Sedentary Behavior Interrupted Randomized Controlled Trial (P2)

NCT03473145 | Completed Results DMC

• 1 other identifier: 1P01AG052352-01A1
• Study Type: interventional
• Target: 407
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sedentary Lifestyle

Outcome Measures

Primary Outcomes (1)

• Insulin Regulation (mU/L)

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

  3 months

Secondary Outcomes (1)

• Self-Reported Physical Functioning

  3 months

Study Arms (3)

Health Living Attention Control

ACTIVE COMPARATOR

Participants in the attention control condition will receive a healthy aging educational intervention. This group will receive one in-person health coaching sessions and 6 phone counseling sessions.

Behavioral: Health Coaching

Reduce Sitting

EXPERIMENTAL

Participants in the Reduce Sitting condition will receive an intervention aimed at reducing daily sitting time. This group will receive five in-person health coaching sessions and two phone counseling sessions.

Behavioral: Health Coaching; Device: activPAL inclinometer; Other: Tools to Prompt Standing or Prompt Sit-to-Stand Transitions.

Sit-to-Stand Transition

EXPERIMENTAL

Participants in the Sit-to-Stand Transition condition will receive an intervention aimed at increasing the daily number of brief sit-to-stand transitions. This group will receive five in-person health coaching sessions and two phone counseling sessions.

Behavioral: Health Coaching; Device: activPAL inclinometer; Other: Tools to Prompt Standing or Prompt Sit-to-Stand Transitions.

Interventions

Health Coaching BEHAVIORAL

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

Health Living Attention Control; Reduce Sitting; Sit-to-Stand Transition

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.

Reduce Sitting; Sit-to-Stand Transition

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.

Reduce Sitting; Sit-to-Stand Transition

Eligibility Criteria

• Age: 55 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female;
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UC San Diego

La Jolla, California, 92093, United States

Location

Related Publications (3)

• Hartman SJ, LaCroix AZ, Sears DD, Natarajan L, Zablocki RW, Chen R, Patterson JS, Dillon L, Sallis JF, Schenk S, Dunstan DW, Owen N, Rosenberg DE. Impacts of Reducing Sitting Time or Increasing Sit-to-Stand Transitions on Blood Pressure and Glucose Regulation in Postmenopausal Women: Three-Arm Randomized Controlled Trial. Circulation. 2025 Aug 26;152(8):492-504. doi: 10.1161/CIRCULATIONAHA.124.073385. Epub 2025 Jul 25.

  PMID: 40709462 DERIVED

• Zablocki RW, Hartman SJ, Di C, Zou J, Carlson JA, Hibbing PR, Rosenberg DE, Greenwood-Hickman MA, Dillon L, LaCroix AZ, Natarajan L. Using functional principal component analysis (FPCA) to quantify sitting patterns derived from wearable sensors. Int J Behav Nutr Phys Act. 2024 Apr 26;21(1):48. doi: 10.1186/s12966-024-01585-8.

  PMID: 38671485 DERIVED

• Hartman SJ, Dillon LW, LaCroix AZ, Natarajan L, Sears DD, Owen N, Dunstan DW, Sallis JF, Schenk S, Allison M, Takemoto M, Herweck AM, Nguyen B, Rosenberg DE. Interrupting Sitting Time in Postmenopausal Women: Protocol for the Rise for Health Randomized Controlled Trial. JMIR Res Protoc. 2021 May 13;10(5):e28684. doi: 10.2196/28684.

  PMID: 33983131 DERIVED

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Sheri Hartman
• Organization: UC San Diego

sjhartman@health.ucsd.edu

(858) 534-9235

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: March 22, 2018
• Study Start: May 30, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2024
• Last Updated: November 3, 2025
• Results First Posted: November 3, 2025

Record last verified: 2025-09

Locations

US (1)