An interventional study of Health Coaching and activPAL inclinometer in Sedentary Lifestyle, sponsored by University of California, San Diego. Completed at 1 site in United States. Open to female participants aged 55 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-03.
Sponsored by University of California, San Diego · Not applicable, Interventional, and Prevention
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.
Primary Aims:
In our primary biomarker outcomes of glucose regulation (fasting insulin \& glucose, HbA1c, HOMA-IR) \& blood pressure (BP):
Secondary aims
Exploratory aims
1,273 studies on the registry are indexed under Sedentary Behavior; 300 are open to participants now.
This study's enrollment of 407 is above the median of 60 across 1,076 interventional studies indexed under Sedentary Behavior.
Browse Sedentary Behavior studies →University of California, San Diego is the lead sponsor of 980 studies on the registry; 195 are open to participants now.
Of its 113 completed or terminated interventional studies of FDA-regulated products, 71 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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 · Device: activPAL inclinometer · Other: Tools to Prompt Standing or Prompt Sit-to-Stand Transitions.
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 · Device: activPAL inclinometer · Other: Tools to Prompt Standing or Prompt Sit-to-Stand Transitions.
Health Coaching sessions will be aimed at goal setting, implementing strategies, overcoming barriers, \& relapse prevention.
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.
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.
Insulin Regulation (mU/L)
Mean Insulin (mU/L) collected via fasting blood draw at Baseline and 3-Months
Time frame: 3 months
Self-Reported Physical Functioning
Self-reported physical functioning was assessed using the Rand SF 36-Item Health Survey that assesses 8 health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. The range of scores is 0 - 100 with higher scores meaning better physical functioning.
Time frame: 3 months
| Milestone | Health Living Attention Control | Reduce Sitting | Sit-to-Stand Transition |
|---|---|---|---|
| Started | 135 | 136 | 136 |
| Completed | 130 | 130 | 128 |
| Not completed | 5 | 6 | 8 |
Mean Insulin (mU/L) collected via fasting blood draw at Baseline and 3-Months
| mU/L | Health Living Attention Control | Reduce Sitting | Sit-to-Stand Transition |
|---|---|---|---|
| Baseline Mean | 15.93 (14.25 to 17.62) | 15.68 (14.03 to 17.33) | 15.27 (13.68 to 16.86) |
| 3-Month Mean | 16.72 (14.94 to 18.51) | 15.85 (14.17 to 17.53) | 14.84 (13.26 to 16.41) |
Self-reported physical functioning was assessed using the Rand SF 36-Item Health Survey that assesses 8 health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. The range of scores is 0 - 100 with higher scores meaning better physical functioning.
| score on a scale | Health Living Attention Control | Reduce Sitting | Sit-to-Stand Transition |
|---|---|---|---|
| Baseline Mean | 74.9 ± 1.81 | 72.8 ± 1.81 | 75.8 ± 1.81 |
| 3-Months Mean | 75.9 ± 1.83 | 74.6 ± 1.83 | 80.5 ± 1.84 |
Collected over Adverse event data were collected while the participants were active in the study for 3-months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Health Living Attention Control | 0/135 (0%) | 0/135 (0%) | 8/135 (5.9%) |
| Reduce Sitting | 0/136 (0%) | 0/136 (0%) | 28/136 (20.6%) |
| Sit-to-Stand Transition | 0/136 (0%) | 0/136 (0%) | 26/136 (19.1%) |
| Event | Health Living Attention Control | Reduce Sitting | Sit-to-Stand Transition |
|---|---|---|---|
| Skin IrritationSkin and subcutaneous tissue disorders | 8/135 | 16/136 | 18/136 |
| PainMusculoskeletal and connective tissue disorders | 0/135 | 12/136 | 8/136 |
| Age, Continuous(years) | Health Living Attention Control | Reduce Sitting | Sit-to-Stand Transition | Total |
|---|---|---|---|---|
| Mean | 67.76 ± 7.43 | 68.39 ± 4.66 | 67.29 ± 6.55 | 67.81 ± 32.13 |
| Sex: Female, Male(Participants) | Health Living Attention Control | Reduce Sitting | Sit-to-Stand Transition | Total |
|---|---|---|---|---|
| Female | 135 | 136 | 136 | 407 |
| Male | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Health Living Attention Control | Reduce Sitting | Sit-to-Stand Transition | Total |
|---|---|---|---|---|
| Hispanic or Latino | 12 | 13 | 10 | 35 |
| Not Hispanic or Latino | 123 | 123 | 124 | 370 |
| Unknown or Not Reported | 0 | 0 | 2 | 2 |
| Race (NIH/OMB)(Participants) | Health Living Attention Control | Reduce Sitting | Sit-to-Stand Transition | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 | 2 |
| Asian | 3 | 2 | 5 | 10 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 7 | 4 | 4 | 15 |
| White | 120 | 126 | 125 | 371 |
| More than one race | 2 | 2 | 1 | 5 |
| Unknown or Not Reported | 2 | 2 | 0 | 4 |
| Region of Enrollment(participants) | Health Living Attention Control | Reduce Sitting | Sit-to-Stand Transition | Total |
|---|---|---|---|---|
| United States | 135 | 136 | 136 | 407 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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