NCT03473145

Sedentary Behavior Interrupted Randomized Controlled Trial (P2)

Sedentary Behavior Interrupted: A Randomized Trial of 3-month Effects on Biomarkers of Healthy Aging and Physical Functioning in the Real World (Project 2)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 407 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: Female
• Age: 55 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Sedentary Lifestyle

Interventions

Type	Name	Description
BEHAVIORAL	Health Coaching	Health Coaching sessions will be aimed at goal setting, implementing strategies, overcoming barriers, \& relapse prevention.
DEVICE	activPAL inclinometer	Participants in the intervention study arms (B \& C) will wear the ActivPAL device for the first 4 weeks of the program and then again in weeks 8 and 9. The device will monitor their sitting and standing time and will allow Health Coaches to provide feedback and will assist the participant in developing an action plan.
OTHER	Tools to Prompt Standing or Prompt Sit-to-Stand Transitions.	Participants in the intervention study arms (B \& C) will receive tools to prompt standing or sit-to-stand transitions such as wearable wrist devices, standing desks or tables (Group B only), mechanical and/or electronic timers, or access to mobile apps or computer programs.

Timeline

• Start date: 2018-05-30
• Primary completion: 2022-12-31
• Completion: 2024-12-31
• First posted: 2018-03-22
• Last updated: 2025-11-03
• Results posted: 2025-11-03

Locations

1 site across 1 country: United States