Trial Outcomes & Findings for Exergame Study for Family Caregivers (NCT NCT05032872)
NCT ID: NCT05032872
Last Updated: 2023-07-19
Results Overview
Steps were automatically synced from the Fitbit for both conditions daily. Days with 500 or fewer recorded steps were coded as missing. Weekly step averages were calculated for weeks with 4 or more days not coded missing. The first two weeks of baseline steps were averaged to form the baseline step. Percent change of steps was calculated as the difference between the average weekly steps during the intervention (weeks 3-8) and baseline steps divided by baseline steps.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
Percent Change of Steps from baseline to Weeks 3, 4, 5, 6, 7, and 8
Results posted on
2023-07-19
Participant Flow
80 participants enrolled (agreed to participate in the study following completion of informed consent), and were all assigned to each arm/group. However, only 38/42 people assigned in the control group completed the pretest, thus we don't have complete pretest data for 4 people in the control group, and 2 of these 4 people didn't complete any demographic information, so we don't have their baseline characteristic measures.
Participant milestones
| Measure |
Social Exergame Treatment Group
The treatment group will wear a Fitbit step counter for 8 weeks. In addition, participants will use the full version of the Go\&Grow fitness app for 6 weeks.
Social Exergame Treatment Group: - Physical activity tracking, walk to grow flowers and plant their own garden
* Follow workout tutorials
* Daily steps tracked by Fitbit and workout log tracked by the app
* Daily reminders to wear Fitbit, use the app, and share stories to unlock new flowers to grow
* Includes social features: like, reply, and see other's stories, and share their stories; Access to other people's gardens
* In-app rewards (unlock new flowers to grow each week) if participants post stories
|
Control Group
The control group will wear a Fitbit step counter for 8 weeks. In addition, participants will use the Go\&Grow fitness app without the social features for 6 weeks.
Control Group: - Physical activity tracking, walk to grow flowers and plant their own garden
* Follow workout tutorials
* Daily steps tracked by Fitbit and workout log tracked by the app
* Daily reminders to wear Fitbit and use the app
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
42
|
|
Overall Study
Completed Pretest
|
38
|
38
|
|
Overall Study
COMPLETED
|
31
|
35
|
|
Overall Study
NOT COMPLETED
|
7
|
7
|
Reasons for withdrawal
| Measure |
Social Exergame Treatment Group
The treatment group will wear a Fitbit step counter for 8 weeks. In addition, participants will use the full version of the Go\&Grow fitness app for 6 weeks.
Social Exergame Treatment Group: - Physical activity tracking, walk to grow flowers and plant their own garden
* Follow workout tutorials
* Daily steps tracked by Fitbit and workout log tracked by the app
* Daily reminders to wear Fitbit, use the app, and share stories to unlock new flowers to grow
* Includes social features: like, reply, and see other's stories, and share their stories; Access to other people's gardens
* In-app rewards (unlock new flowers to grow each week) if participants post stories
|
Control Group
The control group will wear a Fitbit step counter for 8 weeks. In addition, participants will use the Go\&Grow fitness app without the social features for 6 weeks.
Control Group: - Physical activity tracking, walk to grow flowers and plant their own garden
* Follow workout tutorials
* Daily steps tracked by Fitbit and workout log tracked by the app
* Daily reminders to wear Fitbit and use the app
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
4
|
|
Overall Study
Withdrawal by Subject
|
4
|
3
|
Baseline Characteristics
Exergame Study for Family Caregivers
Baseline characteristics by cohort
| Measure |
Social Exergame Treatment Group
n=38 Participants
The treatment group will wear a Fitbit step counter for 8 weeks. In addition, participants will use the full version of the Go\&Grow fitness app for 6 weeks.
Social Exergame Treatment Group: - Physical activity tracking, walk to grow flowers and plant their own garden
* Follow workout tutorials
* Daily steps tracked by Fitbit and workout log tracked by the app
* Daily reminders to wear Fitbit, use the app, and share stories to unlock new flowers to grow
* Includes social features: like, reply, and see other's stories, and share their stories; Access to other people's gardens
* In-app rewards (unlock new flowers to grow each week) if participants post stories
|
Control Group
n=40 Participants
The control group will wear a Fitbit step counter for 8 weeks. In addition, participants will use the Go\&Grow fitness app without the social features for 6 weeks.
Control Group: - Physical activity tracking, walk to grow flowers and plant their own garden
* Follow workout tutorials
* Daily steps tracked by Fitbit and workout log tracked by the app
* Daily reminders to wear Fitbit and use the app
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.71 years
STANDARD_DEVIATION 10.04 • n=5 Participants
|
57.03 years
STANDARD_DEVIATION 11.99 • n=7 Participants
|
56.38 years
STANDARD_DEVIATION 11.03 • n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
38 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Percent Change of Steps from baseline to Weeks 3, 4, 5, 6, 7, and 8Population: some weeks were coded as missing since not all participants recorded steps for all weeks
Steps were automatically synced from the Fitbit for both conditions daily. Days with 500 or fewer recorded steps were coded as missing. Weekly step averages were calculated for weeks with 4 or more days not coded missing. The first two weeks of baseline steps were averaged to form the baseline step. Percent change of steps was calculated as the difference between the average weekly steps during the intervention (weeks 3-8) and baseline steps divided by baseline steps.
Outcome measures
| Measure |
Social Exergame Treatment Group
n=31 Participants
The treatment group will wear a Fitbit step counter for 8 weeks. In addition, participants will use the full version of the Go\&Grow fitness app for 6 weeks.
Social Exergame Treatment Group: - Physical activity tracking, walk to grow flowers and plant their own garden
* Follow workout tutorials
* Daily steps tracked by Fitbit and workout log tracked by the app
* Daily reminders to wear Fitbit, use the app, and share stories to unlock new flowers to grow
* Includes social features: like, reply, and see other's stories, and share their stories; Access to other people's gardens
* In-app rewards (unlock new flowers to grow each week) if participants post stories
|
Control Group
n=33 Participants
The control group will wear a Fitbit step counter for 8 weeks. In addition, participants will use the Go\&Grow fitness app without the social features for 6 weeks.
Control Group: - Physical activity tracking, walk to grow flowers and plant their own garden
* Follow workout tutorials
* Daily steps tracked by Fitbit and workout log tracked by the app
* Daily reminders to wear Fitbit and use the app
|
|---|---|---|
|
Percent Change in Steps
Percent Change From Baseline to Week 3
|
4.68 Percent Change of Steps from Baseline
Standard Deviation 29
|
4.77 Percent Change of Steps from Baseline
Standard Deviation 23
|
|
Percent Change in Steps
Percent Change From Baseline to Week 4
|
11.87 Percent Change of Steps from Baseline
Standard Deviation 33
|
2.69 Percent Change of Steps from Baseline
Standard Deviation 22
|
|
Percent Change in Steps
Percent Change From Baseline to Week 5
|
10 Percent Change of Steps from Baseline
Standard Deviation 46
|
11.11 Percent Change of Steps from Baseline
Standard Deviation 26
|
|
Percent Change in Steps
Percent Change From Baseline to Week 6
|
5.33 Percent Change of Steps from Baseline
Standard Deviation 38
|
11.26 Percent Change of Steps from Baseline
Standard Deviation 28
|
|
Percent Change in Steps
Percent Change From Baseline to Week 7
|
3.11 Percent Change of Steps from Baseline
Standard Deviation 35
|
5.66 Percent Change of Steps from Baseline
Standard Deviation 33
|
|
Percent Change in Steps
Percent Change From Baseline to Week 8
|
10 Percent Change of Steps from Baseline
Standard Deviation 48
|
-6.45 Percent Change of Steps from Baseline
Standard Deviation 24
|
PRIMARY outcome
Timeframe: Pretest (before week 1) and posttest (after week 8)Population: N=38 in each condition completed the pretest. N=31 in the treatment and N=35 in the control completed the posttest.
Self-report measure of social support from the Lubben Social Network Scale for family and friends with scores summed across 18 items. Possible scores range from 0-60, with higher scores indicating higher social support.
Outcome measures
| Measure |
Social Exergame Treatment Group
n=38 Participants
The treatment group will wear a Fitbit step counter for 8 weeks. In addition, participants will use the full version of the Go\&Grow fitness app for 6 weeks.
Social Exergame Treatment Group: - Physical activity tracking, walk to grow flowers and plant their own garden
* Follow workout tutorials
* Daily steps tracked by Fitbit and workout log tracked by the app
* Daily reminders to wear Fitbit, use the app, and share stories to unlock new flowers to grow
* Includes social features: like, reply, and see other's stories, and share their stories; Access to other people's gardens
* In-app rewards (unlock new flowers to grow each week) if participants post stories
|
Control Group
n=38 Participants
The control group will wear a Fitbit step counter for 8 weeks. In addition, participants will use the Go\&Grow fitness app without the social features for 6 weeks.
Control Group: - Physical activity tracking, walk to grow flowers and plant their own garden
* Follow workout tutorials
* Daily steps tracked by Fitbit and workout log tracked by the app
* Daily reminders to wear Fitbit and use the app
|
|---|---|---|
|
Lubben Social Network Scale (LSNS)
Pretest
|
32.32 score on a scale
Standard Deviation 7.98
|
30.64 score on a scale
Standard Deviation 9.26
|
|
Lubben Social Network Scale (LSNS)
Posttest
|
32.23 score on a scale
Standard Deviation 9.81
|
28.40 score on a scale
Standard Deviation 9.15
|
PRIMARY outcome
Timeframe: Baseline (Average of Week 1 and 2), Weekly during the intervention from Week 3 to 8Population: not all participants completed each weekly survey. There were missing weekly surveys for some participants on some weeks
Social Connectedness Scale was administered weekly during the intervention with the following subscales: relationship salience, shared understandings, knowing other's experiences, satisfaction with the contact quantity and quality, and dissatisfaction with contact quantity. Scores were averaged across items from each subscale and possible scores ranged from 1 to 7 with higher scores indicating a higher level of the subscale.
Outcome measures
| Measure |
Social Exergame Treatment Group
n=35 Participants
The treatment group will wear a Fitbit step counter for 8 weeks. In addition, participants will use the full version of the Go\&Grow fitness app for 6 weeks.
Social Exergame Treatment Group: - Physical activity tracking, walk to grow flowers and plant their own garden
* Follow workout tutorials
* Daily steps tracked by Fitbit and workout log tracked by the app
* Daily reminders to wear Fitbit, use the app, and share stories to unlock new flowers to grow
* Includes social features: like, reply, and see other's stories, and share their stories; Access to other people's gardens
* In-app rewards (unlock new flowers to grow each week) if participants post stories
|
Control Group
n=36 Participants
The control group will wear a Fitbit step counter for 8 weeks. In addition, participants will use the Go\&Grow fitness app without the social features for 6 weeks.
Control Group: - Physical activity tracking, walk to grow flowers and plant their own garden
* Follow workout tutorials
* Daily steps tracked by Fitbit and workout log tracked by the app
* Daily reminders to wear Fitbit and use the app
|
|---|---|---|
|
Social Connectedness Scale
Satisfaction with contact quantity week 6
|
4.3 score on a scale
Standard Deviation 1.36
|
4.36 score on a scale
Standard Deviation 1.48
|
|
Social Connectedness Scale
Knowing Others' Experience Baseline (Average of Week 1 and 2)
|
4.88 score on a scale
Standard Deviation .92
|
4.72 score on a scale
Standard Deviation 1.06
|
|
Social Connectedness Scale
Knowing Others' Experience Week 3
|
4.7 score on a scale
Standard Deviation 1.22
|
4.72 score on a scale
Standard Deviation 1.18
|
|
Social Connectedness Scale
Knowing Others' Experience Week 4
|
4.96 score on a scale
Standard Deviation 1.23
|
4.87 score on a scale
Standard Deviation 1.12
|
|
Social Connectedness Scale
Knowing Others' Experience Week 5
|
4.85 score on a scale
Standard Deviation 1.4
|
4.67 score on a scale
Standard Deviation 1.17
|
|
Social Connectedness Scale
Knowing Others' Experience Week 6
|
5 score on a scale
Standard Deviation 1.14
|
4.67 score on a scale
Standard Deviation 1.28
|
|
Social Connectedness Scale
Knowing Others' Experience Week 7
|
4.63 score on a scale
Standard Deviation 1.22
|
4.66 score on a scale
Standard Deviation 1.27
|
|
Social Connectedness Scale
Knowing Others' Experience Week 8
|
4.77 score on a scale
Standard Deviation 1.31
|
4.70 score on a scale
Standard Deviation 1.33
|
|
Social Connectedness Scale
Relationship Salience Baseline (Average of Week 1 and 2)
|
4.55 score on a scale
Standard Deviation 1.22
|
4.47 score on a scale
Standard Deviation 1.36
|
|
Social Connectedness Scale
Relationship Salience Week 3
|
4.60 score on a scale
Standard Deviation 1.37
|
4.46 score on a scale
Standard Deviation 1.33
|
|
Social Connectedness Scale
Relationship Salience Week 4
|
4.82 score on a scale
Standard Deviation 1.19
|
4.59 score on a scale
Standard Deviation 1.21
|
|
Social Connectedness Scale
Relationship Salience Week 5
|
4.69 score on a scale
Standard Deviation 1.21
|
4.71 score on a scale
Standard Deviation 1.32
|
|
Social Connectedness Scale
Relationship Salience Week 6
|
4.80 score on a scale
Standard Deviation 1.34
|
4.64 score on a scale
Standard Deviation 1.36
|
|
Social Connectedness Scale
Relationship Salience Week 7
|
4.79 score on a scale
Standard Deviation 1.23
|
4.74 score on a scale
Standard Deviation 1.24
|
|
Social Connectedness Scale
Relationship Salience Week 8
|
4.79 score on a scale
Standard Deviation 1.14
|
4.57 score on a scale
Standard Deviation 1.28
|
|
Social Connectedness Scale
Satisfaction with contact quality Baseline (Average of Week 1 and 2)
|
4.71 score on a scale
Standard Deviation 1.44
|
4.69 score on a scale
Standard Deviation 1.63
|
|
Social Connectedness Scale
Satisfaction with contact quality week 3
|
4.98 score on a scale
Standard Deviation 1.55
|
4.69 score on a scale
Standard Deviation 1.85
|
|
Social Connectedness Scale
Satisfaction with contact quality week 4
|
4.96 score on a scale
Standard Deviation 1.45
|
4.66 score on a scale
Standard Deviation 1.76
|
|
Social Connectedness Scale
Satisfaction with contact quality week 5
|
5.01 score on a scale
Standard Deviation 1.6
|
4.77 score on a scale
Standard Deviation 1.79
|
|
Social Connectedness Scale
Satisfaction with contact quality week 6
|
5.18 score on a scale
Standard Deviation 1.46
|
4.84 score on a scale
Standard Deviation 1.76
|
|
Social Connectedness Scale
Satisfaction with contact quality week 7
|
5.23 score on a scale
Standard Deviation 1.48
|
4.72 score on a scale
Standard Deviation 1.90
|
|
Social Connectedness Scale
Satisfaction with contact quality week 8
|
5.21 score on a scale
Standard Deviation 1.44
|
4.57 score on a scale
Standard Deviation 1.95
|
|
Social Connectedness Scale
Dissatisfaction with contact quantity Baseline (Average of Week 1 and 2)
|
3.98 score on a scale
Standard Deviation 1.29
|
4.47 score on a scale
Standard Deviation 1.42
|
|
Social Connectedness Scale
Dissatisfaction with contact quantity week 3
|
4.16 score on a scale
Standard Deviation 1.49
|
4.41 score on a scale
Standard Deviation 1.52
|
|
Social Connectedness Scale
Dissatisfaction with contact quantity week 4
|
3.88 score on a scale
Standard Deviation 1.45
|
4.34 score on a scale
Standard Deviation 1.59
|
|
Social Connectedness Scale
Dissatisfaction with contact quantity week 5
|
3.78 score on a scale
Standard Deviation 1.40
|
4.37 score on a scale
Standard Deviation 1.63
|
|
Social Connectedness Scale
Dissatisfaction with contact quantity week 6
|
3.76 score on a scale
Standard Deviation 1.48
|
4.43 score on a scale
Standard Deviation 1.48
|
|
Social Connectedness Scale
Dissatisfaction with contact quantity week 7
|
3.8 score on a scale
Standard Deviation 1.44
|
4.36 score on a scale
Standard Deviation 1.66
|
|
Social Connectedness Scale
Dissatisfaction with contact quantity week 8
|
3.74 score on a scale
Standard Deviation 1.50
|
4.30 score on a scale
Standard Deviation 1.54
|
|
Social Connectedness Scale
Satisfaction with contact quantity Baseline (Average of Week 1 and 2)
|
4.21 score on a scale
Standard Deviation 1.34
|
4.3 score on a scale
Standard Deviation 1.36
|
|
Social Connectedness Scale
Satisfaction with contact quantity week 3
|
4.13 score on a scale
Standard Deviation 1.53
|
4.51 score on a scale
Standard Deviation 1.55
|
|
Social Connectedness Scale
Satisfaction with contact quantity week 4
|
4.37 score on a scale
Standard Deviation 1.32
|
4.31 score on a scale
Standard Deviation 1.51
|
|
Social Connectedness Scale
Satisfaction with contact quantity week 5
|
4.3 score on a scale
Standard Deviation 1.28
|
4.31 score on a scale
Standard Deviation 1.48
|
|
Social Connectedness Scale
Satisfaction with contact quantity week 7
|
4.09 score on a scale
Standard Deviation 1.51
|
4.4 score on a scale
Standard Deviation 1.37
|
|
Social Connectedness Scale
Satisfaction with contact quantity week 8
|
4.3 score on a scale
Standard Deviation 1.55
|
4.2 score on a scale
Standard Deviation 1.55
|
|
Social Connectedness Scale
shared understanding Baseline (Average of Week 1 and 2)
|
4.91 score on a scale
Standard Deviation 1.38
|
4.77 score on a scale
Standard Deviation 1.39
|
|
Social Connectedness Scale
shared understanding week 3
|
4.72 score on a scale
Standard Deviation 1.57
|
4.84 score on a scale
Standard Deviation 1.46
|
|
Social Connectedness Scale
shared understanding week 5
|
4.96 score on a scale
Standard Deviation 1.28
|
4.74 score on a scale
Standard Deviation 1.59
|
|
Social Connectedness Scale
shared understanding week 6
|
4.83 score on a scale
Standard Deviation 1.36
|
4.79 score on a scale
Standard Deviation 1.49
|
|
Social Connectedness Scale
shared understanding week 7
|
4.93 score on a scale
Standard Deviation 1.24
|
4.88 score on a scale
Standard Deviation 1.43
|
|
Social Connectedness Scale
shared understanding week 8
|
5.04 score on a scale
Standard Deviation 1.23
|
4.79 score on a scale
Standard Deviation 1.41
|
|
Social Connectedness Scale
shared understanding week 4
|
4.89 score on a scale
Standard Deviation 1.21
|
4.75 score on a scale
Standard Deviation 1.54
|
PRIMARY outcome
Timeframe: Pretest (before week 1) and posttest (after week 8)Population: N=38 in each condition completed the pretest. N=31 in the treatment and N=35 in the control completed the posttest.
The UCLA Loneliness Scale captures one's subjective feelings of loneliness over the past week for weekly surveys and over the past month for pretest and posttest surveys (20 items with ratings from 1 "Never" to 4 "Often"). The scores were averaged across the 20 items, with a score ranging from 1-4. A higher score indicates more loneliness.
Outcome measures
| Measure |
Social Exergame Treatment Group
n=38 Participants
The treatment group will wear a Fitbit step counter for 8 weeks. In addition, participants will use the full version of the Go\&Grow fitness app for 6 weeks.
Social Exergame Treatment Group: - Physical activity tracking, walk to grow flowers and plant their own garden
* Follow workout tutorials
* Daily steps tracked by Fitbit and workout log tracked by the app
* Daily reminders to wear Fitbit, use the app, and share stories to unlock new flowers to grow
* Includes social features: like, reply, and see other's stories, and share their stories; Access to other people's gardens
* In-app rewards (unlock new flowers to grow each week) if participants post stories
|
Control Group
n=38 Participants
The control group will wear a Fitbit step counter for 8 weeks. In addition, participants will use the Go\&Grow fitness app without the social features for 6 weeks.
Control Group: - Physical activity tracking, walk to grow flowers and plant their own garden
* Follow workout tutorials
* Daily steps tracked by Fitbit and workout log tracked by the app
* Daily reminders to wear Fitbit and use the app
|
|---|---|---|
|
UCLA Loneliness Scale
Pretest
|
2.21 score on a scale
Standard Deviation 0.63
|
2.21 score on a scale
Standard Deviation 0.73
|
|
UCLA Loneliness Scale
Posttest
|
2.08 score on a scale
Standard Deviation 0.75
|
2.24 score on a scale
Standard Deviation 0.76
|
PRIMARY outcome
Timeframe: Pretest (before week 1) and posttest (after week 8)Population: N=38 in each condition completed the pretest. N=31 in the treatment and N=35 in the control completed the posttest.
Positive and Negative Affect Schedule (PANAS) (20 items) asks participants to report how often participants felt positive and negative feelings over the past week for weekly surveys, and over the past month for pre-test and post-test surveys. Scores were averaged across the items (Total positive and negative affect scores can range from 0-4, with a higher score indicating a higher level of positive affect or negative affect).
Outcome measures
| Measure |
Social Exergame Treatment Group
n=38 Participants
The treatment group will wear a Fitbit step counter for 8 weeks. In addition, participants will use the full version of the Go\&Grow fitness app for 6 weeks.
Social Exergame Treatment Group: - Physical activity tracking, walk to grow flowers and plant their own garden
* Follow workout tutorials
* Daily steps tracked by Fitbit and workout log tracked by the app
* Daily reminders to wear Fitbit, use the app, and share stories to unlock new flowers to grow
* Includes social features: like, reply, and see other's stories, and share their stories; Access to other people's gardens
* In-app rewards (unlock new flowers to grow each week) if participants post stories
|
Control Group
n=38 Participants
The control group will wear a Fitbit step counter for 8 weeks. In addition, participants will use the Go\&Grow fitness app without the social features for 6 weeks.
Control Group: - Physical activity tracking, walk to grow flowers and plant their own garden
* Follow workout tutorials
* Daily steps tracked by Fitbit and workout log tracked by the app
* Daily reminders to wear Fitbit and use the app
|
|---|---|---|
|
Positive and Negative Affect Schedule (PANAS) (20 Items)
Positive Affect Pretest
|
2.32 score on a scale
Standard Deviation 0.85
|
2.13 score on a scale
Standard Deviation 0.93
|
|
Positive and Negative Affect Schedule (PANAS) (20 Items)
Positive Affect Posttest
|
2.14 score on a scale
Standard Deviation 1.05
|
2.02 score on a scale
Standard Deviation 1.03
|
|
Positive and Negative Affect Schedule (PANAS) (20 Items)
Negative Affect Pretest
|
1.09 score on a scale
Standard Deviation 0.80
|
0.9 score on a scale
Standard Deviation 0.67
|
|
Positive and Negative Affect Schedule (PANAS) (20 Items)
Negative Affect Posttest
|
1.00 score on a scale
Standard Deviation 0.92
|
0.9 score on a scale
Standard Deviation 0.74
|
PRIMARY outcome
Timeframe: Pretest (before week 1) and posttest (after week 8)Population: N=38 in each condition completed the pretest. N=31 in the treatment and N=35 in the control completed the posttest.
Perceived Stress Scale (PSS) asks participants' stress perception over the last month and scores were summed across the items (Possible scores range from 0 to 40 with higher scores indicating higher stress).
Outcome measures
| Measure |
Social Exergame Treatment Group
n=38 Participants
The treatment group will wear a Fitbit step counter for 8 weeks. In addition, participants will use the full version of the Go\&Grow fitness app for 6 weeks.
Social Exergame Treatment Group: - Physical activity tracking, walk to grow flowers and plant their own garden
* Follow workout tutorials
* Daily steps tracked by Fitbit and workout log tracked by the app
* Daily reminders to wear Fitbit, use the app, and share stories to unlock new flowers to grow
* Includes social features: like, reply, and see other's stories, and share their stories; Access to other people's gardens
* In-app rewards (unlock new flowers to grow each week) if participants post stories
|
Control Group
n=38 Participants
The control group will wear a Fitbit step counter for 8 weeks. In addition, participants will use the Go\&Grow fitness app without the social features for 6 weeks.
Control Group: - Physical activity tracking, walk to grow flowers and plant their own garden
* Follow workout tutorials
* Daily steps tracked by Fitbit and workout log tracked by the app
* Daily reminders to wear Fitbit and use the app
|
|---|---|---|
|
Perceived Stress Scale (PSS)
Pretest
|
23.08 score on a scale
Standard Deviation 7.92
|
22.82 score on a scale
Standard Deviation 8.66
|
|
Perceived Stress Scale (PSS)
Posttest
|
22.32 score on a scale
Standard Deviation 8.44
|
22.20 score on a scale
Standard Deviation 7.78
|
PRIMARY outcome
Timeframe: Baseline (Average of Week 1 and 2), Weekly during the intervention from Week 3 to 8Population: not all participants completed each weekly survey. There were missing weekly surveys for some participants on some weeks
Brief Symptom Inventory (BSI) captures participants' psychological distress over the past week, scores were summed across the items (Total score ranges from 0-72, with higher scores indicating more stress) (Derogatis, 1975).
Outcome measures
| Measure |
Social Exergame Treatment Group
n=35 Participants
The treatment group will wear a Fitbit step counter for 8 weeks. In addition, participants will use the full version of the Go\&Grow fitness app for 6 weeks.
Social Exergame Treatment Group: - Physical activity tracking, walk to grow flowers and plant their own garden
* Follow workout tutorials
* Daily steps tracked by Fitbit and workout log tracked by the app
* Daily reminders to wear Fitbit, use the app, and share stories to unlock new flowers to grow
* Includes social features: like, reply, and see other's stories, and share their stories; Access to other people's gardens
* In-app rewards (unlock new flowers to grow each week) if participants post stories
|
Control Group
n=36 Participants
The control group will wear a Fitbit step counter for 8 weeks. In addition, participants will use the Go\&Grow fitness app without the social features for 6 weeks.
Control Group: - Physical activity tracking, walk to grow flowers and plant their own garden
* Follow workout tutorials
* Daily steps tracked by Fitbit and workout log tracked by the app
* Daily reminders to wear Fitbit and use the app
|
|---|---|---|
|
Brief Symptom Inventory (BSI)
Baseline (Average of Week 1 and 2)
|
19.26 units on a scale
Standard Deviation 12.07
|
21.01 units on a scale
Standard Deviation 12.67
|
|
Brief Symptom Inventory (BSI)
Week 3
|
20.55 units on a scale
Standard Deviation 13.09
|
20.17 units on a scale
Standard Deviation 13.96
|
|
Brief Symptom Inventory (BSI)
Week 4
|
20.4 units on a scale
Standard Deviation 14.7
|
20.44 units on a scale
Standard Deviation 13.76
|
|
Brief Symptom Inventory (BSI)
Week 5
|
19.65 units on a scale
Standard Deviation 14.88
|
19.8 units on a scale
Standard Deviation 13.21
|
|
Brief Symptom Inventory (BSI)
Week 6
|
18.72 units on a scale
Standard Deviation 15.03
|
19.2 units on a scale
Standard Deviation 13.75
|
|
Brief Symptom Inventory (BSI)
Week 7
|
20.17 units on a scale
Standard Deviation 16.08
|
19.32 units on a scale
Standard Deviation 13.79
|
|
Brief Symptom Inventory (BSI)
Week 8
|
17.71 units on a scale
Standard Deviation 15.83
|
19.69 units on a scale
Standard Deviation 14.03
|
PRIMARY outcome
Timeframe: Pretest (before week 1) and posttest (after week 8)Population: N=38 in each condition completed the pretest. N=31 in the treatment and N=35 in the control completed the posttest.
Caregiver's Stress Scale has a series of subscales based on a conceptual model of caregivers' stress: overload, relational deprivation, job and caregiving conflict, role captivity, sense of self, caregiving competence, personal gain, management of situation, management of meaning, management of distress, and expressive support. Each subscale ranges from 1 (strongly disagree) to 4 (strongly agree), and each subscale was averaged (with possible score ranging from 1-4) so that higher scores would indicate a higher value.
Outcome measures
| Measure |
Social Exergame Treatment Group
n=38 Participants
The treatment group will wear a Fitbit step counter for 8 weeks. In addition, participants will use the full version of the Go\&Grow fitness app for 6 weeks.
Social Exergame Treatment Group: - Physical activity tracking, walk to grow flowers and plant their own garden
* Follow workout tutorials
* Daily steps tracked by Fitbit and workout log tracked by the app
* Daily reminders to wear Fitbit, use the app, and share stories to unlock new flowers to grow
* Includes social features: like, reply, and see other's stories, and share their stories; Access to other people's gardens
* In-app rewards (unlock new flowers to grow each week) if participants post stories
|
Control Group
n=38 Participants
The control group will wear a Fitbit step counter for 8 weeks. In addition, participants will use the Go\&Grow fitness app without the social features for 6 weeks.
Control Group: - Physical activity tracking, walk to grow flowers and plant their own garden
* Follow workout tutorials
* Daily steps tracked by Fitbit and workout log tracked by the app
* Daily reminders to wear Fitbit and use the app
|
|---|---|---|
|
Caregiver's Stress Scale
Personal Gain Posttest
|
3.37 score on a scale
Standard Deviation 0.70
|
2.98 score on a scale
Standard Deviation 0.76
|
|
Caregiver's Stress Scale
Overload Pretest
|
1.84 score on a scale
Standard Deviation 0.92
|
1.61 score on a scale
Standard Deviation 0.68
|
|
Caregiver's Stress Scale
Overload Posttest
|
1.77 score on a scale
Standard Deviation 0.80
|
1.58 score on a scale
Standard Deviation 0.73
|
|
Caregiver's Stress Scale
Relational Deprivation Pretest
|
1.97 score on a scale
Standard Deviation 0.97
|
1.83 score on a scale
Standard Deviation 0.85
|
|
Caregiver's Stress Scale
Relational Deprivation Posttest
|
1.83 score on a scale
Standard Deviation 0.86
|
1.83 score on a scale
Standard Deviation 0.77
|
|
Caregiver's Stress Scale
Job Caregiving Conflict Pretest
|
2.18 score on a scale
Standard Deviation 0.72
|
2.11 score on a scale
Standard Deviation 0.60
|
|
Caregiver's Stress Scale
Job Caregiving Conflict Posttest
|
2.25 score on a scale
Standard Deviation 0.73
|
2.27 score on a scale
Standard Deviation 0.75
|
|
Caregiver's Stress Scale
Role Captivity Pretest
|
1.88 score on a scale
Standard Deviation 0.90
|
1.93 score on a scale
Standard Deviation 0.83
|
|
Caregiver's Stress Scale
Role Captivity Posttest
|
1.82 score on a scale
Standard Deviation 1.02
|
2.13 score on a scale
Standard Deviation 1.04
|
|
Caregiver's Stress Scale
Sense of Self Pretest
|
3.66 score on a scale
Standard Deviation 0.51
|
3.34 score on a scale
Standard Deviation 0.58
|
|
Caregiver's Stress Scale
Sense of Self Posttest
|
3.55 score on a scale
Standard Deviation 0.68
|
3.39 score on a scale
Standard Deviation 0.57
|
|
Caregiver's Stress Scale
Caregiving Competence Pretest
|
3.34 score on a scale
Standard Deviation 0.51
|
3.13 score on a scale
Standard Deviation 0.75
|
|
Caregiver's Stress Scale
Caregiving Competence Posttest
|
3.32 score on a scale
Standard Deviation 0.64
|
3.07 score on a scale
Standard Deviation 0.60
|
|
Caregiver's Stress Scale
Management of Situation Pretest
|
2.84 score on a scale
Standard Deviation 0.60
|
2.65 score on a scale
Standard Deviation 0.63
|
|
Caregiver's Stress Scale
Management of Situation Posttest
|
2.73 score on a scale
Standard Deviation 0.72
|
2.66 score on a scale
Standard Deviation 0.47
|
|
Caregiver's Stress Scale
Expressive Support Pretest
|
3.16 score on a scale
Standard Deviation 0.50
|
3.10 score on a scale
Standard Deviation 0.41
|
|
Caregiver's Stress Scale
Expressive Support Posttest
|
3.12 score on a scale
Standard Deviation 0.52
|
3.04 score on a scale
Standard Deviation 0.61
|
|
Caregiver's Stress Scale
Management of Distress Pretest
|
2.18 score on a scale
Standard Deviation 0.37
|
2.25 score on a scale
Standard Deviation 0.35
|
|
Caregiver's Stress Scale
Management of Distress Posttest
|
2.37 score on a scale
Standard Deviation 0.31
|
2.23 score on a scale
Standard Deviation 0.39
|
|
Caregiver's Stress Scale
Management of Meaning Pretest
|
3.20 score on a scale
Standard Deviation 0.52
|
2.94 score on a scale
Standard Deviation 0.51
|
|
Caregiver's Stress Scale
Management of Meaning Posttest
|
3.25 score on a scale
Standard Deviation 0.44
|
2.97 score on a scale
Standard Deviation 0.46
|
|
Caregiver's Stress Scale
Personal Gain Pretest
|
3.32 score on a scale
Standard Deviation 0.65
|
2.93 score on a scale
Standard Deviation 0.81
|
PRIMARY outcome
Timeframe: Pretest (before week 1) and posttest (after week 8)Population: N=38 in each condition completed the pretest. N=31 in the treatment and N=35 in the control completed the posttest.
International Physical Activity Questionnaire - Short Version. A continuous score was calculated expressed as MET (Metabolic Equivalents) minutes per week: Total MET-min/week = (Walk METs\*min\*days) + (Mod METs\*min\*days) + Vig METs\*min\*days). A higher score means a higher level of physical activity.
Outcome measures
| Measure |
Social Exergame Treatment Group
n=38 Participants
The treatment group will wear a Fitbit step counter for 8 weeks. In addition, participants will use the full version of the Go\&Grow fitness app for 6 weeks.
Social Exergame Treatment Group: - Physical activity tracking, walk to grow flowers and plant their own garden
* Follow workout tutorials
* Daily steps tracked by Fitbit and workout log tracked by the app
* Daily reminders to wear Fitbit, use the app, and share stories to unlock new flowers to grow
* Includes social features: like, reply, and see other's stories, and share their stories; Access to other people's gardens
* In-app rewards (unlock new flowers to grow each week) if participants post stories
|
Control Group
n=38 Participants
The control group will wear a Fitbit step counter for 8 weeks. In addition, participants will use the Go\&Grow fitness app without the social features for 6 weeks.
Control Group: - Physical activity tracking, walk to grow flowers and plant their own garden
* Follow workout tutorials
* Daily steps tracked by Fitbit and workout log tracked by the app
* Daily reminders to wear Fitbit and use the app
|
|---|---|---|
|
International Physical Activity Questionnaire (IPAQ) Short Version
Pretest
|
1523.69 Total METs minutes per week
Standard Deviation 1324.89
|
1234.46 Total METs minutes per week
Standard Deviation 1382.82
|
|
International Physical Activity Questionnaire (IPAQ) Short Version
Posttest
|
2066.86 Total METs minutes per week
Standard Deviation 1482.13
|
1375.50 Total METs minutes per week
Standard Deviation 1640.83
|
SECONDARY outcome
Timeframe: Pretest (before week 1) and posttest (after week 8)Population: N=38 in each condition completed the pretest. N=31 in the treatment and N=35 in the control completed the posttest.
9 items assessed how certain participants will exercise under certain circumstances (e.g., when you are feeling under pressure or when you are away from home). Items are assessed from 1 (very sure) to 4 (not at all sure). Items were reverse coded and summed across all items with a score ranging from 9 to 36. A higher score indicates higher exercise self-efficacy.
Outcome measures
| Measure |
Social Exergame Treatment Group
n=38 Participants
The treatment group will wear a Fitbit step counter for 8 weeks. In addition, participants will use the full version of the Go\&Grow fitness app for 6 weeks.
Social Exergame Treatment Group: - Physical activity tracking, walk to grow flowers and plant their own garden
* Follow workout tutorials
* Daily steps tracked by Fitbit and workout log tracked by the app
* Daily reminders to wear Fitbit, use the app, and share stories to unlock new flowers to grow
* Includes social features: like, reply, and see other's stories, and share their stories; Access to other people's gardens
* In-app rewards (unlock new flowers to grow each week) if participants post stories
|
Control Group
n=38 Participants
The control group will wear a Fitbit step counter for 8 weeks. In addition, participants will use the Go\&Grow fitness app without the social features for 6 weeks.
Control Group: - Physical activity tracking, walk to grow flowers and plant their own garden
* Follow workout tutorials
* Daily steps tracked by Fitbit and workout log tracked by the app
* Daily reminders to wear Fitbit and use the app
|
|---|---|---|
|
Exercise Self-Efficacy
Pretest
|
19.74 score on a scale
Standard Deviation 6.31
|
19.10 score on a scale
Standard Deviation 6.99
|
|
Exercise Self-Efficacy
Posttest
|
22.87 score on a scale
Standard Deviation 6.70
|
22.86 score on a scale
Standard Deviation 6.68
|
SECONDARY outcome
Timeframe: Pretest (before week 1) and posttest (after week 8)Population: N=38 in each condition completed the pretest. N=31 in the treatment and N=35 in the control completed the posttest.
Items are assessed from 1 (disagree strongly) to 7 (agree strongly) summed across all items, ranging from 5-35. A higher score indicates a higher satisfaction with life.
Outcome measures
| Measure |
Social Exergame Treatment Group
n=38 Participants
The treatment group will wear a Fitbit step counter for 8 weeks. In addition, participants will use the full version of the Go\&Grow fitness app for 6 weeks.
Social Exergame Treatment Group: - Physical activity tracking, walk to grow flowers and plant their own garden
* Follow workout tutorials
* Daily steps tracked by Fitbit and workout log tracked by the app
* Daily reminders to wear Fitbit, use the app, and share stories to unlock new flowers to grow
* Includes social features: like, reply, and see other's stories, and share their stories; Access to other people's gardens
* In-app rewards (unlock new flowers to grow each week) if participants post stories
|
Control Group
n=38 Participants
The control group will wear a Fitbit step counter for 8 weeks. In addition, participants will use the Go\&Grow fitness app without the social features for 6 weeks.
Control Group: - Physical activity tracking, walk to grow flowers and plant their own garden
* Follow workout tutorials
* Daily steps tracked by Fitbit and workout log tracked by the app
* Daily reminders to wear Fitbit and use the app
|
|---|---|---|
|
Satisfaction With Life Scale
Pretest
|
19.84 score on a scale
Standard Deviation 7.50
|
19.95 score on a scale
Standard Deviation 7.95
|
|
Satisfaction With Life Scale
Posttest
|
20.61 score on a scale
Standard Deviation 7.43
|
18.66 score on a scale
Standard Deviation 8.73
|
SECONDARY outcome
Timeframe: Pretest (before week 1) and posttest (after week 8)Population: N=38 in each condition completed the pretest. N=31 in the treatment and N=35 in the control completed the posttest.
items were used to assess sense of control. For example: "There is little I can do to change many of the important things in my life." Items are assessed from 1 (strongly disagree) to 7 (strongly agree) and reverse coded. A sum across all items was calculated ranging from 6-42. A higher score indicates a higher sense of control.
Outcome measures
| Measure |
Social Exergame Treatment Group
n=38 Participants
The treatment group will wear a Fitbit step counter for 8 weeks. In addition, participants will use the full version of the Go\&Grow fitness app for 6 weeks.
Social Exergame Treatment Group: - Physical activity tracking, walk to grow flowers and plant their own garden
* Follow workout tutorials
* Daily steps tracked by Fitbit and workout log tracked by the app
* Daily reminders to wear Fitbit, use the app, and share stories to unlock new flowers to grow
* Includes social features: like, reply, and see other's stories, and share their stories; Access to other people's gardens
* In-app rewards (unlock new flowers to grow each week) if participants post stories
|
Control Group
n=38 Participants
The control group will wear a Fitbit step counter for 8 weeks. In addition, participants will use the Go\&Grow fitness app without the social features for 6 weeks.
Control Group: - Physical activity tracking, walk to grow flowers and plant their own garden
* Follow workout tutorials
* Daily steps tracked by Fitbit and workout log tracked by the app
* Daily reminders to wear Fitbit and use the app
|
|---|---|---|
|
Sense of Control
Pretest
|
31.96 score on a scale
Standard Deviation 6.05
|
29.77 score on a scale
Standard Deviation 6.76
|
|
Sense of Control
Posttest
|
31.10 score on a scale
Standard Deviation 7.32
|
29.07 score on a scale
Standard Deviation 7.82
|
SECONDARY outcome
Timeframe: Posttest (after week 8)Population: N=31 in the treatment and N=35 in the control completed the posttest.
Exergame Enjoyment Questionnaire (EEQ) was included in the posttest, which measured how much participants enjoyed the exergame (Fitzgerald et al., 2020). 20 items ranged from strongly disagree (1) to strongly agree (5) were summed. Scores rannged from 20 - 100, with a higher score indicating more exergame enjoyment.
Outcome measures
| Measure |
Social Exergame Treatment Group
n=31 Participants
The treatment group will wear a Fitbit step counter for 8 weeks. In addition, participants will use the full version of the Go\&Grow fitness app for 6 weeks.
Social Exergame Treatment Group: - Physical activity tracking, walk to grow flowers and plant their own garden
* Follow workout tutorials
* Daily steps tracked by Fitbit and workout log tracked by the app
* Daily reminders to wear Fitbit, use the app, and share stories to unlock new flowers to grow
* Includes social features: like, reply, and see other's stories, and share their stories; Access to other people's gardens
* In-app rewards (unlock new flowers to grow each week) if participants post stories
|
Control Group
n=35 Participants
The control group will wear a Fitbit step counter for 8 weeks. In addition, participants will use the Go\&Grow fitness app without the social features for 6 weeks.
Control Group: - Physical activity tracking, walk to grow flowers and plant their own garden
* Follow workout tutorials
* Daily steps tracked by Fitbit and workout log tracked by the app
* Daily reminders to wear Fitbit and use the app
|
|---|---|---|
|
Exergame Enjoyment Questionnaire (EEQ)
|
67.29 score on a scale
Standard Deviation 10.96
|
62.91 score on a scale
Standard Deviation 13.67
|
Adverse Events
Social Exergame Treatment Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Social Exergame Treatment Group
n=38 participants at risk
The treatment group will wear a Fitbit step counter for 8 weeks. In addition, participants will use the full version of the Go\&Grow fitness app for 6 weeks.
Social Exergame Treatment Group: - Physical activity tracking, walk to grow flowers and plant their own garden
* Follow workout tutorials
* Daily steps tracked by Fitbit and workout log tracked by the app
* Daily reminders to wear Fitbit, use the app, and share stories to unlock new flowers to grow
* Includes social features: like, reply, and see other's stories, and share their stories; Access to other people's gardens
* In-app rewards (unlock new flowers to grow each week) if participants post stories
|
Control Group
n=42 participants at risk
The control group will wear a Fitbit step counter for 8 weeks. In addition, participants will use the Go\&Grow fitness app without the social features for 6 weeks.
Control Group: - Physical activity tracking, walk to grow flowers and plant their own garden
* Follow workout tutorials
* Daily steps tracked by Fitbit and workout log tracked by the app
* Daily reminders to wear Fitbit and use the app
|
|---|---|---|
|
Injury, poisoning and procedural complications
Broken Ankle
|
2.6%
1/38 • Number of events 1 • 2 months
any adverse event was documented and reported.
|
0.00%
0/42 • 2 months
any adverse event was documented and reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place