Sedentary Behavior Interrupted Randomized Controlled Trial (P2)

NCT ID: NCT03473145

Last Updated: 2025-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 407 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-30
• Study Completion Date: 2024-12-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Health Living Attention Control

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.

Group Type: ACTIVE_COMPARATOR

Health Coaching

Intervention Type: BEHAVIORAL

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

Reduce Sitting

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.

Group Type: EXPERIMENTAL

Health Coaching

Intervention Type: BEHAVIORAL

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

activPAL inclinometer

Intervention Type: 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.

Intervention Type: 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.

Sit-to-Stand Transition

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.

Group Type: EXPERIMENTAL

Health Coaching

Intervention Type: BEHAVIORAL

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

activPAL inclinometer

Intervention Type: 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.

Intervention Type: 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.

Interventions

Health Coaching

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

Intervention Type: BEHAVIORAL

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Female;

2. 55 years of age and above;

3. any ethnicity or race;

4. screened to sit for 7 or more hours per day, perform less than 70 sit-to-stand transitions per day

5. ambulatory;

6. medically stable without any health conditions that would inhibit standing or PA;

7. able to give informed consent & comply with study protocols;

8. able to read and write fluently in English;

9. able to travel to study visits; and

10. no menstruation for at least one year;

11. BMI 25-45

12. able to walk, stand and transition without high risk of falling.

Exclusion Criteria

1. Male;

2. younger than 55 years of age;

3. sit for less than 7 hours per day, perform 71 or more sit-to-stand transitions per day

4. mental state that would preclude complete understanding of the protocol or compliance;

5. physical limitations to completing any of the study conditions;

6. menstruation less than one year prior;

7. unable to complete the Short Physical Performance Battery,

8. Active cancer

9. body Mass Index <25 or >45kg/m2,

10. use of insulin

• Minimum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Sheri Hartman

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UC San Diego

La Jolla, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 40709462 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 38671485 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33983131 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1P01AG052352-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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