Sedentary Behavior Interrupted Randomized Controlled Trial (P2)

Status Active, not recruiting

Clinical Trial Summary

Epidemiological findings indicate that older adults do not meet physical activity (PA) guidelines & spend up to 11 hrs/day sitting. Given the high prevalence of sedentary behavior (SB), the higher chronic disease risk in this population, & the age-associated challenges of meeting traditional PA guidelines, involving longer bouts of moderate PA, the investigators hypothesize that older adult health will benefit from new strategies to interrupt sitting. This protocol "Sedentary Behavior Interrupted: A randomized trial of 3-month effects on biomarkers of healthy aging and physical functioning in the real world (Project 2)" is part of a National Institutes of Aging Program Grant called "Sedentary Time & Aging Mortality and Physical Function (STAR). The overall purpose of the STAR program to is to better understand how to interrupt sitting time and the consequences for healthy aging in postmenopausal women. This protocol (also referred to Project 2 of the STAR program) is a 3-arm randomized control trial designed to assess ways of interrupting sitting in 405 overweight, postmenopausal women.

Clinical Trial Description

Primary Aims: In our primary biomarker outcomes of glucose regulation (fasting insulin & glucose, HbA1c, HOMA-IR) & blood pressure (BP): 1. Investigate the 12 week effects of increased standing and additional brief sit-to-stand compared to attention controls. 2. Investigate the dose-response effects of behavioral change on the biomarkers & BP. Secondary aims 1. Assess the effect of changes in standing and sit-to-stand transitions at 12 weeks on physical, emotional & cognitive functioning. 2. Assess the effect of changes in standing and sit-to-stand transitions at 12 weeks on in vivo skeletal muscle mitochondrial function. Exploratory aims 1. Explore the possible modifying effect of age on the relationship between intervention conditions & primary & secondary outcomes. 2. Explore the psychosocial & environmental mediators & moderators of changes in sitting time, standing time, and transitions. 3. Explore differences in outcomes between the 2 sitting interruption conditions. ;

Study Design

Related Conditions & MeSH terms

Sedentary Lifestyle

Clinical Trial Details

NCT number	NCT03473145
Study type	Interventional
Source	University of California, San Diego
Contact
Status	Active, not recruiting
Phase	N/A
Start date	May 30, 2018
Completion date	December 31, 2024

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.