Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sedentary Behavior Interrupted Randomized Controlled Trial (P2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03473145
Recruitment Status : Recruiting
First Posted : March 22, 2018
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Sheri Hartman, University of California, San Diego

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.

Layout table for study information
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group A - Health Living Attention Control
Participants in the attention control condition will receive a healthy aging educational intervention. This group will receive two in-person health coaching sessions and 8 phone counseling sessions.
Behavioral: Health Coaching
Health Coaching sessions will be aimed at goal setting, implementing strategies, overcoming barriers, & relapse prevention.

Experimental: Group B - Stand More
Participants in the Stand More condition will receive an intervention aimed at increasing daily standing time. This group will receive seven in-person health coaching sessions and three 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 6 weeks of the program. 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: Group C - 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 seven in-person health coaching sessions and three 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 6 weeks of the program. 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.




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 8 or more hours per day, perform less than 60 sit-to-stand transitions per day & engage in less than 20 minutes of moderate PA 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 8 hours per day, perform 60 or more sit-to-stand transitions per day or engages in more than 20 minutes of moderate PA 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
  11. diagnosis of sickle cell trait / disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03473145


Contacts
Layout table for location contacts
Contact: Lindsay Dillon, MPH 858-534-9333 ldillon@ucsd.edu

Locations
Layout table for location information
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

Layout table for additonal information
Responsible Party: Sheri Hartman, Assistant Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03473145     History of Changes
Other Study ID Numbers: 1P01AG052352-01A1 ( U.S. NIH Grant/Contract )
First Posted: March 22, 2018    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No