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Completed

NCT Number: NCT02878486

Intervention to Reduce Sedentary Time

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.

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Key information

Conditions

Mild Cognitive Impairment Alzheimer Disease Behavior Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Mental Disorders Metabolic Diseases Motor Activity Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Nutritional and Metabolic Diseases Sedentary Behavior Tauopathies

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Jawbone UP

Device

Jawbone Up is a wrist wore water resistant activity monitor.

Physical activity education

Behavioral

A study team member will discuss benefits of changing sitting habits and ways to make changes to personal habits.

ActivPAL

Device

Devices measures postural changes over time. Participants will wear device for 7 days. The device measures time sitting, standing, and posture changes (i.e. sit-to-stand).

Primary outcomes

  1. Change in Average Daily Sitting Time

    Time frame: 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

Secondary outcomes

  1. Change in Average Daily Sitting Time

    Time frame: Change from Baseline to Week 12

    Average daily sitting time (minus sleep) at 12 weeks minus average daily sitting time (minus sleep) at baseline measured using the ActivPAL monitor

  2. Number of Sitting Bouts Greater Than 30 Min

    Time frame: Week 12

    Change in the number of sitting bouts greater than 30 min measured using the ActivPAL monitor

  3. Change in Glucose Levels Area Under the Curve in Response to Mixed Meal Tolerance Test

    Time frame: Change from Baseline to Week 12

    The average area under the curve at week 12 minus the average area under the curve at baseline. Blood was collected at baseline (pre-mixed meal). Post-mixed meal it was collected at 15, 30, 45, 60, 90, 120 minutes. The Area Under the Curve (AUC) was computed using the trapezoidal rule as we have previously described (Burns et. al. 2012, Morris et al 2014). This results in a single AUC pre-intervention value, and a single AUC post-intervention value for each metabolic outcome measure (glucose, insulin, etc).

    The Area Under the Curve (AUC) for each individual is calculated as a single unitless value that results from calculating the definite integral under a timecourse curve. This method has been widely used and cited in metabolic studies for more than two decades https://doi.org/10.2337/diacare.17.2.152. This results in a single unitless AUC pre-intervention value, and a single AUC post-intervention value for each metabolic outcome response measure (glucose, insulin, etc).

  4. Change in Insulin Levels Area Under the Curve Based on a Mixed Meal Tolerance Test

    Time frame: Change from Baseline to Week 12

    The average area under the curve at week 12 minus the average area under the curve at baseline. Blood was collected at baseline (pre-mixed meal). Post-mixed meal it was collected at 15, 30, 45, 60, 90, 120 minutes. The Area Under the Curve (AUC) was computed using the trapezoidal rule as we have previously described (Burns et. al. 2012, Morris et al 2014). This results in a single AUC pre-intervention value, and a single AUC post-intervention value for each metabolic outcome measure (glucose, insulin, etc).

    The Area Under the Curve (AUC) for each individual is calculated as a single unitless value that results from calculating the definite integral under a timecourse curve. This method has been widely used and cited in metabolic studies for more than two decades https://doi.org/10.2337/diacare.17.2.152. This results in a single unitless AUC pre-intervention value, and a single AUC post-intervention value for each metabolic outcome response measure (glucose, insulin, etc).

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Official study title

Intervention to Reduce Sitting Time in Mild Cognitive Impairment

Acronym: ReST-MCI

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 25, 2016
Registry last updated
Jul 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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