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A Randomized Controlled Trial of Precision Vestibular Rehabilitation in Adolescents following Concussion: Preliminary Findings.
Kontos, AP, Eagle, SR, Mucha, A, Kochick, V, Reichard, J, Moldolvan, C, Holland, CL, Blaney, NA, Collins, MW
The Journal of pediatrics. 2021;:193-199
Abstract
OBJECTIVE To compare the effectiveness of a 4-week precision vestibular rehabilitation intervention compared with a behavioral management control intervention for adolescents with vestibular symptoms/impairment within 21 days of a concussion. STUDY DESIGN This study used double-blind, randomized controlled trial design involving adolescent (12-18 years) patients with a diagnosed sport/recreation-related concussion with vestibular symptoms/impairment from a concussion-specialty clinic between October 2018 and February 2020. Eligible participants were randomized in a 1:1 to either a 4-week vestibular intervention group (VESTIB) or a behavioral management control group (CONTROL). CONTROLS (n = 25) were prescribed behavioral management strategies (eg, physical activity, sleep, hydration, nutrition, stress management) and instructed to perform stretching/physical activity (eg, walking, stationary cycle) 30 minutes/day. VESTIB (n = 25) were prescribed precision vestibular rehabilitation exercises and instructed to perform at-home exercises for 30 minutes/day. Primary outcomes were improvement in Vestibular/Ocular Motor Screening vestibular items (ie, horizontal/vertical vestibular-ocular reflex, visual motion sensitivity) at 4 weeks postenrollment. RESULTS We screened 310 and enrolled a total of 55 (18%) adolescent patients who were randomized to one of the interventions. Fifty of fifty-five (91%) participants completed all aspects of the study protocol. Participants in VESTIB improved significantly across the intervention period in horizontal (mean difference-1.628; 95% CI [-3.20, -0.06]; P = .04) and vertical (mean difference-2.24; 95% CI [-4.01, -0.48]; P = .01) vestibular-ocular reflex, but not visual motion sensitivity (mean difference-2.03; 95% CI [-4.26, 0.19]) of the Vestibular/Ocular Motor Screening score compared with CONTROLS. CONCLUSIONS Overall, the vestibular intervention group experienced greater clinical improvements in vestibular symptoms/impairment than controls across the 4-week intervention. TRIAL REGISTRATION ClinicalTrials.gov: NCT03555370.
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Design and rationale of the randomized trial of comprehensive lifestyle modification, optimal pharmacological treatment and utilizing PET imaging for quantifying and managing stable coronary artery disease (the CENTURY study).
Kitkungvan, D, Johnson, NP, Kirkeeide, R, Haynie, M, Carter, C, Patel, MB, Bui, L, Madjid, M, Mendoza, P, Roby, AE, et al
American heart journal. 2021;:135-146
Abstract
BACKGROUND The literature reports no randomized trial in chronic coronary artery disease (CAD) of a comprehensive management strategy integrating intense lifestyle management, maximal medical treatment to specific goals and high precision quantitative cardiac positron emission tomography (PET) for identifying high mortality risk patients needing essential invasive procedures. We hypothesize that this comprehensive strategy achieves greater risk factor reduction, lower major adverse cardiovascular events and fewer invasive procedures than standard practice. METHODS The CENTURY Study (NCT00756379) is a randomized-controlled-trial study in patients with stable or at high risk for CAD. Patients are randomized to standard of care (Standard group) or intense comprehensive lifestyle-medical treatment to targets and PET guided interventions (Comprehensive group). Comprehensive Group patients are regularly consulted by the CENTURY team implementing diet/lifestyle/exercise program and medical treatment to target risk modification. Cardiac PET at baseline, 24-, and 60-months quantify the physiologic severity of CAD and guide interventions in the Comprehensive group while patients and referring physicians of the Standard group are blinded to PET results. The primary end-point is the CENTURY risk score reduction during 5 years follow-up. The secondary endpoint is a composite of death, non-fatal myocardial infarction, stroke, and coronary revascularization. CONCLUSIONS The CENTURY Study is the first study in stable CAD to test the incremental benefit of a comprehensive strategy integrating intense lifestyle modification, medical treatment to specific goals, and high-precision quantitative myocardial perfusion imaging to guide revascularization. A total of 1028 patients have been randomized, and the 5 years follow-up will conclude in 2022.
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Effect of Behaviorally Designed Gamification With Social Incentives on Lifestyle Modification Among Adults With Uncontrolled Diabetes: A Randomized Clinical Trial.
Patel, MS, Small, DS, Harrison, JD, Hilbert, V, Fortunato, MP, Oon, AL, Rareshide, CAL, Volpp, KG
JAMA network open. 2021;(5):e2110255
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IMPORTANCE Gamification is increasingly being used to promote healthy behaviors. However, it has not been well tested among patients with chronic conditions and over longer durations. OBJECTIVE To test the effectiveness of behaviorally designed gamification interventions to enhance support, collaboration, or competition to promote physical activity and weight loss among adults with uncontrolled type 2 diabetes. DESIGN, SETTING, AND PARTICIPANTS A 4-arm randomized clinical trial with a 1-year intervention was conducted from January 23, 2017, to January 27, 2020, with remotely monitored intervention. Analyses were conducted between February 10 and October 6, 2020. Participants included 361 adults with type 2 diabetes with hemoglobin A1c levels greater than or equal to 8% and body mass index greater than or equal to 25. INTERVENTIONS All participants received a wearable device, smart weight scale, and laboratory testing. Participants in the control group received feedback from their devices but no other interventions. Participants in the gamification arms conducted goal setting and were entered into a 1-year game designed using insights from behavioral economics with points and levels for achieving step goals and weight loss targets. The game varied by trial arm to promote either support, collaboration, or competition. MAIN OUTCOMES AND MEASURES Co-primary outcomes included daily step count, weight, and hemoglobin A1c level. Secondary outcome was low-density lipoprotein cholesterol level. Intention-to-treat analysis was used. RESULTS Participants had a mean (SD) age of 52.5 (10.1) years; hemoglobin A1c level, 9.6% (1.6%); daily steps, 4632 (2523); weight, 107.4 kg (20.8 kg); and body mass index, 37.1 (6.6). Of the 361 participants, 202 (56.0%) were women, 143 (39.6%) were White, and 185 (51.2%) were Black; with 87 (24.1%) randomized to control; 92 (25.4%) randomized to gamification with support and intervention; 95 (26.3%) randomized to gamification with collaboration; and 87 (24.1%) randomized to gamification with competition. Compared with the control group over 1 year, there was a significant increase in mean daily steps from baseline among participants receiving gamification with support (adjusted difference relative to control group, 503 steps; 95% CI, 103 to 903 steps; P = .01) and competition (606 steps; 95% CI, 201 to 1011 steps; P = .003) but not collaboration (280 steps; 95% CI, -115 to 674 steps; P = .16). All trial arms had significant reductions in weight and hemoglobin A1c levels from baseline, but there were no significant differences between any of the intervention arms and the control arm. There was only 1 adverse event reported that may have been related to the trial (arthritic knee pain). CONCLUSIONS AND RELEVANCE Among adults with uncontrolled type 2 diabetes, a behaviorally designed gamification intervention in this randomized clinical trial significantly increased physical activity over a 1-year period when designed to enhance either support or competition but not collaboration. No differences between intervention and control groups were found for other outcomes. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02961192.
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Effect of a Smartphone App on Weight Change and Metabolic Outcomes in Asian Adults With Type 2 Diabetes: A Randomized Clinical Trial.
Lim, SL, Ong, KW, Johal, J, Han, CY, Yap, QV, Chan, YH, Chooi, YC, Zhang, ZP, Chandra, CC, Thiagarajah, AG, et al
JAMA network open. 2021;(6):e2112417
Abstract
IMPORTANCE Lifestyle interventions are effective in diabetes management, with smartphone apps that manage health data and dietary and exercise schedules gaining popularity. However, limited evidence from randomized clinical trials exists regarding the effectiveness of smartphone-based interventions among Asian adults with type 2 diabetes. OBJECTIVE To compare the effects of a culturally contextualized smartphone-based intervention with usual care on weight and metabolic outcomes. DESIGN, SETTING, AND PARTICIPANTS This randomized clinical trial conducted at multiple primary care centers in Singapore included 305 adults with type 2 diabetes and body mass index (BMI) of 23 or greater who had literacy in English and smartphone access. Participants were recruited between October 3, 2017, and September 9, 2019, and were randomly assigned (1:1; stratified by gender, age, and BMI) to intervention (99 participants) or control (105 participants) groups. Participants' data were analyzed using intention-to-treat analysis. INTERVENTIONS Both control and intervention participants received diet and physical activity advice from a dietitian at a baseline face-to-face visit. Intervention participants additionally used a smartphone app to track weight, diet, physical activity, and blood glucose and then communicated with dietitians for 6 months. MAIN OUTCOMES AND MEASURES Primary outcome was change in body weight, while secondary outcomes were changes in hemoglobin A1c (HbA1c), fasting blood glucose, blood pressure, lipids, and diet. Post hoc analyses included glycemic changes in the subgroup with HbA1c levels of 8% or greater and diabetes medication changes. RESULTS Among the 204 randomized participants (mean [SD] age, 51.2 [9.7] years; 132 [64.7%] men), baseline mean (SD) BMI was 30.6 (4.3). Compared with the control group, intervention participants achieved significantly greater reductions in weight (mean [SD] change, -3.6 [4.7] kg vs -1.2 [3.6] kg) and HbA1c levels (mean [SD] change, -0.7% [1.2] vs -0.3% [1.0]), with a greater proportion having a reduction in diabetes medications (17 participants [23.3%] vs 4 participants [5.4%]) at 6 months. The intervention led to a greater HbA1c reduction among participants with HbA1c levels of 8% or higher (mean [SD] change, -1.8% [1.4] vs -1.0% [1.4]; P = .001). Intergroup differences favoring the intervention were also noted for fasting blood glucose, diastolic blood pressure, and dietary changes. CONCLUSIONS AND RELEVANCE In this study, a smartphone-based lifestyle intervention was more effective in achieving weight and glycemic reductions among Asian adults with type 2 diabetes compared with usual care, supporting the use of apps in lifestyle intervention delivery. TRIAL REGISTRATION anzctr.org.au Identifier: ACTRN12617001112358.
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Automated Behavioral Workplace Intervention to Prevent Weight Gain and Improve Diet: The ChooseWell 365 Randomized Clinical Trial.
Thorndike, AN, McCurley, JL, Gelsomin, ED, Anderson, E, Chang, Y, Porneala, B, Johnson, C, Rimm, EB, Levy, DE
JAMA network open. 2021;(6):e2112528
Abstract
IMPORTANCE Personalized interventions that leverage workplace data and environments could improve effectiveness, sustainability, and scalability of employee wellness programs. OBJECTIVE To test an automated behavioral intervention to prevent weight gain and improve diet using employee cafeteria purchasing data. DESIGN, SETTING, AND PARTICIPANTS This individual-level randomized clinical trial of a 12-month intervention with 12 months of follow-up was conducted among employees of a hospital in Boston, Massachusetts, who purchased food at on-site cafeterias that used traffic-light labels (ie, green indicates healthy; yellow, less healthy; red, unhealthy). Participants were enrolled September 2016 to February 2018. Data were analyzed from May to September 2020. INTERVENTIONS For 12 months, participants in the intervention group received 2 emails per week with feedback on previous cafeteria purchases and personalized health and lifestyle tips and 1 letter per month with peer comparisons and financial incentives for healthier purchases. Emails and letters were automatically generated using survey, health, and cafeteria data. Control group participants received 1 letter per month with general healthy lifestyle information. MAIN OUTCOMES AND MEASURES The main outcome was change in weight from baseline to 12 months and 24 months of follow-up. Secondary outcomes included changes in cafeteria purchases, including proportion of green- and red-labeled purchases and calories purchased per day, from baseline (12 months preintervention) to the intervention (months 1-12) and follow-up (months 13-24) periods. Baseline Healthy Eating Index-15 (HEI-15) scores were compared to HEI-15 scores at 6, 12, and 24 months. RESULTS Among 602 employees enrolled (mean [SD] age, 43.6 [12.2] years; 478 [79.4%] women), 299 were randomized to the intervention group and 303 were randomized to the control group. Baseline mean (SD) body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) was 28.3 (6.6) and HEI-15 score was 60.4 (12.4). There were no between-group differences in weight change at 12 (0.2 [95% CI, -0.6 to 1.0] kg) or 24 (0.6 [95% CI, -0.3 to 1.4] kg) months. Compared with baseline, the intervention group increased green-labeled purchases by 7.3% (95% CI, 5.4% to 9.3%) and decreased red-labeled purchases by 3.9% (95% CI, -5.0% to -2.7%) and calories purchased per day by 49.5 (95% CI, -75.2 to -23.9) kcal more than the control group during the intervention period. In the intervention group, differences in changes in green (4.8% [95% CI, 2.9% to 6.8%]) and red purchases (-3.1% [95% CI, -4.3% to -2.0%]) were sustained at the 24-month follow-up. Differences in changes in HEI-15 scores were not significantly different in the intervention compared with the control group at 6 (2.2 [95% CI, 0 to 4.4]), 12 (1.8 [95% CI, -0.6 to 4.1]), and 24 (1.6, 95% CI, -0.7 to 3.8]) months. CONCLUSIONS AND RELEVANCE The findings of this randomized clinical trial suggest that an automated behavioral intervention using workplace cafeteria data improved employees' food choices but did not prevent weight gain over 2 years. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02660086.
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The INTER-ACT E-Health Supported Lifestyle Intervention Improves Postpartum Food Intake and Eating Behavior, but Not Physical Activity and Sedentary Behavior-A Randomized Controlled Trial.
Bijlholt, M, Ameye, L, Van Uytsel, H, Devlieger, R, Bogaerts, A
Nutrients. 2021;(4)
Abstract
Unhealthy postpartum lifestyle is related to long-term adverse psychological, metabolic and cardiovascular health outcomes as well as to complications in the next pregnancy. Especially women with preceding excessive gestational weight gain are at risk. This paper aims to evaluate the effect of the postpartum phase of the INTER-ACT randomized controlled trial (RCT) on food intake, eating behavior, physical activity and sedentary time at the end of the intervention (six months postpartum) and at six-months follow-up (12 months postpartum). The study population comprised women with excessive gestational weight gain in the preceding pregnancy. The lifestyle intervention combined a smartphone application with four face-to-face coaching sessions between six weeks and six months postpartum. After the intervention, restrained eating score was 1 point higher (95% CI 0.5, 1.5; p < 0.001), uncontrolled eating score was 1 point lower (95% CI -1.9, -0.2; p = 0.02) and energy intake was 69 kcal lower (95% CI -123, -15; p = 0.01) in the intervention group compared to the control group. The differences were no longer statistically significant at follow-up. No significant effects on emotional eating, physical activity and sedentary behavior were found. In conclusion, the postpartum phase of the INTER-ACT RCT was effective in improving nutrition-related outcomes, however, these improvements could not be sustained at follow-up. ClinicalTrials.gov identifier: NCT02989142.
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Feasibility of Integration of Yoga in a Behavioral Weight-Loss Intervention: A Randomized Trial.
Jakicic, JM, Davis, KK, Rogers, RJ, Sherman, SA, Barr, S, Marcin, ML, Collins, KA, Collins, AM, Yuan, N, Lang, W
Obesity (Silver Spring, Md.). 2021;(3):512-520
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OBJECTIVE This study examined the feasibility and comparison of two styles of yoga within the context of a standard behavioral weight-loss intervention (SBWI). METHODS Fifty adults with obesity (BMI: 31.3 ± 3.8 kg/m2 ) participated in this 6-month study that included a SBWI and a calorie- and fat-reduced diet. Randomization was to restorative Hatha (SBWI+RES) or Vinyasa (SBWI+VIN) yoga. Yoga was prescribed to increase from 20 to 40 to 60 minutes per session across the intervention. Weight was assessed at baseline and 6 months. Perceptions of yoga were assessed at the completion of the intervention. RESULTS Adjusted weight loss was -3.4 kg (95% CI: -6.4 to -0.5) in SBWI+RES and -3.8 kg (95% CI: -6.8 to -0.9) in SBWI+VIN (P < 0.001), with no difference between groups. Of all participants, 74.4% reported that they would continue participation in yoga after the SBWI. Session duration was a barrier as yoga increased from 20 to 40 to 60 minutes per day, with 0%, 7.5%, and 48.8% reporting this barrier, respectively. CONCLUSIONS Among adults with obesity, yoga participation, within the context of a SBWI, appears to be feasible, with weight loss not differing by style of yoga. Progressing to 60 minutes per session appears to be a barrier to engagement in yoga in this population.
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A Behavioral Lifestyle Intervention to Limit Gestational Weight Gain in Pregnant Women with Overweight and Obesity.
Liu, J, Wilcox, S, Wingard, E, Turner-McGrievy, G, Hutto, B, Burgis, J
Obesity (Silver Spring, Md.). 2021;(4):672-680
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OBJECTIVE This study aimed to evaluate the effects of an antenatal behavioral lifestyle intervention on total gestational weight gain (GWG) and perinatal outcomes. METHODS Pregnant women with overweight and obesity in South Carolina were recruited into a theory-based randomized controlled trial (n = 112 intervention, n = 105 standard care), which was designed to target weight self-monitoring, increased physical activity, and improved dietary practices. RESULTS Participants were racially/ethnically diverse (44% African American). Intervention and standard care participants had similar total GWG at delivery (12.9 ± 6.9 vs. 12.4 ± 8.3 kg, respectively), but intervention participants had a smaller standard deviation (P = 0.04) in total GWG. The treatment effects were moderated by race/ethnicity and prepregnancy BMI. Among African American participants with overweight, intervention participants gained 4.5 kg less, whereas, among African American women with obesity, intervention participants gained 4.1 kg more than standard care participants. Total GWG among White participants was similar regardless of weight status and group assignment. Fewer intervention participants than standard care participants had adverse pregnancy outcomes (P ≤ 0.01). CONCLUSIONS The behavioral lifestyle intervention favorably impacted GWG in African American participants with overweight but not African American participants with obesity. The intervention's overall favorable impact on perinatal outcomes suggests that the mechanisms beyond total GWG may drive these outcomes.
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Measures of adherence as predictors of early and total weight loss with intensive behavioral therapy for obesity combined with liraglutide 3.0 mg.
Tronieri, JS, Wadden, TA, Walsh, O, Berkowitz, RI, Alamuddin, N, Chao, AM
Behaviour research and therapy. 2020;:103639
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Individual weight loss outcomes with intensive behavioral therapy (IBT) for obesity are variable. The present study assessed whether visit attendance, dietary self-monitoring, medication, and meal-replacement adherence were associated with 52-week weight loss with IBT and tested whether these relationships were independent of associations with early weight loss. This was a secondary analysis of a randomized trial in which 150 participants (76.1% female, 55.8% white, BMI = 38.8 ± 4.8 kg/m2) received either IBT alone, IBT with liraglutide 3.0 mg/d, or IBT-liraglutide combined with a 12-week meal replacement diet (Multi-component). In the full sample, visit attendance accounted for 14.8% of the variance in 52-week weight loss and dietary self-monitoring added 14.9%. Only self-monitoring was independently associated with weight loss. In the 100 liraglutide-treated participants, medication adherence accounted for an additional 9.9% of the variance in 52-week weight loss, and both self-monitoring and medication adherence were independent correlates. For the 50 Multi-component participants, meal replacement adherence did not predict weight loss. Early weight loss was associated with higher early and subsequent session attendance and dietary self-monitoring. However, self-monitoring and medication adherence remained important correlates of total weight loss when controlling for this variable. Strategies that help improve self-monitoring consistency and medication usage could improve weight loss with IBT.
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Understanding, comparing and learning from the four EPOCH early childhood obesity prevention interventions: A multi-methods study.
Seidler, AL, Hunter, KE, Johnson, BJ, Ekambareshwar, M, Taki, S, Mauch, CE, Mihrshahi, S, Askie, L, Campbell, KJ, Daniels, L, et al
Pediatric obesity. 2020;(11):e12679
Abstract
BACKGROUND Childhood obesity is a global problem. Early obesity prevention interventions are complex and differ in effectiveness. Novel frameworks, taxonomies and experience from the Early Prevention of Obesity in CHildren (EPOCH) trials were applied to unpack interventions. OBJECTIVES Deconstruct interventions into their components (target behaviours, delivery features and behaviour change techniques [BCTs]). Identify lessons learned and future recommendations for intervention planning, delivery, evaluation and implementation. METHODS This multi-methods study deconstructed the four EPOCH interventions into target behaviours, delivery features and BCTs from unpublished and published materials using systematic frameworks. Additionally, semi-structured interviews were conducted with intervention facilitators and principal investigators. RESULTS Each trial targeted between 10 and 14 obesity-related behaviours. Key variations in delivery features related to intensity, delivery mode and tailoring. BCTs consistently used across trials included goal-setting, social support, shaping knowledge, role-modelling and credible source. Recommendations from interview analyses include the importance of stakeholder collaboration and consideration of implementation throughout the study process. CONCLUSIONS The combination of frameworks, methodologies and interviews used in this study is a major step towards understanding complex early obesity prevention interventions. Future work will link systematic intervention deconstruction with quantitative models to identify which intervention components are most effective and for whom.