Randomized Trial to Reduce Sitting Time and Improve Cardiometabolic Health in Obese Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 283
- 试验地点
- 1
- 主要终点
- Change in Time Spent Sitting or Lying Down at 6 Months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
i-STAND
i-STAND participants have a Baseline visit followed by the 1st Coaching visit. They receive wristbands that vibrate every 15 minutes to prompt a standing break, standing desks, workbook & 10 phone-based coaching calls focused on sitting less/standing more. There is a 3 month measurement visit. Program ends at 6 months when they wear an activPAL & have a measurement visit. Coach provides feedback on activPAL sitting time after all activPAL wears (Bsln, 3, 6 & 12 month). They may opt to wear activPAL at 6 weeks & get feedback. They are re-randomized at 6 months; half to be assigned to intervention boosters (5 more phone sessions/a 9-month optional activPAL) before the 12 month final activPAL & final measurement visit. Those not randomized to boosters will have no contact until the 12 month visit. UPDATE: As of 3/31/2022, (final year 5), i-STAND ppts will no longer be re-randomized at 6 months. We will no longer follow to the 12-month timepoint & will end all activities after 6-months.
干预措施: i-STAND (Behavioral)
Healthy Living control
In this arm, participants have a phone-based Baseline visit followed by the 1st phone-based Coaching visit. No prompting devices/desks are offered; coaching focuses on topics related to healthy living, but with no focus on sitting less/standing more. They have 10 phone calls with a health coach. Participants receive a workbook. All content is from KaiserPermanente WA and is available to all members. Participants select topics & review them with their health coach. At 3 months, participants have a measurement visit. The program ends at 6 months where participants will wear an activPAL and have a measurement visit. After that, there is no contact with the study team until 12 months when they will again wear an activPAL & have a final measurement visit. UPDATE: As of 3/31/2022, our final year (year 5) of the study, participants randomized to the control arm will no longer be followed to the 12-month timepoint and will end all activities after the 6-month timepoint.
干预措施: Healthy Living control (Other)
结局指标
主要结局
Change in Time Spent Sitting or Lying Down at 6 Months
时间窗: Change from Baseline 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 in SystolicBlood Pressure at 6 Months
时间窗: Change from Baseline 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 in Diastolic Blood Pressure at 6 Months
时间窗: Change from Baseline at 6 months
Another primary outcome is change in diastolic blood pressure
次要结局
- Change in Waist Circumference at 6 Months(Change from Baseline at 6 months)
- Change in Weight at 6 Months(Change from Baseline at 6 months)
- Change in BMI at 6 Months(Change from Baseline at 6 months)