Comparative effect of saxagliptin and glimepiride with a composite endpoint of adequate glycaemic control without hypoglycaemia and without weight gain in patients uncontrolled with metformin therapy: Results from the SPECIFY study, a 48‐week, multi‐centre, randomized, controlled trial

2019 ◽  
Vol 21 (4) ◽  
pp. 939-948 ◽  
Author(s):  
Tianwei Gu ◽  
Jianhua Ma ◽  
Qiu Zhang ◽  
Liangying Zhu ◽  
Hong Zhang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Weight Gain ◽  
Glycaemic Control ◽  
Controlled Trial ◽  
Composite Endpoint ◽  
Comparative Effect ◽  
Metformin Therapy ◽  
Randomized Controlled

Rationale, design, and challenges with implementing a clinical intervention to teach appropriate gestational weight gain (TAGG): Protocol of a Randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Awathif Mackeen ◽  
Danielle Downs ◽  
Vonda Hetherington ◽  
Shawnee Lutcher ◽  
Jacob Mowery ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Weight Gain ◽  
Gestational Diabetes ◽  
Usual Care ◽  
Gestational Weight Gain ◽  
Perceived Stress ◽  
Controlled Trial ◽  
Household Food Security ◽  
Gestational Weight ◽  
Randomized Controlled

BACKGROUND Excessive gestational weight gain (GWG) has public health implications including preterm birth, preeclampsia, gestational diabetes, and cesarean delivery. In an effort to mitigate adverse consequences of excessive GWG, this study tests a health intervention that includes enhancements to improve knowledge and awareness of appropriate GWG, and patient-centered nutritional counseling to promote appropriate GWG. OBJECTIVE The primary objective of the study was to increase the proportion of women who are managing their GWG as recommended by the IOM.4,5 METHODS This randomized controlled trial was conducted at Geisinger in Pennsylvania where excessive GWG is common among women with pre-conception obesity. Eligible, consenting participants with pre-pregnancy body mass index >30.0 kg/m2 were randomized (1:1) to: 1) Usual Care: usual written educational materials and counseling by an obstetric care provider or 2) Enhanced Care: Usual Care plus a) a personalized letter from a physician detailing appropriate GWG, b) exposure to individualized GWG chart in the electronic health record via the patient portal, and c) a consult with a Registered Dietitian Nutritionist and follow-up via tele-health counseling (10-20 mins/1-2 weeks) for the duration of the pregnancy. RESULTS The primary outcome was the proportion of women that gain less than 20 pounds over the course of the pregnancy. Secondary outcomes include knowledge, expectations, and attitude about pregnancy weight gain; increased self-efficacy for ability to eat healthy and being physically active to manage weight; and eating behavior. Potential moderators that will be explored include sleep, perceived stress, perceived involvement in care, and household food security. Data collection has been completed as of November 2019. CONCLUSIONS As GWG care was initiated for mothers with pre-pregnancy BMI >30 kg/m2 within the first and second trimesters, the intervention may have the additional benefit of reducing other adverse pregnancy outcomes including the incidence of gestational diabetes due to healthier rates of GWG. In addition to assessing appropriate GWG, this project will assess eating habits, physical activity, GWG attitudes, sleep quality, and psychological measures, all of which are associated with GWG. Exploratory mediators including perceived stress and food insecurity will also be evaluated. CLINICALTRIAL ClinicalTrials.gov NCT02963428

Nurse‐led telephone intervention for lifestyle changes on glycaemic control in people with prediabetes: Study protocol for a randomized controlled trial

2021 ◽  
Author(s):  
Manuela Abbate ◽  
Sergio Fresneda ◽  
Aina Yañez ◽  
Ignacio Ricci‐Cabello ◽  
Aina M Galmes‐Panades ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Glycaemic Control ◽  
Study Protocol ◽  
Controlled Trial ◽  
Lifestyle Changes ◽  
Telephone Intervention ◽  
Randomized Controlled

scholarly journals Starch or Saline After Cardiac Surgery: A Double-Blinded Randomized Controlled Trial

2020 ◽  
Vol 7 ◽  
pp. 205435812094043
Author(s):  
A. Dave Nagpal ◽  
Andrea Cowan ◽  
Linna Li ◽  
Graeme Nusca ◽  
Linrui Guo ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cardiac Surgery ◽  
Weight Gain ◽  
Controlled Trial ◽  
Coronary Revascularization ◽  
Small Sample ◽  
Resource Limitations ◽  
Randomized Controlled ◽  
Surgery Patient ◽  
Double Blinded

Background: Despite decades of investigation, the balance of clinical risks and benefits of fluid supplementation with starch remain unresolved. Patient-centered outcomes have not been well explored in a “real-world” trial in cardiac surgery. Objective: We sought to compare a starch-based fluid strategy with a saline-based fluid strategy in the cardiac surgery patient. Design: A pragmatic blinded randomized controlled trial comparing starch-based with saline-based fluid strategy. Setting: A large tertiary academic center in London Ontario between September 2009 and February 2011. Participants: Patients undergoing planned, isolated coronary revascularization. Measurements: Serum creatinine and patient weight were measured daily postoperatively. Methods: Patients were randomized to receive 6% hydroxyethyl starch (Voluven) or saline for perioperative fluid requirements. Fluid administration was not protocolized. Co-primary outcomes were incidence of acute kidney injury (AKI) and maximum postoperative weight gain. Secondary outcomes included bleeding, transfusion, inotropic and ventilator support, and fluid utilization. Results: The study was prematurely terminated due to resource limitations. A total of 69 patients (19% female, mean age = 65) were randomized. Using RIFLE criteria for AKI, “risk” occurred in 12 patients in each group (risk ratio [RR] = 1.0; 95% confidence interval [CI] = 0.5-1.9; P = 1.00), whereas “injury” occurred in 7 of 35 (20%) and 3 of 34 (9%) of patients in the starch and saline groups, respectively (RR = 2.3; 95% CI = 0.6-8.1; P = .31). Maximum weight gain, bleeding and blood product usage, and overall fluid requirement were similar between groups. Limitations: The study had to be prematurely terminated due to resource limitations which led to a small sample size which was not sufficiently powered to detect a difference in the primary outcomes. Conclusions: This pragmatic double-blinded randomized controlled trial revealed a number of interesting hypothesis-generating trends and confirmed the feasibility of undertaking a logistically complex trial in a pragmatic fashion.

Limiting Excess Weight Gain in High-Risk Pregnancies: A Randomized Controlled Trial

2011 ◽  
pp. P1-466-P1-466
Author(s):  
Cheryce L Harrison ◽  
Catherine B Lombard ◽  
Melanie Gibson-Helm ◽  
Amanda Deeks ◽  
Helena J Teede
Keyword(s):  
Randomized Controlled Trial ◽  
Weight Gain ◽  
High Risk ◽  
Controlled Trial ◽  
Excess Weight ◽  
Randomized Controlled ◽  
Excess Weight Gain

scholarly journals Targeted prevention of excess weight gain and eating disorders in high-risk adolescent girls: a randomized controlled trial

2014 ◽  
Vol 100 (4) ◽  
pp. 1010-1018 ◽  
Author(s):  
Marian Tanofsky-Kraff ◽  
Lauren B Shomaker ◽  
Denise E Wilfley ◽  
Jami F Young ◽  
Tracy Sbrocco ◽  
...  
Keyword(s):  
Eating Disorders ◽  
Randomized Controlled Trial ◽  
Weight Gain ◽  
High Risk ◽  
Adolescent Girls ◽  
Controlled Trial ◽  
Excess Weight ◽  
Targeted Prevention ◽  
Randomized Controlled ◽  
Excess Weight Gain

The Effect of Psychological Intervention on Thirst and Interdialytic Weight Gain in Patients on Chronic Hemodialysis: A Randomized Controlled Trial

2015 ◽  
Vol 25 (5) ◽  
pp. 426-432 ◽  
Author(s):  
Gianni Bellomo ◽  
Pamela Coccetta ◽  
Franca Pasticci ◽  
Davide Rossi ◽  
Antonio Selvi
Keyword(s):  
Randomized Controlled Trial ◽  
Weight Gain ◽  
Psychological Intervention ◽  
Controlled Trial ◽  
Chronic Hemodialysis ◽  
Randomized Controlled ◽  
Interdialytic Weight Gain
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