Optimizing Sedentary Behavior Interventions to Affect Acute Physiological Changes

September 4, 2015 updated by: Jacqueline Kerr, University of California, San Diego

Optimizing Sedentary Behavior Interventions to Affect Acute Physiological

An emerging body of epidemiological evidence suggests that various forms of sedentary behavior, including TV viewing, occupational sitting, and total daily sitting, may be associated with all-cause and cardiovascular mortality, overweight and obesity, type 2 diabetes, depression and psychological well-being. Importantly, many of these associations were independent of participation in moderate to vigorous intensity physical activity. We propose a pilot study to assess the feasibility, acceptability and preliminary efficacy of two interventions targeting sedentary behavior. Since it is currently unknown what component of sedentary behavior exposure presents the greatest risk to health, we propose separate interventions to reduce overall sedentary time and to promote breaks in sedentary time.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Primary aim: To determine the acceptability and feasibility of selected personal, social and environmental strategies to reduce overall sitting time and increase the number of times participants stand up in a day.

Secondary aim: To assess whether existing and new measurement approaches can detect specific changes in sedentary behavior.

Exploratory aim: To establish whether specified intervention strategies were efficacious in reducing sedentary behavior and whether intervention effects were specific to the targeted sedentary behavior construct (e.g. decreased overall sitting time or increased number of breaks in sitting).

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • La Jolla, California, United States, 92093
        • University of California, San Diego

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Males or females 50 -70 years of age
  2. Able to attend 4 measurement visits with study staff in 3 consecutive weeks
  3. Spend at least 8 hours per day sitting
  4. Willing and able to wear study device for 21 days
  5. Able to read and write in English
  6. Able to provide written informed consent

Exclusion Criteria:

  1. Do not sit for at least 8 hours per day
  2. Unable to attend 4 visits
  3. Diagnosis of serious chronic condition that would limit the ability to stand

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Reduction in sitting time
Those randomized to this condition focused on reducing their overall sitting time by two hours per day (a goal achieved in similar studies [17,18] that represented approximately a 25% reduction in daily sitting time). Participants were encouraged to reach this goal by standing in bouts of roughly 10 minutes per hour. The purpose of this arm was to investigate whether we could replicate improvements in sitting time achieved in other worksite studies in our cohort of older adults, which included both workers and non-workers.
Participants were randomized to either reduce their total sitting time or increase sit-to-stand transitions. Information was provided in person, through written materials and by emails and phone calls in both conditions. Both groups received written educational materials on the dangers of excessive sitting and reviewed a generic day to illustrate how many sitting opportunities individuals face each day. During each session, the health educator also discussed the benefits of sitting less or increasing sit-to-stand transitions (depending on study condition) and brainstormed potential barriers to implementing the new behavior as well as strategies to overcome these barriers.
Experimental: Increase in sit-to-stand transitions
Those randomized to the sit-to-stand condition focused on increasing the number of sit-to-stand transitions they performed throughout the day with a goal of adding 30 additional transitions per day. Previous studies have not succeeded in increasing the number of sit-to-stand transitions in older adults, possibly because they focused on reducing overall sitting time, encouraged longer standing breaks and did not provide a specific goal for sit-to-stand transitions [26-28]. An increase in sit-to-stand transitions would not be expected with an increase standing intervention alone, as prolonged standing reduces the opportunity for sit-to-stand transitions.
Participants were randomized to either reduce their total sitting time or increase sit-to-stand transitions. Information was provided in person, through written materials and by emails and phone calls in both conditions. Both groups received written educational materials on the dangers of excessive sitting and reviewed a generic day to illustrate how many sitting opportunities individuals face each day. During each session, the health educator also discussed the benefits of sitting less or increasing sit-to-stand transitions (depending on study condition) and brainstormed potential barriers to implementing the new behavior as well as strategies to overcome these barriers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability and feasibility
Time Frame: 3 weeks
To determine the acceptability and feasibility of selected personal, social and environmental strategies to reduce overall sitting time and increase the number of times participants stand up in a day
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement
Time Frame: 3 weeks
To assess whether existing and new measurement approaches can detect specific changes in sedentary behavior.
3 weeks
Sedentary behavior
Time Frame: 3 weeks
To establish whether specified intervention strategies were efficacious in reducing sedentary behavior and whether intervention effects were specific to the targeted sedentary behavior construct (e.g. decreased overall sitting time or increased number of breaks in sitting).
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jacqueline Kerr, Phd, UCSD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

September 4, 2015

First Submitted That Met QC Criteria

September 4, 2015

First Posted (Estimate)

September 9, 2015

Study Record Updates

Last Update Posted (Estimate)

September 9, 2015

Last Update Submitted That Met QC Criteria

September 4, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • HRPP Project #130817

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sedentary Behavior

Clinical Trials on Sedentary behavior

3
Subscribe