scholarly journals App Technology to Support Physical Activity and Intake of Vitamins and Minerals After Bariatric Surgery (the PromMera Study): Protocol of a Randomized Controlled Clinical Trial (Preprint)

2020 ◽  
Author(s):  
Stephanie Erika Bonn ◽  
Mari Hult ◽  
Kristina Spetz ◽  
Marie Löf ◽  
Ellen Andersson ◽  
...  
Keyword(s):  
Physical Activity ◽  
Bariatric Surgery ◽  
Controlled Trial ◽  
Intervention Group ◽  
Study Participant ◽  
Lifestyle Factors ◽  
Lifestyle Changes ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled

BACKGROUND To optimize postoperative outcomes after bariatric surgery, lifestyle changes including increased physical activity are needed. Micronutrient deficiency after surgery is also common and daily supplementation is recommended. OBJECTIVE The aim of the PromMera study is to evaluate the effects of a 12-week smartphone app intervention on promotion of physical activity (primary outcome) and adherence to postsurgery vitamin and mineral supplementation, as well as on other lifestyle factors and overall health in patients undergoing bariatric surgery. METHODS The PromMera study is a two-arm, randomized controlled trial comprising patients undergoing bariatric surgery. Participants are randomized postsurgery 1:1 to either the intervention group (ie, use of the PromMera app for 12 weeks) or the control group receiving only standard care. Clinical and lifestyle variables are assessed pre- and postsurgery after 18 weeks (postintervention assessment), 6 months, 1 year, and 2 years. Assessments include body composition using Tanita or BOD POD analyzers, muscle function using handgrip, biomarkers in blood, and an extensive questionnaire on lifestyle factors. Physical activity is objectively measured using the ActiGraph wGT3X-BT triaxial accelerometer. RESULTS A total of 154 participants have been enrolled in the study. The last study participant was recruited in May 2019. Data collection will be complete in May 2021. CONCLUSIONS Implementing lifestyle changes are crucial after bariatric surgery and new ways to reach patients and support such changes are needed. An app-based intervention is easily delivered at any time and can be a key factor in the adoption of healthier behavioral patterns in this rapidly growing group of patients. CLINICALTRIAL ClinicalTrials.gov NCT03480464; https://clinicaltrials.gov/ct2/show/NCT03480464 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/19624

scholarly journals App Technology to Support Physical Activity and Intake of Vitamins and Minerals After Bariatric Surgery (the PromMera Study): Protocol of a Randomized Controlled Clinical Trial

10.2196/19624 ◽  
2020 ◽  
Vol 9 (8) ◽  
pp. e19624
Author(s):  
Stephanie Erika Bonn ◽  
Mari Hult ◽  
Kristina Spetz ◽  
Marie Löf ◽  
Ellen Andersson ◽  
...  
Keyword(s):  
Physical Activity ◽  
Bariatric Surgery ◽  
Controlled Trial ◽  
Intervention Group ◽  
Study Participant ◽  
Lifestyle Factors ◽  
Lifestyle Changes ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled

Background To optimize postoperative outcomes after bariatric surgery, lifestyle changes including increased physical activity are needed. Micronutrient deficiency after surgery is also common and daily supplementation is recommended. Objective The aim of the PromMera study is to evaluate the effects of a 12-week smartphone app intervention on promotion of physical activity (primary outcome) and adherence to postsurgery vitamin and mineral supplementation, as well as on other lifestyle factors and overall health in patients undergoing bariatric surgery. Methods The PromMera study is a two-arm, randomized controlled trial comprising patients undergoing bariatric surgery. Participants are randomized postsurgery 1:1 to either the intervention group (ie, use of the PromMera app for 12 weeks) or the control group receiving only standard care. Clinical and lifestyle variables are assessed pre- and postsurgery after 18 weeks (postintervention assessment), 6 months, 1 year, and 2 years. Assessments include body composition using Tanita or BOD POD analyzers, muscle function using handgrip, biomarkers in blood, and an extensive questionnaire on lifestyle factors. Physical activity is objectively measured using the ActiGraph wGT3X-BT triaxial accelerometer. Results A total of 154 participants have been enrolled in the study. The last study participant was recruited in May 2019. Data collection will be complete in May 2021. Conclusions Implementing lifestyle changes are crucial after bariatric surgery and new ways to reach patients and support such changes are needed. An app-based intervention is easily delivered at any time and can be a key factor in the adoption of healthier behavioral patterns in this rapidly growing group of patients. Trial Registration ClinicalTrials.gov NCT03480464; https://clinicaltrials.gov/ct2/show/NCT03480464 International Registered Report Identifier (IRRID) DERR1-10.2196/19624

scholarly journals Influence of physical activity on periodontal health in patients with type 2 diabetes mellitus. A blinded, randomized, controlled trial

2021 ◽  
Author(s):  
K. Wernicke ◽  
J. Grischke ◽  
M. Stiesch ◽  
S. Zeissler ◽  
K. Krüger ◽  
...  
Keyword(s):  
Physical Activity ◽  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Periodontal Health ◽  
Randomized Controlled ◽  
Hba1c Levels

Abstract Objectives The aim was to investigate the effect of physical activity on periodontal health and HbA1c levels in patients with type 2 diabetes mellitus (T2DM) over a period of 6 months. Materials and methods Thirty-seven patients with non-insulin-dependent T2DM were included in the study. The intervention group (n=20) performed physical activity over a period of 6 months. The control group (n=17) did not receive any intervention. Baseline and final examinations included dental parameters and concentrations of glycosylated hemoglobin (HbA1c) and high-sensitivity C-reactive protein (hsCRP). Results Physical activity showed a positive effect on periodontal health. Both the BOP (p= 0.005) and the severity of periodontitis (p= 0.001) were significantly reduced in the intervention group compared to the control group. Furthermore, HbA1c levels were reduced (p= 0.010) significantly in the intervention group while hsCRP levels significantly increased in the control group (p= 0.04). Conclusions Within the limitations of this randomized, controlled trial, physical activity over a period of 6 months is a health-promoting measure for patients with T2DM and improves both periodontal health and HbA1c concentrations.

scholarly journals Effectiveness of a Worksite Intervention for Male Construction Workers on Dietary and Physical Activity Behaviors, Body Mass Index, and Health Outcomes: Results of a Randomized Controlled Trial

2017 ◽  
Vol 32 (3) ◽  
pp. 795-805 ◽  
Author(s):  
Laura Viester ◽  
Evert A. L. M. Verhagen ◽  
Paulien M. Bongers ◽  
Allard J. van der Beek
Keyword(s):  
Physical Activity ◽  
Controlled Trial ◽  
Intervention Group ◽  
Construction Workers ◽  
Blue Collar ◽  
Control Group ◽  
Intervention Effect ◽  
Lifestyle Behavior ◽  
Randomized Controlled ◽  
Sweetened Beverages

Purpose: To evaluate the effectiveness of an individually tailored intervention for improvement in lifestyle behavior, health indicators, and prevention and reduction of overweight among construction workers. Design: Randomized controlled trial. Setting: Various blue-collar departments of a large construction company in the Netherlands. Participants: Blue-collar workers randomized to an intervention (n = 162) or a control group (n = 152). Intervention: The intervention group received individual coaching sessions, tailored information, and materials to improve lifestyle behavior during a 6-month period, and the control group received usual care. Measures: Body weight, body mass index (BMI), waist circumference, physical activity (PA) levels, dietary behavior, blood pressure, and blood cholesterol were assessed. Analysis: Effectiveness of the intervention on outcome measures at 6- and 12-month follow-up was assessed by using linear and logistic regression models adjusting for baseline levels. Results: After 6 months, a statistically significant intervention effect was found on body weight ( B = −1.06, P = .010), BMI ( B = −0.32, P = .010), and waist circumference ( B = −1.38, P = .032). At 6 months, the percentage of those meeting public health guidelines for PA increased significantly in the intervention group compared to the control group ( B = 2.06, P = .032), and for sugar-sweetened beverages, an intervention effect was found at 6 months as well ( B = −2.82, P = .003). At 12 months, for weight-related outcomes, these differences were slightly smaller and no longer statistically significant. The intervention was not effective on the total amount of moderate to vigorous PA and other dietary and health outcomes. Conclusion: Intervention participants showed positive changes in vigorous PA and intake of sugar-sweetened beverages compared to controls, as well as effects on weight-related outcomes at 6 months. Long-term effects were still promising but not statistically significant.

scholarly journals Effect of a Smartphone-Based App on the Quality of Life of Patients With Heart Failure: Randomized Controlled Trial

JMIR Nursing ◽  
10.2196/20747 ◽  
2020 ◽  
Vol 3 (1) ◽  
pp. e20747
Author(s):  
Mahboube Davoudi ◽  
Tahereh Najafi Ghezeljeh ◽  
Farveh Vakilian Aghouee
Keyword(s):  
Quality Of Life ◽  
Heart Failure ◽  
Clinical Symptoms ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Patients With Heart Failure

Background Patients with heart failure have low quality of life because of physical impairments and advanced clinical symptoms. One of the main goals of caring for patients with heart failure is to improve their quality of life. Objective The aim of this study was to investigate the effect of the use of a smartphone-based app on the quality of life of patients with heart failure. Methods This randomized controlled clinical trial with a control group was conducted from June to October 2018 in an urban hospital. In this study, 120 patients with heart failure hospitalized in cardiac care units were randomly allocated to control and intervention groups. Besides routine care, patients in the intervention group received a smartphone-based app and used it every day for 3 months. Both the groups completed the Minnesota Living with Heart Failure Questionnaire before entering the study and at 3 months after entering the study. Data were analyzed using the SPSS software V.16. Results The groups showed statistically significant differences in the mean scores of quality of life and its dimensions after the intervention, thereby indicating a better quality of life in the intervention group (P<.001). The effect size of the intervention on the quality of life was 1.85 (95% CI 1.41-2.3). Moreover, the groups showed statistically significant differences in the changes in the quality of life scores and its dimensions (P<.001). Conclusions Use of a smartphone-based app can improve the quality of life in patients with heart failure. The results of our study recommend that digital apps be used for improving the management of patients with heart failure. Trial Registration Iranian Registry of Clinical Trials IRCT2017061934647N1; https://www.irct.ir/trial/26434

scholarly journals Effect of dental intervention on improvements in metabolic syndrome patients: a randomized controlled clinical trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Midori Doke ◽  
Yuriko Komagamine ◽  
Manabu Kanazawa ◽  
Maiko Iwaki ◽  
Hiroyuki Suzuki ◽  
...  
Keyword(s):  
Metabolic Syndrome ◽  
Medical Information ◽  
Controlled Trial ◽  
Intervention Group ◽  
University Hospital ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Dental Intervention ◽  
Water Rate

Abstract Background Metabolic syndrome (MetS), caused by the accumulation of visceral fat, is considered a major cause of cardiovascular disease. This randomized controlled trial aimed to clarify the effect of dental intervention, including prosthodontics and/or periodontal treatment, combined with dietary and exercise guidance on MetS. Methods In total, 112 patients who met the Japanese waist circumference criteria of MetS were recruited. The intervention group (ITG) received dental intervention along with dietary and exercise guidance, while the control group (CTG) received dietary and exercise guidance alone. Three outcome measurements were obtained before intervention (BL), 1 month after intervention (1M), and 3 months after intervention (3M). Results Body water rate (p = 0.043) was significantly higher in ITG than in CTG at 1M. Simultaneously, fasting blood sugar level (p = 0.098) tended to be lower in ITG than in CTG. Lean mass (p = 0.037) and muscle mass (p = 0.035) were significantly higher and body weight (p = 0.044) significantly lower in ITG than in CTG at 3M. Body mass index (p = 0.052) tended to be lower in ITG than in CTG. Conclusions Dental intervention combined with lifestyle guidance may improve anthropometric status and reduce the risk of MetS. Trial registration University Hospital Medical Information Network Center Unique UMIN000022753. https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000026176.

scholarly journals Push Notifications From a Mobile App to Improve the Body Composition of Overweight or Obese Women: Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Alberto Hernández-Reyes ◽  
Fernando Cámara-Martos ◽  
Guillermo Molina Recio ◽  
Rafael Molina-Luque ◽  
Manuel Romero-Saldaña ◽  
...  
Keyword(s):  
Physical Activity ◽  
Clinical Trial ◽  
Weight Loss ◽  
Body Composition ◽  
Controlled Trial ◽  
Intervention Group ◽  
The Body ◽  
Control Group ◽  
Obese Women ◽  
Randomized Controlled

BACKGROUND Technology—in particular, access to the Internet from a mobile device—has forever changed the way we relate to others and how we behave in our daily life settings. In recent years, studies have been carried out to analyze the effectiveness of different actions via mobile phone in the field of health: telephone calls, short message service (SMS), telemedicine, and, more recently, the use of push notifications. We have continued to explore ways to increase user interaction with mobile apps, one of the pending subjects in the area of mHealth. By analyzing the data produced by subjects during a clinical trial, we were able to extract behavior patterns and, according to them, design effective protocols in weight loss programs. OBJECTIVE A clinical trial was proposed to (1) evaluate the efficacy of push notifications in an intervention aimed at improving the body composition of adult women who are overweight or obese, through a dietary procedure, and (2) analyze the evolution of body composition based on push notifications and prescribed physical activity (PA). METHODS A two-arm randomized controlled trial was carried out. A sample size of 117 adult obese women attended a face-to-face, 30-minute consultation once a week for 6 months. All patients were supplied with an app designed for this study and a pedometer. The control group did not have access to functionalities related to the self-monitoring of weight at home, gamification, or prescription of PA. The intervention group members were assigned objectives to achieve a degree of compliance with diet and PA through exclusive access to specific functionalities of the app and push notifications. The same diet was prescribed for all patients. Three possible PA scenarios were studied for both the control and intervention groups: light physical activity (LPA), moderate physical activity (MPA), and intense physical activity (IPA). For the analysis of three or more means, the analysis of variance (ANOVA) of repeated means was performed to evaluate the effects of the intervention at baseline and at 3 and 6 months. RESULTS Receiving notifications during the intervention increased body fat loss (mean -12.9% [SD 6.7] in the intervention group vs mean -7.0% [SD 5.7] in the control group; <i>P</i>&lt;.001) and helped to maintain muscle mass (mean -0.8% [SD 4.5] in the intervention group vs mean -3.2% [SD 2.8] in the control group; <i>P</i>&lt;.018). These variations between groups led to a nonsignificant difference in weight loss (mean -7.9 kg [SD 3.9] in the intervention group vs mean -7.1 kg [SD 3.4] in the control group; <i>P</i>&gt;.05). CONCLUSIONS Push notifications have proven effective in the proposed weight loss program, leading women who received them to achieve greater loss of fat mass and a maintenance or increase of muscle mass, specifically among those who followed a program of IPA. Future interventions should include a longer evaluation period; the impact of different message contents, as well as message delivery times and frequency, should also be researched. CLINICALTRIAL ClinicalTrials.gov NCT03911583; https://www.clinicaltrials.gov/ct2/show/NCT03911583

scholarly journals Effect of a Smartphone-Based App on the Quality of Life of Patients With Heart Failure: Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Mahboube Davoudi ◽  
Tahereh Najafi Ghezeljeh ◽  
Farveh Vakilian Aghouee
Keyword(s):  
Quality Of Life ◽  
Heart Failure ◽  
Clinical Symptoms ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Patients With Heart Failure

BACKGROUND Patients with heart failure have low quality of life because of physical impairments and advanced clinical symptoms. One of the main goals of caring for patients with heart failure is to improve their quality of life. OBJECTIVE The aim of this study was to investigate the effect of the use of a smartphone-based app on the quality of life of patients with heart failure. METHODS This randomized controlled clinical trial with a control group was conducted from June to October 2018 in an urban hospital. In this study, 120 patients with heart failure hospitalized in cardiac care units were randomly allocated to control and intervention groups. Besides routine care, patients in the intervention group received a smartphone-based app and used it every day for 3 months. Both the groups completed the Minnesota Living with Heart Failure Questionnaire before entering the study and at 3 months after entering the study. Data were analyzed using the SPSS software V.16. RESULTS The groups showed statistically significant differences in the mean scores of quality of life and its dimensions after the intervention, thereby indicating a better quality of life in the intervention group (<i>P</i>&lt;.001). The effect size of the intervention on the quality of life was 1.85 (95% CI 1.41-2.3). Moreover, the groups showed statistically significant differences in the changes in the quality of life scores and its dimensions (<i>P</i>&lt;.001). CONCLUSIONS Use of a smartphone-based app can improve the quality of life in patients with heart failure. The results of our study recommend that digital apps be used for improving the management of patients with heart failure. CLINICALTRIAL Iranian Registry of Clinical Trials IRCT2017061934647N1; https://www.irct.ir/trial/26434

Does Additional Extracorporeal Shock Wave Therapy Improve the Effect of Isolated Percutaneous Radiofreqency Coblation in Patients with Insertional Achilles Tendinopathy? Study Protocol for A Randomized Controlled Clinical Trial

2020 ◽  
Author(s):  
Yu-Jie Song ◽  
Wen-Kai Xuan ◽  
Ying-Hui Hua
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Achilles Tendinopathy ◽  
Conclusive Evidence ◽  
Secondary Outcome ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Extracorporeal Shock Wave ◽  
Insertional Achilles Tendinopathy

Abstract Background: No conclusive evidence recommends a prior treatment for insertional Achilles tendinopathy (IAT). It is theorized that both percutaneous radiofreqency coblation and extracorporeal shockwave therapy (ESWT) relieve pain within the insertion. However, no clinical evidence shows that either treatment promote the regeneration of the tendon or if the combination of these 2 interventions offer better function and less pain than one therapy. Methods: The study is a randomized, controlled trial with patients allocated in a 1:1 ratio to one of two parallel groups. Patients with insertional Achilles tendinopathy who are not satisfied with the effect of conservative treatment will be screened. A minimum of 38 patients will be enrolled after deciding to participate in the trial on an informed basis. Then the intervention group and the control group perform radial ESWT and sham-ESWT respectively at 6 months after percutaneous radiofreqency coblation. The primary outcome will be the Victorian Institute of Sports Assessment Achilles (VISA-A) Score. Secondary outcome measures will be Foot and Ankle Outcome Score (FAOS) scale, Visual Analogue Scale (VAS), Tegner Score, and MRI ultra-short echo time (UTE) T2* value. The assessments will occur in 6 months, 1 year, and 2 years post-operatively. The differences between 2 groups will be conducted as intention-to-treat basis. Discussion: We aim to investigate if radiofreqency coblation associated with ESWT can provide more encouraging imaging findings as well as functional and clinical outcomes regarding the treatment of the IAT comparing to the single radiofreqency coblation treatment.Trial registration: ChiCTR1800017898; Pre-results. Registered on 20 August 2018.

scholarly journals Lifestyle, environmental exposures and male fertility in healthy young men in North Italy

2019 ◽  
Vol 29 (Supplement_4) ◽  
Author(s):  
C Zani ◽  
D Zani ◽  
F Donato ◽  
M Marullo ◽  
G C V Viola ◽  
...  
Keyword(s):  
Physical Activity ◽  
Semen Quality ◽  
Controlled Trial ◽  
Intervention Group ◽  
Young Men ◽  
Lifestyle Changes ◽  
Abdominal Circumference ◽  
Semen Parameters ◽  
Control Group ◽  
Sperm Analysis

Abstract Background Human semen quality is affected by metabolic, lifestyle and environmental factors. We planned a randomized controlled trial to evaluate the effects of lifestyle changes on semen quality in healthy young men living in Italian highly polluted areas. We present here some preliminary baseline data on the association between lifestyle and semen quality. Methods 150 non-smokers, non-alcohol drinkers and non-obese young healthy men, aged 18-22 years, have been assigned to an intervention or control group according to a 1:1 randomization plan. The intervention group follows a 4-month nutritional pathway based on a Mediterranean dietary pattern and receives suggestions on practice of physical activity. All subjects undergo urologic examination, measurement of weight, height and abdominal circumference, an interview on lifestyle variables, and provide blood and semen samples in fasting conditions, at the enrollment and at the end of the intervention and follow-up (after 8 months). Adherence to Mediterranean diet is assessed using the “PREvención con DIeta MEDiterránea” (PREDIMED) tool, and physical activity using the “International Physical Activity Questionnaire” (IPAQ). Automated sperm analysis for all semen parameters is performed on the SQA-V GOLD. Results The data of 101 subjects living in a highly industrialized area in North Italy (mean±SD: age: 20.3±1.2 years, BMI: 22.3±2.2) were analyzed. The sperm cell concentration was higher in subjects with IPAQ score &gt; median than those with lower values (68.3±48.6 vs 63.7±47.0 106/mL). Total percent motility was higher in subjects with abdominal circumference &lt; median (50.7±13.6 vs 41.2±18.8, p = 0.004), in subjects with IPAQ score &gt; median (48.2±16.8 vs 44.2±16.8), and in subjects with PREDIMED score &gt; 7 (47.6±18.8 vs 45.0±15.0). Conclusions These preliminary data suggest that semen quality is associated with abdominal fat and physical activity in healthy young men. Key messages The semen quality is a sensitive marker of the health status and is predictive of disease occurrence. Our study suggests that semen quality is associated with lifestyle aspects in healthy young men.

Effectiveness of an overall progressive resistance strength program for improving the functional capacity of patients with rheumatoid arthritis: a randomized controlled trial

2017 ◽  
Vol 31 (11) ◽  
pp. 1482-1491 ◽  
Author(s):  
Felipe Martinelli Lourenzi ◽  
Anamaria Jones ◽  
Daniele Freitas Pereira ◽  
João Henrique Costa Alves dos Santos ◽  
Rita Nely Vilar Furtado ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Strength Training ◽  
Functional Capacity ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Sf 36 ◽  
Progressive Resistance

Objective: To evaluate the effectiveness of overall progressive resistance training in patients with rheumatoid arthritis. Design: Randomized controlled clinical trial with blinded assessor and intention-to-treat analysis. Setting: Outpatient clinics. Subjects: Sixty patients with rheumatoid arthritis according to the American College of Rheumatology criteria, aged between 18 and 65 years old, under stable medication and not performing regular physical activity were randomized into two groups: intervention group (IG) and control group (CG). Interventions: IG performed the progressive resistance strength training, twice a week, during 12 weeks. The training consists of exercising various muscle groups using a load of 50% and 70% of one repetition maximum. The load was reassessed and adjusted after six weeks of baseline. Both groups remained in conventional drug treatment during the study. Main measures: Patients were evaluated at baseline and after 6, 12, and 24 weeks, using HAQ and SF-36 questionnaires and strength. Results: Thirty-three patients in the CG and 27 in the IG were evaluated. The groups were homogeneous at baseline. Statistical and clinical improvement were found with better results for the IG in the HAQ questionnaire ( P=0.030), functional capacity (0=0.022) and pain ( P=0.027) domains of SF-36; and muscle strength for flexors of right and left knee ( P=0.005 and p=0.14), abductors of shoulder ( P=0.041) and extensors of right and left wrists ( P=0.003 and P= 0.005). Conclusions: This progressive resistance strength training improves physical function as well as grip and muscular strength of knee flexors, shoulder abductors and wrist extensors in patients with RA, without adverse effects.

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