Trial Outcomes & Findings for Sedentary Behavior Interrupted Randomized Controlled Trial (P2) (NCT NCT03473145)
NCT ID: NCT03473145
Last Updated: 2025-11-03
Results Overview
Mean Insulin (mU/L) collected via fasting blood draw at Baseline and 3-Months
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
407 participants
Primary outcome timeframe
3 months
Results posted on
2025-11-03
Participant Flow
Participant milestones
| Measure |
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.
Health Coaching: Health Coaching sessions will be aimed at goal setting, implementing strategies, overcoming barriers, \& relapse prevention.
|
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.
Health Coaching: Health Coaching sessions will be aimed at goal setting, implementing strategies, overcoming barriers, \& relapse prevention.
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.
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.
|
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.
Health Coaching: Health Coaching sessions will be aimed at goal setting, implementing strategies, overcoming barriers, \& relapse prevention.
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.
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
135
|
136
|
136
|
|
Overall Study
COMPLETED
|
130
|
130
|
128
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sedentary Behavior Interrupted Randomized Controlled Trial (P2)
Baseline characteristics by cohort
| Measure |
Reduce Sitting
n=136 Participants
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.
Health Coaching: Health Coaching sessions will be aimed at goal setting, implementing strategies, overcoming barriers, \& relapse prevention.
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.
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.
|
Sit-to-Stand Transition
n=136 Participants
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.
Health Coaching: Health Coaching sessions will be aimed at goal setting, implementing strategies, overcoming barriers, \& relapse prevention.
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.
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.
|
Total
n=407 Participants
Total of all reporting groups
|
Health Living Attention Control
n=135 Participants
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.
Health Coaching: Health Coaching sessions will be aimed at goal setting, implementing strategies, overcoming barriers, \& relapse prevention.
|
|---|---|---|---|---|
|
Age, Continuous
|
68.39 years
STANDARD_DEVIATION 4.66 • n=15 Participants
|
67.29 years
STANDARD_DEVIATION 6.55 • n=18 Participants
|
67.81 years
STANDARD_DEVIATION 32.13 • n=4 Participants
|
67.76 years
STANDARD_DEVIATION 7.43 • n=3 Participants
|
|
Sex: Female, Male
Female
|
136 Participants
n=15 Participants
|
136 Participants
n=18 Participants
|
407 Participants
n=4 Participants
|
135 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=15 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=15 Participants
|
10 Participants
n=18 Participants
|
35 Participants
n=4 Participants
|
12 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
123 Participants
n=15 Participants
|
124 Participants
n=18 Participants
|
370 Participants
n=4 Participants
|
123 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=15 Participants
|
1 Participants
n=18 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=15 Participants
|
0 Participants
n=18 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=3 Participants
|
|
Region of Enrollment
United States
|
136 participants
n=15 Participants
|
136 participants
n=18 Participants
|
407 participants
n=4 Participants
|
135 participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants
|
2 Participants
n=18 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=15 Participants
|
1 Participants
n=18 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=15 Participants
|
5 Participants
n=18 Participants
|
10 Participants
n=4 Participants
|
3 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=15 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=15 Participants
|
4 Participants
n=18 Participants
|
15 Participants
n=4 Participants
|
7 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
126 Participants
n=15 Participants
|
125 Participants
n=18 Participants
|
371 Participants
n=4 Participants
|
120 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: 3 monthsMean Insulin (mU/L) collected via fasting blood draw at Baseline and 3-Months
Outcome measures
| Measure |
Health Living Attention Control
n=131 Participants
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.
Health Coaching: Health Coaching sessions will be aimed at goal setting, implementing strategies, overcoming barriers, \& relapse prevention.
|
Reduce Sitting
n=133 Participants
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.
Health Coaching: Health Coaching sessions will be aimed at goal setting, implementing strategies, overcoming barriers, \& relapse prevention.
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.
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.
|
Sit-to-Stand Transition
n=135 Participants
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.
Health Coaching: Health Coaching sessions will be aimed at goal setting, implementing strategies, overcoming barriers, \& relapse prevention.
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.
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.
|
|---|---|---|---|
|
Insulin Regulation (mU/L)
Baseline Mean
|
15.93 mU/L
Interval 14.25 to 17.62
|
15.68 mU/L
Interval 14.03 to 17.33
|
15.27 mU/L
Interval 13.68 to 16.86
|
|
Insulin Regulation (mU/L)
3-Month Mean
|
16.72 mU/L
Interval 14.94 to 18.51
|
15.85 mU/L
Interval 14.17 to 17.53
|
14.84 mU/L
Interval 13.26 to 16.41
|
SECONDARY outcome
Timeframe: 3 monthsSelf-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.
Outcome measures
| Measure |
Health Living Attention Control
n=135 Participants
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.
Health Coaching: Health Coaching sessions will be aimed at goal setting, implementing strategies, overcoming barriers, \& relapse prevention.
|
Reduce Sitting
n=136 Participants
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.
Health Coaching: Health Coaching sessions will be aimed at goal setting, implementing strategies, overcoming barriers, \& relapse prevention.
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.
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.
|
Sit-to-Stand Transition
n=136 Participants
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.
Health Coaching: Health Coaching sessions will be aimed at goal setting, implementing strategies, overcoming barriers, \& relapse prevention.
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.
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.
|
|---|---|---|---|
|
Self-Reported Physical Functioning
Baseline Mean
|
74.9 score on a scale
Standard Error 1.81
|
72.8 score on a scale
Standard Error 1.81
|
75.8 score on a scale
Standard Error 1.81
|
|
Self-Reported Physical Functioning
3-Months Mean
|
75.9 score on a scale
Standard Error 1.83
|
74.6 score on a scale
Standard Error 1.83
|
80.5 score on a scale
Standard Error 1.84
|
Adverse Events
Health Living Attention Control
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Reduce Sitting
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Sit-to-Stand Transition
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Health Living Attention Control
n=135 participants at risk
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.
Health Coaching: Health Coaching sessions will be aimed at goal setting, implementing strategies, overcoming barriers, \& relapse prevention.
|
Reduce Sitting
n=136 participants at risk
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.
Health Coaching: Health Coaching sessions will be aimed at goal setting, implementing strategies, overcoming barriers, \& relapse prevention.
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.
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.
|
Sit-to-Stand Transition
n=136 participants at risk
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.
Health Coaching: Health Coaching sessions will be aimed at goal setting, implementing strategies, overcoming barriers, \& relapse prevention.
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.
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.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
5.9%
8/135 • Number of events 9 • Adverse event data were collected while the participants were active in the study for 3-months.
|
11.8%
16/136 • Number of events 16 • Adverse event data were collected while the participants were active in the study for 3-months.
|
13.2%
18/136 • Number of events 18 • Adverse event data were collected while the participants were active in the study for 3-months.
|
|
Musculoskeletal and connective tissue disorders
Pain
|
0.00%
0/135 • Adverse event data were collected while the participants were active in the study for 3-months.
|
8.8%
12/136 • Number of events 12 • Adverse event data were collected while the participants were active in the study for 3-months.
|
5.9%
8/136 • Number of events 8 • Adverse event data were collected while the participants were active in the study for 3-months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place