NCT02998892

Brief Summary

Population studies suggest that time spent in sedentary behaviors is associated with all-cause mortality including obesity, diabetes, and cardiovascular diseases, independent of time spent in exercise. Frequent interruptions to sedentary time are however beneficially associated with metabolic health outcomes, even in individuals who exercise regularly. The goal is to use integrative approach to understand the biological mechanisms that underlie these associations in a longitudinal intervention study in overweight sedentary adults. The investigators believe that the proposed study will provide an initial evidence base for the health benefits of breaking up prolonged sitting with short bursts of activity. This innovative strategy may be more effective at combating the adverse effects of sedentary behaviors than more traditional approaches.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 21, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

May 9, 2017

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 8, 2021

Completed
Last Updated

November 18, 2024

Status Verified

November 1, 2024

Enrollment Period

4.4 years

First QC Date

December 2, 2016

Last Update Submit

November 13, 2024

Conditions

Keywords

Sedentary Behavior

Outcome Measures

Primary Outcomes (3)

  • Changes in sedentary time as measured by ActiPAL

    Over each 2 week period, participants will be instructed to wear an ActiPAL (PALTechnologies: Glasgow, Scotland) activity monitor on their right leg. Participants will be instructed to wear the monitors at all times except when sleeping or participating in water-based activities. The time-stamped "event" data file from the activPAL software will be used to determine time spent sitting/lying, standing and stepping per day.

    weeks 1-2 and weeks 5-6

  • Changes in insulin sensitivity

    Insulin sensitivity will be determined via an insulin modified frequently sampled intra-venous glucose tolerance test (IVGTT). After baseline samples, intravenous glucose (0.3 g/kg) will be infused over 1 minute, followed by insulin at 0.03 U/kg, 20 minutes after glucose administration. Blood samples will be frequently sampled over 5 hours, and insulin sensitivity will be calculated using the Bergman minimal model.

    Week 2 and week 8

  • Postprandial glycemia

    Incremental area under the curve of plasma glucose concentration measured in fasting and every hour for 14 hours.

    Week 2 and week 8

Secondary Outcomes (12)

  • Changes in total energy expenditure (TEE)

    week 1-2 and week 5-6

  • Changes in Moderate-to-vigorous physical activity as measured by ActiGraph

    weeks 1-6

  • 24hr substrate oxidation and energy expenditure

    Week 2 and week 8

  • Changes in Dietary Carbohydrate Oxidation

    week 2 and week 8

  • Changes in Dietary Fat Oxidation

    week 2 and week 8

  • +7 more secondary outcomes

Other Outcomes (1)

  • Self-perceived appetite and hunger

    Week 2 and week 8

Study Arms (2)

Traditional Exercise Training

ACTIVE COMPARATOR

Participants will be asked to perform moderate-intensity exercise (brisk walking) for 45 minutes for 5 days/week for 6 weeks. This intervention corresponds to the current recommendations.

Behavioral: Traditional Exercise Training

Daily Microbursts of Activity

EXPERIMENTAL

Participants will be asked to break up their sedentary activities of daily living for 5-minutes every hour for 9 hours, 5 days/week, by brisk walking for 6 weeks.

Behavioral: Daily Microbursts of Activity

Interventions

Participants will be asked to perform moderate-intensity exercise (brisk walking) for 45 minutes for 5 days/week for 6 weeks. This intervention corresponds to the current recommendations.

Traditional Exercise Training

Participants will be asked to break up their sedentary activities of daily living for 5-minutes every hour for 9 hours, 5 days/week, by brisk walking for 6 weeks.

Daily Microbursts of Activity

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Overweight but weight stable (+/- 3kg over previous 6 months) sedentary male and female adults (n=30) will be recruited.
  • Ages between 18-45 years old
  • BMI of 25-35 kg/m2
  • Sedentary ( self report \< 150min/wk of moderate-to-vigorous activity or less than 6,500 steps per day as measured for 5 days in free-living conditions with a pedometer).
  • The use of birth pill control will be accepted

You may not qualify if:

  • Any history of renal (present or past kidney failure, kidney transplant, dialysis or kidney cysts),
  • Uncontrolled hypertension
  • Cardiovascular (present or past atherosclerosis, heart attack, ischemic stroke, heart failure)
  • Hepatic diseases (past or present hepatitis B or C, fibrosis, cirrhosis, NAFLD/NASH)
  • Type 1 or 2 diabetes
  • Cancer
  • Smoking
  • Consumption of drugs (marijuana included)
  • Consumption of alcohol (\>40g/d)
  • HIV positivity
  • Psychiatric disorders
  • Any medications known to interfere with lipid or energy metabolism
  • Known physical activity contraindications
  • Major illness/physical problems (acute or chronic) that may limit their ability to perform the walking activities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Health BehaviorSedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Audrey Bergouignan, PhD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2016

First Posted

December 21, 2016

Study Start

May 9, 2017

Primary Completion

October 8, 2021

Study Completion

October 8, 2021

Last Updated

November 18, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations