Optimizing Sedentary Behavior Interventions to Affect Acute Physiological Changes

Sedentary Behavior Clinical Trial

Official title:

Optimizing Sedentary Behavior Interventions to Affect Acute Physiological

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02544867
• Other study ID #: HRPP Project #130817
• Status: Completed
• Phase: N/A
• First received: September 4, 2015
• Last updated: September 4, 2015
• Start date: September 2013
• Est. completion date: March 2014

Study information

• Verified date: September 2015
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Sedentary Behavior

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of California, San Diego	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability and feasibility	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	No
Secondary	Measurement	To assess whether existing and new measurement approaches can detect specific changes in sedentary behavior.	3 weeks	No
Secondary	Sedentary behavior	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	No