Optimizing Sedentary Behavior Interventions to Affect Acute Physiological Changes

NCT ID: NCT02544867

Last Updated: 2015-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2014-03-31

Brief Summary

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.

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).

Conditions

Sedentary Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Sedentary behavior

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

Sedentary behavior

Intervention Type: BEHAVIORAL

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.

Interventions

Sedentary behavior

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Jacqueline Kerr

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jacqueline Kerr, Phd

Role: PRINCIPAL_INVESTIGATOR

UCSD

Locations

University of California, San Diego

La Jolla, California, United States

Countries

United States

References

Takemoto M, Godbole S, Rosenberg DE, Nebeker C, Natarajan L, Madanat H, Nichols J, Kerr J. The search for the ejecting chair: a mixed-methods analysis of tool use in a sedentary behavior intervention. Transl Behav Med. 2020 Feb 3;10(1):186-194. doi: 10.1093/tbm/iby106.

Reference Type: DERIVED

PMID: 30476335 (View on PubMed)

Kerr J, Takemoto M, Bolling K, Atkin A, Carlson J, Rosenberg D, Crist K, Godbole S, Lewars B, Pena C, Merchant G. Two-Arm Randomized Pilot Intervention Trial to Decrease Sitting Time and Increase Sit-To-Stand Transitions in Working and Non-Working Older Adults. PLoS One. 2016 Jan 6;11(1):e0145427. doi: 10.1371/journal.pone.0145427. eCollection 2016.

Reference Type: DERIVED

PMID: 26735919 (View on PubMed)

Other Identifiers

HRPP Project #130817

Identifier Type: -

Identifier Source: org_study_id