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Completed

NCT Number: NCT03473145

Sedentary Behavior Interrupted Randomized Controlled Trial (P2)

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.

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Key information

Conditions

Sedentary Lifestyle Behavior Sedentary Behavior

Age range

55 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UC San Diego

La Jolla, California, 92093, United States

About this study

Primary Aims:

In our primary biomarker outcomes of glucose regulation (fasting insulin & glucose, HbA1c, HOMA-IR) & blood pressure (BP):

  • Investigate the 12 week effects of increased standing and additional brief sit-to-stand compared to attention controls.
  • Investigate the dose-response effects of behavioral change on the biomarkers & BP.

Secondary aims

  • Assess the effect of changes in standing and sit-to-stand transitions at 12 weeks on physical, emotional & cognitive functioning.
  • Assess the effect of changes in standing and sit-to-stand transitions at 12 weeks on in vivo skeletal muscle mitochondrial function.

Exploratory aims

  • Explore the possible modifying effect of age on the relationship between intervention conditions & primary & secondary outcomes.
  • Explore the psychosocial & environmental mediators & moderators of changes in sitting time, standing time, and transitions.
  • Explore differences in outcomes between the 2 sitting interruption conditions.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female;
  • 55 years of age and above;
  • any ethnicity or race;
  • screened to sit for 7 or more hours per day, perform less than 70 sit-to-stand transitions per day
  • ambulatory;
  • medically stable without any health conditions that would inhibit standing or PA;
  • able to give informed consent & comply with study protocols;
  • able to read and write fluently in English;
  • able to travel to study visits; and
  • no menstruation for at least one year;
  • BMI 25-45
  • able to walk, stand and transition without high risk of falling.

Exclusion criteria

  • Male;
  • younger than 55 years of age;
  • sit for less than 7 hours per day, perform 71 or more sit-to-stand transitions per day
  • mental state that would preclude complete understanding of the protocol or compliance;
  • physical limitations to completing any of the study conditions;
  • menstruation less than one year prior;
  • unable to complete the Short Physical Performance Battery,
  • Active cancer
  • body Mass Index <25 or >45kg/m2,
  • use of insulin

Treatment and study plan

Health Coaching

Behavioral

Health Coaching sessions will be aimed at goal setting, implementing strategies, overcoming barriers, & relapse prevention.

activPAL inclinometer

Device

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.

Tools to Prompt Standing or Prompt Sit-to-Stand Transitions.

Other

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.

Primary outcomes

  1. Insulin Regulation (mU/L)

    Time frame: 3 months

    Mean Insulin (mU/L) collected via fasting blood draw at Baseline and 3-Months

Secondary outcomes

  1. Self-Reported Physical Functioning

    Time frame: 3 months

    Self-reported physical functioning was assessed using the Rand SF 36-Item Health Survey that assesses 8 health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. The range of scores is 0 - 100 with higher scores meaning better physical functioning.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2024
First posted
Mar 22, 2018
Registry last updated
Nov 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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