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1.
Stat Med ; 2020 May 11.
Artigo em Inglês | MEDLINE | ID: mdl-32394455

RESUMO

We propose a method to test for the presence of differential ascertainment in case-control studies, when data are collected by multiple sources. We show that, when differential ascertainment is present, the use of only the observed cases leads to severe bias in the computation of the odds ratio. We can alleviate the effect of such bias using the estimates that our method of testing for differential ascertainment naturally provides. We apply it to a dataset obtained from the National Violent Death Reporting System, with the goal of checking for the presence of differential ascertainment by race in the count of deaths caused by child maltreatment.

2.
J Phys Act Health ; : 1-9, 2020 May 11.
Artigo em Inglês | MEDLINE | ID: mdl-32396866

RESUMO

BACKGROUND: Social comparison feedback is often used in physical activity interventions but the optimal design of feedback is unknown. METHODS: This 4-arm, randomized trial consisted of a 13-week intervention period and 13-week follow-up period. During the intervention, 4-person teams were entered into a weekly lottery valued at about $1.40/day and contingent on the team averaging ≥7000 steps per day. Social comparison feedback on performance was delivered weekly for 26 weeks, and varied by reference point (50th vs 75th percentile) and forgiveness in use of activity data (all 7 d or best 5 of 7 d). The primary outcome was the mean proportion of participant-days achieving the 7000-step goal. RESULTS: During the intervention period, the unadjusted mean proportion of participant-days that the goal was achieved was 0.47 (95% confidence interval [CI]: 0.38 to 0.56) in the 50th percentile arm, 0.38 (95% CI: 0.30 to 0.37) in the 75th percentile arm, 0.40 (95% CI: 0.31 to 0.49) in the 50th percentile with forgiveness arm, and 0.47 (95% CI: 0.38 to 0.55) in the 75th percentile with forgiveness arm. In adjusted models during the intervention and follow-up periods, there were no significant differences between arms. CONCLUSIONS: Changing social comparison feedback did not impact physical activity.

3.
JAMA Netw Open ; 3(3): e201742, 2020 Mar 02.
Artigo em Inglês | MEDLINE | ID: mdl-32227179

RESUMO

Importance: There is limited evidence regarding how patients make choices in advance directives (ADs) or whether these choices influence subsequent care. Objective: To examine whether default options in ADs influence care choices and clinical outcomes. Design, Setting, and Participants: This randomized clinical trial included 515 patients who met criteria for having serious illness and agreed to participate. Patients were enrolled at 20 outpatient clinics affiliated with the University of Pennsylvania Health System and the University of Pittsburgh Medical Center from February 2014 to April 2016 and had a median follow-up of 18 months. Data analysis was conducted from November 2018 to April 2019. Interventions: Patients were randomly assigned to complete 1 of the 3 following ADs: (1) a comfort-promoting plan of care and nonreceipt of potentially life-sustaining therapies were selected by default (comfort AD), (2) a life-extending plan of care and receipt of potentially life-sustaining therapies were selected by default (life-extending AD), or (3) no choices were preselected (standard AD). Main Outcomes and Measures: This trial was powered to rule out a reduction in hospital-free days in the intervention groups. Secondary outcomes included choices in ADs for an overall comfort-oriented approach to care, choices to forgo 4 forms of life support, patients' quality of life, decision conflict, place of death, admissions to hospitals and intensive care units, and costs of inpatient care. Results: Among 515 patients randomized, 10 withdrew consent and 13 were later found to be ineligible, leaving 492 (95.5%) in the modified intention-to-treat (mITT) sample (median [interquartile range] age, 63 [56-70] years; 279 [56.7%] men; 122 [24.8%] black; 363 [73.8%] with cancer). Of these, 264 (53.7%) returned legally valid ADs and were debriefed about their assigned intervention. Among these, patients completing comfort ADs were more likely to choose comfort care (54 of 85 [63.5%]) than those returning standard ADs (45 of 91 [49.5%]) or life-extending ADs (33 of 88 [37.5%]) (P = .001). Among 492 patients in the mITT sample, 57 of 168 patients [33.9%] who completed the comfort AD, 47 of 165 patients [28.5%] who completed the standard AD, and 35 of 159 patients [22.0%] who completed the life-extending AD chose comfort care (P = .02), with patients not returning ADs coded as not selecting comfort care. In mITT analyses, median (interquartile range) hospital-free days among 168 patients assigned to comfort ADs and 159 patients assigned to life-extending default ADs were each noninferior to those among 165 patients assigned to standard ADs (standard AD: 486 [306-717] days; comfort AD: 554 [296-833] days; rate ratio, 1.05; 95% CI, 0.90-1.23; P < .001; life-extending AD: 550 [325-783] days; rate ratio, 1.03; 95% CI, 0.88-1.20; P < .001). There were no differences among groups in other secondary outcomes. Conclusions and Relevance: In this randomized clinical trial, default options in ADs altered the choices seriously ill patients made regarding their future care without changing clinical outcomes. Trial Registration: ClinicalTrials.gov Identifier: NCT02017548.

4.
Pediatr Infect Dis J ; 39(4): 277-282, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-32168246

RESUMO

BACKGROUND: Cerebral malaria (CM) remains a leading cause of mortality and morbidity in children in sub-Saharan Africa. Recent studies using brain magnetic resonance imaging have revealed increased brain volume as a major predictor of death. Similar morphometric predictors of morbidity at discharge are lacking. The aim of this study was to investigate the utility of serial cranial cisternal cerebrospinal fluid (CSF) volume measurements in predicting morbidity at discharge in pediatric CM survivors. METHODS: In this case-control study, 54 Malawian pediatric CM survivors with neurologic sequelae evident at discharge who underwent serial magnetic resonance imaging scans while comatose were matched to concurrently admitted children with serial imaging who made full recoveries. Serial cranial cisternal CSF volume quantified by radiologists blinded to outcome was evaluated as a predictor of neurologic deficits at discharge. The probability of neurologic sequelae was determined using a model that included coma duration and changes in cisternal CSF volume over time. RESULTS: Coma duration before admission was similar between cases and controls (16.1 vs. 15.3; P = 0.81), but overall coma was longer among children with sequelae (60 vs. 38 hours; P < 0.01). Lower initial CSF volumes and decreased volumes over time were both associated with a higher probability of neurologic sequelae at discharge. CONCLUSIONS: Among pediatric CM survivors with prolonged coma, lower initial CSF volume and decreasing volume during coma is associated with neurologic sequelae at discharge. These findings suggest that cerebral edema is an underlying contributor to both morbidity and mortality in pediatric CM.

5.
PLoS One ; 15(3): e0229978, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32155206

RESUMO

Concerned about potentially increased risk of neurodegenerative disease, several health professionals and policy makers have proposed limiting or banning youth participation in American-style tackle football. Given the large affected population (over 1 million boys play high school football annually), careful estimation of the long-term health effects of playing football is necessary for developing effective public health policy. Unfortunately, existing attempts to estimate these effects tend not to generalize to current participants because they either studied a much older cohort or, more seriously, failed to account for potential confounding. We leverage data from a nationally representative cohort of American men who were in grades 7-12 in the 1994-95 school year to estimate the effect of playing football in adolescent on depression in early adulthood. We control for several potential confounders related to subjects' health, behavior, educational experience, family background, and family health history through matching and regression adjustment. We found no evidence of even a small harmful effect of football participation on scores on a version of the Center for Epidemiological Studies Depression scale (CES-D) nor did we find evidence of adverse associations with several secondary outcomes including anxiety disorder diagnosis or alcohol dependence in early adulthood. For men who were in grades 7-12 in the 1994-95 school year, participating or intending to participate in school football does not appear to be a major risk factor for early adulthood depression.

6.
Anesthesiology ; 132(5): 1151-1164, 2020 May.
Artigo em Inglês | MEDLINE | ID: mdl-32101973

RESUMO

BACKGROUND: In 2014, the U.S. Drug Enforcement Agency reclassified hydrocodone from Schedule III to Schedule II of the Controlled Substances Act, resulting in new restrictions on refills. The authors hypothesized that hydrocodone rescheduling led to decreases in total opioid dispensing within 30 days of surgery and reduced new long-term opioid dispensing among surgical patients. METHODS: The authors studied privately insured, opioid-naïve adults undergoing 10 general or orthopedic surgeries between 2011 and 2015. The authors conducted a differences-in-differences analysis that compared overall opioid dispensing before versus after the rescheduling rule for patients treated by surgeons who frequently prescribed hydrocodone before rescheduling (i.e., patients who were functionally exposed to rescheduling's impact) while adjusting for secular trends via a comparison group of patients treated by surgeons who rarely prescribed hydrocodone (i.e., unexposed patients). The primary outcome was any filled opioid prescription between 90 and 180 days after surgery; secondary outcomes included the 30-day refill rate and the amount of opioids dispensed initially and at 30 days postoperatively. RESULTS: The sample included 65,136 patients. The percentage of patients filling a prescription beyond 90 days was similar after versus before rescheduling (absolute risk difference, -1.1%; 95% CI, -2.3% to 0.1%; P = 0.084). The authors estimated the rescheduling rule to be associated with a 45.4-mg oral morphine equivalent increase (difference-in-differences estimate; 95% CI, 34.2-56.7 mg; P < 0.001) in initial opioid dispensing, a 4.1% absolute decrease (95% CI, -5.5% to -2.7%; P < 0.001) in refills within 30 days, and a 37.7-mg oral morphine equivalent increase (95% CI, 20.6-54.8 mg; P = 0.008) in opioids dispensed within 30 days. CONCLUSIONS: Among patients treated by surgeons who frequently prescribed hydrocodone before the Drug Enforcement Agency 2014 hydrocodone rescheduling rule, rescheduling did not impact long-term opioid receipt, although it was associated with an increase in opioid dispensing within 30 days of surgery.

8.
Am J Epidemiol ; 189(3): 243-249, 2020 Mar 02.
Artigo em Inglês | MEDLINE | ID: mdl-31912138

RESUMO

A study has 2 evidence factors if it permits 2 statistically independent inferences about 1 treatment effect such that each factor is immune to some bias that would invalidate the other factor. Because the 2 factors are statistically independent, the evidence they provide can be combined using methods associated with meta-analysis for independent studies, despite using the same data twice in different ways. We illustrate evidence factors, applying them in a new way in investigations that have both an exposure biomarker and a coarse external measure of exposure to a treatment. To illustrate, we consider the possible effects of cigarette smoking on homocysteine levels, with self-reported smoking and a cotinine biomarker. We examine joint sensitivity of 2 factors to bias from confounding, a central aspect of any observational study.

9.
Am J Epidemiol ; 2019 Nov 29.
Artigo em Inglês | MEDLINE | ID: mdl-31781744

RESUMO

American football is the most popular high school sport yet its association with health in adulthood has not been widely studied. We investigated the association between high school football and self-rated health, obesity, and pain in adulthood using a retrospective cohort study of the Wisconsin Longitudinal Study from 1957 to 2004. We matched 925 high school males who played varsity football with 1,521 males who did not play football. After matching, playing football was not associated with poor or fair self-rated health (odds ratio [OR] 0.88, 95% confidence interval [CI]: 0.63, 1.24; P = 0.48) or pain that limited activities (OR 0.86, 95% CI: 0.59, 1.25; P = 0.43) at age 65. Football was associated with an obese body mass index in adulthood (OR 1.32, 95% CI: 1.06, 1.64; P = 0.01). In conclusion, our findings suggest that playing football in high school was not significantly associated with poor or fair self-related health at the age of 65 but was associated with the risk of being obese as an adult compared to not playing football in high school. Our findings provide needed information about the risk of playing football to broader set of health outcomes.

10.
JAMA Netw Open ; 2(11): e1915619, 2019 Nov 01.
Artigo em Inglês | MEDLINE | ID: mdl-31730186

RESUMO

Importance: Early cancer detection can lead to improved outcomes, but cancer screening tests are often underused. Objective: To evaluate the association of an active choice intervention in the electronic health record directed to medical assistants with changes in clinician ordering and patient completion of breast and colorectal cancer screening tests. Design, Setting, and Participants: A retrospective quality improvement study was conducted among 69 916 patients eligible for breast or colorectal cancer screening at 25 primary care practices at the University of Pennsylvania Health System between September 1, 2014, and August 31, 2017. Data analysis was conducted from January 21 to July 8, 2019. Interventions: From 2016 to 2017, 3 primary care practices at the University of Pennsylvania Health System implemented an active choice intervention in the electronic health record that prompted medical assistants to inform patients about cancer screening during check-in and template orders for clinicians to review during the visit. Main Outcomes and Measures: The primary outcome was clinician ordering of cancer screening tests. The secondary outcome was patient completion of cancer screening tests within 1 year of the primary care visit. Results: The sample eligible for breast cancer screening comprised 26 269 women with a mean (SD) age of 60.4 (6.9) years; 15 873 (60.4%) were white and 7715 (29.4%) were black. The sample eligible for colorectal cancer screening comprised 43 647 patients with a mean (SD) age of 59.4 (7.5) years; 24 416 (55.9%) were women, 19 231 (44.1%) were men, 29 029 (66.5%) were white, and 9589 (22.0%) were black. For breast cancer screening, the intervention was associated with a significant increase in clinician ordering of tests (22.2 percentage points; 95% CI, 17.2-27.6 percentage points; P < .001) but no change in patient completion (0.1 percentage points; 95% CI, -4.0 to 4.3 percentage points; P = .45). For colorectal cancer screening, the intervention was associated with a significant increase in clinician ordering of tests (13.7 percentage points; 95% CI, 8.0-18.9 percentage points; P < .001) but no change in patient completion (1.0 percentage points; 95% CI, -3.2 to 4.6 percentage points; P = .36). Conclusions and Relevance: An active choice intervention in the electronic health record directed to medical assistants was associated with a significant increase in clinician ordering of breast and colorectal cancer screening tests. However, it was not associated with a significant change in patient completion of either cancer screening test during a 1-year follow-up.

11.
JAMA Intern Med ; : 1-9, 2019 Sep 09.
Artigo em Inglês | MEDLINE | ID: mdl-31498375

RESUMO

Importance: Gamification, the use of game design elements in nongame contexts, is increasingly being used in workplace wellness programs and digital health applications. However, the best way to design social incentives in gamification interventions has not been well examined. Objective: To assess the effectiveness of support, collaboration, and competition within a behaviorally designed gamification intervention to increase physical activity among overweight and obese adults. Design, Setting, and Participants: This 36-week randomized clinical trial with a 24-week intervention and 12-week follow-up assessed 602 adults from 40 states with body mass indexes (calculated as weight in kilograms divided by height in meters squared) of 25 or higher from February 12, 2018, to March 17, 2019. Interventions: Participants used a wearable device to track daily steps, established a baseline, selected a step goal increase, were randomly assigned to a control (n = 151) or to 1 of 3 gamification interventions (support [n = 151], collaboration [n = 150], and competition [n = 150]), and were remotely monitored. The control group received feedback from the wearable device but no other interventions for 36 weeks. The gamification arms were entered into a 24-week game designed using insights from behavioral economics with points and levels for achieving step goals. No gamification interventions occurred during follow-up. Main Outcomes and Measures: The primary outcome was change in mean daily steps from baseline through the 24-week intervention period. Results: A total of 602 participants (mean [SD] age, 39 [10] years; mean [SD] body mass index, 30 [5]; 427 [70.9%] male) were included in the study. Compared with controls, participants had a significantly greater increase in mean daily steps from baseline during the intervention in the competition arm (adjusted difference, 920; 95% CI, 513-1328; P < .001), support arm (adjusted difference, 689; 95% CI, 267-977; P < .001), and collaboration arm (adjusted difference, 637; 95% CI, 258-1017; P = .001). During follow-up, physical activity remained significantly greater in the competition arm than in the control arm (adjusted difference, 569; 95% CI, 142-996; P = .009) but was not significantly greater in the support (adjusted difference, 428; 95% CI, 19-837; P = .04) and collaboration (adjusted difference, 126; 95% CI, -248 to 468; P = .49) arms than in the control arm. Conclusions and Relevance: All 3 gamification interventions significantly increased physical activity during the 24-week intervention, and competition was the most effective. Physical activity was lower in all arms during follow-up and only remained significantly greater in the competition arm than in the control arm. Trial Registration: ClinicalTrials.gov identifier: NCT03311230.

12.
J Behav Med ; 42(4): 591-602, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31367925

RESUMO

Laws have been enacted to keep firearms out of the hands of abusers. In this study, we examined one such effort-removal of a firearm at the scene of intimate partner violence (IPV)-to assess the subsequent occurrence and number of IPV incidents responded to by police and subsequent risk of injury to the victim. Using the 28,977 IPV calls in one large U.S. city to which officers responded during the 2013 calendar year, we identified 220 first-time incidents in which offenders used (i.e., brandished, pistol whipped, shot) a pistol, revolver, rifle, or shotgun. Officers reported removing a firearm from 52 (24%) of the offenders. After using full propensity score matching to control for potential confounders, logistic and Poisson regressions were used to assess differences between those from whom a firearm was removed and those whose firearm was not removed. Firearm removal at the scene of an IPV incident appears to increase the likelihood of subsequent IPV reports to police and suggestive evidence that subsequent injury to the victim might increase as well. The offender shifting from threats with a firearm to physical violence and a change (an increase as well as a decrease) in victim willingness to summon police may account for the findings.

13.
Stat Med ; 38(20): 3960, 2019 Sep 10.
Artigo em Inglês | MEDLINE | ID: mdl-31379022
14.
Int J Epidemiol ; 48(5): 1478-1492, 2019 10 01.
Artigo em Inglês | MEDLINE | ID: mdl-31298269

RESUMO

BACKGROUND: Summary-data Mendelian randomization (MR) has become a popular research design to estimate the causal effect of risk exposures. With the sample size of GWAS continuing to increase, it is now possible to use genetic instruments that are only weakly associated with the exposure. DEVELOPMENT: We propose a three-sample genome-wide design where typically 1000 independent genetic instruments across the whole genome are used. We develop an empirical partially Bayes statistical analysis approach where instruments are weighted according to their strength; thus weak instruments bring less variation to the estimator. The estimator is highly efficient with many weak genetic instruments and is robust to balanced and/or sparse pleiotropy. APPLICATION: We apply our method to estimate the causal effect of body mass index (BMI) and major blood lipids on cardiovascular disease outcomes, and obtain substantially shorter confidence intervals (CIs). In particular, the estimated causal odds ratio of BMI on ischaemic stroke is 1.19 (95% CI: 1.07-1.32, P-value <0.001); the estimated causal odds ratio of high-density lipoprotein cholesterol (HDL-C) on coronary artery disease (CAD) is 0.78 (95% CI: 0.73-0.84, P-value <0.001). However, the estimated effect of HDL-C attenuates and become statistically non-significant when we only use strong instruments. CONCLUSIONS: A genome-wide design can greatly improve the statistical power of MR studies. Robust statistical methods may alleviate but not solve the problem of horizontal pleiotropy. Our empirical results suggest that the relationship between HDL-C and CAD is heterogeneous, and it may be too soon to completely dismiss the HDL hypothesis.

15.
Contemp Clin Trials ; 83: 53-56, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31265915

RESUMO

BACKGROUND: Hospital readmission prediction models often perform poorly. A critical limitation is that they use data collected up until the time of discharge but do not leverage information on patient behaviors at home after discharge. METHODS: PREDICT is a two-arm, randomized trial comparing ways to use remotely-monitored patient activity levels after hospital discharge to improve hospital readmission prediction models. Patients are randomly assigned to use a wearable device or smartphone application to track physical activity data. The study collects also validated assessments on patient characteristics as well as disparate data on credit scores and medication adherence. Patients are followed for 6 months. We evaluate whether these data sources can improve prediction compared to standard modelling approaches. CONCLUSION: The PREDICT Trial tests a novel method of remotely-monitoring patient behaviors after hospital discharge. Findings from the trial could inform new ways to improve the identification of patients at high-risk for hospital readmission. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT02983812.

17.
JAMA Netw Open ; 2(5): e193403, 2019 05 03.
Artigo em Inglês | MEDLINE | ID: mdl-31074811

RESUMO

Importance: As the clinic day progresses, clinicians may fall behind schedule and experience decision fatigue. However, the association of time of day with cancer screening rates is unknown. Objective: To evaluate the association of primary care clinic appointment time with clinician ordering and patient completion of breast and colorectal cancer screening. Design, Setting, and Participants: Retrospective, quality improvement study of 33 primary care practices in Pennsylvania and New Jersey from September 1, 2014, to August 31, 2016. Participants included adults eligible for breast or colorectal cancer screening. Data analysis was conducted from April 24, 2018, to November 8, 2018. Exposures: Clinic appointment time during each patient's first primary care physician visit in the study period. Main Outcomes and Measures: Primary outcome was clinician ordering of the screening test during the visit. Secondary outcome was patient completion of the tests within 1 year of the visit. Results: Among the 19 254 patients eligible for breast cancer screening, the mean (SD) age was 60.2 (6.9) years; 19 254 (100%) were female, 11 682 (60.7%) were white, and 5495 (28.5%) were black. Screening test order rates were highest at 8 am at 63.7%, decreased throughout the morning to 48.7% at 11 am, increased to 56.2% at noon, and then decreased to 47.8% at 5 pm (adjusted odds ratio [OR] for overall trend, 0.94; 95% CI, 0.93-0.96; P < .001). Trends in screening test completion rates were similar beginning at 33.2% at 8 am and decreasing to 17.8% at 5 pm (adjusted OR, 0.95; 95% CI, 0.94-0.97; P < .001). Among the 33 468 patients eligible for colorectal cancer screening, the mean (SD) age was 59.6 (7.4) years; 18 672 (55.8%) were female, 22 157 (66.2%) were white, and 7296 (21.8%) were black. Screening test order rates were 36.5% at 8 am, decreased to 31.3% by 11 am, increased at noon to 34.4%, and then decreased to 23.4% at 5 pm (adjusted OR, 0.94; 95% CI, 0.93-0.95; P < .001). Trends in screening test completion rates were similar beginning at 28.0% at 8 am and decreasing to 17.8% at 5 pm (adjusted OR, 0.97; 95% CI, 0.96-0.98; P < .001). Conclusions and Relevance: Clinician ordering of cancer screening tests significantly decreased as the clinic day progressed. Patient completion of cancer screening tests within 1 year of the visit was also lower as the primary care appointment time was later in the day. Future interventions targeting improvements in cancer screening should consider how time of day may influence these behaviors.


Assuntos
Agendamento de Consultas , Cooperação do Paciente/estatística & dados numéricos , Padrões de Prática Médica/estatística & dados numéricos , Idoso , Colonoscopia/estatística & dados numéricos , Feminino , Humanos , Masculino , Mamografia/estatística & dados numéricos , Pessoa de Meia-Idade , Atenção Primária à Saúde/métodos , Melhoria de Qualidade , Estudos Retrospectivos
19.
Epidemiology ; 30(3): 371-379, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-30969945

RESUMO

In the comparative interrupted time series design (also called the method of difference-in-differences), the change in outcome in a group exposed to treatment in the periods before and after the exposure is compared with the change in outcome in a control group not exposed to treatment in either period. The standard difference-in-difference estimator for a comparative interrupted time series design will be biased for estimating the causal effect of the treatment if there is an interaction between history in the after period and the groups; for example, there is a historical event besides the start of the treatment in the after period that benefits the treated group more than the control group. We present a bracketing method for bounding the effect of an interaction between history and the groups that arises from a time-invariant unmeasured confounder having a different effect in the after period than the before period. The method is applied to a study of the effect of the repeal of Missouri's permit-to-purchase handgun law on its firearm homicide rate. We estimate that the effect of the permit-to-purchase repeal on Missouri's firearm homicide rate is bracketed between 0.9 and 1.3 homicides per 100,000 people, corresponding to a percentage increase of 17% to 27% (95% confidence interval: 0.6, 1.7 or 11%, 35%). A placebo study provides additional support for the hypothesis that the repeal has a causal effect of increasing the rate of state-wide firearm homicides.


Assuntos
Métodos Epidemiológicos , Armas de Fogo/legislação & jurisprudência , Homicídio/estatística & dados numéricos , Humanos , Missouri/epidemiologia
20.
Contemp Clin Trials ; 80: 55-60, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-30954675

RESUMO

BACKGROUND: Less than half of adults in the United States (US) obtain the recommended level of physical activity. Social incentives, the influences that impact 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. Gamification, or the use of game design in non-game situations, is commonly used in the real world, but in most cases has not appropriately leveraged principles from theories of health behavior. METHODS: We are conducting a four-arm, randomized, controlled trial of 602 overweight and obese adults to evaluate the effectiveness of gamification interventions that leverage insights from behavioral economics to enhance either supportive, competitive, or collaborative social incentives. Daily step counts are monitored using wearable devices that transmit data to the study platform. Participants established a baseline step count, selected a step goal increase, and then were randomly assigned to control or one of three interventions for a 24-week intervention and 12-week follow-up period. To understand predictors of strong or poor performance, we had participants complete validated questionnaires on a range of areas including their personality, risk preferences, social network, and habits relating to physical activity, eating, and sleep. Trial enrollment was conducted in partnership with Deloitte Consulting and included employees from 40 states across the US. CONCLUSION: The STEP UP Trial represents a scalable model and interventions found to be effective could be deployed more broadly to increase physical activity. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT03311230.

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