Effect of a Game-Based Intervention Designed to Enhance Social Incentives to Increase Physical Activity Among Families: The BE FIT Randomized Clinical Trial

May combine two claims.

In the control arm, the change in daily steps from baseline was near 1000 in week 1, declined to less than 400 by week 5, and then increased to near 800 by week 12.

“In the control arm, the change in daily steps from baseline was near 1000 in week 1, declined to less than 400 by week 5, and then increased to near 800 by week 12 (Figure 3).”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

One participant in the control arm died for reasons deemed unrelated to the study, and no other major adverse events were reported.

“One participant in the control arm died for reasons deemed by the institutional review boards and data and safety monitoring board as unrelated to the study.No other major adverse events were reported (eTable 8 in Supplement 2).”

Probably not a substantial claim: may not pass S3 (load-bearing).

Enrollment rates were significantly higher than those of previous similar studies.

“enrollment rates were significantly higher than those of previous similar studies, [13][14][15]”

• cites [13][14][15]Not checked yet

  Not checked in the free run.

May combine two claims.

Activity levels in the gamification arm declined in the follow-up period, more quickly after week 20.

“However, activity levels in the gamification arm declined in the follow-up period, more quickly after week 20.”

The quote only partly states this claim.

Overall during the follow-up period, physical activity levels remained significantly greater in the gamification arm than in the control arm.

“Overall during the follow-up period, physical activity levels remained significantly greater in the gamification arm.”

Probably not a substantial claim: may not pass S3 (load-bearing).

All investigators, statisticians, and data analysts were masked to study arm assignments until the study and analysis were completed.

“All investigators, statisticians, and data analysts were masked to study arm assignments until the study and analysis were completed.”

Probably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing).

By incorporating insights from behavioral economics, approaches could be designed to anticipate predictable barriers to behavior change.

“By incorporating insights from behavioral economics, approaches could be designed to anticipate predictable barriers to behavior change.[12][13][14][15]”

• cites [12][13][14][15]Not checked yet

  Not checked in the free run.

Probably not a substantial claim: may not pass S3 (load-bearing).

Gamification is increasingly being used in digital health interventions to promote changes in health behaviors, such as physical activity.

“Gamification, the application of game design elements such as points and levels in nongame contexts, is increasingly being used in digital health interventions to promote changes in health behaviors, such as physical activity.[4][5][6][7]”

• cites [4][5][6][7]Not checked yet

  Not checked in the free run.

Probably not a substantial claim: may not pass S2 (checkable). May combine two claims.

Social incentives are ubiquitous and could be leveraged within gamification interventions to provide a scalable, low-cost approach to increase engagement.

“Social incentives, or the influences that motivate individuals to adjust their behaviors based on social ties or connections, are ubiquitous and could be leveraged within gamification interventions to provide a scalable, low-cost approach to increase engagement.16”

• cites [16]Not checked yet

  Not checked in the free run.

Probably not a substantial claim: may not pass S3 (load-bearing).

The rapidly expanding availability of mobile technologies such as wearable devices and smartphones provides a platform to monitor daily health behaviors and to deploy interventions on a broader scale.

“The rapidly expanding availability of mobile technologies such as wearable devices and smartphones provides a platform to monitor daily health behaviors and to deploy interventions on a broader scale.11”

• cites [11]Not checked yet

  Not checked in the free run.

May combine two claims.

Evidence on the effectiveness of gamification is limited, and most applications have not appropriately leveraged principles from theories of health behavior.

“Whereas interest in these approaches is growing, evidence on their effectiveness is limited, and most applications have not appropriately leveraged principles from theories of health behavior.[8][9][10]”

• cites [8][9][10]Not checked yet

  Not checked in the free run.

Probably not a substantial claim: may not pass S3 (load-bearing).

The trial protocol was approved by the institutional review boards at the University of Pennsylvania and Boston University Medical Center.

“The trial protocol is available in Supplement 1 and was approved by the institutional review boards at the University of Pennsylvania and Boston University Medical Center.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Families composed of 2 or 3 members were randomly assigned to a study arm using a computerized random number generator with block sizes of 2 families stratified on family size.

“Families composed of 2 or 3 members were randomly assigned to a study arm.A computerized random number generator was used with block sizes of 2 families stratified on family size.”

Classified as probably not a substantial claim.

Baseline step count was estimated using the second week of run-in data, ignoring the first week to diminish potential upward bias from higher activity during initial device use.

“During this run-in period, we estimated a baseline step count using the second week of data.The first week of data was ignored to diminish the potential upward bias of the estimate from higher activity during initial device use.”

Classified as probably not a substantial claim. May combine two claims.

Multiple imputation was used for data that were missing and for step values less than 1000.

“For the main analysis, we used multiple imputation (using the mice package in the R Project for Statistical Computing) for data that were missing and step values less than 1000.”

May combine two claims.

During the intervention period, step data that were missing or had values less than 1000 steps per day represented 12.7% of observations in the control arm and 10.1% in the gamification arm; during follow-up these percentages increased to 37.0% and 42.1%, respectively.

“During the intervention period, step data that were missing or had values less than 1000 steps per day represented 12.7% (1090 of 8568 participantdays) of observations in the control arm and 10.1% (835 of 8232 participant-days) of observations in the gamification arm.During the follow-up period, these percentages increased to 37.0% (3166 of 8568) and 42.1% (3462 of 8232), respectively (eTable 5 in”

May combine two claims.

Mean baseline daily steps were 7662 in the control arm and 7244 in the gamification arm, which were not significantly different (P = .41).

“The mean (SD) numbers of participant baseline daily steps were 7662 (3378) in the control arm and 7244 (3368) in the gamification arm, which were not significantly different (P = .41).”

Classified as probably not a substantial claim.

All randomly assigned participants who received an intervention (n = 200) were included in the modified intent-to-treat analysis.

“All other randomly assigned participants who received an intervention (n = 200) were included in the modified intentto-treat analysis.”

Probably not a substantial claim: may not pass S3 (load-bearing).

The prespecified main model adjusted for baseline steps and calendar month fixed effects.

“The prespecified main model also adjusted for baseline steps and calendar month fixed effects.”

Probably not a substantial claim: may not pass S3 (load-bearing).

A data and safety monitoring board met before the start of the study and after the intervention and follow-up periods were completed.

“A data and safety monitoring board met before the start of the study and after the intervention and follow-up periods were completed.”

Classified as probably not a substantial claim.

A priori, a sample of at least 170 participants (85 per study arm) would ensure 80% power to detect a 0.15 difference in the proportion of participant-days that step goals were achieved between study arms, with a 2-sided alpha level of .05 and accounting for clustering at the level of the family.

“A priori, we estimated that a sample of at least 170 participants (85 per study arm) would ensure 80% power to detect a 0.15 difference in the proportion of participant-days that step goals were achieved between study arms, with a 2-sided α level of .05 and accounting for clustering at the level of the family.”

Classified as probably not a substantial claim.

Adjusted analyses used generalized estimating equations with an exchangeable correlation structure to account for correlation within a family cluster and among a participant's repeated observations.

“In adjusted analyses, models were fit with generalized estimating equations (using the geeglm function in the R Project for Statistical Computing) with an exchangeable correlation structure to account for the correlation within a family cluster and among a participant's repeated observations.30”

• cites [30]Not checked yet

  Not checked in the free run.

Probably not a substantial claim: may not pass S2 (checkable).

The use of family networks is a strength of our study design.

“The use of family networks is a strength of our study design because these relationships are widespread and long-standing.”

• AssumptionRests on an assumption: Family networks are widespread and long-standing.

Probably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing), S4 (based).

The use of wearable devices and smartphones may offer a scalable approach to deliver these types of interventions on a broader scale.

“The use of wearable devices and smartphones may offer a scalable approach to deliver these types of interventions on a broader scale.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Because this intervention offered only trivial material reward (a coffee mug), it could be deployed more widely at low cost.

“Because this intervention offered only trivial material reward (a coffee mug), it could be deployed more widely at low cost.”

May combine two claims.

The mean increase of approximately 1700 steps is almost an additional 1 mile per day.

“The mean increase from baseline among participants in the gamification arm was approximately 1700 steps, which is almost an additional 1 mile per day.33”

• cites [33]Not checked yet

  Not checked in the free run.

Classified as probably not a substantial claim.

A study by Finkelstein and colleagues randomly assigned 800 adults to control, activity monitoring, cash incentives, or charity incentives.

“A study by Finkelstein and colleagues 37 randomly assigned 800 adults to control, activity monitoring, cash incentives, or charity incentives.”

• cites [37]Not checked yet

  Not checked in the free run.

May combine two claims.

The Zhang and colleagues studies were conducted among graduate students and offered financial incentives, making the effect of social incentives more challenging to isolate and apply to the general community.

“these studies were conducted among graduate students, and financial incentives were also offered, making the effect of social incentives more challenging to isolate and apply to the general community.”

• cites [35]Not checked yet

  Not checked in the free run.

• cites [36]Not checked yet

  Not checked in the free run.

Classified as probably not a substantial claim.

Several retrospective studies have identified associations between social networks and health behaviors.

“several retrospective studies [17][18][19] have identified associations between social networks and health behaviors”

• cites [17][18][19]Not checked yet

  Not checked in the free run.

Probably not a substantial claim: may not pass S2 (checkable).

The trial findings indicate that gamification and social incentive approaches could be more effective if designed to leverage insights from behavioral economics.

“Our findings indicate that these approaches could be more effective if designed to leverage insights from behavioral economics.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Step counts are most commonly displayed by wearable devices and have been successfully used in interventions to improve clinical outcomes across different populations.

“Step counts are most commonly displayed by wearable devices and have been successfully used in interventions to improve clinical outcomes across different populations.33”

• cites [33]Not checked yet

  Not checked in the free run.

May combine two claims.

In the Finkelstein study, the effects and the use of the activity tracking device declined during the 6 months after incentives ceased.

“However, these effects and the use of the activity tracking device declined during the 6 months after incentives ceased.”

• cites [37]Not checked yet

  Not checked in the free run.

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

We evaluated physical activity using step counts and did not have data on other measures of physical activity, device wear time, or other health outcomes.

“we evaluated physical activity using step counts and did not have data on other measures of physical activity, device wear time, or other health outcomes.”

May combine two claims.

Participants were members of the Framingham Heart Study, had European ancestry, and needed either a smartphone or a computer.

“participants were members of the Framingham Heart Study, had European ancestry, and needed either a smartphone or a computer, 38”

• cites [38]Not checked yet

  Not checked in the free run.

Probably not a substantial claim: may not pass S3 (load-bearing).

More physical activity is associated with greater health benefits for all individuals.

“more physical activity is associated with greater health benefits for all individuals, 39”

• cites [39]Not checked yet

  Not checked in the free run.

Probably not a substantial claim: may not pass S3 (load-bearing).

We did not test the effect of the intervention in nonfamily networks.

“we did not test the effect of the intervention in nonfamily networks.”