Targeting human milk fortification to improve very preterm infant growth and brain development: study protocol for Nourish, a single-center randomized, controlled clinical trial

Abstract Background Human milk is recommended for very preterm infants, but its variable macronutrient content may contribute to undernutrition during a critical period in development. We hypothesize that individually targeted human milk fortification is more effective in meeting macronutrient requirements than the current standard of care. Methods We designed a single-center randomized, controlled trial enrolling 130 infants born < 31 completed weeks’ gestation. Participants will receive fortified maternal and/or pasteurized donor milk but no formula. For participants in the intervention group, milk will be individually fortified with protein and fat modulars to achieve target levels based on daily point-of-care milk analysis with mid-infrared spectroscopy, in addition to standard fortification. The study diet will continue through 36 weeks’ postmenstrual age (PMA). Clinical staff and parents will be masked to study group. Primary outcomes include: 1) body length and lean body mass by air displacement plethysmography at 36 weeks’ PMA; 2) quantitative magnetic resonance imaging-based measures of brain size and microstructure at term equivalent age; and 3) Bayley-IV scales at 2 years’ corrected age. Discussion We expect this trial to provide important data regarding the effectiveness of individually targeted human milk fortification in the neonatal intensive care unit (NICU). Trial registration NCT03977259, registered 6 June, 2019.

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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)

10.2196/preprints.19624 ◽

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

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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

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

BMC Oral Health ◽

10.1186/s12903-020-01373-3 ◽

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.

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

10.2196/preprints.20747 ◽

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><.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><.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

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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

10.21203/rs.3.rs-35074/v1 ◽

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.

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

Clinical Rehabilitation ◽

10.1177/0269215517698732 ◽

2017 ◽

Vol 31 (11) ◽

pp. 1482-1491 ◽

Cited By ~ 5

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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The effectiveness of intervention based on the transactional model on improving coping efforts and stress moderators in hemodialysis patients in Tehran: a randomized controlled trial

BMC Nephrology ◽

10.1186/s12882-021-02592-8 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Mohtasham Ghaffari ◽

Mohammad Ali Morowatisharifabad ◽

Mohammad Saeed Jadgal ◽

Yadollah Mehrabi ◽

Somayeh Alizadeh

Keyword(s):

Social Support ◽

Emotional Regulation ◽

Coping Style ◽

Controlled Trial ◽

Intervention Group ◽

Hemodialysis Patients ◽

Controlled Clinical Trial ◽

Transactional Model ◽

Dispositional Coping ◽

Randomized Controlled

Abstract Background Present study was conducted to determine the effect of training on coping efforts and stress moderators, based on transactional model of Lazarus and Folkman, in hemodialysis patients. Methods This is a randomized controlled clinical trial on 116 hemodialysis patients referred to dialysis centers in Tehran from May to August 2018. The patients were assigned to two experimental and control groups using a simple randomization method. The intervention included 6 training sessions in the form of coping efforts and moderators of transactional model. Data were collected before and 3 months after the intervention. Data were analyzed using SPSS 16. Results After 3 months training intervention, there was significant increase in the intervention group in the mean scores of coping efforts (P < 0.001), moderators and subscales of emotional regulation from 51.18 ± 20.42 to 64.87 ± 13.18 (P < 0.001), dispositional coping style from 45.56 ± 19.45 to 55.84 ± 18.03 and social support from 49.61 ± 20.14 to 55.55 ± 17.35 (P < 0.005). Conclusion The training based on transactional model was successful in the increase of social support, dispositional coping style and emotional regulation in hemodialysis patients. Therefore, Nurses and healthcare providers can use this program to help hemodialysis patients to increase their adaptation to the illness and reduce stress. Trial registration IRCT registration number: IRCT20180524039814N1; Registration date: 13-08-2018; Registration timing: retrospectively registered: Last update: 13-08-2018.

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The effect of counseling on fathers’ stress and anxiety during pregnancy: a randomized controlled clinical trial

BMC Psychiatry ◽

10.1186/s12888-021-03217-y ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Maryam Mohammadpour ◽

Sakineh Mohammad-Alizadeh Charandabi ◽

Jamileh Malakouti ◽

Mehriar Nadar Mohammadi ◽

Mojgan Mirghafourvand

Keyword(s):

Perceived Stress ◽

State Anxiety ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Controlled Clinical Trial ◽

Randomized Controlled ◽

Significant Difference ◽

Expectant Fathers ◽

And Control

Abstract Background Pregnancy is a challenging period for mothers and fathers. This study aimed to investigate the effect of counseling on stress and anxiety levels of fathers. Methods This randomized controlled trial was conducted on 102 spouses of pregnant women in Ardabil, Iran. The participants were randomly assigned to intervention and control groups. The intervention group attended four 60-min counseling sessions at weekly intervals. The perceived stress and anxiety questionnaires were completed before and 4 weeks after the intervention. Results The mean scores of state anxiety in the intervention group decreased significantly 4 weeks after the intervention compared with the control group (MD: -2.4; 95%CI: − 4.7 to − 0.2; p = 0.030). Four weeks after the intervention, no significant difference was found between the two groups in terms of trait anxiety (p = 0.472) and perceived stress (p = 0.635). Conclusions The findings indicate that counseling reduced state anxiety in expectant fathers; therefore, this intervention is recommended to be used to reduce fathers’ anxiety. Trial registration IRCT2017042910324N38. Registered 25 June 2017

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The effectiveness of the robotic game kit on anxiety among hospitalized preschool children: A non-randomized controlled trial

Nursing Practice Today ◽

10.18502/npt.v8i4.6703 ◽

2021 ◽

Author(s):

Sima Pourteimour ◽

Sahar Kazemi

Keyword(s):

Separation Anxiety ◽

Controlled Trial ◽

Intervention Group ◽

Analysis Of Covariance ◽

Control Group ◽

Controlled Clinical Trial ◽

Psychological Burden ◽

Randomized Controlled ◽

Significant Difference ◽

The Mean

Background & Aim: Hospitalization is a challenging experience all children go through in their lives, leading to their utmost anxiety. In this sense, interactive games and activities can help ease this psychological burden. Therefore, we endeavored to determine the effectiveness of a robotic game kit (RGK) on the anxiety of hospitalized preschoolers. Methods & Materials: This non-randomized controlled clinical trial was conducted in a pediatric hospital, Iran, between March and July 2019. 59 participants were assigned to intervention (n=30) or control (n=29) groups through available sampling. Inclusion criteria were Iranian native children aged 3-7 years with communication ability. The RGK was applied in eight sessions at least seven consecutive days of hospitalization. The collected data by using the demographic information form and the preschool anxiety scale (PAS) were analyzed in descriptive, chi-square, t-test, the one-way ANCOVA (analysis of covariance), and multivariate analysis of covariance (MANCOVA). Results: Two groups were homogenous in terms of demographic variables (p>0.05). There was no statistically significant difference between the mean score of PAS before the intervention in the intervention 46.33±15.81 and control groups 37.24±19.65 (p=0.055). However, the mean score of PAS in the intervention group was significantly lower than the control group (P=0.030). Also, using the RGK was effective in two subscales related to separation anxiety and physical injury fears (P=0.034). Conclusion: The modern RGKs could have a significant place in pediatric health care in hospitals. It is thus an undeniable fact that high-quality, comprehensive care can be boosted through RGK based interventions for children encountering stressful situations.

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Effect of far infrared therapy on arteriovenous fistula maturation, survival and stenosis in hemodialysis patients, a randomized, controlled clinical trial: the FAITH on fistula trial

BMC Nephrology ◽

10.1186/s12882-021-02476-x ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

K. Lindhard ◽

M. Rix ◽

J. G. Heaf ◽

H. P. Hansen ◽

B. L. Pedersen ◽

...

Keyword(s):

Clinical Trial ◽

Arteriovenous Fistula ◽

Primary Outcome ◽

Controlled Trial ◽

Intervention Group ◽

Far Infrared ◽

Control Group ◽

Controlled Clinical Trial ◽

Protective Mechanism ◽

Randomized Controlled

Abstract Background An arteriovenous fistula (AVF) is the preferred vascular access for hemodialysis treatment. After creation many of the AVFs will never mature or if functioning will need an intervention within 1 year due to an AVF stenosis. Studies investigating possible therapies that improves the AVF maturation and survival are scarce. Far infrared therapy (FIR) has shown promising results. In minor single centre and industry supported trials FIR has shown improved AVF maturation and survival. There is a need of a randomized multicentre controlled trial to examine the effect of FIR on the AVF maturation and survival and to explore the possible AVF protective mechanism induced by the FIR treatment. Methods This investigator initiated, randomized, controlled, open-labeled, multicenter clinical trial will examine the effect of FIR on AVF maturation in patients with a newly created AVF (incident) and AVF patency rate after 1 year of treatment in patients with an existing AVF (prevalent) compared to a control group. The intervention group will receive FIR to the skin above their AVF three times a week for 1 year. The control group will be observed without any treatment. The primary outcome for incident AVFs is the time from surgically creation of the AVF to successful cannulation. The primary outcome for the prevalent AVFs is the difference in number of AVFs without intervention and still functioning in the treatment and control group after 12 months. Furthermore, the acute changes in inflammatory and vasodilating factors during FIR will be explored. Arterial stiffness as a marker of long term AVF patency will also be examined. Discussion FIR is a promising new treatment modality that may potentially lead to improved AVF maturation and survival. This randomized controlled open-labelled trial will investigate the effect of FIR and its possible mechanisms. Trial registration Clinicaltrialsgov NCT04011072 (7th of July 2019).

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