Healthy Aging Resources to Thrive (HART)
Condition: Sedentary Lifestyle
Study type: Interventional

Summary: 
      Healthy Aging Resources to Thrive (HART) uses a rigorous two-stage randomized control design,
      adapted and refined based on pilot studies, to test a novel intervention to reduce sitting
      time in older adults. Half the participants will be randomized to the intervention aimed at
      decreasing sitting time, and the other half will be randomized to a healthy living control
      that does not focus on reduced sitting time. After 6 months, the intervention group will be
      further randomized so that half continue with the intervention and the other half receive no
      further intervention. All participants will be followed for 12 months.
    

Detailed description: 
      Healthy Aging Resources to Thrive (HART) is a two-stage randomized controlled trial (RCT) of
      adults over age 60 with obesity to determine the efficacy of a novel sitting-reduction
      intervention and its impact on cardiometabolic risk markers. Participants will be randomized
      to a 6-month sitting reduction intervention (termed I-STAND) or healthy-living attention
      control (Stage 1). All participants will be mailed a scale and a blood pressure monitor (to
      keep) which will be used during the phone-based measurement visits at Baseline, 3, 6 and 12
      months. All participants will have phone-based Coaching sessions.

      After 6 months, I-STAND participants will be re-randomized to receive either booster sessions
      or no further intervention (Stage 2). Attention control participants will receive no further
      intervention. All participants will be followed for 12 months total with phone-based
      assessments at baseline, 3, 6, and 12 months. Primary outcomes are reduction in sitting time
      at 6 months, objectively measured using the activPAL device, and blood pressure. The design
      will answer novel questions about the impact of sitting reduction on cardiometabolic risk
      markers as well as maintenance of sitting reduction.

      UPDATE: As of 3/31/31, (final year 5) of the study, participants randomized to the i-STAND
      intervention will no longer be re-randomized at 6 months. We will no longer follow
      participants to the 12-month timepoint & will end all activities after 6-months.
    

Intervention name(s): i-STAND; Healthy Living control
Intervention type(s): Behavioral; Other
Intervention description(s): Via in-person and phone coaching sessions, participants randomized to this arm will be coached to find ways to sit less and stand more, and look for ways to change their home environment to encourage this, as well as look at how their lifestyle may contribute to their sitting time. Participants in this arm may be re-randomized at the half-way point to continue with additional phone coaching sessions. (As of 3/31/2022 Re-randomizations are no longer taking place); In this arm, participants will have phone coaching sessions focused on a variety of topics aimed at improving healthy habits. There is no focus on standing more or sitting less.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized into one of two cohorts/arms: one called "i-STAND" with coaching sessions focused directly on sitting less and standing more; the other called "Healthy Living" with coaching sessions focused on various topics related to a healthy lifestyle, but without a focus on standing more. Those randomized to the i-STAND intervention will also be re-randomized half-way through the study, with half of that cohort moving on to phase 2, which involves booster sessions on sitting less and standing more. All participants regardless of cohort will be mailed a blood pressure monitor and a scale to keep. UPDATE: As of March 31, 2022, beginning in our final year (year 5) of the study, participants randomized to the i-STAND intervention will no longer be re-randomized at 6 months. We will no longer follow participants to the 12-month timepoint and will end all activities after the 6-month timepoint.
Masking: None (Open Label)
Primary purpose: Supportive Care