scholarly journals Adherence to and acceptability of three alcohol‐free, antiseptic oral rinses: A community‐based pilot randomized controlled trial among pregnant women in rural Nepal

2020 ◽  
Vol 48 (6) ◽  
pp. 501-512
Author(s):  
Daniel J. Erchick ◽  
Nitin K. Agrawal ◽  
Subarna K. Khatry ◽  
Joanne Katz ◽  
Steven C. LeClerq ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Community Based ◽  
Randomized Controlled ◽  
Rural Nepal ◽  
Pilot Randomized Controlled Trial

Abstract MP72: Feasibility, Safety and Acceptability of Soy-Based Diet for Pregnant Women: Preliminary Results From a Pilot Randomized Controlled Trial

Circulation ◽  
2018 ◽  
Vol 137 (suppl_1) ◽  
Author(s):  
Ling Shi ◽  
Vidya Iyer ◽  
Errol Norwitz ◽  
Tiffany A Moore Simas ◽  
Nirupa Matthan ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Adverse Events ◽  
Pregnant Women ◽  
Health Effects ◽  
Cardiometabolic Risk ◽  
Controlled Trial ◽  
Cardiometabolic Health ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial ◽  
Whole Foods

Introduction: Previous evidence suggests that soy containing foods may have beneficial effects on lipid and glycemic metabolism due to their biologically active components, including soy protein and isoflavones. Pregnancy is associated with changes in glucose and lipid metabolism, partially attributable to elevated estrogen concentrations. We have previously reported a significant, inverse association between urinary excretion of isoflavones and cardiometabolic risk markers in pregnant women, using data from the National Health and Nutrition Examination Survey (NHANES). Further studies are needed to determine the cardiometabolic health effects of soy intake in pregnant women. Hypothesis: We hypothesize that consumption of soy-based whole foods is safe and acceptable for pregnant women and has beneficial cardiometabolic health effects. Methods: A pilot randomized controlled trial (RCT) was conducted in 30 pregnant women who received counseling to consume either a high-soy or low-soy foods containing diet. Assessments (physical and anthropometric measurements, food frequency questionnaires, fasting blood samples) were conducted at 14 and 28 weeks of pregnancy, and 6 weeks’ postpartum. Monthly follow-up calls were conducted by research team coordinator to assess safety and encourage adherence. Results: Both the high-soy and low-soy groups demonstrated high adherence (80-90%), defined as consuming soy foods ≥ 15 days in the past four weeks for high-soy group and ≤ 5 days for low-soy group. Five subjects in the high-soy group reported adverse events (nausea, vomiting, diarrhea, itchy mouth); all were transient and resolved without sequelae. No adverse events were reported in the low-soy group. Skinfold thickness decreased (-4.8 mm) in the high-soy group and increased (+3.6 mm) in the low-soy group (p=0.04). There was a trend towards lower BMI in the high-soy compared to low-soy group at 28 weeks (+1.4 vs. +3.6 kg/m 2 , respectively, p=0.15) and postpartum (-1.2 vs. +0.6 kg/m 2 , respectively, p=0.14). This decrease in BMI was predominantly a loss of body fat and not lean mass. There were no significant differences between groups in fasting glucose, HDL-C, LDL-C, TG, or VLDL concentrations. Conclusions: In conclusion, results from this pilot RCT support the acceptability and safety of consuming soy-based whole foods during pregnancy. A larger-scale RCT is needed to further elucidate the effects of soy-based foods on cardiometabolic risk factors during pregnancy, as well as the transgenerational effects on their offspring.

scholarly journals Effects of a low–glycemic load diet in overweight and obese pregnant women: a pilot randomized controlled trial

2010 ◽  
Vol 92 (6) ◽  
pp. 1306-1315 ◽  
Author(s):  
Erinn T Rhodes ◽  
Dorota B Pawlak ◽  
Tamara C Takoudes ◽  
Cara B Ebbeling ◽  
Henry A Feldman ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Glycemic Load ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

scholarly journals Dose-Response of Aerobic Exercise on Cognition: A Community-Based, Pilot Randomized Controlled Trial

PLoS ONE ◽  
2015 ◽  
Vol 10 (7) ◽  
pp. e0131647 ◽  
Author(s):  
Eric D. Vidoni ◽  
David K. Johnson ◽  
Jill K. Morris ◽  
Angela Van Sciver ◽  
Colby S. Greer ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Aerobic Exercise ◽  
Dose Response ◽  
Controlled Trial ◽  
Community Based ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

scholarly journals Acceptability and feasibility of a community-based strength, balance, and Tai Chi rehabilitation program in improving physical function and balance of patients after total knee arthroplasty: study protocol for a pilot randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Cathy W. T. Lo ◽  
Matthew A. Brodie ◽  
William W. N. Tsang ◽  
Chun-Hoi Yan ◽  
Priscillia L. Lam ◽  
...  
Keyword(s):  
Total Knee Arthroplasty ◽  
Randomized Controlled Trial ◽  
Knee Arthroplasty ◽  
Tai Chi ◽  
Controlled Trial ◽  
Effectiveness Trial ◽  
Community Based ◽  
Randomized Controlled ◽  
Total Knee ◽  
Pilot Randomized Controlled Trial

Abstract Background The rate of falls in patients after total knee arthroplasty (TKA) is high and related to lower limb muscle weakness and poor balance control. However, since routine post-TKA rehabilitation is uncommon, it is paramount to explore alternative strategies to enhance balance and physical functioning in post-TKA patients. As Tai Chi is a proven strategy for improving balance in older people, the proposed study aims to determine the feasibility and acceptability of a 12-week community-based post-TKA multimodal Tai Chi program and to collect preliminary data with respect to the efficacy of such a program in improving balance and physical functioning in post-TKA patients as compared to usual postoperative care. Methods A single-blinded 2-arm pilot randomized controlled trial will recruit 52 community-dwelling post-TKA patients (aged > 60 years) in Hong Kong. In addition, 26 untreated asymptomatic controls will be recruited for comparison purposes. The TKA patients will be randomized into either a 12-week multimodal Tai Chi rehabilitation group or a postoperative usual care group (26 each). Participants will perform the outcome assessments at baseline, 6, 12, 24, and 52 weeks after TKA, while asymptomatic controls will have the same assessments at baseline, 12, and 52 weeks after baseline. The rate of recruitment, retention, and attrition, as well as adherence to the intervention, will be measured and used to determine the feasibility of the study and whether a full-scale effectiveness trial is warranted. Further, qualitative interviews will be conducted to explore the acceptability and possible barriers to the implementation of the intervention. Primary and secondary outcomes including both patient-reported surveys and performance-based tests will be compared within and between groups. Discussion The study will determine the feasibility and acceptability/potential efficacy of community-based rehabilitation for post-TKA patients and assess whether the intervention has the potential to be assessed in a future fully powered effectiveness trial. The findings will also be used to refine the study design and guide the conduction of a future definitive randomized controlled trial. Trial registration ClinicalTrials.gov NCT03615638. Registered on 30 May 2018. https://clinicaltrials.gov/ct2/show/NCT03565380

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