Trial Outcomes & Findings for Healthy Hearts Healthy Minds (NCT NCT03373110)
NCT ID: NCT03373110
Last Updated: 2022-02-02
Results Overview
Participants randomized to the CBT+fitbit and MBCT+fitbit groups completed 8 weeks of online intervention sessions with biweekly questionnaires whereas participants in the fitbit only group completed 8 weeks of biweekly questionnaires alone. After the first 8 weeks of the study, participants received no new online intervention material (regardless of their initial group assignment), but were instructed to continue wearing their fitbit for the remaining 8 weeks of the study and the MBCT+fitbit and CBT+fitbit groups continued to have access to the intervention material presented in the first 8 weeks of the study. At week 16, participants completed a follow-up assessment. The Fitbit records start and stop times of the day (e.g., indicating when participants were in bed) and therefore, steps were only counted during these times. Participants without any step count data for a given day were treated as missing values for that day.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
506 participants
Primary outcome timeframe
Baseline, 8 weeks, and 16 weeks
Results posted on
2022-02-02
Participant Flow
491 participants were consented, 361 participants met eligibility criteria and were randomized to study intervention arms. 21 participants withdrew their consent and, thus, data from these 21 participants are not used or presented. Of the 340 randomized participants, 314 participants had usable Fitbit data. Therefore, 314 participants were included in all analyses (i.e., primary and secondary outcomes). We have added adverse event data on all randomized participants (i.e., 361 participants).
Participant milestones
| Measure |
Online Mindfulness Based Cognitive Therapy +Fitbit
A central aspect of MBCT is the concept of awareness. Participants practice a variety of meditation types (e.g. breath awareness) and learn to bring mindfulness to everyday situations. Awareness will be directed to elements in participants' lives that interfere with living a more productive, physically active life (e.g. thoughts and feelings that interfere with becoming more physically active; stressful situations and circumstances that prevent them from engaging in exercise). Two hundred participants will be randomized into this group.
Online Mindfulness Based Cognitive Therapy: see arm description
|
Online Cognitive Behavioral Therapy +Fitbit
1)identifying and setting realistic exercise-based goals and intermediate goals (to maximize success to increase motivation); (2) behavioral scheduling to optimize when to exercise, identify rewards for exercising, and problem solve obstacles to exercising; and (3) identify dysfunctional, maladaptive thoughts about exercise (which decrease motivation) and skills to identify more adaptive, positive thoughts (to overcome thoughts of being too tired or too stressed to exercise). Two hundred participants will be randomized into this group.
Online Cognitive Behavioral Therapy: see arm description
|
Fitbit Alone
Participants assigned to the Fitbit-only control study group you will not be receiving therapy. However, they will receive a Fitbit, which they will be asked to wear over the course of 16 weeks as well as to complete the same schedule of assessments as the therapy arms. One hundred participants will be randomized into this group.
Fitbit Alone: see arm description
|
|---|---|---|---|
|
Overall Study
STARTED
|
133
|
137
|
70
|
|
Overall Study
Provided Fitbit Data
|
123
|
130
|
63
|
|
Overall Study
COMPLETED
|
55
|
58
|
26
|
|
Overall Study
NOT COMPLETED
|
78
|
79
|
44
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
3 participants were missing bipolar disorder diagnosis
Baseline characteristics by cohort
| Measure |
Online Mindfulness Based Cognitive Therapy +Fitbit
n=133 Participants
A central aspect of MBCT is the concept of awareness. Participants practice a variety of meditation types (e.g. breath awareness) and learn to bring mindfulness to everyday situations. Awareness will be directed to elements in participants' lives that interfere with living a more productive, physically active life (e.g. thoughts and feelings that interfere with becoming more physically active; stressful situations and circumstances that prevent them from engaging in exercise). Two hundred participants will be randomized into this group.
Online Mindfulness Based Cognitive Therapy: see arm description
|
Online Cognitive Behavioral Therapy +Fitbit
n=137 Participants
1)identifying and setting realistic exercise-based goals and intermediate goals (to maximize success to increase motivation); (2) behavioral scheduling to optimize when to exercise, identify rewards for exercising, and problem solve obstacles to exercising; and (3) identify dysfunctional, maladaptive thoughts about exercise (which decrease motivation) and skills to identify more adaptive, positive thoughts (to overcome thoughts of being too tired or too stressed to exercise). Two hundred participants will be randomized into this group.
Online Cognitive Behavioral Therapy: see arm description
|
Fitbit Alone
n=70 Participants
Participants assigned to the Fitbit-only control study group you will not be receiving therapy. However, they will receive a Fitbit, which they will be asked to wear over the course of 16 weeks as well as to complete the same schedule of assessments as the therapy arms. One hundred participants will be randomized into this group.
Fitbit Alone: see arm description
|
Total
n=340 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
42.5 years
STANDARD_DEVIATION 11.6 • n=133 Participants
|
43.9 years
STANDARD_DEVIATION 11.2 • n=137 Participants
|
43.4 years
STANDARD_DEVIATION 10.8 • n=70 Participants
|
43.3 years
STANDARD_DEVIATION 11.3 • n=340 Participants
|
|
Sex: Female, Male
Female
|
108 Participants
n=133 Participants
|
110 Participants
n=137 Participants
|
61 Participants
n=70 Participants
|
279 Participants
n=340 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=133 Participants
|
27 Participants
n=137 Participants
|
9 Participants
n=70 Participants
|
61 Participants
n=340 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=133 Participants
|
12 Participants
n=137 Participants
|
5 Participants
n=70 Participants
|
26 Participants
n=340 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
122 Participants
n=133 Participants
|
124 Participants
n=137 Participants
|
64 Participants
n=70 Participants
|
310 Participants
n=340 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=133 Participants
|
1 Participants
n=137 Participants
|
1 Participants
n=70 Participants
|
4 Participants
n=340 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=133 Participants
|
0 Participants
n=137 Participants
|
0 Participants
n=70 Participants
|
0 Participants
n=340 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=133 Participants
|
0 Participants
n=137 Participants
|
0 Participants
n=70 Participants
|
0 Participants
n=340 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=133 Participants
|
0 Participants
n=137 Participants
|
0 Participants
n=70 Participants
|
0 Participants
n=340 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=133 Participants
|
10 Participants
n=137 Participants
|
7 Participants
n=70 Participants
|
23 Participants
n=340 Participants
|
|
Race (NIH/OMB)
White
|
111 Participants
n=133 Participants
|
112 Participants
n=137 Participants
|
58 Participants
n=70 Participants
|
281 Participants
n=340 Participants
|
|
Race (NIH/OMB)
More than one race
|
11 Participants
n=133 Participants
|
10 Participants
n=137 Participants
|
3 Participants
n=70 Participants
|
24 Participants
n=340 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=133 Participants
|
5 Participants
n=137 Participants
|
2 Participants
n=70 Participants
|
12 Participants
n=340 Participants
|
|
Bipolar Disorder
|
18 Participants
n=132 Participants • 3 participants were missing bipolar disorder diagnosis
|
21 Participants
n=136 Participants • 3 participants were missing bipolar disorder diagnosis
|
12 Participants
n=69 Participants • 3 participants were missing bipolar disorder diagnosis
|
51 Participants
n=337 Participants • 3 participants were missing bipolar disorder diagnosis
|
|
Education
Some high school
|
1 Participants
n=133 Participants
|
1 Participants
n=137 Participants
|
0 Participants
n=70 Participants
|
2 Participants
n=340 Participants
|
|
Education
High school graduate/GED
|
8 Participants
n=133 Participants
|
9 Participants
n=137 Participants
|
8 Participants
n=70 Participants
|
25 Participants
n=340 Participants
|
|
Education
Some college/2-year degree
|
43 Participants
n=133 Participants
|
50 Participants
n=137 Participants
|
21 Participants
n=70 Participants
|
114 Participants
n=340 Participants
|
|
Education
4-year college graduate
|
31 Participants
n=133 Participants
|
37 Participants
n=137 Participants
|
14 Participants
n=70 Participants
|
82 Participants
n=340 Participants
|
|
Education
More than 4-year college
|
49 Participants
n=133 Participants
|
39 Participants
n=137 Participants
|
27 Participants
n=70 Participants
|
115 Participants
n=340 Participants
|
|
Education
Missing/unknown
|
1 Participants
n=133 Participants
|
1 Participants
n=137 Participants
|
0 Participants
n=70 Participants
|
2 Participants
n=340 Participants
|
|
Sexual Orientation
Straight
|
103 Participants
n=133 Participants
|
118 Participants
n=137 Participants
|
54 Participants
n=70 Participants
|
275 Participants
n=340 Participants
|
|
Sexual Orientation
Lesbian
|
4 Participants
n=133 Participants
|
1 Participants
n=137 Participants
|
5 Participants
n=70 Participants
|
10 Participants
n=340 Participants
|
|
Sexual Orientation
Gay
|
5 Participants
n=133 Participants
|
2 Participants
n=137 Participants
|
2 Participants
n=70 Participants
|
9 Participants
n=340 Participants
|
|
Sexual Orientation
Bisexual
|
5 Participants
n=133 Participants
|
11 Participants
n=137 Participants
|
6 Participants
n=70 Participants
|
22 Participants
n=340 Participants
|
|
Sexual Orientation
Asexual
|
5 Participants
n=133 Participants
|
2 Participants
n=137 Participants
|
0 Participants
n=70 Participants
|
7 Participants
n=340 Participants
|
|
Sexual Orientation
Other
|
7 Participants
n=133 Participants
|
1 Participants
n=137 Participants
|
2 Participants
n=70 Participants
|
10 Participants
n=340 Participants
|
|
Sexual Orientation
Missing/Unknown
|
4 Participants
n=133 Participants
|
2 Participants
n=137 Participants
|
1 Participants
n=70 Participants
|
7 Participants
n=340 Participants
|
PRIMARY outcome
Timeframe: Baseline, 8 weeks, and 16 weeksParticipants randomized to the CBT+fitbit and MBCT+fitbit groups completed 8 weeks of online intervention sessions with biweekly questionnaires whereas participants in the fitbit only group completed 8 weeks of biweekly questionnaires alone. After the first 8 weeks of the study, participants received no new online intervention material (regardless of their initial group assignment), but were instructed to continue wearing their fitbit for the remaining 8 weeks of the study and the MBCT+fitbit and CBT+fitbit groups continued to have access to the intervention material presented in the first 8 weeks of the study. At week 16, participants completed a follow-up assessment. The Fitbit records start and stop times of the day (e.g., indicating when participants were in bed) and therefore, steps were only counted during these times. Participants without any step count data for a given day were treated as missing values for that day.
Outcome measures
| Measure |
Online Mindfulness Based Cognitive Therapy +Fitbit
n=123 Participants
A central aspect of MBCT is the concept of awareness. Participants practice a variety of meditation types (e.g. breath awareness) and learn to bring mindfulness to everyday situations. Awareness will be directed to elements in participants' lives that interfere with living a more productive, physically active life (e.g. thoughts and feelings that interfere with becoming more physically active; stressful situations and circumstances that prevent them from engaging in exercise). Two hundred participants will be randomized into this group.
Online Mindfulness Based Cognitive Therapy: see arm description
|
Online Cognitive Behavioral Therapy +Fitbit
n=130 Participants
1)identifying and setting realistic exercise-based goals and intermediate goals (to maximize success to increase motivation); (2) behavioral scheduling to optimize when to exercise, identify rewards for exercising, and problem solve obstacles to exercising; and (3) identify dysfunctional, maladaptive thoughts about exercise (which decrease motivation) and skills to identify more adaptive, positive thoughts (to overcome thoughts of being too tired or too stressed to exercise). Two hundred participants will be randomized into this group.
Online Cognitive Behavioral Therapy: see arm description
|
Fitbit Alone
n=63 Participants
Participants assigned to the Fitbit-only control study group you will not be receiving therapy. However, they will receive a Fitbit, which they will be asked to wear over the course of 16 weeks as well as to complete the same schedule of assessments as the therapy arms. One hundred participants will be randomized into this group.
Fitbit Alone: see arm description
|
|---|---|---|---|
|
Change (Per Day) in Average Daily Steps From Baseline
8 weeks
|
2.8 Change (per day) in Average Daily Steps
Interval -1.7 to 7.0
|
2.9 Change (per day) in Average Daily Steps
Interval -1.3 to 7.0
|
-8.2 Change (per day) in Average Daily Steps
Interval -14.5 to -1.9
|
|
Change (Per Day) in Average Daily Steps From Baseline
16 weeks
|
-1.2 Change (per day) in Average Daily Steps
Interval -2.9 to 0.5
|
-1.8 Change (per day) in Average Daily Steps
Interval -3.5 to -0.1
|
-2.6 Change (per day) in Average Daily Steps
Interval -5.1 to -0.1
|
SECONDARY outcome
Timeframe: Baseline, 8 and 16 weeksChange per day in average daily steps stratified by the Patient Health Questionnaire (PHQ-9). The PHQ-9 is a 9 item self-report measure assessing presence of depression. Individuals are asked to rank how often they have experienced each item over the past two weeks on a scale from 0 (not at all) - 3 (nearly every day). Possible total scores range from 0-27, with higher scores indicate higher levels of depression. The PHQ-9 is a continuous measure and thus, was left continuous in our model and was not categorized. Because the PHQ-9 is a continuous measure, we assumed a continuous linear change in the effect per unit change. For purposes of presenting the results, we selected scores of 5, 10, and 15 as values to report the model-based slopes.
Outcome measures
| Measure |
Online Mindfulness Based Cognitive Therapy +Fitbit
n=123 Participants
A central aspect of MBCT is the concept of awareness. Participants practice a variety of meditation types (e.g. breath awareness) and learn to bring mindfulness to everyday situations. Awareness will be directed to elements in participants' lives that interfere with living a more productive, physically active life (e.g. thoughts and feelings that interfere with becoming more physically active; stressful situations and circumstances that prevent them from engaging in exercise). Two hundred participants will be randomized into this group.
Online Mindfulness Based Cognitive Therapy: see arm description
|
Online Cognitive Behavioral Therapy +Fitbit
n=130 Participants
1)identifying and setting realistic exercise-based goals and intermediate goals (to maximize success to increase motivation); (2) behavioral scheduling to optimize when to exercise, identify rewards for exercising, and problem solve obstacles to exercising; and (3) identify dysfunctional, maladaptive thoughts about exercise (which decrease motivation) and skills to identify more adaptive, positive thoughts (to overcome thoughts of being too tired or too stressed to exercise). Two hundred participants will be randomized into this group.
Online Cognitive Behavioral Therapy: see arm description
|
Fitbit Alone
n=63 Participants
Participants assigned to the Fitbit-only control study group you will not be receiving therapy. However, they will receive a Fitbit, which they will be asked to wear over the course of 16 weeks as well as to complete the same schedule of assessments as the therapy arms. One hundred participants will be randomized into this group.
Fitbit Alone: see arm description
|
|---|---|---|---|
|
Change (Per Day) in Average Daily Steps Stratified by the Patient Health Questionnaire (PHQ-9)
8 weeks: PHQ-9 Score of 5
|
6.3 Change (per day) in Avg Daily Steps
Interval 0.6 to 12.1
|
5.7 Change (per day) in Avg Daily Steps
Interval -0.2 to 11.6
|
-9.1 Change (per day) in Avg Daily Steps
Interval -17.4 to -0.7
|
|
Change (Per Day) in Average Daily Steps Stratified by the Patient Health Questionnaire (PHQ-9)
8 weeks: PHQ-9 Score of 10
|
3.0 Change (per day) in Avg Daily Steps
Interval -1.3 to 7.2
|
3.2 Change (per day) in Avg Daily Steps
Interval -0.9 to 7.4
|
-8.3 Change (per day) in Avg Daily Steps
Interval -14.6 to -2.0
|
|
Change (Per Day) in Average Daily Steps Stratified by the Patient Health Questionnaire (PHQ-9)
8 weeks: PHQ-9 Score of 15
|
-.4 Change (per day) in Avg Daily Steps
Interval -5.9 to 5.0
|
.7 Change (per day) in Avg Daily Steps
Interval -4.5 to 5.9
|
-7.5 Change (per day) in Avg Daily Steps
Interval -15.2 to 0.2
|
|
Change (Per Day) in Average Daily Steps Stratified by the Patient Health Questionnaire (PHQ-9)
16 weeks: PHQ-9 Score of 5
|
-1.1 Change (per day) in Avg Daily Steps
Interval -3.4 to 1.2
|
0.9 Change (per day) in Avg Daily Steps
Interval -1.5 to 3.2
|
-2.2 Change (per day) in Avg Daily Steps
Interval -5.5 to 1.1
|
|
Change (Per Day) in Average Daily Steps Stratified by the Patient Health Questionnaire (PHQ-9)
16 weeks: PHQ-9 Score of 10
|
-1.2 Change (per day) in Avg Daily Steps
Interval -2.9 to 0.5
|
-1.6 Change (per day) in Avg Daily Steps
Interval -3.3 to 0.1
|
-2.6 Change (per day) in Avg Daily Steps
Interval -5.0 to -0.1
|
|
Change (Per Day) in Average Daily Steps Stratified by the Patient Health Questionnaire (PHQ-9)
16 weeks: PHQ-9 Score of 15
|
-1.3 Change (per day) in Avg Daily Steps
Interval -3.5 to 0.9
|
-4.1 Change (per day) in Avg Daily Steps
Interval -6.4 to -1.9
|
-2.9 Change (per day) in Avg Daily Steps
Interval -6.0 to 0.1
|
SECONDARY outcome
Timeframe: Baseline, 8 and 16 weeksChange per day in average daily steps stratified by the Altman Self-Rating Mania Scale (ASRM), specifically using summed scores of 0,1, and 3. 5-item self rating scale, designed to asses the presence and/or severity of manic symptoms. Each item can be scored from 0-4. Possible total scores range from 0-25, and a score of 6 or higher indicates a high probability of a manic or hypomanic condition. The ASRM is a continuous measure and thus, was left continuous in our model and was not categorized. Because the ASRM is a continuous measure, we assumed a continuous linear change in the effect per unit change. For purposes of presenting the results, we selected scores of 0, 1, and 3 as values to report the model-based slopes.
Outcome measures
| Measure |
Online Mindfulness Based Cognitive Therapy +Fitbit
n=123 Participants
A central aspect of MBCT is the concept of awareness. Participants practice a variety of meditation types (e.g. breath awareness) and learn to bring mindfulness to everyday situations. Awareness will be directed to elements in participants' lives that interfere with living a more productive, physically active life (e.g. thoughts and feelings that interfere with becoming more physically active; stressful situations and circumstances that prevent them from engaging in exercise). Two hundred participants will be randomized into this group.
Online Mindfulness Based Cognitive Therapy: see arm description
|
Online Cognitive Behavioral Therapy +Fitbit
n=130 Participants
1)identifying and setting realistic exercise-based goals and intermediate goals (to maximize success to increase motivation); (2) behavioral scheduling to optimize when to exercise, identify rewards for exercising, and problem solve obstacles to exercising; and (3) identify dysfunctional, maladaptive thoughts about exercise (which decrease motivation) and skills to identify more adaptive, positive thoughts (to overcome thoughts of being too tired or too stressed to exercise). Two hundred participants will be randomized into this group.
Online Cognitive Behavioral Therapy: see arm description
|
Fitbit Alone
n=63 Participants
Participants assigned to the Fitbit-only control study group you will not be receiving therapy. However, they will receive a Fitbit, which they will be asked to wear over the course of 16 weeks as well as to complete the same schedule of assessments as the therapy arms. One hundred participants will be randomized into this group.
Fitbit Alone: see arm description
|
|---|---|---|---|
|
Change (Per Day) in Average Daily Steps Stratified by the Altman Self-Rating Mania Scale (ASRM)
8 week: ASRM score 0
|
2.6 Change (per day) in Avg Daily Steps
Interval -2.8 to 8.0
|
3.1 Change (per day) in Avg Daily Steps
Interval -2.3 to 8.6
|
-11.6 Change (per day) in Avg Daily Steps
Interval -19.1 to -4.1
|
|
Change (Per Day) in Average Daily Steps Stratified by the Altman Self-Rating Mania Scale (ASRM)
8 week: ASRM score 1
|
2.7 Change (per day) in Avg Daily Steps
Interval -1.8 to 7.2
|
3.0 Change (per day) in Avg Daily Steps
Interval -1.5 to 7.6
|
-9.9 Change (per day) in Avg Daily Steps
Interval -16.6 to -3.3
|
|
Change (Per Day) in Average Daily Steps Stratified by the Altman Self-Rating Mania Scale (ASRM)
8 week: ASRM score 3
|
2.9 Change (per day) in Avg Daily Steps
Interval -1.9 to 7.7
|
2.8 Change (per day) in Avg Daily Steps
Interval -1.6 to 7.2
|
-6.6 Change (per day) in Avg Daily Steps
Interval -13.2 to 0.0
|
|
Change (Per Day) in Average Daily Steps Stratified by the Altman Self-Rating Mania Scale (ASRM)
16 week: ASRM score 0
|
0.3 Change (per day) in Avg Daily Steps
Interval -1.9 to 2.5
|
-.6 Change (per day) in Avg Daily Steps
Interval -2.9 to 1.6
|
-5.1 Change (per day) in Avg Daily Steps
Interval -8.0 to -2.2
|
|
Change (Per Day) in Average Daily Steps Stratified by the Altman Self-Rating Mania Scale (ASRM)
16 week: ASRM score 1
|
-.5 Change (per day) in Avg Daily Steps
Interval -2.4 to 1.3
|
-1.2 Change (per day) in Avg Daily Steps
Interval -3.1 to 0.7
|
-3.9 Change (per day) in Avg Daily Steps
Interval -6.5 to -1.3
|
|
Change (Per Day) in Average Daily Steps Stratified by the Altman Self-Rating Mania Scale (ASRM)
16 week: ASRM score 3
|
-2.2 Change (per day) in Avg Daily Steps
Interval -4.1 to -0.2
|
-2.3 Change (per day) in Avg Daily Steps
Interval -4.1 to -0.5
|
-1.4 Change (per day) in Avg Daily Steps
Interval -4.0 to 1.2
|
SECONDARY outcome
Timeframe: Baseline, 8 and 16 weeksChange per day in average daily steps stratified by the Well Being Index (WHO-5). 5 item self report measure (rated on a 6 point Likert scale) to assess quality of life. Possible total scores range from 0-100 with 0 representing worst possible quality of life and 100 representing best possible quality of life. The WHO-5 is a continuous measure and thus, was left continuous in our model and was not categorized. Because the WHO-5 is a continuous measure, we assumed a continuous linear change in the effect per unit change. For purposes of presenting the results, we selected scores of 15, 30, and 45 as values to report the model-based slopes.
Outcome measures
| Measure |
Online Mindfulness Based Cognitive Therapy +Fitbit
n=133 Participants
A central aspect of MBCT is the concept of awareness. Participants practice a variety of meditation types (e.g. breath awareness) and learn to bring mindfulness to everyday situations. Awareness will be directed to elements in participants' lives that interfere with living a more productive, physically active life (e.g. thoughts and feelings that interfere with becoming more physically active; stressful situations and circumstances that prevent them from engaging in exercise). Two hundred participants will be randomized into this group.
Online Mindfulness Based Cognitive Therapy: see arm description
|
Online Cognitive Behavioral Therapy +Fitbit
n=137 Participants
1)identifying and setting realistic exercise-based goals and intermediate goals (to maximize success to increase motivation); (2) behavioral scheduling to optimize when to exercise, identify rewards for exercising, and problem solve obstacles to exercising; and (3) identify dysfunctional, maladaptive thoughts about exercise (which decrease motivation) and skills to identify more adaptive, positive thoughts (to overcome thoughts of being too tired or too stressed to exercise). Two hundred participants will be randomized into this group.
Online Cognitive Behavioral Therapy: see arm description
|
Fitbit Alone
n=70 Participants
Participants assigned to the Fitbit-only control study group you will not be receiving therapy. However, they will receive a Fitbit, which they will be asked to wear over the course of 16 weeks as well as to complete the same schedule of assessments as the therapy arms. One hundred participants will be randomized into this group.
Fitbit Alone: see arm description
|
|---|---|---|---|
|
Change (Per Day) in Average Daily Steps Stratified by the Well Being Index (WHO-5)
16 weeks: WHO-5 score 15
|
-2.0 Change (per day) in Avg Daily Steps
Interval -4.4 to 0.4
|
-3.5 Change (per day) in Avg Daily Steps
Interval -5.8 to -1.2
|
-3.9 Change (per day) in Avg Daily Steps
Interval -6.8 to -1.0
|
|
Change (Per Day) in Average Daily Steps Stratified by the Well Being Index (WHO-5)
16 weeks: WHO-5 score 30
|
-1.4 Change (per day) in Avg Daily Steps
Interval -3.1 to 0.4
|
-2.0 Change (per day) in Avg Daily Steps
Interval -3.8 to -0.3
|
-2.5 Change (per day) in Avg Daily Steps
Interval -5.0 to -0.1
|
|
Change (Per Day) in Average Daily Steps Stratified by the Well Being Index (WHO-5)
16 weeks: WHO-5 score 45
|
-.7 Change (per day) in Avg Daily Steps
Interval -2.8 to 1.5
|
-.6 Change (per day) in Avg Daily Steps
Interval -2.6 to 1.5
|
-1.2 Change (per day) in Avg Daily Steps
Interval -4.2 to 1.8
|
|
Change (Per Day) in Average Daily Steps Stratified by the Well Being Index (WHO-5)
8 weeks: WHO-5 score 15
|
-1.4 Change (per day) in Avg Daily Steps
Interval -7.2 to 4.4
|
-1.3 Change (per day) in Avg Daily Steps
Interval -6.9 to 4.3
|
-10.2 Change (per day) in Avg Daily Steps
Interval -17.5 to -2.9
|
|
Change (Per Day) in Average Daily Steps Stratified by the Well Being Index (WHO-5)
8 weeks: WHO-5 score 30
|
2.2 Change (per day) in Avg Daily Steps
Interval -2.1 to 6.6
|
2.5 Change (per day) in Avg Daily Steps
Interval -1.7 to 6.6
|
-8.0 Change (per day) in Avg Daily Steps
Interval -14.3 to -1.7
|
|
Change (Per Day) in Average Daily Steps Stratified by the Well Being Index (WHO-5)
8 weeks: WHO-5 score 45
|
5.8 Change (per day) in Avg Daily Steps
Interval 0.5 to 11.1
|
6.3 Change (per day) in Avg Daily Steps
Interval 1.1 to 11.4
|
-5.9 Change (per day) in Avg Daily Steps
Interval -13.6 to 1.9
|
SECONDARY outcome
Timeframe: Baseline, 8 and 16 weeksChange per day in average daily steps stratified by the Perceived Stress Scale (PSS), specifically using scores of 15, 20, and 25. 10 item scale (rated 0-4) that aims to measure the degree to which situations in one's life are appraised as stressful. Possible total scores range from 0-40 with higher scores are associated with higher levels of perceived stress. The PSS is a continuous measure and thus, was left continuous in our model and was not categorized. Because the PSS is a continuous measure, we assumed a continuous linear change in the effect per unit change. For purposes of presenting the results, we selected scores of 15, 20, and 25 as values to report the model-based slopes.
Outcome measures
| Measure |
Online Mindfulness Based Cognitive Therapy +Fitbit
n=123 Participants
A central aspect of MBCT is the concept of awareness. Participants practice a variety of meditation types (e.g. breath awareness) and learn to bring mindfulness to everyday situations. Awareness will be directed to elements in participants' lives that interfere with living a more productive, physically active life (e.g. thoughts and feelings that interfere with becoming more physically active; stressful situations and circumstances that prevent them from engaging in exercise). Two hundred participants will be randomized into this group.
Online Mindfulness Based Cognitive Therapy: see arm description
|
Online Cognitive Behavioral Therapy +Fitbit
n=130 Participants
1)identifying and setting realistic exercise-based goals and intermediate goals (to maximize success to increase motivation); (2) behavioral scheduling to optimize when to exercise, identify rewards for exercising, and problem solve obstacles to exercising; and (3) identify dysfunctional, maladaptive thoughts about exercise (which decrease motivation) and skills to identify more adaptive, positive thoughts (to overcome thoughts of being too tired or too stressed to exercise). Two hundred participants will be randomized into this group.
Online Cognitive Behavioral Therapy: see arm description
|
Fitbit Alone
n=63 Participants
Participants assigned to the Fitbit-only control study group you will not be receiving therapy. However, they will receive a Fitbit, which they will be asked to wear over the course of 16 weeks as well as to complete the same schedule of assessments as the therapy arms. One hundred participants will be randomized into this group.
Fitbit Alone: see arm description
|
|---|---|---|---|
|
Change (Per Day) in Average Daily Steps Stratified by the Perceived Stress Scale (PSS)
8 weeks: PSS score 15
|
8.2 Change (per day) in Avg Daily Steps
Interval 2.2 to 14.3
|
6.3 Change (per day) in Avg Daily Steps
Interval 0.2 to 12.4
|
-4.8 Change (per day) in Avg Daily Steps
Interval -13.2 to 3.6
|
|
Change (Per Day) in Average Daily Steps Stratified by the Perceived Stress Scale (PSS)
8 weeks: PSS score 20
|
3.9 Change (per day) in Avg Daily Steps
Interval -0.5 to 8.3
|
4.0 Change (per day) in Avg Daily Steps
Interval -0.4 to 8.4
|
-7.2 Change (per day) in Avg Daily Steps
Interval -13.7 to -0.7
|
|
Change (Per Day) in Average Daily Steps Stratified by the Perceived Stress Scale (PSS)
8 weeks: PSS score 25
|
-.5 Change (per day) in Avg Daily Steps
Interval -5.5 to 4.5
|
1.6 Change (per day) in Avg Daily Steps
Interval -2.8 to 6.1
|
-9.5 Change (per day) in Avg Daily Steps
Interval -16.2 to -2.9
|
|
Change (Per Day) in Average Daily Steps Stratified by the Perceived Stress Scale (PSS)
16 weeks: PSS score 15
|
-.8 Change (per day) in Avg Daily Steps
Interval -3.2 to 1.7
|
-0.6 Change (per day) in Avg Daily Steps
Interval -3.1 to 1.9
|
-2.3 Change (per day) in Avg Daily Steps
Interval -5.6 to 1.1
|
|
Change (Per Day) in Average Daily Steps Stratified by the Perceived Stress Scale (PSS)
16 weeks: PSS score 20
|
-1.1 Change (per day) in Avg Daily Steps
Interval -2.9 to 0.5
|
-1.5 Change (per day) in Avg Daily Steps
Interval -3.2 to 0.3
|
-2.5 Change (per day) in Avg Daily Steps
Interval -5.1 to 0.1
|
|
Change (Per Day) in Average Daily Steps Stratified by the Perceived Stress Scale (PSS)
16 weeks: PSS score 25
|
-1.5 Change (per day) in Avg Daily Steps
Interval -3.5 to 0.6
|
-2.3 Change (per day) in Avg Daily Steps
Interval -4.2 to -0.4
|
-2.7 Change (per day) in Avg Daily Steps
Interval -5.4 to -0.1
|
SECONDARY outcome
Timeframe: Baseline, 8 and 16 weeksChange per day in average daily steps stratified by age. Participants self-reported age on the demographics form. Age is a continuous measure and thus, was left continuous in our model and was not categorized. Because age is a continuous measure, we assumed a continuous linear change in the effect per unit change. For purposes of presenting the results, we selected ages of 35, 45, and 55 as values to report the model-based slopes.
Outcome measures
| Measure |
Online Mindfulness Based Cognitive Therapy +Fitbit
n=123 Participants
A central aspect of MBCT is the concept of awareness. Participants practice a variety of meditation types (e.g. breath awareness) and learn to bring mindfulness to everyday situations. Awareness will be directed to elements in participants' lives that interfere with living a more productive, physically active life (e.g. thoughts and feelings that interfere with becoming more physically active; stressful situations and circumstances that prevent them from engaging in exercise). Two hundred participants will be randomized into this group.
Online Mindfulness Based Cognitive Therapy: see arm description
|
Online Cognitive Behavioral Therapy +Fitbit
n=130 Participants
1)identifying and setting realistic exercise-based goals and intermediate goals (to maximize success to increase motivation); (2) behavioral scheduling to optimize when to exercise, identify rewards for exercising, and problem solve obstacles to exercising; and (3) identify dysfunctional, maladaptive thoughts about exercise (which decrease motivation) and skills to identify more adaptive, positive thoughts (to overcome thoughts of being too tired or too stressed to exercise). Two hundred participants will be randomized into this group.
Online Cognitive Behavioral Therapy: see arm description
|
Fitbit Alone
n=63 Participants
Participants assigned to the Fitbit-only control study group you will not be receiving therapy. However, they will receive a Fitbit, which they will be asked to wear over the course of 16 weeks as well as to complete the same schedule of assessments as the therapy arms. One hundred participants will be randomized into this group.
Fitbit Alone: see arm description
|
|---|---|---|---|
|
Change (Per Day) in Average Daily Steps Stratified by Age
8 weeks: age 35
|
-2.8 Change (per day) in Avg Daily Steps
Interval -8.0 to 2.5
|
-2.2 Change (per day) in Avg Daily Steps
Interval -7.6 to 3.2
|
-2.5 Change (per day) in Avg Daily Steps
Interval -10.3 to 5.4
|
|
Change (Per Day) in Average Daily Steps Stratified by Age
8 weeks: age 45
|
.6 Change (per day) in Avg Daily Steps
Interval -3.9 to 5.0
|
3.3 Change (per day) in Avg Daily Steps
Interval -0.9 to 7.4
|
-9.4 Change (per day) in Avg Daily Steps
Interval -15.8 to -3.1
|
|
Change (Per Day) in Average Daily Steps Stratified by Age
8 weeks: age 55
|
10.7 Change (per day) in Avg Daily Steps
Interval 4.6 to 16.8
|
8.7 Change (per day) in Avg Daily Steps
Interval 3.0 to 14.4
|
-16.4 Change (per day) in Avg Daily Steps
Interval -25.6 to -7.1
|
|
Change (Per Day) in Average Daily Steps Stratified by Age
16 weeks: age 35
|
-2.8 Change (per day) in Avg Daily Steps
Interval -4.9 to -0.8
|
-2.6 Change (per day) in Avg Daily Steps
Interval -4.9 to -0.4
|
-2.0 Change (per day) in Avg Daily Steps
Interval -5.1 to 1.2
|
|
Change (Per Day) in Average Daily Steps Stratified by Age
16 weeks: age 45
|
-1.8 Change (per day) in Avg Daily Steps
Interval -3.5 to 0.0
|
-1.8 Change (per day) in Avg Daily Steps
Interval -3.5 to -0.1
|
-2.7 Change (per day) in Avg Daily Steps
Interval -5.2 to -0.2
|
|
Change (Per Day) in Average Daily Steps Stratified by Age
16 weeks: age 55
|
1.5 Change (per day) in Avg Daily Steps
Interval -1.1 to 4.1
|
-.9 Change (per day) in Avg Daily Steps
Interval -3.2 to 1.4
|
-3.4 Change (per day) in Avg Daily Steps
Interval -7.0 to 0.1
|
SECONDARY outcome
Timeframe: Baseline, 8 and 16 weeksChange per day in average daily steps stratified by sex. Participants self-reported male or female on the demographics form.
Outcome measures
| Measure |
Online Mindfulness Based Cognitive Therapy +Fitbit
n=123 Participants
A central aspect of MBCT is the concept of awareness. Participants practice a variety of meditation types (e.g. breath awareness) and learn to bring mindfulness to everyday situations. Awareness will be directed to elements in participants' lives that interfere with living a more productive, physically active life (e.g. thoughts and feelings that interfere with becoming more physically active; stressful situations and circumstances that prevent them from engaging in exercise). Two hundred participants will be randomized into this group.
Online Mindfulness Based Cognitive Therapy: see arm description
|
Online Cognitive Behavioral Therapy +Fitbit
n=130 Participants
1)identifying and setting realistic exercise-based goals and intermediate goals (to maximize success to increase motivation); (2) behavioral scheduling to optimize when to exercise, identify rewards for exercising, and problem solve obstacles to exercising; and (3) identify dysfunctional, maladaptive thoughts about exercise (which decrease motivation) and skills to identify more adaptive, positive thoughts (to overcome thoughts of being too tired or too stressed to exercise). Two hundred participants will be randomized into this group.
Online Cognitive Behavioral Therapy: see arm description
|
Fitbit Alone
n=63 Participants
Participants assigned to the Fitbit-only control study group you will not be receiving therapy. However, they will receive a Fitbit, which they will be asked to wear over the course of 16 weeks as well as to complete the same schedule of assessments as the therapy arms. One hundred participants will be randomized into this group.
Fitbit Alone: see arm description
|
|---|---|---|---|
|
Change (Per Day) in Average Daily Steps Stratified by Sex
8 weeks: Male
|
-1.9 Change (per day) in Avg Daily Steps
Interval -11.8 to 8.0
|
-10.7 Change (per day) in Avg Daily Steps
Interval -20.6 to -0.8
|
-3.2 Change (per day) in Avg Daily Steps
Interval -21.5 to 15.1
|
|
Change (Per Day) in Average Daily Steps Stratified by Sex
8 weeks: Female
|
3.8 Change (per day) in Avg Daily Steps
Interval -0.9 to 8.6
|
5.8 Change (per day) in Avg Daily Steps
Interval 1.2 to 10.3
|
-8.8 Change (per day) in Avg Daily Steps
Interval -15.5 to -2.1
|
|
Change (Per Day) in Average Daily Steps Stratified by Sex
16 weeks: Male
|
0.4 Change (per day) in Avg Daily Steps
Interval -3.8 to 4.6
|
-4.4 Change (per day) in Avg Daily Steps
Interval -8.7 to -0.1
|
-12.0 Change (per day) in Avg Daily Steps
Interval -20.4 to -3.7
|
|
Change (Per Day) in Average Daily Steps Stratified by Sex
16 weeks: Female
|
-1.5 Change (per day) in Avg Daily Steps
Interval -3.4 to 0.4
|
-1.3 Change (per day) in Avg Daily Steps
Interval -3.1 to 0.6
|
-1.7 Change (per day) in Avg Daily Steps
Interval -4.3 to 0.9
|
SECONDARY outcome
Timeframe: Baseline, 8 and 16 weeksChange per day in average daily steps stratified by anxiety. Comorbid anxiety was self-reported in the psychiatric history questionnaire.
Outcome measures
| Measure |
Online Mindfulness Based Cognitive Therapy +Fitbit
n=133 Participants
A central aspect of MBCT is the concept of awareness. Participants practice a variety of meditation types (e.g. breath awareness) and learn to bring mindfulness to everyday situations. Awareness will be directed to elements in participants' lives that interfere with living a more productive, physically active life (e.g. thoughts and feelings that interfere with becoming more physically active; stressful situations and circumstances that prevent them from engaging in exercise). Two hundred participants will be randomized into this group.
Online Mindfulness Based Cognitive Therapy: see arm description
|
Online Cognitive Behavioral Therapy +Fitbit
n=137 Participants
1)identifying and setting realistic exercise-based goals and intermediate goals (to maximize success to increase motivation); (2) behavioral scheduling to optimize when to exercise, identify rewards for exercising, and problem solve obstacles to exercising; and (3) identify dysfunctional, maladaptive thoughts about exercise (which decrease motivation) and skills to identify more adaptive, positive thoughts (to overcome thoughts of being too tired or too stressed to exercise). Two hundred participants will be randomized into this group.
Online Cognitive Behavioral Therapy: see arm description
|
Fitbit Alone
n=70 Participants
Participants assigned to the Fitbit-only control study group you will not be receiving therapy. However, they will receive a Fitbit, which they will be asked to wear over the course of 16 weeks as well as to complete the same schedule of assessments as the therapy arms. One hundred participants will be randomized into this group.
Fitbit Alone: see arm description
|
|---|---|---|---|
|
Change (Per Day) in Average Daily Steps Stratified by Anxiety
8 weeks: Anxiety
|
-1.5 Change (per day) in Avg Daily Steps
Interval -7.2 to 4.2
|
4.5 Change (per day) in Avg Daily Steps
Interval -1.0 to 9.9
|
-5.7 Change (per day) in Avg Daily Steps
Interval -13.3 to 1.9
|
|
Change (Per Day) in Average Daily Steps Stratified by Anxiety
8 weeks: No anxiety
|
9.6 Change (per day) in Avg Daily Steps
Interval 3.0 to 16.2
|
.7 Change (per day) in Avg Daily Steps
Interval -5.7 to 7.0
|
-13.8 Change (per day) in Avg Daily Steps
Interval -25.0 to -2.5
|
|
Change (Per Day) in Average Daily Steps Stratified by Anxiety
16 weeks: Anxiety
|
-1.8 Change (per day) in Avg Daily Steps
Interval -4.1 to 0.4
|
-3.6 Change (per day) in Avg Daily Steps
Interval -5.9 to -1.4
|
-.2 Change (per day) in Avg Daily Steps
Interval -3.2 to 2.8
|
|
Change (Per Day) in Average Daily Steps Stratified by Anxiety
16 weeks: No anxiety
|
.7 Change (per day) in Avg Daily Steps
Interval -2.0 to 3.4
|
.7 Change (per day) in Avg Daily Steps
Interval -1.9 to 3.2
|
-7.7 Change (per day) in Avg Daily Steps
Interval -12.0 to -3.4
|
SECONDARY outcome
Timeframe: Baseline, 8 and 16 weeksChange per day in average daily steps stratified by smoking status. Smoker or non-smoker was self-reported on the psychiatric history questionnaire.
Outcome measures
| Measure |
Online Mindfulness Based Cognitive Therapy +Fitbit
n=133 Participants
A central aspect of MBCT is the concept of awareness. Participants practice a variety of meditation types (e.g. breath awareness) and learn to bring mindfulness to everyday situations. Awareness will be directed to elements in participants' lives that interfere with living a more productive, physically active life (e.g. thoughts and feelings that interfere with becoming more physically active; stressful situations and circumstances that prevent them from engaging in exercise). Two hundred participants will be randomized into this group.
Online Mindfulness Based Cognitive Therapy: see arm description
|
Online Cognitive Behavioral Therapy +Fitbit
n=137 Participants
1)identifying and setting realistic exercise-based goals and intermediate goals (to maximize success to increase motivation); (2) behavioral scheduling to optimize when to exercise, identify rewards for exercising, and problem solve obstacles to exercising; and (3) identify dysfunctional, maladaptive thoughts about exercise (which decrease motivation) and skills to identify more adaptive, positive thoughts (to overcome thoughts of being too tired or too stressed to exercise). Two hundred participants will be randomized into this group.
Online Cognitive Behavioral Therapy: see arm description
|
Fitbit Alone
n=70 Participants
Participants assigned to the Fitbit-only control study group you will not be receiving therapy. However, they will receive a Fitbit, which they will be asked to wear over the course of 16 weeks as well as to complete the same schedule of assessments as the therapy arms. One hundred participants will be randomized into this group.
Fitbit Alone: see arm description
|
|---|---|---|---|
|
Change (Per Day) in Average Daily Steps Stratified by Smoking
8 weeks: Smoker
|
-18.2 Change (per day) in Avg Daily Steps
Interval -39.6 to 3.2
|
-17.3 Change (per day) in Avg Daily Steps
Interval -34.4 to -0.2
|
-20.2 Change (per day) in Avg Daily Steps
Interval -37.5 to -2.8
|
|
Change (Per Day) in Average Daily Steps Stratified by Smoking
8 weeks: Non-smoker
|
3.6 Change (per day) in Avg Daily Steps
Interval -0.8 to 8.0
|
4.1 Change (per day) in Avg Daily Steps
Interval -0.1 to 8.4
|
-6.4 Change (per day) in Avg Daily Steps
Interval -13.2 to 0.4
|
|
Change (Per Day) in Average Daily Steps Stratified by Smoking
16 weeks: Smoker
|
-7.2 Change (per day) in Avg Daily Steps
Interval -16.0 to 1.7
|
-12.5 Change (per day) in Avg Daily Steps
Interval -19.9 to -5.1
|
-2.6 Change (per day) in Avg Daily Steps
Interval -9.1 to 4.0
|
|
Change (Per Day) in Average Daily Steps Stratified by Smoking
16 weeks: Non-smoker
|
-1.0 Change (per day) in Avg Daily Steps
Interval -2.7 to 0.8
|
-1.2 Change (per day) in Avg Daily Steps
Interval -2.9 to 0.6
|
-2.6 Change (per day) in Avg Daily Steps
Interval -5.3 to 0.1
|
SECONDARY outcome
Timeframe: Baseline, 8 and 16 weeksChange per day in average daily steps stratified by Self-efficacy for exercise (SEE), specifically using scores of 30, 45, and 55. Possible total scores range from 0-90. This 9-item measure, administered at study randomization, asks participants to indicate their self-confidence that they could exercise three times per week for twenty minutes under a variety of conditions. Sample items include being able to exercise if "You were bored by the program or activity" and "The weather was bothering you." Higher total scores on this measure reflect increased self-efficacy for exercise. The SEE is a continuous measure and thus, was left continuous in our model and was not categorized. Because the SEE is a continuous measure, we assumed a continuous linear change in the effect per unit change. For purposes of presenting the results, we selected scores of 30, 45, and 55 as values to report the model-based slopes.
Outcome measures
| Measure |
Online Mindfulness Based Cognitive Therapy +Fitbit
n=133 Participants
A central aspect of MBCT is the concept of awareness. Participants practice a variety of meditation types (e.g. breath awareness) and learn to bring mindfulness to everyday situations. Awareness will be directed to elements in participants' lives that interfere with living a more productive, physically active life (e.g. thoughts and feelings that interfere with becoming more physically active; stressful situations and circumstances that prevent them from engaging in exercise). Two hundred participants will be randomized into this group.
Online Mindfulness Based Cognitive Therapy: see arm description
|
Online Cognitive Behavioral Therapy +Fitbit
n=137 Participants
1)identifying and setting realistic exercise-based goals and intermediate goals (to maximize success to increase motivation); (2) behavioral scheduling to optimize when to exercise, identify rewards for exercising, and problem solve obstacles to exercising; and (3) identify dysfunctional, maladaptive thoughts about exercise (which decrease motivation) and skills to identify more adaptive, positive thoughts (to overcome thoughts of being too tired or too stressed to exercise). Two hundred participants will be randomized into this group.
Online Cognitive Behavioral Therapy: see arm description
|
Fitbit Alone
n=70 Participants
Participants assigned to the Fitbit-only control study group you will not be receiving therapy. However, they will receive a Fitbit, which they will be asked to wear over the course of 16 weeks as well as to complete the same schedule of assessments as the therapy arms. One hundred participants will be randomized into this group.
Fitbit Alone: see arm description
|
|---|---|---|---|
|
Change (Per Day) in Average Daily Steps Stratified by Self-efficacy for Exercise (SEE)
8 week: SEE score 30
|
1.2 Change (per day) in Avg Daily Steps
Interval -4.0 to 6.3
|
4.5 Change (per day) in Avg Daily Steps
Interval -0.1 to 9.9
|
-6.0 Change (per day) in Avg Daily Steps
Interval -13.3 to 1.2
|
|
Change (Per Day) in Average Daily Steps Stratified by Self-efficacy for Exercise (SEE)
8 week: SEE score 45
|
3.3 Change (per day) in Avg Daily Steps
Interval -1.1 to 7.7
|
2.8 Change (per day) in Avg Daily Steps
Interval -1.3 to 7.0
|
-9.0 Change (per day) in Avg Daily Steps
Interval -15.4 to -2.5
|
|
Change (Per Day) in Average Daily Steps Stratified by Self-efficacy for Exercise (SEE)
8 week: SEE score 55
|
4.7 Change (per day) in Avg Daily Steps
Interval -0.8 to 10.2
|
1.8 Change (per day) in Avg Daily Steps
Interval -3.1 to 6.6
|
-11.0 Change (per day) in Avg Daily Steps
Interval -18.7 to -3.2
|
|
Change (Per Day) in Average Daily Steps Stratified by Self-efficacy for Exercise (SEE)
16 weeks: SEE score 30
|
-1.0 Change (per day) in Avg Daily Steps
Interval -3.1 to 1.1
|
-.8 Change (per day) in Avg Daily Steps
Interval -3.0 to 1.4
|
-.3 Change (per day) in Avg Daily Steps
Interval -3.1 to 2.6
|
|
Change (Per Day) in Average Daily Steps Stratified by Self-efficacy for Exercise (SEE)
16 weeks: SEE score 45
|
-1.3 Change (per day) in Avg Daily Steps
Interval -3.0 to 0.5
|
-1.9 Change (per day) in Avg Daily Steps
Interval -3.6 to -0.2
|
-3.4 Change (per day) in Avg Daily Steps
Interval -5.9 to -0.9
|
|
Change (Per Day) in Average Daily Steps Stratified by Self-efficacy for Exercise (SEE)
16 weeks: SEE score 55
|
-1.4 Change (per day) in Avg Daily Steps
Interval -3.6 to 0.8
|
-2.5 Change (per day) in Avg Daily Steps
Interval -4.5 to -0.5
|
-5.4 Change (per day) in Avg Daily Steps
Interval -8.4 to -2.4
|
SECONDARY outcome
Timeframe: Baseline, 8 and 16 weeksChange (per day) in Average Daily Steps Stratified by the Duke Activity Status Index (DASI), specifically using summed scores of 40, 50, and 60. Possible total scores range from 0-58.2. This 12-item questionnaire, administered at the screening session, assesses an individual's current functional capabilities when engaging in various activities that involve physical exertion. Items include "Can you walk a block or two on level ground?" and "Can you climb a flight of stairs or walk up a hill?" Individual item responses are weighted based upon their metabolic cost, and subsequently summed to yield a total score. A higher score indicates better functional capability. The DASI is a continuous measure and thus, was left continuous in our model and was not categorized. Because the DASI is a continuous measure, we assumed a continuous linear change in the effect per unit change. For purposes of presenting the results, we selected scores of 40, 50, and 60 as values to report the model-based
Outcome measures
| Measure |
Online Mindfulness Based Cognitive Therapy +Fitbit
n=133 Participants
A central aspect of MBCT is the concept of awareness. Participants practice a variety of meditation types (e.g. breath awareness) and learn to bring mindfulness to everyday situations. Awareness will be directed to elements in participants' lives that interfere with living a more productive, physically active life (e.g. thoughts and feelings that interfere with becoming more physically active; stressful situations and circumstances that prevent them from engaging in exercise). Two hundred participants will be randomized into this group.
Online Mindfulness Based Cognitive Therapy: see arm description
|
Online Cognitive Behavioral Therapy +Fitbit
n=137 Participants
1)identifying and setting realistic exercise-based goals and intermediate goals (to maximize success to increase motivation); (2) behavioral scheduling to optimize when to exercise, identify rewards for exercising, and problem solve obstacles to exercising; and (3) identify dysfunctional, maladaptive thoughts about exercise (which decrease motivation) and skills to identify more adaptive, positive thoughts (to overcome thoughts of being too tired or too stressed to exercise). Two hundred participants will be randomized into this group.
Online Cognitive Behavioral Therapy: see arm description
|
Fitbit Alone
n=70 Participants
Participants assigned to the Fitbit-only control study group you will not be receiving therapy. However, they will receive a Fitbit, which they will be asked to wear over the course of 16 weeks as well as to complete the same schedule of assessments as the therapy arms. One hundred participants will be randomized into this group.
Fitbit Alone: see arm description
|
|---|---|---|---|
|
Change (Per Day) in Average Daily Steps Stratified by the Duke Activity Status Index (DASI)
8 week: DASI score 40
|
3.3 Change (per day) in Avg Daily Steps
Interval -1.7 to 8.3
|
4.5 Change (per day) in Avg Daily Steps
Interval -0.7 to 9.6
|
-7.6 Change (per day) in Avg Daily Steps
Interval -14.7 to -0.5
|
|
Change (Per Day) in Average Daily Steps Stratified by the Duke Activity Status Index (DASI)
8 week: DASI score 50
|
2.6 Change (per day) in Avg Daily Steps
Interval -1.8 to 7.0
|
2.4 Change (per day) in Avg Daily Steps
Interval -1.8 to 6.6
|
-8.4 Change (per day) in Avg Daily Steps
Interval -15.0 to -1.8
|
|
Change (Per Day) in Average Daily Steps Stratified by the Duke Activity Status Index (DASI)
8 week: DASI score 60
|
2.0 Change (per day) in Avg Daily Steps
Interval -4.2 to 8.2
|
.3 Change (per day) in Avg Daily Steps
Interval -5.9 to 6.5
|
-9.2 Change (per day) in Avg Daily Steps
Interval -18.6 to 0.2
|
|
Change (Per Day) in Average Daily Steps Stratified by the Duke Activity Status Index (DASI)
16 week: DASI score 40
|
-2.0 Change (per day) in Avg Daily Steps
Interval -4.0 to 0.1
|
-1.9 Change (per day) in Avg Daily Steps
Interval -4.0 to 0.2
|
-3.5 Change (per day) in Avg Daily Steps
Interval -6.2 to -0.7
|
|
Change (Per Day) in Average Daily Steps Stratified by the Duke Activity Status Index (DASI)
16 week: DASI score 50
|
-1.0 Change (per day) in Avg Daily Steps
Interval -2.7 to -0.8
|
-1.8 Change (per day) in Avg Daily Steps
Interval -3.5 to 0.0
|
-2.0 Change (per day) in Avg Daily Steps
Interval -4.6 to 0.5
|
|
Change (Per Day) in Average Daily Steps Stratified by the Duke Activity Status Index (DASI)
16 week: DASI score 60
|
0.0 Change (per day) in Avg Daily Steps
Interval -2.4 to 2.5
|
-1.6 Change (per day) in Avg Daily Steps
Interval -4.2 to 1.0
|
-.6 Change (per day) in Avg Daily Steps
Interval -4.2 to 3.1
|
SECONDARY outcome
Timeframe: Baseline, 8 and 16 weeksChange (per day) in Average Daily Steps Stratified by the International Physical Activity Questionnaire (IPAQ) - Short Form, specifically at scores of 150, 350, and 850. This 7-item measure, administered at the screening and study randomization sessions, evaluates engagement in vigorous, moderate, and light (e.g., walking) activity in the prior 7 days. Higher scores on the IPAQ indicate higher activity levels. The IPAQ is a continuous measure and thus, was left continuous in our model and was not categorized. Because the IPAQ is a continuous measure, we assumed a continuous linear change in the effect per unit change. For purposes of presenting the results, we selected scores of 150, 350, and 850 as values to report the model-based slopes. We reported those values based on approximate 25th, 50th, 75th percentiles among baseline IPAQ scores among H3M participants.
Outcome measures
| Measure |
Online Mindfulness Based Cognitive Therapy +Fitbit
n=133 Participants
A central aspect of MBCT is the concept of awareness. Participants practice a variety of meditation types (e.g. breath awareness) and learn to bring mindfulness to everyday situations. Awareness will be directed to elements in participants' lives that interfere with living a more productive, physically active life (e.g. thoughts and feelings that interfere with becoming more physically active; stressful situations and circumstances that prevent them from engaging in exercise). Two hundred participants will be randomized into this group.
Online Mindfulness Based Cognitive Therapy: see arm description
|
Online Cognitive Behavioral Therapy +Fitbit
n=137 Participants
1)identifying and setting realistic exercise-based goals and intermediate goals (to maximize success to increase motivation); (2) behavioral scheduling to optimize when to exercise, identify rewards for exercising, and problem solve obstacles to exercising; and (3) identify dysfunctional, maladaptive thoughts about exercise (which decrease motivation) and skills to identify more adaptive, positive thoughts (to overcome thoughts of being too tired or too stressed to exercise). Two hundred participants will be randomized into this group.
Online Cognitive Behavioral Therapy: see arm description
|
Fitbit Alone
n=70 Participants
Participants assigned to the Fitbit-only control study group you will not be receiving therapy. However, they will receive a Fitbit, which they will be asked to wear over the course of 16 weeks as well as to complete the same schedule of assessments as the therapy arms. One hundred participants will be randomized into this group.
Fitbit Alone: see arm description
|
|---|---|---|---|
|
Change (Per Day) in Average Daily Steps Stratified by the International Physical Activity Questionnaire (IPAQ) - Short Form
8 week: IPAQ score 150
|
1.1 Change (per day) in Avg Daily Steps
Interval -3.8 to 6.0
|
3.0 Change (per day) in Avg Daily Steps
Interval -1.9 to 7.9
|
-8.7 Change (per day) in Avg Daily Steps
Interval -16.7 to -1.7
|
|
Change (Per Day) in Average Daily Steps Stratified by the International Physical Activity Questionnaire (IPAQ) - Short Form
8 week: IPAQ score 350
|
2.0 Change (per day) in Avg Daily Steps
Interval -2.8 to 6.8
|
2.9 Change (per day) in Avg Daily Steps
Interval -1.9 to 7.7
|
-9.8 Change (per day) in Avg Daily Steps
Interval -17.4 to -2.2
|
|
Change (Per Day) in Average Daily Steps Stratified by the International Physical Activity Questionnaire (IPAQ) - Short Form
8 week: IPAQ score 850
|
4.2 Change (per day) in Avg Daily Steps
Interval -0.4 to 8.9
|
2.7 Change (per day) in Avg Daily Steps
Interval -1.9 to 7.2
|
-12.5 Change (per day) in Avg Daily Steps
Interval -19.8 to -5.1
|
|
Change (Per Day) in Average Daily Steps Stratified by the International Physical Activity Questionnaire (IPAQ) - Short Form
16 week: IPAQ score 150
|
-3.1 Change (per day) in Avg Daily Steps
Interval -5.1 to -1.1
|
-1.6 Change (per day) in Avg Daily Steps
Interval -3.6 to 0.4
|
-1.7 Change (per day) in Avg Daily Steps
Interval -4.8 to 1.5
|
|
Change (Per Day) in Average Daily Steps Stratified by the International Physical Activity Questionnaire (IPAQ) - Short Form
16 week: IPAQ score 350
|
-2.8 Change (per day) in Avg Daily Steps
Interval -4.7 to -0.9
|
-1.8 Change (per day) in Avg Daily Steps
Interval -3.8 to 0.2
|
-2.2 Change (per day) in Avg Daily Steps
Interval -5.2 to 0.7
|
|
Change (Per Day) in Average Daily Steps Stratified by the International Physical Activity Questionnaire (IPAQ) - Short Form
16 week: IPAQ score 850
|
-2.2 Change (per day) in Avg Daily Steps
Interval -4.0 to -0.3
|
-2.4 Change (per day) in Avg Daily Steps
Interval -4.3 to -0.5
|
-3.6 Change (per day) in Avg Daily Steps
Interval -6.5 to -0.7
|
SECONDARY outcome
Timeframe: Baseline, 8 and 16 weeksChange (per day) in Average Daily Steps Stratified by education. Education was self-reported in the demographics questionnaire. Education is reported as: less than 4-year college, 4-year college, and more than 4-year college
Outcome measures
| Measure |
Online Mindfulness Based Cognitive Therapy +Fitbit
n=133 Participants
A central aspect of MBCT is the concept of awareness. Participants practice a variety of meditation types (e.g. breath awareness) and learn to bring mindfulness to everyday situations. Awareness will be directed to elements in participants' lives that interfere with living a more productive, physically active life (e.g. thoughts and feelings that interfere with becoming more physically active; stressful situations and circumstances that prevent them from engaging in exercise). Two hundred participants will be randomized into this group.
Online Mindfulness Based Cognitive Therapy: see arm description
|
Online Cognitive Behavioral Therapy +Fitbit
n=137 Participants
1)identifying and setting realistic exercise-based goals and intermediate goals (to maximize success to increase motivation); (2) behavioral scheduling to optimize when to exercise, identify rewards for exercising, and problem solve obstacles to exercising; and (3) identify dysfunctional, maladaptive thoughts about exercise (which decrease motivation) and skills to identify more adaptive, positive thoughts (to overcome thoughts of being too tired or too stressed to exercise). Two hundred participants will be randomized into this group.
Online Cognitive Behavioral Therapy: see arm description
|
Fitbit Alone
n=70 Participants
Participants assigned to the Fitbit-only control study group you will not be receiving therapy. However, they will receive a Fitbit, which they will be asked to wear over the course of 16 weeks as well as to complete the same schedule of assessments as the therapy arms. One hundred participants will be randomized into this group.
Fitbit Alone: see arm description
|
|---|---|---|---|
|
Change (Per Day) in Average Daily Steps Stratified by Education
8 weeks: less than 4 year college
|
-2.3 Change (per day) in Avg Daily Steps
Interval -9.3 to 4.8
|
-1.8 Change (per day) in Avg Daily Steps
Interval -8.2 to 4.6
|
-7.2 Change (per day) in Avg Daily Steps
Interval -17.3 to 2.8
|
|
Change (Per Day) in Average Daily Steps Stratified by Education
8 weeks: 4-year college
|
2.1 Change (per day) in Avg Daily Steps
Interval -6.9 to 11.1
|
5.5 Change (per day) in Avg Daily Steps
Interval -2.2 to 13.1
|
9.3 Change (per day) in Avg Daily Steps
Interval -5.9 to 24.5
|
|
Change (Per Day) in Average Daily Steps Stratified by Education
8 weeks: more than 4-year college
|
8.2 Change (per day) in Avg Daily Steps
Interval 1.3 to 15.0
|
7.4 Change (per day) in Avg Daily Steps
Interval -0.4 to 15.1
|
-15.9 Change (per day) in Avg Daily Steps
Interval -25.4 to -6.3
|
|
Change (Per Day) in Average Daily Steps Stratified by Education
16 weeks: less than 4-year college
|
-.1 Change (per day) in Avg Daily Steps
Interval -3.0 to 2.8
|
-1.8 Change (per day) in Avg Daily Steps
Interval -4.4 to 0.9
|
-3.9 Change (per day) in Avg Daily Steps
Interval -7.7 to 0.0
|
|
Change (Per Day) in Average Daily Steps Stratified by Education
16 weeks: 4-year college
|
-4.9 Change (per day) in Avg Daily Steps
Interval -8.5 to -1.3
|
-2.4 Change (per day) in Avg Daily Steps
Interval -5.7 to 0.9
|
-4.2 Change (per day) in Avg Daily Steps
Interval -10.0 to 1.5
|
|
Change (Per Day) in Average Daily Steps Stratified by Education
16 weeks: more than 4-year college
|
.1 Change (per day) in Avg Daily Steps
Interval -2.6 to 2.9
|
-.9 Change (per day) in Avg Daily Steps
Interval -3.9 to 2.1
|
-.6 Change (per day) in Avg Daily Steps
Interval -4.4 to 3.3
|
SECONDARY outcome
Timeframe: Baseline, 8 and 16 weeksChange (per day) in Average Daily Steps Stratified by the employment. Employment was self-reported in the demographics questionnaire. Employment is reported as employed, unemployed, and other.
Outcome measures
| Measure |
Online Mindfulness Based Cognitive Therapy +Fitbit
n=133 Participants
A central aspect of MBCT is the concept of awareness. Participants practice a variety of meditation types (e.g. breath awareness) and learn to bring mindfulness to everyday situations. Awareness will be directed to elements in participants' lives that interfere with living a more productive, physically active life (e.g. thoughts and feelings that interfere with becoming more physically active; stressful situations and circumstances that prevent them from engaging in exercise). Two hundred participants will be randomized into this group.
Online Mindfulness Based Cognitive Therapy: see arm description
|
Online Cognitive Behavioral Therapy +Fitbit
n=137 Participants
1)identifying and setting realistic exercise-based goals and intermediate goals (to maximize success to increase motivation); (2) behavioral scheduling to optimize when to exercise, identify rewards for exercising, and problem solve obstacles to exercising; and (3) identify dysfunctional, maladaptive thoughts about exercise (which decrease motivation) and skills to identify more adaptive, positive thoughts (to overcome thoughts of being too tired or too stressed to exercise). Two hundred participants will be randomized into this group.
Online Cognitive Behavioral Therapy: see arm description
|
Fitbit Alone
n=70 Participants
Participants assigned to the Fitbit-only control study group you will not be receiving therapy. However, they will receive a Fitbit, which they will be asked to wear over the course of 16 weeks as well as to complete the same schedule of assessments as the therapy arms. One hundred participants will be randomized into this group.
Fitbit Alone: see arm description
|
|---|---|---|---|
|
Change (Per Day) in Average Daily Steps Stratified by Employment
8 week: employed
|
6.1 Change (per day) in Avg Daily Steps
Interval 0.9 to 11.4
|
2.4 Change (per day) in Avg Daily Steps
Interval -2.7 to 7.4
|
-8.4 Change (per day) in Avg Daily Steps
Interval -15.5 to -1.3
|
|
Change (Per Day) in Average Daily Steps Stratified by Employment
8 week: unemployed
|
-15.8 Change (per day) in Avg Daily Steps
Interval -17.6 to -4.0
|
11.7 Change (per day) in Avg Daily Steps
Interval 0.2 to 23.3
|
2.8 Change (per day) in Avg Daily Steps
Interval -21.8 to 27.5
|
|
Change (Per Day) in Average Daily Steps Stratified by Employment
8 week: other
|
3.2 Change (per day) in Avg Daily Steps
Interval -7.1 to 13.5
|
-1.0 Change (per day) in Avg Daily Steps
Interval -10.5 to 8.4
|
-11.5 Change (per day) in Avg Daily Steps
Interval -27.6 to 4.7
|
|
Change (Per Day) in Average Daily Steps Stratified by Employment
16 week: employed
|
.8 Change (per day) in Avg Daily Steps
Interval -1.3 to 2.8
|
-.6 Change (per day) in Avg Daily Steps
Interval -2.7 to 1.5
|
-2.1 Change (per day) in Avg Daily Steps
Interval -5.0 to 0.8
|
|
Change (Per Day) in Average Daily Steps Stratified by Employment
16 week: unemployed
|
-14.9 Change (per day) in Avg Daily Steps
Interval -19.7 to -10.0
|
.5 Change (per day) in Avg Daily Steps
Interval -4.2 to 5.2
|
-2.6 Change (per day) in Avg Daily Steps
Interval -11.7 to 6.5
|
|
Change (Per Day) in Average Daily Steps Stratified by Employment
16 week: other
|
1.3 Change (per day) in Avg Daily Steps
Interval -2.9 to 5.5
|
-7.6 Change (per day) in Avg Daily Steps
Interval -11.5 to -3.7
|
-4.4 Change (per day) in Avg Daily Steps
Interval -10.2 to 1.4
|
Adverse Events
Online Mindfulness Based Cognitive Therapy +Fitbit
Serious events: 0 serious events
Other events: 53 other events
Deaths: 0 deaths
Online Cognitive Behavioral Therapy +Fitbit
Serious events: 1 serious events
Other events: 45 other events
Deaths: 0 deaths
Fitbit Alone
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Online Mindfulness Based Cognitive Therapy +Fitbit
n=144 participants at risk
A central aspect of MBCT is the concept of awareness. Participants practice a variety of meditation types (e.g. breath awareness) and learn to bring mindfulness to everyday situations. Awareness will be directed to elements in participants' lives that interfere with living a more productive, physically active life (e.g. thoughts and feelings that interfere with becoming more physically active; stressful situations and circumstances that prevent them from engaging in exercise). Two hundred participants will be randomized into this group.
Online Mindfulness Based Cognitive Therapy: see arm description
|
Online Cognitive Behavioral Therapy +Fitbit
n=145 participants at risk
1)identifying and setting realistic exercise-based goals and intermediate goals (to maximize success to increase motivation); (2) behavioral scheduling to optimize when to exercise, identify rewards for exercising, and problem solve obstacles to exercising; and (3) identify dysfunctional, maladaptive thoughts about exercise (which decrease motivation) and skills to identify more adaptive, positive thoughts (to overcome thoughts of being too tired or too stressed to exercise). Two hundred participants will be randomized into this group.
Online Cognitive Behavioral Therapy: see arm description
|
Fitbit Alone
n=72 participants at risk
Participants assigned to the Fitbit-only control study group you will not be receiving therapy. However, they will receive a Fitbit, which they will be asked to wear over the course of 16 weeks as well as to complete the same schedule of assessments as the therapy arms. One hundred participants will be randomized into this group.
Fitbit Alone: see arm description
|
|---|---|---|---|
|
Cardiac disorders
Angina
|
0.00%
0/144 • 16 weeks
Data on adverse events were collected via a two-question survey designed to assess if participants have experienced any adverse events, related to the study, since starting to participate.
|
0.69%
1/145 • 16 weeks
Data on adverse events were collected via a two-question survey designed to assess if participants have experienced any adverse events, related to the study, since starting to participate.
|
0.00%
0/72 • 16 weeks
Data on adverse events were collected via a two-question survey designed to assess if participants have experienced any adverse events, related to the study, since starting to participate.
|
Other adverse events
| Measure |
Online Mindfulness Based Cognitive Therapy +Fitbit
n=144 participants at risk
A central aspect of MBCT is the concept of awareness. Participants practice a variety of meditation types (e.g. breath awareness) and learn to bring mindfulness to everyday situations. Awareness will be directed to elements in participants' lives that interfere with living a more productive, physically active life (e.g. thoughts and feelings that interfere with becoming more physically active; stressful situations and circumstances that prevent them from engaging in exercise). Two hundred participants will be randomized into this group.
Online Mindfulness Based Cognitive Therapy: see arm description
|
Online Cognitive Behavioral Therapy +Fitbit
n=145 participants at risk
1)identifying and setting realistic exercise-based goals and intermediate goals (to maximize success to increase motivation); (2) behavioral scheduling to optimize when to exercise, identify rewards for exercising, and problem solve obstacles to exercising; and (3) identify dysfunctional, maladaptive thoughts about exercise (which decrease motivation) and skills to identify more adaptive, positive thoughts (to overcome thoughts of being too tired or too stressed to exercise). Two hundred participants will be randomized into this group.
Online Cognitive Behavioral Therapy: see arm description
|
Fitbit Alone
n=72 participants at risk
Participants assigned to the Fitbit-only control study group you will not be receiving therapy. However, they will receive a Fitbit, which they will be asked to wear over the course of 16 weeks as well as to complete the same schedule of assessments as the therapy arms. One hundred participants will be randomized into this group.
Fitbit Alone: see arm description
|
|---|---|---|---|
|
Psychiatric disorders
Suicidal thoughts
|
29.9%
43/144 • 16 weeks
Data on adverse events were collected via a two-question survey designed to assess if participants have experienced any adverse events, related to the study, since starting to participate.
|
26.9%
39/145 • 16 weeks
Data on adverse events were collected via a two-question survey designed to assess if participants have experienced any adverse events, related to the study, since starting to participate.
|
31.9%
23/72 • 16 weeks
Data on adverse events were collected via a two-question survey designed to assess if participants have experienced any adverse events, related to the study, since starting to participate.
|
|
Psychiatric disorders
Sleeping difficulty
|
0.00%
0/144 • 16 weeks
Data on adverse events were collected via a two-question survey designed to assess if participants have experienced any adverse events, related to the study, since starting to participate.
|
0.00%
0/145 • 16 weeks
Data on adverse events were collected via a two-question survey designed to assess if participants have experienced any adverse events, related to the study, since starting to participate.
|
1.4%
1/72 • 16 weeks
Data on adverse events were collected via a two-question survey designed to assess if participants have experienced any adverse events, related to the study, since starting to participate.
|
|
Psychiatric disorders
Negative health event
|
4.9%
7/144 • 16 weeks
Data on adverse events were collected via a two-question survey designed to assess if participants have experienced any adverse events, related to the study, since starting to participate.
|
3.4%
5/145 • 16 weeks
Data on adverse events were collected via a two-question survey designed to assess if participants have experienced any adverse events, related to the study, since starting to participate.
|
6.9%
5/72 • 16 weeks
Data on adverse events were collected via a two-question survey designed to assess if participants have experienced any adverse events, related to the study, since starting to participate.
|
|
General disorders
Hip injury
|
0.69%
1/144 • 16 weeks
Data on adverse events were collected via a two-question survey designed to assess if participants have experienced any adverse events, related to the study, since starting to participate.
|
0.00%
0/145 • 16 weeks
Data on adverse events were collected via a two-question survey designed to assess if participants have experienced any adverse events, related to the study, since starting to participate.
|
0.00%
0/72 • 16 weeks
Data on adverse events were collected via a two-question survey designed to assess if participants have experienced any adverse events, related to the study, since starting to participate.
|
|
Psychiatric disorders
Hospitalized for alcoholism
|
0.00%
0/144 • 16 weeks
Data on adverse events were collected via a two-question survey designed to assess if participants have experienced any adverse events, related to the study, since starting to participate.
|
0.69%
1/145 • 16 weeks
Data on adverse events were collected via a two-question survey designed to assess if participants have experienced any adverse events, related to the study, since starting to participate.
|
0.00%
0/72 • 16 weeks
Data on adverse events were collected via a two-question survey designed to assess if participants have experienced any adverse events, related to the study, since starting to participate.
|
|
Cardiac disorders
Cardiovascular procedure
|
1.4%
2/144 • 16 weeks
Data on adverse events were collected via a two-question survey designed to assess if participants have experienced any adverse events, related to the study, since starting to participate.
|
0.00%
0/145 • 16 weeks
Data on adverse events were collected via a two-question survey designed to assess if participants have experienced any adverse events, related to the study, since starting to participate.
|
0.00%
0/72 • 16 weeks
Data on adverse events were collected via a two-question survey designed to assess if participants have experienced any adverse events, related to the study, since starting to participate.
|
|
General disorders
Chronic kidney disease
|
0.00%
0/144 • 16 weeks
Data on adverse events were collected via a two-question survey designed to assess if participants have experienced any adverse events, related to the study, since starting to participate.
|
0.00%
0/145 • 16 weeks
Data on adverse events were collected via a two-question survey designed to assess if participants have experienced any adverse events, related to the study, since starting to participate.
|
1.4%
1/72 • 16 weeks
Data on adverse events were collected via a two-question survey designed to assess if participants have experienced any adverse events, related to the study, since starting to participate.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place