Browsing by Author "Gallis, John A"
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Item Open Access A cluster-randomized trial of client and provider-directed financial interventions to align incentives with appropriate case management in retail medicine outlets: Results of the TESTsmART Trial in western Kenya.(PLOS global public health, 2024-01) Laktabai, Jeremiah; Kimachas, Emmah; Kipkoech, Joseph; Menya, Diana; Arthur, David; Zhou, Yunji; Chepkwony, Tabitha; Abel, Lucy; Robie, Emily; Amunga, Mark; Ambani, George; Woldeghebriel, Meley; Garber, Elizabeth; Eze, Nwamaka; Mudabai, Pamela; Gallis, John A; Fashanu, Chizoba; Saran, Indrani; Woolsey, Aaron; Visser, Theodoor; Turner, Elizabeth L; Prudhomme O'Meara, WendyACTs are responsible for a substantial proportion of the global reduction in malaria mortality over the last ten years, made possible by publicly-funded subsidies making these drugs accessible and affordable in the private sector. However, inexpensive ACTs available in retail outlets have contributed substantially to overconsumption. We test an innovative, scalable strategy to target ACT-subsidies to clients with a confirmatory diagnosis. We supported malaria testing(mRDTs) in 39 medicine outlets in western Kenya, randomized to three study arms; control arm offering subsidized mRDT testing (0.4USD), client-directed intervention where all clients who received a positive RDT at the outlet were eligible for a free (fully-subsidized) ACT, and a combined client and provider directed intervention where clients with a positive RDT were eligible for free ACT and outlets received 0.1USD for every RDT performed. Our primary outcome was the proportion of ACT dispensed to individuals with a positive diagnostic test. Secondary outcomes included proportion of clients tested at the outlet and adherence to diagnostic test results. 43% of clients chose to test at the outlet. Test results informed treatment decisions, resulting in targeting of ACTs to confirmed malaria cases- 25.3% of test-negative clients purchased an ACT compared to 75% of untested clients. Client-directed and client+provider-directed interventions did not offer further improvements, compared to the control arm, in testing rates(RD = 0.09, 95%CI:-0.08,0.26) or dispensing of ACTs to test-positive clients(RD = 0.01,95% CI:-0.14, 0.16). Clients were often unaware of the price they paid for the ACT leading to uncertainty in whether the ACT subsidy was passed on to the client. This uncertainty undermines our ability to definitively conclude that client-directed subsidies are not effective for improving testing and appropriate treatment. We conclude that mRDTs could reduce ACT overconsumption in the private retail sector, but incentive structures are difficult to scale and their value to private providers is uncertain. Trial registration: ClinicalTrials.gov NCT04428307.Item Open Access Cell phone intervention for you (CITY): A randomized, controlled trial of behavioral weight loss intervention for young adults using mobile technology.(Obesity (Silver Spring, Md.), 2015-11) Svetkey, Laura P; Batch, Bryan C; Lin, Pao-Hwa; Intille, Stephen S; Corsino, Leonor; Tyson, Crystal C; Bosworth, Hayden B; Grambow, Steven C; Voils, Corrine; Loria, Catherine; Gallis, John A; Schwager, Jenifer; Bennett, Gary GObjective
To determine the effect on weight of two mobile technology-based (mHealth) behavioral weight loss interventions in young adults.Methods
Randomized, controlled comparative effectiveness trial in 18- to 35-year-olds with BMI ≥ 25 kg/m(2) (overweight/obese), with participants randomized to 24 months of mHealth intervention delivered by interactive smartphone application on a cell phone (CP); personal coaching enhanced by smartphone self-monitoring (PC); or Control.Results
The 365 randomized participants had mean baseline BMI of 35 kg/m(2) . Final weight was measured in 86% of participants. CP was not superior to Control at any measurement point. PC participants lost significantly more weight than Controls at 6 months (net effect -1.92 kg [CI -3.17, -0.67], P = 0.003), but not at 12 and 24 months.Conclusions
Despite high intervention engagement and study retention, the inclusion of behavioral principles and tools in both interventions, and weight loss in all treatment groups, CP did not lead to weight loss, and PC did not lead to sustained weight loss relative to Control. Although mHealth solutions offer broad dissemination and scalability, the CITY results sound a cautionary note concerning intervention delivery by mobile applications. Effective intervention may require the efficiency of mobile technology, the social support and human interaction of personal coaching, and an adaptive approach to intervention design.Item Open Access Development of an Interactive Global Surgery Course for Interdisciplinary Learners.(Annals of global health, 2021-03) Fitzgerald, Tamara N; Muma, Nyagetuba JK; Gallis, John A; Reavis, Grey; Ukachukwu, Alvan; Smith, Emily R; Ogbuoji, Osondu; Rice, Henry EIntroduction
Global surgical care is increasingly recognized in the global health agenda and requires multidisciplinary engagement. Despite high interest among medical students, residents and other learners, many surgical faculty and health experts remain uniformed about global surgical care.Methods
We have operated an interdisciplinary graduate-level course in Global Surgical Care based on didactics and interactive group learning. Students completed a pre- and post-course survey regarding their learning experiences and results were analyzed using the Wilcoxon signed-rank test.Results
Fourteen students completed the pre-course survey, and 11 completed the post-course survey. Eleven students (79%) were enrolled in a Master's degree program in global health, with eight students (57%) planning to attend medical school. The median ranking of surgery on the global health agenda was fifth at the beginning of the course and third at the conclusion (p = 0.11). Non-infectious disease priorities tended to stay the same or increase in rank from pre- to post-course. Infectious disease priorities tended to decrease in rank (HIV/AIDS, p = 0.07; malaria, p = 0.02; neglected infectious disease, p = 0.3). Students reported that their understanding of global health (p = 0.03), global surgery (p = 0.001) and challenges faced by the underserved (p = 0.03) improved during the course. When asked if surgery was an indispensable part of healthcare, before the course 64% of students strongly agreed, while after the course 91% of students strongly agreed (p = 0.3). Students reported that the interactive nature of the course strengthened their skills in collaborative problem-solving.Conclusions
We describe an interdisciplinary global surgery course that integrates didactics with team-based projects. Students appeared to learn core topics and held a different view of global surgery after the course. Similar courses in global surgery can educate clinicians and other stakeholders about strategies for building healthy surgical systems worldwide.Item Open Access Erratum: Cell phone intervention for you (CITY): A randomized, controlled trial of behavioral weight loss intervention for young adults using mobile technology.(Obesity (Silver Spring, Md.), 2016-02) Svetkey, Laura P; Batch, Bryan C; Lin, Pao-Hwa; Intille, Stephen S; Corsino, Leonor; Tyson, Crystal C; Bosworth, Hayden B; Grambow, Steven C; Voils, Corrine; Loria, Catherine; Gallis, John A; Schwager, Jenifer; Bennett, Gary GItem Open Access The Association Between Engagement and Weight Loss Through Personal Coaching and Cell Phone Interventions in Young Adults: Randomized Controlled Trial (Preprint)(2018-03-22) Lin, Pao-Hwa; Grambow, Steven; Intille, Stephen; Gallis, John A; Lazenka, Tony; Bosworth, Hayden; Voils, Corrine L; Bennett, Gary G; Batch, Bryan; Allen, Jenifer; Corsino, Leonor; Tyson, Crystal; Svetkey, LauraBACKGROUNDUnderstanding how engagement in mobile health (mHealth) weight loss interventions relates to weight change may help develop effective intervention strategies.
OBJECTIVEThis study aims to examine the (1) patterns of participant engagement overall and with key intervention components within each intervention arm in the Cell Phone Intervention For You (CITY) trial; (2) associations of engagement with weight change; and (3) participant characteristics related to engagement.
METHODSThe CITY trial tested two 24-month weight loss interventions. One was delivered with a smartphone app (cell phone) containing 24 components (weight tracking, etc) and included prompting by the app in predetermined frequency and forms. The other was delivered by a coach via monthly calls (personal coaching) supplemented with limited app components (18 overall) and without any prompting by the app. Engagement was assessed by calculating the percentage of days each app component was used and the frequency of use. Engagement was also examined across 4 weight change categories: gained (≥2%), stable (±2%), mild loss (≥2% to <5%), and greater loss (≥5%).
RESULTSData from 122 cell phone and 120 personal coaching participants were analyzed. Use of the app was the highest during month 1 for both arms; thereafter, use dropped substantially and continuously until the study end. During the first 6 months, the mean percentage of days that any app component was used was higher for the cell phone arm (74.2%, SD 20.1) than for the personal coaching arm (48.9%, SD 22.4). The cell phone arm used the apps an average of 5.3 times/day (SD 3.1), whereas the personal coaching participants used them 1.7 times/day (SD 1.2). Similarly, the former self-weighed more than the latter (57.1% days, SD 23.7 vs 32.9% days, SD 23.3). Furthermore, the percentage of days any app component was used, number of app uses per day, and percentage of days self-weighed all showed significant differences across the 4 weight categories for both arms. Pearson correlation showed a negative association between weight change and the percentage of days any app component was used (cell phone: r=−.213; personal coaching: r=−.319), number of apps use per day (cell phone: r=−.264; personal coaching: r=−.308), and percentage of days self-weighed (cell phone: r=−.297; personal coaching: r=−.354). None of the characteristics examined, including age, gender, race, education, income, energy expenditure, diet quality, and hypertension status, appeared to be related to engagement.
CONCLUSIONSEngagement in CITY intervention was associated with weight loss during the first 6 months. Nevertheless, engagement dropped substantially early on for most intervention components. Prompting may be helpful initially. More flexible and less intrusive prompting strategies may be needed during different stages of an intervention to increase or sustain engagement. Future studies should explore the motivations for engagement and nonengagement to determine meaningful levels of engagement required for effective intervention.
CLINICALTRIALClinicalTrials.gov NCT01092364; https://clinicaltrials.gov/ct2/show/NCT01092364 (Archived by WebCite at http://www.webcitation.org/72V8A4e5X)
Item Open Access The Association Between Engagement and Weight Loss Through Personal Coaching and Cell Phone Interventions in Young Adults: Randomized Controlled Trial.(JMIR mHealth and uHealth, 2018-10) Lin, Pao-Hwa; Grambow, Steven; Intille, Stephen; Gallis, John A; Lazenka, Tony; Bosworth, Hayden; Voils, Corrine L; Bennett, Gary G; Batch, Bryan; Allen, Jenifer; Corsino, Leonor; Tyson, Crystal; Svetkey, LauraBackground
Understanding how engagement in mobile health (mHealth) weight loss interventions relates to weight change may help develop effective intervention strategies.Objective
This study aims to examine the (1) patterns of participant engagement overall and with key intervention components within each intervention arm in the Cell Phone Intervention For You (CITY) trial; (2) associations of engagement with weight change; and (3) participant characteristics related to engagement.Methods
The CITY trial tested two 24-month weight loss interventions. One was delivered with a smartphone app (cell phone) containing 24 components (weight tracking, etc) and included prompting by the app in predetermined frequency and forms. The other was delivered by a coach via monthly calls (personal coaching) supplemented with limited app components (18 overall) and without any prompting by the app. Engagement was assessed by calculating the percentage of days each app component was used and the frequency of use. Engagement was also examined across 4 weight change categories: gained (≥2%), stable (±2%), mild loss (≥2% to <5%), and greater loss (≥5%).Results
Data from 122 cell phone and 120 personal coaching participants were analyzed. Use of the app was the highest during month 1 for both arms; thereafter, use dropped substantially and continuously until the study end. During the first 6 months, the mean percentage of days that any app component was used was higher for the cell phone arm (74.2%, SD 20.1) than for the personal coaching arm (48.9%, SD 22.4). The cell phone arm used the apps an average of 5.3 times/day (SD 3.1), whereas the personal coaching participants used them 1.7 times/day (SD 1.2). Similarly, the former self-weighed more than the latter (57.1% days, SD 23.7 vs 32.9% days, SD 23.3). Furthermore, the percentage of days any app component was used, number of app uses per day, and percentage of days self-weighed all showed significant differences across the 4 weight categories for both arms. Pearson correlation showed a negative association between weight change and the percentage of days any app component was used (cell phone: r=-.213; personal coaching: r=-.319), number of apps use per day (cell phone: r=-.264; personal coaching: r=-.308), and percentage of days self-weighed (cell phone: r=-.297; personal coaching: r=-.354). None of the characteristics examined, including age, gender, race, education, income, energy expenditure, diet quality, and hypertension status, appeared to be related to engagement.Conclusions
Engagement in CITY intervention was associated with weight loss during the first 6 months. Nevertheless, engagement dropped substantially early on for most intervention components. Prompting may be helpful initially. More flexible and less intrusive prompting strategies may be needed during different stages of an intervention to increase or sustain engagement. Future studies should explore the motivations for engagement and nonengagement to determine meaningful levels of engagement required for effective intervention.Trial registration
ClinicalTrials.gov NCT01092364; https://clinicaltrials.gov/ct2/show/NCT01092364 (Archived by WebCite at http://www.webcitation.org/72V8A4e5X).Item Open Access The Balance protocol: a pragmatic weight gain prevention randomized controlled trial for medically vulnerable patients within primary care.(BMC public health, 2019-05-17) Berger, Miriam B; Steinberg, Dori M; Askew, Sandy; Gallis, John A; Treadway, Cayla C; Egger, Joseph R; Kay, Melissa C; Batch, Bryan C; Finkelstein, Eric A; DeVries, Abigail; Brewer, Ashley; Bennett, Gary GBackground
For patients with obesity who are not ready for or experience barriers to weight loss, clinical practice guidelines recommend provider counseling on preventing further weight gain as a first-line treatment approach. Unfortunately, evidence-based weight gain prevention interventions are not routinely available within primary care. To address this gap, we will implement a pragmatic 12-month randomized controlled trial of a digital weight gain prevention intervention delivered to patients receiving primary care within a network of Federally Qualified Community Health Centers in central North Carolina.Methods
Balance (Equilibrio in Spanish) is a pragmatic effectiveness trial that will randomize adult patients who have overweight or obesity (BMI of 25-40 kg/m2) to either: 1) a weight gain prevention intervention with tailored behavior change goals and tracking, daily weighing on a network-connected electronic scale, and responsive weight and goal coaching delivered remotely by health center registered dietitians; or 2) a usual care program with automated healthy living text messages and print materials and routine primary care. The primary outcome will be weight gain prevention at 24-months, defined as ≤3% change in baseline weight. To align with its pragmatic design, trial outcome data will be pulled from the electronic health record of the community health center network.Discussion
For underserved, often rurally-located patients with obesity, digital approaches to promote a healthy lifestyle can curb further weight gain. Yet enrolling medically vulnerable patients into a weight gain prevention trial, many of whom are from racial/ethnic minorities, can be difficult. Despite these potential challenges, we plan to recruit a large, diverse sample from rural areas, and will implement a remotely-delivered weight gain prevention intervention to medically vulnerable patients. Upcoming trial results will demonstrate the effectiveness of this pragmatic approach to implement and evaluate a digital weight gain prevention intervention within primary care.Trials registration
NCT03003403 . Registered December 28, 2016.