comfortable for participants.

      Participants will be asked to complete the 8 total weekly PP exercises, set physical activity
      goals, and attend as many group sessions as they can.

      All sessions will include (a) a review and discussion of the past week's PP exercise, (b) a
      discussion of the rationale of the next week's PP exercise using the PP manual, and (c)
      assignment of the next week's PP exercise. For the goal-setting/MI portion, participants will
      (a) review their goals and steps from the prior week, (b) discuss techniques for improving
      physical activity (e.g., monitoring physical activity, taking standing breaks), and (c) set
      goals for the next week. The exercises and content for both PP and MI will be assigned in the
      same order for all participants receiving them.

      Immediately after the week 8 session, investigators will distribute the same self-report
      questionnaires that were administered at baseline (before week 1). The Actigraphs will then
      be collected at this point and the data will be uploaded to assess for valid wear time. If
      participants have not worn them for enough time (>4 days), investigators will send it home
      with them and ask them to re-wear it and mail it back.
    

Intervention name(s): Intervention arm: PP-MI
Intervention type(s): Behavioral
Intervention description(s): The positive psychology exercises include gratitude-based activities, strengths-based activities, and meaning-based activities. The physical activity goal setting exercises include the following topics: health benefits, social resources, and neighborhood walkability.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment