Obesity
Conditions
Brief summary
This study tests the effectiveness of three social incentive-based gamification interventions to increase physical activity using a 24-week intervention period with a 12-week follow-up.
Detailed description
This is a four-arm randomized, controlled trial with a 24-week intervention period and 12-week follow-up period. Participants are considered ready to be randomized once they have completed all surveys, established a baseline step count, and selected a step goal increase.Participants in the control arm will receive no other interventions during the 24-week intervention period or the 12-week follow-up period. Participants randomized to the one of the three intervention arms will have a 4-week ramp up towards their step goal. The participant will then be asked to maintain their goal during the 20-week maintenance period and the 12-week follow-up period. Participants in arms 2-4 will be entered into an intervention approach that has points and levels designed to incorporate insights from behavioral economics. Participants in the supportive social incentive arm will be asked to identify a family member or friend to be their support sponsor. This sponsor will be encouraged to support the participant in their progress during the study. Participants in the competitive social incentive arm will be in a group of three total participants.At the end of each week the participants will receive notification that ranks them on their cumulative points in the study thus far and also displays their level.This feedback may help to induce participants to compete for the top spot among the group. Participants in the collaborative social incentive arm will be in a group of three total participants as a team. Each day one of the members of the group will be randomly selected to represent their team for that day. In this design, each person is accountable to the others on the team and this may induce a collaborative effort to meet their daily goals.
Interventions
BEHAVIORALSupportive 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.
BEHAVIORALCompetitive social incentive
Participants in this intervention will be competing against each other in the game.
BEHAVIORALCollaborative social incentive
Participants in this intervention will be working with each other in the game.
Sponsors
Deloitte
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 years or older; 2. ability to read and provide informed consent to participate in the study; 3. Self-reported body mass index (BMI) of 25 or greater. 4. Smartphone or tablet compatible with application for the wearable activity tracking device.
Exclusion criteria
1. Conditions that would make participation infeasible such as inability to provide informed consent, illiteracy or inability to speak, read, and write English; 2. conditions that would make participation unsafe such as pregnancy or being told by a physician not to exercise; 3. already enrolled in another study targeting physical activity; 4. any other medical conditions or reasons he or she is unable to participate in a physical activity study for 36 weeks.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean Daily Steps | weeks 5 to 24 of the intervention | Change in mean daily steps from baseline to main intervention period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participant-days That Step Goals Are Achieved | Weeks 5 to 24 of the main intervention period. | proportion of days participants meet their step goal |
| Change in Mean Daily Steps | Weeks 25 to 36 of the follow-up period | Change in mean daily steps from baseline through the follow-up period |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Participants in this arm will receive no other interventions during the 9 month study period | 151 |
| 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. | 151 |
| 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. | 150 |
| 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. | 150 |
| Total | 602 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Unrelated injury | 0 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 4 | 2 | 7 |
Baseline characteristics
| Characteristic | Collaborative Social Incentive | Total | Control | Supportive Social Incentive | Competitive Social Incentive |
|---|---|---|---|---|---|
| Age, Continuous | 38.3 years STANDARD_DEVIATION 10 | 38.7 years STANDARD_DEVIATION 10.2 | 38.5 years STANDARD_DEVIATION 10.9 | 39.4 years STANDARD_DEVIATION 10.1 | 38.7 years STANDARD_DEVIATION 10 |
| Annual household income > 100,000 | 122 Participants | 473 Participants | 117 Participants | 121 Participants | 113 Participants |
| Annual household income < 50,000 | 2 Participants | 5 Participants | 1 Participants | 1 Participants | 1 Participants |
| Annual household income 50,000 - 100,000 | 26 Participants | 124 Participants | 33 Participants | 29 Participants | 36 Participants |
| Baseline step count, Mean (SD) | 6120 steps/day STANDARD_DEVIATION 2583 | 6204 steps/day STANDARD_DEVIATION 2646 | 6086 steps/day STANDARD_DEVIATION 2631 | 6297 steps/day STANDARD_DEVIATION 2571 | 6313 steps/day STANDARD_DEVIATION 2812 |
| BMI, Mean (SD) | 30.1 kg/m^2 STANDARD_DEVIATION 5.7 | 29.7 kg/m^2 STANDARD_DEVIATION 4.9 | 29.5 kg/m^2 STANDARD_DEVIATION 4.1 | 29.2 kg/m^2 STANDARD_DEVIATION 4.8 | 29.7 kg/m^2 STANDARD_DEVIATION 4.9 |
| Diabetes | 11 Participants | 30 Participants | 10 Participants | 4 Participants | 5 Participants |
| Education level College graduate | 145 Participants | 576 Participants | 142 Participants | 146 Participants | 143 Participants |
| Education level High school graduate | 1 Participants | 3 Participants | 1 Participants | 0 Participants | 1 Participants |
| Education level Some college or specialized training | 4 Participants | 23 Participants | 8 Participants | 5 Participants | 6 Participants |
| Hyperlipidemia | 29 Participants | 105 Participants | 27 Participants | 22 Participants | 27 Participants |
| Hypertension | 20 Participants | 76 Participants | 23 Participants | 16 Participants | 17 Participants |
| Marital status Married | 102 Participants | 418 Participants | 102 Participants | 113 Participants | 101 Participants |
| Marital status Other | 9 Participants | 33 Participants | 6 Participants | 7 Participants | 11 Participants |
| Marital status Single | 39 Participants | 151 Participants | 43 Participants | 31 Participants | 38 Participants |
| Prior wearable device use | 94 Participants | 384 Participants | 89 Participants | 100 Participants | 101 Participants |
| Race/Ethnicity, Customized Asian non-Hispanic | 48 Participants | 206 Participants | 49 Participants | 57 Participants | 52 Participants |
| Race/Ethnicity, Customized Black non-Hispanic | 5 Participants | 32 Participants | 10 Participants | 9 Participants | 8 Participants |
| Race/Ethnicity, Customized Hispanic | 7 Participants | 27 Participants | 10 Participants | 7 Participants | 3 Participants |
| Race/Ethnicity, Customized Other | 9 Participants | 32 Participants | 10 Participants | 6 Participants | 7 Participants |
| Race/Ethnicity, Customized White non-Hispanic | 81 Participants | 305 Participants | 72 Participants | 72 Participants | 80 Participants |
| Self-reported measures, health status Excellent | 5 Participants | 30 Participants | 6 Participants | 8 Participants | 11 Participants |
| Self-reported measures, health status Fair | 28 Participants | 84 Participants | 16 Participants | 22 Participants | 18 Participants |
| Self-reported measures, health status Good | 69 Participants | 282 Participants | 84 Participants | 63 Participants | 66 Participants |
| Self-reported measures, health status Poor | 2 Participants | 8 Participants | 2 Participants | 4 Participants | 0 Participants |
| Self-reported measures, health status Very good | 46 Participants | 198 Participants | 43 Participants | 54 Participants | 55 Participants |
| Sex: Female, Male Female | 43 Participants | 175 Participants | 54 Participants | 41 Participants | 37 Participants |
| Sex: Female, Male Male | 107 Participants | 427 Participants | 97 Participants | 110 Participants | 113 Participants |
| Smoking actively | 7 Participants | 22 Participants | 5 Participants | 5 Participants | 5 Participants |
| Step goal increase from baseline, mean (SD) | 2200 steps/day STANDARD_DEVIATION 980 | 2199 steps/day STANDARD_DEVIATION 1169 | 2144 steps/day STANDARD_DEVIATION 1160 | 2243 steps/day STANDARD_DEVIATION 923 | 2210 steps/day STANDARD_DEVIATION 1529 |
| Step goal selection, No. (%) 33% Increase from baseline | 56 Participants | 236 Participants | 64 Participants | 56 Participants | 60 Participants |
| Step goal selection, No. (%) 40% Increase from baseline | 24 Participants | 77 Participants | 19 Participants | 14 Participants | 20 Participants |
| Step goal selection, No. (%) 50% Increase from baseline | 32 Participants | 104 Participants | 19 Participants | 31 Participants | 22 Participants |
| Step goal selection, No. (%) Custom goal at least 1500 steps > than baseline | 38 Participants | 185 Participants | 49 Participants | 50 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 151 | 0 / 151 | 0 / 150 | 0 / 150 |
| other Total, other adverse events | 0 / 151 | 1 / 151 | 0 / 150 | 0 / 150 |
| serious Total, serious adverse events | 0 / 151 | 0 / 151 | 0 / 150 | 0 / 150 |
Outcome results
Primary
Change in Mean Daily Steps
Change in mean daily steps from baseline to main intervention period
Time frame: weeks 5 to 24 of the intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Change in Mean Daily Steps | 6162 Steps/Day | Standard Deviation 2142 |
| Supportive Social Incentive | Change in Mean Daily Steps | 6975 Steps/Day | Standard Deviation 2403 |
| Competitive Social Incentive | Change in Mean Daily Steps | 7237 Steps/Day | Standard Deviation 2934 |
| Collaborative Social Incentive | Change in Mean Daily Steps | 6814 Steps/Day | Standard Deviation 2197 |
Secondary
Change in Mean Daily Steps
Change in mean daily steps from baseline through the follow-up period
Time frame: Weeks 25 to 36 of the follow-up period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Change in Mean Daily Steps | 5899 Steps/Day | Standard Deviation 2128 |
| Supportive Social Incentive | Change in Mean Daily Steps | 6432 Steps/Day | Standard Deviation 2320 |
| Competitive Social Incentive | Change in Mean Daily Steps | 6592 Steps/Day | Standard Deviation 2685 |
| Collaborative Social Incentive | Change in Mean Daily Steps | 6038 Steps/Day | Standard Deviation 1640 |
Secondary
Proportion of Participant-days That Step Goals Are Achieved
proportion of days participants meet their step goal
Time frame: Weeks 5 to 24 of the main intervention period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Proportion of Participant-days That Step Goals Are Achieved | 0.25 Proportion of participant-days |
| Supportive Social Incentive | Proportion of Participant-days That Step Goals Are Achieved | 0.36 Proportion of participant-days |
| Competitive Social Incentive | Proportion of Participant-days That Step Goals Are Achieved | 0.41 Proportion of participant-days |
| Collaborative Social Incentive | Proportion of Participant-days That Step Goals Are Achieved | 0.36 Proportion of participant-days |
Secondary
Proportion of Participant-days That Step Goals Are Achieved
proportion of days participants meet their step goal
Time frame: Weeks 25 to 36 of the follow-up period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Proportion of Participant-days That Step Goals Are Achieved | 0.23 Proportion of participant-days |
| Supportive Social Incentive | Proportion of Participant-days That Step Goals Are Achieved | 0.28 Proportion of participant-days |
| Competitive Social Incentive | Proportion of Participant-days That Step Goals Are Achieved | 0.30 Proportion of participant-days |
| Collaborative Social Incentive | Proportion of Participant-days That Step Goals Are Achieved | 0.26 Proportion of participant-days |