NCT03739762

Healthy Aging Resources to Thrive (HART)

Randomized Trial to Reduce Sitting Time and Improve Cardiometabolic Health in Obese Older Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 283 (actual)
• Sponsor: Kaiser Permanente · Academic / Other
• Sex: All
• Age: 60 Years – 89 Years
• Healthy volunteers: Accepted

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.

Conditions

• Sedentary Lifestyle

Interventions

Type	Name	Description
BEHAVIORAL	i-STAND	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)
OTHER	Healthy Living control	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.

Timeline

• Start date: 2019-02-05
• Primary completion: 2022-11-07
• Completion: 2023-03-31
• First posted: 2018-11-14
• Last updated: 2024-06-25
• Results posted: 2023-12-05

Locations

1 site across 1 country: United States