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)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Sedentary Lifestyle
• Intervention / Treatment: Behavioral: Health Coaching; Device: activPAL inclinometer; Other: Tools to Prompt Standing or Prompt Sit-to-Stand Transitions.

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 Type: Interventional
• Enrollment (Anticipated): 405
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093
      • UC San Diego

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose Regulation	Investigate the 12 week effects of increased standing and additional brief sit-to-stand compared to attention controls.	3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of California, San Diego

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2018
• Primary Completion (Actual): December 31, 2022
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: March 14, 2018
• First Submitted That Met QC Criteria: March 14, 2018
• First Posted (Actual): March 22, 2018

Study Record Updates

• Last Update Posted (Actual): May 15, 2023
• Last Update Submitted That Met QC Criteria: May 12, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 1P01AG052352-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No