Sedentary Behavior Interrupted Randomized Controlled Trial (P2)

Sedentary Lifestyle Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03473145
• Other study ID #: 1P01AG052352-01A1
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 30, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 405
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sedentary Lifestyle

Intervention

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.

Locations

Country	Name	City	State
United States	UC San Diego	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose Regulation	Investigate the 12 week effects of increased standing and additional brief sit-to-stand compared to attention controls.	3 months
Secondary	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
Secondary	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