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临床试验/NCT02878486
NCT02878486已完成不适用

Intervention to Reduce Sitting Time in Mild Cognitive Impairment

University of Kansas Medical Center1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2016年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
6
试验地点
1
主要终点
Change in Average Daily Sitting Time

研究概览

简要总结

The purpose of this study is to determine whether the researchers can help people change the amount of time they spend in sitting activities and whether this change might improve health outcomes.

详细描述

Specific Aim 1: Determine feasibility of a 12-week home and telephone based intervention in older adults with mild cognitive impairment targeting both the impaired individual and their study partner to help initiate and maintain behavior change. We will recruit KUADC registry participants with MCI and their caregivers (as study partners). Behavioral interventions are more effective when there is built in social support. We will evaluate feasibility in terms of successful recruitment and retention of participants, 10% or less of technological failures, rate of participant concerns addressed by phone and at home visits, acceptability of the intervention to participants (measured by questionnaires during home visits).

Specific Aim 2: Determine whether a 12-week home and telephone based intervention results in reduced total sitting time and shorter bouts of sitting in older adults with MCI and their caregivers. Electronic postural monitors will record sitting time for a duration of one week at three time points (pre-intervention, mid-intervention, and post-intervention). The intervention includes 1) feedback from baseline monitoring, 2) educational and goal setting session with the participants and research staff, 3) wrist worn monitors that alert wearers to sitting times >30 minutes, 4) home and telephone visits to address physical, psychological, and home environment barriers to behavior change. Changes in sitting time and breaks from sitting will be compared between baseline, mid-intervention, and post-intervention measurement occasions.

Specific Aim 3: Determine whether sedentary behavior intervention results in improved insulin sensitivity and glycemic control. To evaluate whether reduced sitting results in meaningful metabolic changes, we will measure postprandial insulin and glucose, and body composition, and evaluate changes from pre- to post- intervention adjusting for relevant covariates.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Enrolled in the University of Kansas (KU) Alzheimer's Disease Center (ADC) Registry
  • Clinical Dementia Rating (CDR) = 0.5
  • Inactive status as determined by the Measure of Older Adults' Sedentary Time (MOST) questionnaire
  • Retired or <20 hours/week in an office
  • Lives with partner in a community dwelling setting

排除标准

  • Unable to stand or walk unassisted
  • Inadequate visual, auditory, or English language capacity
  • Adhesive allergy
  • Current uncontrolled Type 2 diabetes
  • Unwilling to change sitting behavior

研究组 & 干预措施

Group 1

Experimental

Subjects will have clinic visits, home visits, and telephone visits. Subjects will be asked to wear a wrist monitor (Jawbone Up) for duration of the study, will meet with the study team to review Physical Activity Education and also be asked to wear the ActivPAL device to assess sitting time.

干预措施: Jawbone Up (Device)

Group 1

Experimental

Subjects will have clinic visits, home visits, and telephone visits. Subjects will be asked to wear a wrist monitor (Jawbone Up) for duration of the study, will meet with the study team to review Physical Activity Education and also be asked to wear the ActivPAL device to assess sitting time.

干预措施: Physical Activity Education (Behavioral)

Group 1

Experimental

Subjects will have clinic visits, home visits, and telephone visits. Subjects will be asked to wear a wrist monitor (Jawbone Up) for duration of the study, will meet with the study team to review Physical Activity Education and also be asked to wear the ActivPAL device to assess sitting time.

干预措施: ActivPAL (Device)

Group 2

Active Comparator

Subjects will make clinic visits. At home visits, subjects will meet with the study team to review Physical Activity Education and also be asked to wear the ActivPAL device to assess sitting time.

干预措施: Physical Activity Education (Behavioral)

Group 2

Active Comparator

Subjects will make clinic visits. At home visits, subjects will meet with the study team to review Physical Activity Education and also be asked to wear the ActivPAL device to assess sitting time.

干预措施: ActivPAL (Device)

结局指标

主要结局

Change in Average Daily Sitting Time

时间窗: Change from Baseline to Week 6

Average daily sitting time (minus sleep) at 6 weeks minus average daily sitting time (minus sleep) at baseline measured using the activPAL monitor

次要结局

  • Change in Glucose Levels Area Under the Curve in Response to Mixed Meal Tolerance Test(Change from Baseline to Week 12)
  • Number of Sitting Bouts Greater Than 30 Min(Week 12)
  • Change in Insulin Levels Area Under the Curve Based on a Mixed Meal Tolerance Test(Change from Baseline to Week 12)
  • Change in Average Daily Sitting Time(Change from Baseline to Week 12)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amber Watts, PhD

Assistant Professor

University of Kansas

研究点 (1)

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