Social Incentives to Improve Diabetes
Condition: Type II; Diabetes; Obesity
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      In this study, we will conduct a one-year, four-arm, randomized, controlled trial to compare
      three social incentive-based gamification interventions to control for promoting physical
      activity and weight loss toward improved glycemic control among type 2 diabetics.
    

Detailed description: 
      This is a four-arm, one-year randomized, controlled trial. The study will be conducted using
      Way to Health, an automated information technology platform at the University of Pennsylvania
      that integrates wireless devices, conducts clinical trial randomization and enrollment
      processes, delivers messaging (text or email) delivers self-administered surveys, automates
      payment transfers, and securely captures data for research purposes.

      The study team will identify potential participants from the electronic health record at the
      University of Pennsylvania Health System. Interested participants will be instructed to visit
      the study website to create an account, review and complete informed consent, and complete an
      eligibility survey. Eligible participants will be instructed to obtain a hemoglobin A1c and
      LDL-C laboratory test. If the hemoglobin A1c is 8.0 or greater and the participant is still
      interested in continuing the enrollment process, a wearable activity tracking device will be
      mailed to them. After that, the participant will be scheduled for an in-person visit with the
      study team to complete the enrollment process.

      Participants will be randomly assigned in blocks of four groups to one of the four study arms
      stratified based on whether the group of individuals already knew each other or not. Groups
      will have three individuals unless the individuals were already socially connected prior to
      the study, in which case they will be allowed to be randomized as a group of two or three.
      Participants randomized to the control arm will receive no other interventions.

      Each participant in the intervention arms will be asked to choose their goals for the study
      as follows: 1) Choose a weight loss goal that is 6%, 7%, or 8% of their baseline weight
      rounded up to the next pound; 2) Choose a daily step count goal that is 33%, 40%, or 50%
      greater than their baseline rounded up to the nearest hundred, or choose their own step goal
      as long as it is at least 1500 steps above their baseline; 3) Choose a HbA1c reduction goal
      of 1.5%, 2%, or 2.5%.

      Participants in arms 2-4 will be entered into an intervention approach that has points and
      levels designed to incorporate insights from behavioral economics. On a daily basis, they
      will be asked to weigh-in. They will have a weekly weight target and mean step goal. Weekly
      feedback will differ among the three arms to induce the different social incentives.

      The primary outcome variables are change in mean daily steps, weight in pounds, and
      hemoglobin A1c from baseline to end of the one-year study.
    

Intervention name(s): Supportive social incentive; Competitive social incentive; Collaborative social incentive
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): A family member or friend will be used as a support person in this study, to receive updates and support the participant in their progress.; Participants in this intervention will be competing against each other in the game.; Participants in this intervention will be working with each other in the game.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Health Services Research