Healthy Aging Resources to Thrive (HART)

Sedentary Lifestyle Clinical Trial

— HART  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03739762
• Other study ID #: 1315055-1
• Secondary ID: 1R01HL132880-01A
• Status: Completed
• Phase: N/A
• Start date: February 5, 2019
• Est. completion date: March 31, 2023

Study information

• Verified date: November 2023
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 283
• Est. completion date: March 31, 2023
• Est. primary completion date: November 7, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 89 Years

Eligibility

Inclusion Criteria: • Self-reported sitting time of 6+ hours per day

• BMI =30 and <50 kg/m2

• men and women of all races and ethnicities from anywhere in the KPWA region (state-wide)

• We will oversample people of color statewide

• Able to walk one block

• Able to speak and read English,

• no self-reported vision limitations, sedentary time, use of an assistive device, able to stand.

• no cognitive impairment that is perceived by the study staff during phone screening

• Willingness to wear device (activPAL)

• Willingness to participate in study for a full year

• Continuously enrolled at KP for previous 12 months

• Not on the No Contact list

• Not previously enrolled in ISTAND or TABS

• Not currently enrolled in ACT, STOP-FALLS or SMARRT studies

Exclusion Criteria:

• unable to speak and read English (phone screen)

• unable to walk 1 block (with or without assistive devices) (phone screen)

• self-reported sitting time less than 6 hours per day (phone screen)

• diagnosis codes indicating hearing loss, dementia or serious mental illness (e.g., schizophrenia, bipolar disorder), or a terminal or serious illness (e.g., cancer) in the past 2 years (from the EMR)

Related Conditions & MeSH terms

• Sedentary Lifestyle

Intervention

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.

Locations

Country	Name	City	State
United States	Kaiser Permanente Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Time Spent Sitting or Lying Down at 6 Months	Time (minutes) spent sitting/lying during waking hours will be measured objectively by the activPAL worn for one week following each measurement visit.	Change from Baseline at 6 months
Primary	Change in SystolicBlood Pressure at 6 Months	Another primary outcome is change in systolic blood pressure. This will be measured at the measurement visits using blood pressure monitors mailed to the participant	Change from Baseline at 6 months
Primary	Change in Diastolic Blood Pressure at 6 Months	Another primary outcome is change in diastolic blood pressure	Change from Baseline at 6 months
Secondary	Change in Weight at 6 Months	Participants provide their weight at each measurement visit. Weight is measured in pounds using a scale mailed to the participant.	Change from Baseline at 6 months
Secondary	Change in BMI at 6 Months	BMI was calculated as [weight in kg]/[height in m]2.	Change from Baseline at 6 months
Secondary	Change in Waist Circumference at 6 Months	Participants provided their waist circumference at each measurement visit. Waist circumference was measured at the superior border of the iliac crest.	Change from Baseline at 6 months