scholarly journals Weight loss before total joint arthroplasty using a remote dietitian and mobile app: study protocol for a multicenter randomized, controlled trial

2020 ◽  
Vol 15 (1) ◽  
Author(s):  
Michael W. Seward ◽  
Brielle J. Antonelli ◽  
Nancy Giunta ◽  
Richard Iorio ◽  
Wolfgang Fitz ◽  
...  
Keyword(s):  
Weight Loss ◽  
Randomized Controlled Trial ◽  
Health Status ◽  
Global Health ◽  
Severe Obesity ◽  
Controlled Trial ◽  
Joint Arthroplasty ◽  
Mobile App ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial

Abstract Background The months prior to elective surgery may present an opportunity for patients to initiate behavior changes that will simultaneously ready them for surgery and improve their overall health status. An upcoming elective total joint arthroplasty (TJA) may serve as motivation for patients with severe obesity (body mass index [BMI]> 40 kg/m2) to lose weight, as it may optimize clinical outcomes following TJA and help them become eligible for TJA since some surgeons use a BMI of 40 kg/m2 as a cut-off for offering surgery in an effort to optimize outcomes. Methods The purpose of this multicenter randomized, controlled trial is to assess the feasibility and efficacy of a 12-week remote dietitian (RD) supervised dietary and physical activity weight loss intervention and mobile app for 60 patients with severe obesity prior to undergoing TJA. Intervention participants will receive access to a smartphone app and connect with an RD who will contact these participants weekly or bi-weekly via video calls for up to nine video calls. Together, participants and RDs will set goals for lifestyle modifications, and RDs will check on progress towards achieving these goals using in-app tools such as food logs and text messages between video calls. All patients will be encouraged to lose at least 20 pounds with a goal BMI < 40 kg/m2 after 12 weeks. Individuals randomized to the control group will receive clinical standard of care, such as nutritionist and/or physical therapy referrals. Outcome and demographic data will be collected from blood serology, chart review, mobile app user data, pre- and postintervention surveys, and phone interviews. The primary outcome measure will be weight change from baseline. Secondary outcome measures will include percentage of patients eligible to undergo TJA, number of sessions completed with dietitians, self-reported global health status (PROMIS Global Health scale), self-reported joint-specific pain and function (Knee injury and Osteoarthritis Outcome Score (KOOS) or Hip disability and Osteoarthritis Outcome Score (HOOS)), and serologies such as hemoglobin A1c, total lymphocyte count, albumin, and transferrin. Qualitative responses transcribed from phone interviews about the intervention will also be analyzed. Discussion This will be the first study to assess pre-operative weight loss in patients with severe obesity anticipating orthopaedic surgery using an RD and mobile app intervention aimed at helping patients become eligible for TJA. Trial registration Registered on 1 April 2020 at Clincialtrials.gov. Trial number is NCT04330391.

scholarly journals Different Limb Lengths in Gastric Bypass Surgery: Study Protocol for A Swiss Multicenter Randomized Controlled Trial (SLIM)

2020 ◽  
Author(s):  
Marko Kraljević ◽  
Romano Schneider ◽  
Bettina Wölnerhanssen ◽  
Marco Bueter ◽  
Tarik Delko ◽  
...  
Keyword(s):  
Bariatric Surgery ◽  
Body Mass Index ◽  
Weight Loss ◽  
Randomized Controlled Trial ◽  
Gastric Bypass ◽  
Body Mass ◽  
Controlled Trial ◽  
Morbidly Obese ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial

Abstract Background Obesity and type 2 diabetes mellitus (T2DM) are reaching epidemic proportions. In morbidly obese patients, bariatric operations lead to sustained weight loss and relief of comorbidities in the majority of patients. Laparoscopic Roux-Y-gastric bypass (RYGB) is one of the most frequently performed operations, but it is still unknown why some patients respond better than others. Therefore, a number of variations of this operation have been introduced. Recent evidence suggests that a longer bypassed biliopancreatic limb (BPL) has the potential to be more effective compared to the standard RYGB with a shorter BPL length. This article describes the design and protocol of a randomized controlled trial comparing the outcome of a RYGB operation with a long versus short BPL.Methods/Design The trial is designed as a multicenter, randomized, patient and observer blinded trial. The relevant ethics committee has approved the trial protocol. To demonstrate that long BPL RYGB is superior compared to short BPL RYGB in terms of weight loss and resolution of T2DM the study is conducted as a superiority trial. Postoperative percent excess body mass index loss (%EBMIL) is the primary endpoint, whereas morbidity, mortality, remission of obesity related comorbidities and quality of life are secondary endpoints. Eight hundred patients, between 18 and 65 years and with a body mass index (BMI) from 35 to 60 kg/m2 who meet the regulatory rules for bariatric surgery in Switzerland will be randomized. The endpoints and baseline measurements will be assessed pre-, intra- and postoperatively.Discussion With its high number of patients and a 5-year follow-up this study will answer questions about effectiveness and safety of long BPL RYGB and provide level I evidence for improvement of the standard RYGB. These findings might therefore potentially influence global bariatric surgery guidelines.Trial registration This trial was registered on ClinicalTrials.gov under the identifier NCT04219787, on January 7th, 2020.

scholarly journals Different limb lengths in gastric bypass surgery: study protocol for a Swiss multicenter randomized controlled trial (SLIM)

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Marko Kraljević ◽  
Romano Schneider ◽  
Bettina Wölnerhanssen ◽  
Marco Bueter ◽  
Tarik Delko ◽  
...  
Keyword(s):  
Bariatric Surgery ◽  
Weight Loss ◽  
Randomized Controlled Trial ◽  
Gastric Bypass ◽  
Gastric Bypass Surgery ◽  
Controlled Trial ◽  
Morbidly Obese ◽  
Randomized Controlled ◽  
Number Of Patients ◽  
Multicenter Randomized Controlled Trial

Abstract Background Obesity and type 2 diabetes mellitus are reaching epidemic proportions. In morbidly obese patients, bariatric operations lead to sustained weight loss and relief of comorbidities in the majority of patients. Laparoscopic Roux-Y-gastric bypass (RYGB) is one of the most frequently performed operations, but it is still unknown why some patients respond better than others. Therefore, a number of variations of this operation have been introduced. Recent evidence suggests that a longer bypassed biliopancreatic limb (BPL) has the potential to be more effective compared to the standard RYGB with a shorter BPL length. This article describes the design and protocol of a randomized controlled trial comparing the outcome of a RYGB operation with a long versus short BPL. Methods/design The trial is designed as a multicenter, randomized, patient- and observer-blinded trial. The relevant ethics committee has approved the trial protocol. To demonstrate that long BPL RYGB is superior compared to short BPL RYGB in terms of weight loss and resolution of T2DM, the study is conducted as a superiority trial. Postoperative percent total weight loss and nutritional deficiency rate are the primary endpoints, whereas morbidity, mortality, remission of obesity-related comorbidities and quality of life are secondary endpoints. Eight hundred patients, between 18 and 65 years and with a body mass index (BMI) from 35 to 60 kg/m2 who meet the regulatory rules for bariatric surgery in Switzerland, will be randomized. The endpoints and baseline measurements will be assessed pre-, intra-, and postoperatively. Discussion With its high number of patients and a 5-year follow-up, this study will answer questions about effectiveness and safety of long BPL RYGB and provide level I evidence for improvement of the standard RYGB. These findings might therefore potentially influence global bariatric surgery guidelines. Trial registration ClinicalTrials.gov NCT04219787. Registered on 7 January 2020.

scholarly journals Effect of Aerobic Exercise Intensity on Energy Expenditure and Weight Loss in Severe Obesity—A Randomized Controlled Trial

Obesity ◽  
2021 ◽  
Vol 29 (2) ◽  
pp. 359-369
Author(s):  
Jarle Berge ◽  
Jøran Hjelmesæth ◽  
Jens K. Hertel ◽  
Espen Gjevestad ◽  
Milada Cvancarova Småstuen ◽  
...  
Keyword(s):  
Weight Loss ◽  
Randomized Controlled Trial ◽  
Energy Expenditure ◽  
Aerobic Exercise ◽  
Exercise Intensity ◽  
Severe Obesity ◽  
Controlled Trial ◽  
Randomized Controlled

scholarly journals Managing persistent wound leakage after total knee and hip arthroplasty. Results of a nationwide survey among Dutch orthopaedic surgeons

2017 ◽  
Vol 2 (4) ◽  
pp. 202-207 ◽  
Author(s):  
Frank-Christiaan Wagenaar ◽  
Claudia A.M. Löwik ◽  
Martin Stevens ◽  
Sjoerd K. Bulstra ◽  
Yvette Pronk ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Clinical Practice ◽  
Controlled Trial ◽  
Joint Arthroplasty ◽  
Diagnosis And Treatment ◽  
Evidence Based ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial ◽  
Maximum Period ◽  
Wound Leakage

Abstract. Background: Persistent wound leakage after joint arthroplasty is a scantily investigated topic, despite the claimed relation with a higher risk of periprosthetic joint infection. This results in a lack of evidence-based clinical guidelines for the diagnosis and treatment of persistent wound leakage after joint arthroplasty. Without such guideline, clinical practice in orthopaedic hospitals varies widely. In preparation of a nationwide multicenter randomized controlled trial on the optimal treatment of persistent wound leakage, we evaluated current Dutch orthopaedic care for persistent wound leakage after joint arthroplasty.Methods: We conducted a questionnaire-based online survey among all 700 members of the Netherlands Orthopaedic Association, consisting of 23 questions on the definition, classification, diagnosis and treatment of persistent wound leakage after joint arthroplasty.Results: The questionnaire was completed by 127 respondents, representing 68% of the Dutch hospitals that perform orthopaedic surgery. The results showed wide variation in the classification, definition, diagnosis and treatment of persistent wound leakage among Dutch orthopaedic surgeons. 56.7% of the respondents used a protocol for diagnosis and treatment of persistent wound leakage, but only 26.8% utilized the protocol in every patient. Most respondents (59.1%) reported a maximum period of persistent wound leakage before starting non-surgical treatment of 3 to 7 days after index surgery and 44.1% of respondents reported a maximum period of wound leakage of 10 days before converting to surgical treatment.Conclusions: The wide variety in clinical practice underscores the importance of developing an evidence-based clinical guideline for the diagnosis and treatment of persistent wound leakage after joint arthroplasty. To this end, a nationwide multicenter randomized controlled trial will be conducted in the Netherlands, which may provide evidence on this important and poorly understood topic.

scholarly journals Effects of Self‐Conditioning Techniques (Self‐Hypnosis) in Promoting Weight Loss in Patients with Severe Obesity: A Randomized Controlled Trial

Obesity ◽  
2018 ◽  
Vol 26 (9) ◽  
pp. 1422-1429 ◽  
Author(s):  
Simona Bo ◽  
Farnaz Rahimi ◽  
Ilaria Goitre ◽  
Bice Properzi ◽  
Valentina Ponzo ◽  
...  
Keyword(s):  
Weight Loss ◽  
Randomized Controlled Trial ◽  
Severe Obesity ◽  
Controlled Trial ◽  
Randomized Controlled

scholarly journals Comparing Self-Monitoring Strategies for Weight Loss in a Smartphone App: Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Michele L Patel ◽  
Christina M Hopkins ◽  
Taylor L Brooks ◽  
Gary G Bennett
Keyword(s):  
Weight Loss ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Mobile App ◽  
Self Report ◽  
Smartphone App ◽  
Weight Loss Intervention ◽  
Behavioral Weight Loss ◽  
Self Monitoring ◽  
Randomized Controlled

BACKGROUND Self-monitoring of dietary intake is a valuable component of behavioral weight loss treatment; however, it declines quickly, thereby resulting in suboptimal treatment outcomes. OBJECTIVE This study aimed to examine a novel behavioral weight loss intervention that aims to attenuate the decline in dietary self-monitoring engagement. METHODS GoalTracker was an automated randomized controlled trial. Participants were adults with overweight or obesity (n=105; aged 21-65 years; body mass index, BMI, 25-45 kg/m2) and were randomized to a 12-week stand-alone weight loss intervention using the MyFitnessPal smartphone app for daily self-monitoring of either (1) both weight and diet, with weekly lessons, action plans, and feedback (Simultaneous); (2) weight through week 4, then added diet, with the same behavioral components (Sequential); or (3) only diet (App-Only). All groups received a goal to lose 5% of initial weight by 12 weeks, a tailored calorie goal, and automated in-app reminders. Participants were recruited via online and offline methods. Weight was collected in-person at baseline, 1 month, and 3 months using calibrated scales and via self-report at 6 months. We retrieved objective self-monitoring engagement data from MyFitnessPal using an application programming interface. Engagement was defined as the number of days per week in which tracking occurred, with diet entries counted if ≥800 kcal per day. Other assessment data were collected in-person via online self-report questionnaires. RESULTS At baseline, participants (84/100 female) had a mean age (SD) of 42.7 (11.7) years and a BMI of 31.9 (SD 4.5) kg/m2. One-third (33/100) were from racial or ethnic minority groups. During the trial, 5 participants became ineligible. Of the remaining 100 participants, 84% (84/100) and 76% (76/100) completed the 1-month and 3-month visits, respectively. In intent-to-treat analyses, there was no difference in weight change at 3 months between the Sequential arm (mean −2.7 kg, 95% CI −3.9 to −1.5) and either the App-Only arm (−2.4 kg, −3.7 to −1.2; P=.78) or the Simultaneous arm (−2.8 kg, −4.0 to −1.5; P=.72). The median number of days of self-monitoring diet per week was 1.9 (interquartile range [IQR] 0.3-5.5) in Sequential (once began), 5.3 (IQR 1.8-6.7) in Simultaneous, and 2.9 (IQR 1.2-5.2) in App-Only. Weight was tracked 4.8 (IQR 1.9-6.3) days per week in Sequential and 5.1 (IQR 1.8-6.3) days per week in Simultaneous. Engagement in neither diet nor weight tracking differed between arms. CONCLUSIONS Regardless of the order in which diet is tracked, using tailored goals and a commercial mobile app can produce clinically significant weight loss. Stand-alone digital health treatments may be a viable option for those looking for a lower intensity approach. CLINICALTRIAL ClinicalTrials.gov NCT03254953; https://clinicaltrials.gov/ct2/show/NCT03254953 (Archived by WebCite at http://www.webcitation.org/72PyQrFjn).

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