SMART goals setting and biometric changes in obese adults with multimorbidity: Secondary analysis of a randomized controlled trial

Objectives: Clinicians recommend diet and exercise for overweight/obese patients. We conducted a secondary analysis of a randomized controlled clinical trial evaluating goal setting and pedometer use versus usual care on weight, waist circumference, and blood pressure of patients with multiple chronic conditions. Methods: In this trial, we recruited and randomized patients over 18 years with multiple chronic conditions. There were two groups with an immediate intervention group who received behavioral coaching and a pedometer versus a delayed control who received the intervention after 2 months. We evaluated body weight, waist circumference, and blood pressure as outcomes. We used analysis of covariance to evaluate differences between the intervention and the control groups. Results: Of 130 patients, mean age was 63.4 years (SD, 17.3). At 2 months, intervention participants lost 0.2 kg versus a 0.1-kg gain in the control participants ( P = .44). The immediate intervention group had significantly smaller waist circumference change at 2-month follow-up compared to control at −1.6 cm (95% confidence interval = −3.1 to −0.1), which was driven by an increase in waist circumference in the delayed control group. No difference in systolic blood pressure was observed. Discussion: We observed no difference in weight or blood pressure between the groups with obesity and multiple chronic conditions.

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The effects of multimedia education on anxiety and physiological status among patients with cerebral angiography: A randomized controlled clinical trial

Nursing Practice Today ◽

10.18502/npt.v5i4.116 ◽

2018 ◽

Cited By ~ 1

Author(s):

Leila Sayadi ◽

Shokoh Varaei ◽

Elham Faghihzadeh ◽

Zahra Ahmadkhani

Keyword(s):

Blood Pressure ◽

Cerebral Angiography ◽

State Anxiety ◽

Intervention Group ◽

Control Group ◽

Physiological Status ◽

Controlled Clinical Trial ◽

Randomized Controlled Clinical Trial ◽

Randomized Controlled ◽

Multimedia Education

Background &Aim: Cerebral angiography is a diagnostic procedure for cerebral disorders, particularly the disorders of cerebral blood vessels. However, as an invasive procedure, it can cause patients anxiety and physiological instability. This study aimed to evaluate the effects of multimedia education on anxiety and physiological status among patients with cerebral angiography. Methods & Materials: This randomized controlled clinical trial was conducted from October 2017 to January 2018 in the angiography unit of a university hospital in Tehran, Iran. Participants were 88 candidates for cerebral angiography who were randomly allocated either to an intervention (n = 44) or a control (n= 44) group. Patients in the intervention group were provided with at least thirty-minute multimedia education consisted of video-based education, verbal education, written materials (an educational booklet), and question and answer. Data on participants’ personal characteristics were collected before the intervention, while their state anxiety was assessed before multimedia education and after cerebral angiography via Spielberger State Anxiety Inventory. Moreover, participants’ physiological parameters were measured and documented in a data sheet before and every two hours after angiography up to their discharge from the angiography unit. The independent-sample t, Chi-square, and McNemar’s tests and the Generalized Estimation Equation were used for data analysis. Results: After the intervention, 95.5% of patients in the intervention group and 86.4% in the control group had low level of anxiety; however, the between-group difference was not statistically significant (P > 0.05). Moreover, anxiety level changed significantly neither in the intervention (P > 0.05) nor in the control (P > 0.05) group. In addition, after adjusting the effects of participants’ age, there were no significant between-group differences respecting the means of systolic blood pressure, the means of body temperature, peripheral oxygen saturation, and respiratory rate. However, the means of diastolic blood pressure and heart rate in the intervention group were significantly lower than the control group, irrespective of the effects of participants’ age. Conclusion: Multimedia education has no significant effects on state anxiety but has significant effects on diastolic blood pressure and heart rate among patients with cerebral angiography.

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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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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 Steamed Potato Bread Intake on Glucose, Lipids, and Urinary Na+ and K+: A Randomized Controlled Trial with Adolescents

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph17062096 ◽

2020 ◽

Vol 17 (6) ◽

pp. 2096

Author(s):

Haiquan Xu ◽

Yanzhi Guo ◽

Shijun Lu ◽

Yunqian Ma ◽

Xiuli Wang ◽

...

Keyword(s):

Blood Pressure ◽

Randomized Controlled Trial ◽

Systolic Blood Pressure ◽

Total Cholesterol ◽

Controlled Trial ◽

Intervention Group ◽

High Density Lipoproteins ◽

Control Group ◽

Randomized Controlled ◽

Potato Bread

Although potatoes are highly nutritious, many epidemiological studies have connected their consumption with abnormal lipids, diabetes, and hypertension. Steamed potato bread has recently become one of China’s staple foods. A randomized controlled trial was designed to evaluate the effect of steamed potato bread consumption on Chinese adolescents. Four classes from a high school were randomly selected and assigned to the intervention group (two classes) or control group (two classes). The steamed wheat bread (100% raw wheat flour) and potato bread (raw wheat flour to cooked potato flour ratio of 3:7) were provided to the control group and intervention group as staple food once a school day for 8 weeks, respectively. Compared with the control group, the intervention group had significant net changes in systolic blood pressure (4.6 mmHg, p = 0.010), insulin (−4.35 mIU/L, p < 0.001), total cholesterol (−0.13 mmol/L, p = 0.032), and high-density lipoproteins cholesterol (−0.07 mmol/L, p = 0.010). The urinary level of Na+/K+ did not differ between the groups. In conclusion, the intake of steamed potato bread for 8 weeks resulted in positive effects on the total cholesterol and insulin profiles but a negative effect on the systolic blood pressure and high-density lipoproteins cholesterol of adolescents.

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Effect of abdominal massage on prevention of aspiration in intubated and enterally fed patients: A randomized controlled trial

Journal of Complementary and Integrative Medicine ◽

10.1515/jcim-2017-0124 ◽

2020 ◽

Vol 17 (3) ◽

Author(s):

Mahlagha Dehghan ◽

Amanollah Fatehi Poor ◽

Roghayeh Mehdipour-Rabori ◽

Mehdi Ahmadinejad

Keyword(s):

Intensive Care ◽

Confidence Interval ◽

Endotracheal Tube ◽

Intervention Group ◽

Control Group ◽

Controlled Clinical Trial ◽

Respiratory Secretion ◽

Intensive Care Patients ◽

Randomized Controlled ◽

Abdominal Massage

AbstractBackgroundAspiration is a serious side effect of delayed gastric emptying and increased residual volume in intensive care patients. Aspiration can increase the risk of pneumonia and death. Currently, pharmaceutical methods are the most commonly used techniques for decreasing aspiration, but non-pharmaceutical methods may also be effective in reducing aspiration. One of these methods is an abdominal massage. The present study aimed to examine the effect of abdominal massage on aspiration incidence in intensive care patients with an endotracheal tube.MethodsThis study was a randomized controlled clinical trial. Seventy intensive care patients with an endotracheal tube were chosen by convenience sampling and allocated to an intervention or a control group by the minimization method. The intervention group was provided with a 15-min abdominal massage twice a day for 3 days, while the control group received only routine cares. The patients’ respiratory secretion was suctioned before and after the intervention, and immediately after suctioning, the incidence of the aspiration was assessed using special strips which are sensitive to respiratory secretion pH and glucose. SPSS 18 was used to analyze data. Descriptive statistics were used. T independent, Mann-Whitney U, χ2, and Fisher exact tests were used to compare two groups.ResultsThe incidence rates of the aspiration were 5.7% (confidence interval: 0.0–14.3%) and 20% (confidence interval: 8.6–34.3%) in the abdominal massage and the control groups, respectively. The incidence of aspiration differed between two groups, but it was not statistically significant (p=0.07).ConclusionAlthough the low rate of aspiration in the abdominal massage group did not differ significantly with that of the control group, it can be clinically important. It is suggested that further studies be conducted to confirm the effect of abdominal massage on the prevention of aspiration in intensive care patients with an endotracheal tube.

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The Effect of Pharmaceutical Care Programs on Blood Pressure Control in Individuals with Hypertension: A Meta-Analysis

Journal of Pharmacy Technology ◽

10.1177/875512250902500503 ◽

2009 ◽

Vol 25 (5) ◽

pp. 292-296 ◽

Cited By ~ 2

Author(s):

Yongbing Ni ◽

Yongfa Chen ◽

Wenlong Huang

Keyword(s):

Blood Pressure ◽

Pharmaceutical Care ◽

Blood Pressure Control ◽

Meta Analysis ◽

Intervention Group ◽

Pressure Control ◽

Control Group ◽

Randomized Controlled ◽

Program Intervention ◽

Review Manager

Objective: To evaluate the effect of pharmaceutical care (PC) programs on blood pressure control in individuals with hypertension. Methods: Studies were retrieved by searching MEDLINE, EMBASE, Cochrane, CNKI, and CBM databases from 1999 to February 2008. Randomized controlled trials (RCTs) on the association of pharmaceutical care programs with blood pressure control in individuals with hypertension were included in this study. Moreover, the studies were selected independently by 2 authors. The analysis was conducted by using Review Manager version 4.2 software. Results: Five RCTs with a total of 585 patients with hypertension were included in this meta-analysis. Compared with the control group, the PC program intervention group had significantly lower endpoint systolic blood pressure (SBP) and diastolic blood pressure (DBP). Moreover, SBP and DBP were significantly improved in the intervention group relative to the control group. Conclusions: PC programs appear to be an effective tool in helping to control blood pressure in hypertensive patients.

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Effect of Daily Avocado Consumption on Vascular Health in Adults With Abdominal Obesity: A Sub-Study of the Habitual Diet and Avocado Trial, a Randomized Controlled Study

Current Developments in Nutrition ◽

10.1093/cdn/nzab033_010 ◽

2021 ◽

Vol 5 (Supplement_2) ◽

pp. 10-10

Author(s):

Kristin Davis ◽

Kristina Petersen ◽

Penny Kris-Etherton

Keyword(s):

Blood Pressure ◽

Waist Circumference ◽

Abdominal Obesity ◽

Cardiovascular Health ◽

Controlled Study ◽

Group Differences ◽

Control Group ◽

Vascular Health ◽

Randomized Controlled ◽

Habitual Diet

Abstract Objectives To examine the effect of providing 1 avocado per day for consumption over a 6-month period on cardiovascular health compared to habitual dietary intake in individuals with abdominal obesity. Methods The Habitual diet and Avocado Trial (HAT), a multicenter parallel randomized controlled trial, included participants ≥25 years of age with an elevated waist circumference (≥88 cm women; ≥102 cm men). Participants were randomized to either an experimental group (AVO: consumed 1 avocado/day for 6 months) or a control group (HD: consumed < 2 avocados/month for 6 months). At the Pennsylvania State University, University Park (n = 126), vascular health was measured using a SphygmoCor XCEL (AtCor Medical) at baseline and at the end of the study period. Outcomes include central systolic blood pressure (cSBP), central diastolic blood pressure (cDBP), and pulse wave velocity (PWV), a marker of arterial stiffness. Mixed models were used to examine between-group differences in change across 6 months. Results The sample was 77% female (BMI 34 ± 4 kg/m2, waist circumference 105 ± 12 cm). No significant between-group differences in 6-month change were observed for cSBP (AVO: 1.06 mmHg 95% CI − 1.57, 3.69; HD: 0.35 mmHg 95% CI −2.26, 2.96; P = 0.62), cDBP (AVO: 0.07 mmHg 95% CI −1.82, 1.96; HD: −0.91 mmHg 95% CI − 2.79, 0.97; P = 0.34), or PWV (AVO: −0.18 m/s 95% CI −0.53, 0.17; HD: 0.08 m/s 95% CI −0.27, 0.43; P = 0.17). Conclusions Results suggest that providing adults with abdominal obesity 1 avocado per day to consume for 6 months is not associated with a statistically significant improvement in central blood pressure or PWV, compared to adults following their habitual diet. Additional research using larger samples and longer intervention periods is needed to clarify whether habitual avocado consumption yields clinically significant benefits to cardiovascular health. Funding Sources Hass Avocado Board and the National Center for Advancing Translational Sciences, National Institutes of Health (1UL1TR002014-01).

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Medication Adherence Support of an In-home Electronic Medication Dispensing System for Individuals living with Chronic Conditions: A Pilot Randomized Controlled Trial

10.21203/rs.3.rs-63597/v3 ◽

2021 ◽

Author(s):

Mubashir Arain ◽

Armghan Ahmad ◽

Venus Chiu ◽

Lorena Kembel

Keyword(s):

Older Adults ◽

Randomized Controlled Trial ◽

Medication Adherence ◽

Chronic Conditions ◽

Controlled Trial ◽

Medication Management ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled ◽

Pilot Randomized Controlled Trial

Abstract Background: Medication adherence is challenging for older adults due to factors such as the number of medications, dosing schedule, and the duration of drug therapy. The objective of this study was to examine the effectiveness of an in-home electronic medication dispensing system (MDS) on improving medication adherence and health perception in older adults with chronic conditions. Methods: A pilot Randomized Controlled Trial (RCT) was conducted using a two-arm parallel assignment model. The intervention group used an MDS as their medication management method. The control group continued to use their current methods of medication management. Block randomization was used to assign participants into the intervention or control group. The inclusion criteria included 1) English speaking 2) age 50 and over 3) diagnosed with one or more chronic condition(s) 4) currently taking five or more oral medications 5) City of Calgary resident. Participants were recruited from a primary care clinic in Alberta, Canada. The study was open label where knowledge about group assigned to participants after randomization was not withheld. Medication adherence was captured over a continuous, six-month period and analyzed using Intention-to-Treat (ITT) analysis. Results: A total of 91 participants were assessed for eligibility and 50 were randomized into the two groups. The number of participants analyzed for ITT was 23 and 25 in the intervention and control group, respectively. Most of the demographic characteristics were comparable in the two groups except mean age of the intervention group, which was higher compared to the control group (63.96±7.86 versus 59.52±5.93, p-value=0.03). The average recorded adherence over 26 weeks was significantly higher in the intervention group than the control group (98.35%±2.15% versus 91.17%±9.76%, p<0.01). The self-rated medication adherence in the intervention group also showed a significant increase from baseline to 6-month (7.63±1.63 versus 9.13±0.81, p<0.01). The control group showed a non-significant increase (7.20±1.74 versus 8.27±2.09, p=0.07). Conclusion: MDS can be an effective, long-term solution to medication non-adherence in older adults experiencing chronic conditions and taking multiple medications. The technology induces better consistency and improvement in medication taking behaviour than simple, non-technological intervention. Trial Registration: Registered with ClinicalTrials.gov on April 09, 2020 with identifier NCT04339296.

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Transcutaneous electrical acupoint stimulation for high-normal blood pressure: study protocol for a randomized controlled pilot trial

10.21203/rs.2.24687/v2 ◽

2020 ◽

Author(s):

Yu Wang ◽

Guang-Xia Shi ◽

Zhong-Xue Tian ◽

Jun-Hong Liu ◽

You-Sheng Qi ◽

...

Keyword(s):

Blood Pressure ◽

Clinical Trial ◽

Lifestyle Modification ◽

Pilot Trial ◽

Intervention Group ◽

Normal Blood ◽

Control Group ◽

Normal Blood Pressure ◽

Randomized Controlled ◽

Acupoint Stimulation

Abstract Background:High-normal blood pressure (BP) is associated with increased all-cause, cardiovascular mortality and frequently progresses to hypertension. Transcutaneous electrical acupoint stimulation (TEAS) might be a non-pharmaceutical therapy option to control BP. This trial aims to determine the efficacy effectiveness and safety of TEAS combined with lifestyle modification for high-normal BP. Methods/design:This prospective, randomized and parallel clinical trial will be conducted in a community service center in China. Sixty participants with high-normal BP will be randomly allocated to receive TEAS plus lifestyle modification (intervention group) or lifestyle modification alone (control group) in a 1:1 ratio. In addition to lifestyle modification, the intervention group will receive TEAS at four acupoints for 30 minutes, 4 times weekly for 12 weeks for a total of 48 sessions at home. The control group will receive same lifestyle modification but no TEAS. The primary outcome will be the change in mean systolic blood pressure at 12-week from the baseline measurement. Secondary outcomes include the change of mean diastolic blood pressure, proportion of subjects with progression to hypertension, quality of life, physical activity, body mass index and waist circumference. Adverse events during the trial will be monitored.Discussion:This trial will explore the feasibility and provide potential evidence for the efficacy effectiveness and safety of TEAS plus lifestyle modification for high-normal BP. Furthermore, this pilot trial is being undertaken to determine the feasibility of a full scale definitive randomized controlled trial. The results of this study will be published in a peer-reviewed journal.Trial registration:Chinese Clinical Trial Registry, ChiCTR 1900024982. Registered on August 6, 2019.

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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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