Trial Outcomes & Findings for Social Incentives To Encourage Physical Activity and Understand Predictors (NCT NCT03311230)
NCT ID: NCT03311230
Last Updated: 2020-03-02
Results Overview
Change in mean daily steps from baseline to main intervention period
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
602 participants
Primary outcome timeframe
weeks 5 to 24 of the intervention
Results posted on
2020-03-02
Participant Flow
Participant milestones
| Measure |
Control
Participants in this arm will receive no other interventions during the 9 month study period
|
Supportive Social Incentive
Participants will identify a family member or friend to support them during a gamification intervention.
Supportive social incentive: A family member or friend will be used as a support person in this study, to receive updates and support the participant in their progress.
|
Competitive Social Incentive
Participants will compete in a gamification intervention in groups of three.
Competitive social incentive: Participants in this intervention will be competing against each other in the game.
|
Collaborative Social Incentive
Participants will collaborate in groups of three in a gamification intervention
Collaborative social incentive: Participants in this intervention will be working with each other in the game.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
151
|
151
|
150
|
150
|
|
Overall Study
COMPLETED
|
150
|
146
|
148
|
143
|
|
Overall Study
NOT COMPLETED
|
1
|
5
|
2
|
7
|
Reasons for withdrawal
| Measure |
Control
Participants in this arm will receive no other interventions during the 9 month study period
|
Supportive Social Incentive
Participants will identify a family member or friend to support them during a gamification intervention.
Supportive social incentive: A family member or friend will be used as a support person in this study, to receive updates and support the participant in their progress.
|
Competitive Social Incentive
Participants will compete in a gamification intervention in groups of three.
Competitive social incentive: Participants in this intervention will be competing against each other in the game.
|
Collaborative Social Incentive
Participants will collaborate in groups of three in a gamification intervention
Collaborative social incentive: Participants in this intervention will be working with each other in the game.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
4
|
2
|
7
|
|
Overall Study
Unrelated injury
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Social Incentives To Encourage Physical Activity and Understand Predictors
Baseline characteristics by cohort
| Measure |
Control
n=151 Participants
Participants in this arm will receive no other interventions during the 9 month study period
|
Supportive Social Incentive
n=151 Participants
Participants will identify a family member or friend to support them during a gamification intervention.
Supportive social incentive: A family member or friend will be used as a support person in this study, to receive updates and support the participant in their progress.
|
Competitive Social Incentive
n=150 Participants
Participants will compete in a gamification intervention in groups of three.
Competitive social incentive: Participants in this intervention will be competing against each other in the game.
|
Collaborative Social Incentive
n=150 Participants
Participants will collaborate in groups of three in a gamification intervention
Collaborative social incentive: Participants in this intervention will be working with each other in the game.
|
Total
n=602 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
38.5 years
STANDARD_DEVIATION 10.9 • n=99 Participants
|
39.4 years
STANDARD_DEVIATION 10.1 • n=107 Participants
|
38.7 years
STANDARD_DEVIATION 10 • n=206 Participants
|
38.3 years
STANDARD_DEVIATION 10 • n=7 Participants
|
38.7 years
STANDARD_DEVIATION 10.2 • n=31 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
43 Participants
n=7 Participants
|
175 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
97 Participants
n=99 Participants
|
110 Participants
n=107 Participants
|
113 Participants
n=206 Participants
|
107 Participants
n=7 Participants
|
427 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
White non-Hispanic
|
72 Participants
n=99 Participants
|
72 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
81 Participants
n=7 Participants
|
305 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Black non-Hispanic
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
32 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Asian non-Hispanic
|
49 Participants
n=99 Participants
|
57 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
48 Participants
n=7 Participants
|
206 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
10 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
27 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Other
|
10 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
32 Participants
n=31 Participants
|
|
Education level
High school graduate
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
|
Education level
Some college or specialized training
|
8 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
23 Participants
n=31 Participants
|
|
Education level
College graduate
|
142 Participants
n=99 Participants
|
146 Participants
n=107 Participants
|
143 Participants
n=206 Participants
|
145 Participants
n=7 Participants
|
576 Participants
n=31 Participants
|
|
Marital status
Single
|
43 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
39 Participants
n=7 Participants
|
151 Participants
n=31 Participants
|
|
Marital status
Married
|
102 Participants
n=99 Participants
|
113 Participants
n=107 Participants
|
101 Participants
n=206 Participants
|
102 Participants
n=7 Participants
|
418 Participants
n=31 Participants
|
|
Marital status
Other
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
33 Participants
n=31 Participants
|
|
Annual household income
< 50,000
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
|
Annual household income
50,000 - 100,000
|
33 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
26 Participants
n=7 Participants
|
124 Participants
n=31 Participants
|
|
Annual household income
> 100,000
|
117 Participants
n=99 Participants
|
121 Participants
n=107 Participants
|
113 Participants
n=206 Participants
|
122 Participants
n=7 Participants
|
473 Participants
n=31 Participants
|
|
Self-reported measures, health status
Excellent
|
6 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
30 Participants
n=31 Participants
|
|
Self-reported measures, health status
Very good
|
43 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
46 Participants
n=7 Participants
|
198 Participants
n=31 Participants
|
|
Self-reported measures, health status
Good
|
84 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
69 Participants
n=7 Participants
|
282 Participants
n=31 Participants
|
|
Self-reported measures, health status
Fair
|
16 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
28 Participants
n=7 Participants
|
84 Participants
n=31 Participants
|
|
Self-reported measures, health status
Poor
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
|
Prior wearable device use
|
89 Participants
n=99 Participants
|
100 Participants
n=107 Participants
|
101 Participants
n=206 Participants
|
94 Participants
n=7 Participants
|
384 Participants
n=31 Participants
|
|
BMI, Mean (SD)
|
29.5 kg/m^2
STANDARD_DEVIATION 4.1 • n=99 Participants
|
29.2 kg/m^2
STANDARD_DEVIATION 4.8 • n=107 Participants
|
29.7 kg/m^2
STANDARD_DEVIATION 4.9 • n=206 Participants
|
30.1 kg/m^2
STANDARD_DEVIATION 5.7 • n=7 Participants
|
29.7 kg/m^2
STANDARD_DEVIATION 4.9 • n=31 Participants
|
|
Diabetes
|
10 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
30 Participants
n=31 Participants
|
|
Hyperlipidemia
|
27 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
29 Participants
n=7 Participants
|
105 Participants
n=31 Participants
|
|
Hypertension
|
23 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
76 Participants
n=31 Participants
|
|
Smoking actively
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
22 Participants
n=31 Participants
|
|
Baseline step count, Mean (SD)
|
6086 steps/day
STANDARD_DEVIATION 2631 • n=99 Participants
|
6297 steps/day
STANDARD_DEVIATION 2571 • n=107 Participants
|
6313 steps/day
STANDARD_DEVIATION 2812 • n=206 Participants
|
6120 steps/day
STANDARD_DEVIATION 2583 • n=7 Participants
|
6204 steps/day
STANDARD_DEVIATION 2646 • n=31 Participants
|
|
Step goal selection, No. (%)
33% Increase from baseline
|
64 Participants
n=99 Participants
|
56 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
56 Participants
n=7 Participants
|
236 Participants
n=31 Participants
|
|
Step goal selection, No. (%)
40% Increase from baseline
|
19 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
24 Participants
n=7 Participants
|
77 Participants
n=31 Participants
|
|
Step goal selection, No. (%)
50% Increase from baseline
|
19 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
32 Participants
n=7 Participants
|
104 Participants
n=31 Participants
|
|
Step goal selection, No. (%)
Custom goal at least 1500 steps > than baseline
|
49 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
38 Participants
n=7 Participants
|
185 Participants
n=31 Participants
|
|
Step goal increase from baseline, mean (SD)
|
2144 steps/day
STANDARD_DEVIATION 1160 • n=99 Participants
|
2243 steps/day
STANDARD_DEVIATION 923 • n=107 Participants
|
2210 steps/day
STANDARD_DEVIATION 1529 • n=206 Participants
|
2200 steps/day
STANDARD_DEVIATION 980 • n=7 Participants
|
2199 steps/day
STANDARD_DEVIATION 1169 • n=31 Participants
|
PRIMARY outcome
Timeframe: weeks 5 to 24 of the interventionChange in mean daily steps from baseline to main intervention period
Outcome measures
| Measure |
Control
n=151 Participants
Participants in this arm will receive no other interventions during the 9 month study period
|
Supportive Social Incentive
n=151 Participants
Participants will identify a family member or friend to support them during a gamification intervention.
Supportive social incentive: A family member or friend will be used as a support person in this study, to receive updates and support the participant in their progress.
|
Competitive Social Incentive
n=150 Participants
Participants will compete in a gamification intervention in groups of three.
Competitive social incentive: Participants in this intervention will be competing against each other in the game.
|
Collaborative Social Incentive
n=150 Participants
Participants will collaborate in groups of three in a gamification intervention
Collaborative social incentive: Participants in this intervention will be working with each other in the game.
|
|---|---|---|---|---|
|
Change in Mean Daily Steps
|
6162 Steps/Day
Standard Deviation 2142
|
6975 Steps/Day
Standard Deviation 2403
|
7237 Steps/Day
Standard Deviation 2934
|
6814 Steps/Day
Standard Deviation 2197
|
SECONDARY outcome
Timeframe: Weeks 25 to 36 of the follow-up periodChange in mean daily steps from baseline through the follow-up period
Outcome measures
| Measure |
Control
n=151 Participants
Participants in this arm will receive no other interventions during the 9 month study period
|
Supportive Social Incentive
n=151 Participants
Participants will identify a family member or friend to support them during a gamification intervention.
Supportive social incentive: A family member or friend will be used as a support person in this study, to receive updates and support the participant in their progress.
|
Competitive Social Incentive
n=150 Participants
Participants will compete in a gamification intervention in groups of three.
Competitive social incentive: Participants in this intervention will be competing against each other in the game.
|
Collaborative Social Incentive
n=150 Participants
Participants will collaborate in groups of three in a gamification intervention
Collaborative social incentive: Participants in this intervention will be working with each other in the game.
|
|---|---|---|---|---|
|
Change in Mean Daily Steps
|
5899 Steps/Day
Standard Deviation 2128
|
6432 Steps/Day
Standard Deviation 2320
|
6592 Steps/Day
Standard Deviation 2685
|
6038 Steps/Day
Standard Deviation 1640
|
SECONDARY outcome
Timeframe: Weeks 5 to 24 of the main intervention period.proportion of days participants meet their step goal
Outcome measures
| Measure |
Control
n=151 Participants
Participants in this arm will receive no other interventions during the 9 month study period
|
Supportive Social Incentive
n=151 Participants
Participants will identify a family member or friend to support them during a gamification intervention.
Supportive social incentive: A family member or friend will be used as a support person in this study, to receive updates and support the participant in their progress.
|
Competitive Social Incentive
n=150 Participants
Participants will compete in a gamification intervention in groups of three.
Competitive social incentive: Participants in this intervention will be competing against each other in the game.
|
Collaborative Social Incentive
n=150 Participants
Participants will collaborate in groups of three in a gamification intervention
Collaborative social incentive: Participants in this intervention will be working with each other in the game.
|
|---|---|---|---|---|
|
Proportion of Participant-days That Step Goals Are Achieved
|
0.25 Proportion of participant-days
|
0.36 Proportion of participant-days
|
0.41 Proportion of participant-days
|
0.36 Proportion of participant-days
|
SECONDARY outcome
Timeframe: Weeks 25 to 36 of the follow-up period.proportion of days participants meet their step goal
Outcome measures
| Measure |
Control
n=151 Participants
Participants in this arm will receive no other interventions during the 9 month study period
|
Supportive Social Incentive
n=151 Participants
Participants will identify a family member or friend to support them during a gamification intervention.
Supportive social incentive: A family member or friend will be used as a support person in this study, to receive updates and support the participant in their progress.
|
Competitive Social Incentive
n=150 Participants
Participants will compete in a gamification intervention in groups of three.
Competitive social incentive: Participants in this intervention will be competing against each other in the game.
|
Collaborative Social Incentive
n=150 Participants
Participants will collaborate in groups of three in a gamification intervention
Collaborative social incentive: Participants in this intervention will be working with each other in the game.
|
|---|---|---|---|---|
|
Proportion of Participant-days That Step Goals Are Achieved
|
0.23 Proportion of participant-days
|
0.28 Proportion of participant-days
|
0.30 Proportion of participant-days
|
0.26 Proportion of participant-days
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Supportive Social Incentive
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Competitive Social Incentive
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Collaborative Social Incentive
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 |
Control
n=151 participants at risk
Participants in this arm will receive no other interventions during the 9 month study period
|
Supportive Social Incentive
n=151 participants at risk
Participants will identify a family member or friend to support them during a gamification intervention.
Supportive social incentive: A family member or friend will be used as a support person in this study, to receive updates and support the participant in their progress.
|
Competitive Social Incentive
n=150 participants at risk
Participants will compete in a gamification intervention in groups of three.
Competitive social incentive: Participants in this intervention will be competing against each other in the game.
|
Collaborative Social Incentive
n=150 participants at risk
Participants will collaborate in groups of three in a gamification intervention
Collaborative social incentive: Participants in this intervention will be working with each other in the game.
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Broken foot
|
0.00%
0/151 • Adverse event data was collected when participants were started in the study through the maintenance and follow-up periods (9 months, or 252 days).
Mortality was not a risk associated with participation in our study.
|
0.66%
1/151 • Adverse event data was collected when participants were started in the study through the maintenance and follow-up periods (9 months, or 252 days).
Mortality was not a risk associated with participation in our study.
|
0.00%
0/150 • Adverse event data was collected when participants were started in the study through the maintenance and follow-up periods (9 months, or 252 days).
Mortality was not a risk associated with participation in our study.
|
0.00%
0/150 • Adverse event data was collected when participants were started in the study through the maintenance and follow-up periods (9 months, or 252 days).
Mortality was not a risk associated with participation in our study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place