Sedentary Behavior Interrupted Randomized Controlled Trial (P2)

• ClinicalTrials.gov Identifier: NCT03473145
• Recruitment Status: Recruiting
• First Posted: March 22, 2018
• Last Update Posted: August 11, 2021
• Sponsor: University of California, San Diego
• Information provided by (Responsible Party): Sheri Hartman, University of California, San Diego

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Sedentary Lifestyle	Behavioral: Health Coaching; Device: activPAL inclinometer; Other: Tools to Prompt Standing or Prompt Sit-to-Stand Transitions.	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 405 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official 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)
• Actual Study Start Date: May 30, 2018
• Estimated Primary Completion Date: May 31, 2022
• Estimated Study Completion Date: May 31, 2022

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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.	Behavioral: Health Coaching; Health Coaching sessions will be aimed at goal setting, implementing strategies, overcoming barriers, & relapse prevention.
Experimental: 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.	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.
Experimental: 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.	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.

Outcome Measures

Primary Outcome Measures :

1. Glucose Regulation [ Time Frame: 3 months ]
   Investigate the 12 week effects of increased standing and additional brief sit-to-stand compared to attention controls.

Secondary Outcome Measures :

1. Functional Changes [ Time Frame: 3 months ]
   1. Assess the effect of changes in standing and sit-to-stand transitions at 12 weeks on physical, emotional & cognitive functioning.
2. Mitochondrial Function [ Time Frame: 3 months ]
   2. Assess the effect of changes in standing and sit-to-stand transitions at 12 weeks on in vivo skeletal muscle mitochondrial function.

Eligibility Criteria

• Ages Eligible for Study: 55 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Contacts

Contact: Lindsay Dillon, MPH; 858-534-9333; ldillon@ucsd.edu

Locations

United States, California

UC San Diego; Recruiting

La Jolla, California, United States, 92093

Contact: Brittany Lewars 858-534-9333 blewars@ucsd.edu

Contact: Lindsay Dillon 8585349333 ldillon@ucsd.edu

Sponsors and Collaborators

University of California, San Diego

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Sheri Hartman, Assistant Professor, University of California, San Diego
• ClinicalTrials.gov Identifier: NCT03473145
• Other Study ID Numbers: 1P01AG052352-01A1 ( U.S. NIH Grant/Contract )
• First Posted: March 22, 2018
• Last Update Posted: August 11, 2021
• Last Verified: August 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No