Browsing by Subject "randomized controlled trial"
Now showing 1 - 9 of 9
Results Per Page
Sort Options
Item Addressing People and Place Microenvironments in Weight Loss Disparities (APP-Me): Design of a randomized controlled trial testing timely messages for weight loss behavior in low income black and white women(Elsevier, 2018) Clark, Daniel O.; Srinivas, Preethi; Bodke, Kunal; Keith, NiCole; Hood, Sula; Tu, Wanzhu; Medicine, School of MedicineBackground Behavioral interventions for weight loss have been less effective in lower income and black women. These poorer outcomes may in part be related to these women having more frequent exposures to social and physical situations that are obesogenic, i.e., eating and sedentary cues or situations. Objectives Working with obese, lower income black and white women, Addressing People and Place Microenvironments (APP-Me) was designed to create awareness of self-behavior at times and places of frequent eating and sedentary behavior. Design APP-Me is being evaluated in a randomized controlled trial with 240 participants recruited from federally qualified health centers located in a single Midwestern city. All participants complete four weeks of ecological momentary assessments (EMA) of situations and behavior. At the end of the four weeks, participants are randomized to enhanced usual care (UC) or UC plus APPMe. Methods APP-Me is an automated short messaging system (SMS). Messages are text, image, audio, or a combination, and are delivered to participants’ mobile devices with the intent of creating awareness at the times and places of frequent eating or sedentary behavior. The EMA data inform the timing of message deliveries. Summary This project aims to create and test timely awareness messages in a subpopulation that has not responded well to traditional behavioral interventions for weight loss. Novel aspects of the study include the involvement of a low income population, the use of data on time and place of obesogenic behavior, and message delivery time tailored to an individual’s behavioral patterns.Item Change in self-efficacy partially mediates the effects of the FRESH START intervention on cancer survivors' dietary outcomes(Wiley, 2008) Mosher, Catherine E.; Fuemmeler, Bernard F.; Sloane, Richard; Kraus, William E.; Lobach, David F.; Snyder, Denise Clutter; Demark-Wahnefried, WendyObjective: This study examined change in self-efficacy as a mediator of the effects of a mailed print intervention on the dietary and exercise practices of newly diagnosed breast and prostate cancer survivors. Method: A total of 543 breast and prostate cancer patients were recruited from 39 states and two provinces within North America. Participants were randomly assigned to receive a 10-month program of tailored mailed print materials that aimed to increase fruit and vegetable consumption, reduce fat intake, and/or increase exercise or a 10-month program of publically available materials on diet and exercise. Telephone surveys conducted at baseline and 1 year assessed dietary practices, physical activity, and self-efficacy for engaging in these health behaviors. Results: Results indicated that changes in self-efficacy for fat restriction and eating more fruits and vegetables were significant mediators of the intervention's effects on dietary outcomes at 1-year follow-up. The intervention did not significantly affect self-efficacy for exercise; however, a significant, positive relationship was found between self-efficacy for exercise and exercise duration at follow-up. Conclusions: Findings are largely consistent with Social Cognitive Theory and support the use of strategies to increase self-efficacy in health promotion interventions for cancer survivors. Copyright © 2008 John Wiley & Sons, Ltd.Item The effects of message framing and healthcare provider recommendation on adult hepatitis B vaccination: A randomized controlled trial(Elsevier, 2019-08-09) Kasting, Monica L.; Head, Katharine J.; Cox, Dena; Cox, Anthony D.; Zimet, Gregory D.; Pediatrics, School of MedicineMany adults in the U.S. do not receive recommended vaccines, and the research literature remains inconclusive on the best communication strategies for increasing this behavior. This study examined the association of message framing (gained-framed vs. loss-framed vs. control), and healthcare provider (HCP) recommendation (offered vs. recommended) on uptake of adult hepatitis B virus (HBV) vaccination in a high risk population using a 3×2 block design randomized controlled trial. Fear of shots, fear of vaccines, and perceived message framing were examined in secondary analyses. Of the 1,747 participants, 47.7% (n=833) received 0 doses of HBV vaccine, 27.8% (n=485) received 1 dose, 10.4% received 2 doses, and 14.1% received all 3 recommended doses. There was not a significant interaction between message framing and HCP recommendation (p =.59). Mean number of doses received by the gain-framed group (m=.96) was not significantly different from the loss-framed group (m=.97, RR=.99, 95% CI=.88–1.12). However, those receiving any framing message received significantly more doses (m= .96) than those in the control condition (m=.81, RR=1.17, 95%CI=1.06–1.31). Participants who received a HCP recommendation received significantly more vaccine doses (m=.95) than those in the vaccine-offered condition (mean=.82, RR=1.16, 95%CI=1.05–1.28). These results suggest there is no difference in vaccine uptake between gain-frame and loss-frame messages, but both are better than a control message. These results also support advising HCP to provide a strong recommendation for vaccinations beyond merely offering it to patients. This study has implications for vaccine uptake beyond HBV, and can inform future research on effective vaccine communication research.Item From the Cochrane Library: Hydrosurgical Debridement Versus Conventional Surgical Debridement for Acute Partial-Thickness Burns(JMIR Publications, 2022-04) Kokoska, Ryan E.; Szeto, Mindy D.; Sivesind, Torunn E.; Dellavalle, Robert P.; Wormald, Justin C. R.; Dermatology, School of MedicineItem In Patients With ST-Segment Elevation Myocardial Infarction, Which Fibrinolytic Agent Is the Safest and Most Effective?(Elsevier, 2018) Shrestha, Ashis; House, Darlene R.; Welch, Julie L.; Emergency Medicine, School of MedicineItem Long-term effect of moxibustion on irritable bowel syndrome with diarrhea: a randomized clinical trial(Sage, 2022-02) Bao, Chunhui; Wu, Luyi; Shi, Yin; Shi, Zheng; Jin, Xiaoming; Shen , Jiacheng; Li , Jing; Hu , Zhihai; Chen, Jianhua; Zeng , Xiaoqing; Zhang, Wei; Ma , Zhe; Weng , Zhijun; Li , Jinmei; Liu , Huirong; Wu , Huangan; Anatomy, Cell Biology and Physiology, School of MedicineBackground: Moxibustion is increasingly used for treatment of irritable bowel syndrome (IBS). This study investigated the long-term effects of moxibustion for IBS with diarrhea (IBS-D). Methods: Patients with IBS-D were assigned to receive moxibustion or sham moxibustion (52 each, 3× per week, 6 weeks) and were followed up to 24 weeks. The acupoints were bilateral ST25 and ST36, body surface temperatures at acupoints were 43°C ± 1°C and 37°C ± 1°C for the moxibustion and sham groups, respectively. Primary outcome was changes in IBS Adequate Relief (IBS-AR) from baseline to 6 weeks. Secondary outcomes included the following: IBS symptom severity scale (IBS-SSS), Bristol stool form scale (BSS), IBS quality of life (IBS-QOL), and Hospital Anxiety and Depression Scale (HADS). Results: Based on an intention-to-treat analysis, the rate of IBS-AR in the moxibustion group was significantly higher than the sham group at 6 weeks (76.9% versus 42.3%; p < 0.001); the mean decrease of total IBS-BSS score in the moxibustion group was lower than that of the sham group (−116.9 versus −61.5; p < 0.001), both of which maintained throughout the follow-up period. Five specific domains of the IBS-SSS were lower in the moxibustion group than the sham, throughout (p < 0.001). At week 6, the rate of reduction >50 points in IBS-SSS of the treatment group was significantly higher than that of the sham (p < 0.001), which persisted throughout the follow-up period. Similar long-lasting improvements were observed in BSS, stool frequency, and stool urgency (p < 0.001). Improvements of IBS-QOL and HADS were comparable between the groups. Conclusions: Moxibustion treatment benefits the long-term relief of symptoms in IBS-D patients. Trial registration: Clinical trials.gov (NCT02421627). Registered on 20 April 2015.Item MIND food and speed of processing training in older adults with low education, the MINDSpeed Alzheimer's disease prevention pilot trial(Elsevier, 2019-09) Clark, Daniel O.; Xu, Huiping; Moser, Lyndsi; Adeoye, Philip; Lin, Annie W.; Tangney, Christy C.; Risacher, Shannon L.; Saykin, Andrew J.; Considine, Robert V.; Unverzagt, Frederick W.; Medicine, School of MedicineBackground Multiple national organizations and leaders have called for increased attention to dementia prevention in those most vulnerable, for example persons with limited formal education. Prevention recommendations have included calls for multicomponent interventions that have the potential to improve both underlying neurobiological health and the ability to function despite neurobiological pathology, or what has been termed cognitive reserve. Objectives Test feasibility, treatment modifier, mechanism, and cognitive function effects of a multicomponent intervention consisting of foods high in polyphenols (i.e., MIND foods) to target neurobiological health, and speed of processing training to enhance cognitive reserve. We refer to this multicomponent intervention as MINDSpeed. Design MINDSpeed is being evaluated in a 2 × 2 randomized factorial design with 180 participants residing independently in a large Midwestern city. Qualifying participants are 60 years of age or older with no evidence of dementia, and who have completed 12 years or less of education. All participants receive a study-issued iPad to access the custom study application that enables participants, depending on randomization, to select either control or MIND food, and to play online cognitive games, either speed of processing or control games. Methods All participants complete informed consent and baseline assessment, including urine and blood samples. Additionally, up to 90 participants will complete neuroimaging. Assessments are repeated immediately following 12 weeks of active intervention, and at 24 weeks post-randomization. The primary outcome is an executive cognitive composite score. Secondary outcomes include oxidative stress, pro-inflammatory cytokines, and neuroimaging-captured structural and functional metrics of the hippocampus and cortical brain regions. Summary MINDSpeed is the first study to evaluate the multicomponent intervention of high polyphenol intake and speed of processing training. It is also one of the first dementia prevention trials to target older adults with low education. The results of the study will guide future dementia prevention efforts and trials in high risk populations.Item Narrow-band imaging versus white light for the detection of proximal colon serrated lesions: a randomized, controlled trial(Elsevier, 2016-01) Rex, Douglas K.; Clodfelter, Ryan; Rahmani, Farrah; Fatima, Hala; James-Stevenson, Toyia N.; Tang, John C.; Kim, Hak Nam; McHenry, Lee; Kahi, Charles J.; Rogers, Nicholas A.; Helper, Debra J.; Sagi, Sashidhar V.; Kessler, William R.; Wo, John M.; Fischer, Monika; Kwo, Paul Y.; Department of Medicine, School of MedicineBackground The value of narrow-band imaging (NBI) for detecting serrated lesions is unknown. Objective To assess NBI for the detection of proximal colon serrated lesions. Design Randomized, controlled trial. Setting Two academic hospital outpatient units. Patients Eight hundred outpatients 50 years of age and older with intact colons undergoing routine screening, surveillance, or diagnostic examinations. Interventions Randomization to colon inspection in NBI versus white-light colonoscopy. Main Outcome Measurements The number of serrated lesions (sessile serrated polyps plus hyperplastic polyps) proximal to the sigmoid colon. Results The mean inspection times for the whole colon and proximal colon were the same for the NBI and white-light groups. There were 204 proximal colon lesions in the NBI group and 158 in the white light group (P = .085). Detection of conventional adenomas was comparable in the 2 groups. Limitations Lack of blinding, endoscopic estimation of polyp location. Conclusion NBI may increase the detection of proximal colon serrated lesions, but the result in this trial did not reach significance. Additional study of this issue is warranted. (Clinical trial registration number: NCT01572428.)Item Randomized Placebo-Controlled Trial of Reloxaliase in Enteric Hyperoxaluria(NEJM Group, 2022-05-06) Lieske, John C.; Lingeman, James E.; Ferraro, Pietro M.; Wyatt, Christina M.; Tosone, Christine; Kausz, Annamaria T.; Knauf, Felix; Urology, School of MedicineBACKGROUND Enteric hyperoxaluria is caused by increased intestinal oxalate absorption and can lead to kidney stones, chronic kidney disease, and kidney failure. Reloxaliase is an orally administered recombinant enzyme that degrades oxalate along the gastrointestinal tract, thereby preventing its absorption. METHODS We randomly assigned participants with enteric hyperoxaluria to reloxaliase or placebo, three to five times per day with food for 4 weeks. The primary end point was percent change from baseline in 24-hour urinary oxalate (UOx) excretion during weeks 1 to 4. Secondary end points included the proportion of participants with more than a 20% reduction in 24-hour UOx and an efficacy assessment in the bariatric surgery subgroup. RESULTS A total of 115 patients underwent randomization. The 24-hour UOx decreased from a baseline geometric mean of 83.2 to 67.4 mg/24 hr during weeks 1 to 4 in reloxaliase-treated participants. Corresponding data for placebo-treated participants were 84.2 to 78.1 mg/24 hr. Estimates from the mixed-effect model repeated-measures (MMRM) analysis showed a 22.6% reduction in geometric mean UOx during weeks 1 to 4 for reloxaliase and 9.7% for placebo, a difference of 14.3 percentage points (95% confidence interval [CI], 4.9 to 22.8; P=0.004). A 20% or greater reduction in 24-hour UOx was observed in 48.3% of reloxaliase-treated participants and 31.6% of placebo-treated participants (P=0.06). In the bariatric surgery subgroup, MMRM analysis showed a 21.2% reduction in geometric mean UOx for reloxaliase and a 6.0% reduction for placebo, for a difference of 16.2 percentage points (95% CI, 4.2% to 26.7%). Adverse events occurred in 69% of reloxaliase-treated participants versus 53% of individuals taking placebo and were most commonly gastrointestinal. All but one of the adverse events were grade 1 or 2 in severity; no reloxaliase-treated participants discontinued the study. CONCLUSIONS Reloxaliase treatment for 4 weeks reduced UOx excretion in patients with enteric hyperoxaluria; adverse events were relatively common, but not dose-limiting. These data establish the foundation for a clinical trial to determine the impact of reloxaliase on nephrolithiasis in patients with enteric hyperoxaluria. (Funded by Allena Pharmaceuticals; ClinicalTrials.gov number, NCT03456830.)