Nutritional supplementation and growth after hospital discharge in very low birthweight newborns: Randomized controlled trial / Suplementação nutricional e crescimento de recém-nascidos de muito baixo peso após alta hospitalar: Ensaio clínico randomizado

Background Evidence is insufficient to show whether fortification has any effect on growth in preterm infants after discharge. Objective to verify whether VLBW preterm infants who are supplemented with multicomponent present greater anthropometric measurements than those not supplemented. Study Design Parallel randomized controlled trial. A computer-generated random number table was used to allocate the participants. Participants Preterm infants discharged from the NICU of a University Hospital from northeast, Brazil, weighing less than 1,500 g exclusively breastfed at discharge and followed up until they reached 6 months corrected gestational age. Intervention intervention group received Nestlé® PreNan® formula, fractionated in 2 g of powder, mixed with the mother's milk twice a day. Control group was exclusively breastfed. Follow-up was conducted until the infants reached 6 months corrected gestational age (CGA). Outcomes Growth of the anthropometrics parameters weight, head circumference (HC) and lenth with 6 months of corrected age. Mixed effects model for longitudinal data was used. Interaction according to sex was detected and ajusted. Results Weight gain was significantly higher in the intervention group. This effect was verified only for males (p = 0.001). No statistically significant association was observed between the intervention and the head circumference or length (p = 0.211; 0.597). The weaning rate at the end of follow-up was similar in both groups. Conclusions Breastmilk supplementation may improve the weight gain of very low birthweight preterm infants up to six months corrected gestational age. This effect differed by sex and was considered significant only for males.

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Effect of physician prescribed information on hospital readmission and death after discharge among patients with health failure: A randomized controlled trial

Health Informatics Journal ◽

10.1177/1460458221996409 ◽

2021 ◽

Vol 27 (1) ◽

pp. 146045822199640

Author(s):

Faranak Kazemi Majd ◽

Vahideh Zarea Gavgani ◽

Ali Golmohammadi ◽

Ali Jafari-Khounigh

Keyword(s):

Randomized Controlled Trial ◽

Hospital Readmission ◽

Medical Information ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled ◽

Long Term Follow Up ◽

Oral Information

In order to understand if a physician prescribed medical information changes, the number of hospital readmission, and death among the heart failure patients. A 12-month randomized controlled trial was conducted (December 2013–2014). Totally, 120 patients were randomly allocated into two groups of intervention ( n = 60) and control ( n = 60). Accordingly, the control group was given the routine oral information by the nurse or physician, and the intervention group received the Information Prescription (IP) prescribed by the physician as well as the routine oral information. The data was collected via telephone interviews with the follow-up intervals of 6 and 12 months, and also for 1 year after the discharge. The patients with the median age of (IQR) 69.5 years old (19.8) death upon adjusting a Cox survival model, [RR = 0.67, 95%CI: 0.46–0.97]. Few patients died during 1 year in the intervention group compared to the controls (7 vs 15) [RR = 0.47, 95%CI: 0.20–1.06]. During a period of 6-month follow-up there was not statistically significant on death and readmission between two groups. Physician prescribed information was clinically and statistically effective on the reduction of death and hospital readmission rates among the HF patients in long term follow-up.

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Administration of breast milk cell fractions to neonates with birthweight equal to or less than 1800 g: a randomized controlled trial

International Breastfeeding Journal ◽

10.1186/s13006-021-00405-0 ◽

2021 ◽

Vol 16 (1) ◽

Author(s):

Minoo Fallahi ◽

Seyed Masoud Shafiei ◽

Naeeme Taslimi Taleghani ◽

Maryam Khoshnood Shariati ◽

Shamsollah Noripour ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Breast Milk ◽

Hospital Mortality ◽

Low Birthweight ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled ◽

Cell Fractions ◽

Breast Milk Cell

Abstract Background Most premature and very low birthweight infants cannot tolerate breast milk feeding in the first few days of life and are deprived of its benefits. This study evaluates the clinical outcomes of administering breast milk cell fractions to neonates with a birthweight of ≤1800 g. Methods We conducted a randomized controlled trial on 156 infants in the neonatal intensive care unit of Mahdieh Maternity Hospital in Tehran, Iran, from May 2019 to April 2020. All neonates with a birthweight ≤1800 g were enrolled and divided into intervention and control groups using stratified block randomization. Neonates in the intervention group received the extracted breast milk cell fractions (BMCFs) of their own mother’s milk after being centrifuged in the first 6 to 12 h after birth. The control group received routine care, and breastfeeding was started as soon as tolerated in both groups. Study outcomes were necrotizing enterocolitis (NEC), death, and in-hospital complications. Results We divided participants into two groups: 75 neonates in the intervention group and 81 neonates in the control group. The mean birthweight of neonates was 1390.1 ± 314.4 g, and 19 (12.2%) neonates deceased during their in-hospital stay. The incidence of NEC was similar in both groups. After adjustment for possible confounders in the multivariable model, receiving BMCFs were independently associated with lower in-hospital mortality (5 [26.3%] vs. 70 (51.1%]; odds ratio (OR): 0.24; 95% confidence interval [CI] 0.07, 0.86). Also, in a subgroup analysis of neonates with birthweight less than 1500 g, in-hospital mortality was significantly lower in the intervention group (4 [9.5%] vs. 13 [30.2%]; OR: 0.24; 95% CI 0.07, 0.82). There were no differences in major complications such as bronchopulmonary dysplasia and retinopathy of prematurity between the two groups. No adverse effects occurred. Conclusions Our research demonstrated a significantly lower mortality rate in neonates (with a birthweight of ≤1800 g) who received breast milk cell fractions on the first day of life. Since this is a novel method with minimal intervention, we are looking forward to developing and evaluating this method in larger studies. Trial registration IIranian Registry of Clinical Trials. Registered 25 May 2019, IRCT20190228042868N1.

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Abstract MP07: Automated, Personalized Feedback and Behavioral Nudges to Improve Workplace Food Choices and Prevent Weight Gain: Choosewell 365 Randomized Controlled Trial

Circulation ◽

10.1161/circ.141.suppl_1.mp07 ◽

2020 ◽

Vol 141 (Suppl_1) ◽

Author(s):

Anne N Thorndike ◽

Jessica L McCurley ◽

Emily D Gelsomin ◽

Eric B Rimm ◽

Yuchiao Chang ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Weight Gain ◽

Health Outcomes ◽

Controlled Trial ◽

Intervention Group ◽

Food Choices ◽

Healthy Food ◽

Traffic Light ◽

Randomized Controlled ◽

Prevent Weight Gain

Importance: Workplace health promotion programs often have limited reach and effectiveness because they are time-intensive and not integrated with the work environment. Objective: Conduct a randomized controlled trial testing an automated intervention combined with workplace cafeteria traffic-light labels to prevent weight gain and increase healthy food choices. Methods: 602 hospital employees who regularly used 6 on-site cafeterias and paid with their ID were randomized in 2016-18. Cafeteria labels identified healthy (green), less healthy (yellow), and unhealthy (red) items. Participants completed visits, surveys, and dietary recalls at baseline and 12 months (end of intervention). The intervention group received personalized emails (2/week) and letters (1/month) that were automatically generated by a software platform that integrated cafeteria sales, health, and survey data. Emails included a log of weekly purchases (item, traffic light label, and calories) and health tips. Letters included social norm comparisons and small incentives for healthy purchases. The control group received standard lifestyle advice in monthly letters. A Healthy Purchasing Score was calculated by weighting purchased items by traffic light labels (red=0; yellow=0.5; green=1) using 12 mo of purchases during both baseline (pre-intervention) and intervention. Differences in differences in health outcomes, purchases, and dietary quality were compared, with missing values imputed. Results: Participants were 43.6 years (mean), 79% female, and 81% white. The intervention group increased healthy purchases compared to control, but changes in BMI and health outcomes were not different (see Table). Conclusion: An automated intervention linked to the workplace food environment increased healthy food choices but did not prevent weight gain. To improve health, this scalable healthy eating intervention could be augmented with additional technology to improve other health behaviors, such as physical activity, both at work and home.

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Family-Centered Care Enhanced Neonatal Neurophysiological Function in Preterm Infants: Randomized Controlled Trial

Physical Therapy ◽

10.1093/ptj/pzz120 ◽

2019 ◽

Vol 99 (12) ◽

pp. 1690-1702 ◽

Cited By ~ 1

Author(s):

Yen-Ting Yu ◽

Wan-Chi Huang ◽

Wu-Shiun Hsieh ◽

Jui-Hsing Chang ◽

Chyi-Her Lin ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Birth Weight ◽

Preterm Infants ◽

Gestational Age ◽

Controlled Trial ◽

Randomized Controlled ◽

Oddball Task ◽

Appropriate For Gestational Age ◽

Related Potentials ◽

Family Centered

Abstract Background Family-centered intervention for preterm infants has shown short- to medium-term developmental benefits; however, the neurological effects of intervention have rarely been explored. Objective The objectives of this study were to examine the effect of a family-centered intervention program (FCIP) on neurophysiological functions in preterm infants with very low birth weight (VLBW; birth weight of < 1500 g) in Taiwan, to compare the effect of the FCIP with that of a usual-care program (UCP), and to explore the FCIP-induced changes in neurobehavioral and neurophysiological functions. Design This was a multicenter, single-blind randomized controlled trial. Setting The study took place in 3 medical centers in northern and southern Taiwan. Participants Two hundred fifty-one preterm infants with VLBW were included. Intervention The FCIP group received a family-centered intervention and the UCP group received standard care during hospitalization. Measurements Infants were assessed in terms of neurobehavioral performance using the Neonatal Neurobehavioral Examination–Chinese version, and their neurophysiological function was assessed using electroencephalography/event-related potentials during sleep and during an auditory oddball task during the neonatal period. Results The FCIP promoted more mature neurophysiological function than the UCP, including greater negative mean amplitudes of mismatch negativities in the left frontal region in the oddball task in all infants, lower intrahemispheric prefrontal-central coherence during sleep in infants who were small for gestational age, and higher interhemispheric frontal coherence during sleep in those who were appropriate for gestational age. Furthermore, interhemispheric coherence was positively associated with the total neurobehavioral score in preterm infants who were appropriate for gestational age (r = 0.20). Limitations The fact that more parental adherence strategies were used in the FCIP group than in the UCP group might have favored the intervention effect in this study. Conclusions Family-centered intervention facilitates short-term neurophysiological maturation in preterm infants with VLBW in Taiwan.

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A Pilot Randomized Controlled Trial of Distress Tolerance Treatment for Weight Concern in Smoking Cessation Among Women

Nicotine & Tobacco Research ◽

10.1093/ntr/ntaa026 ◽

2020 ◽

Vol 22 (9) ◽

pp. 1578-1586

Author(s):

Erika Litvin Bloom ◽

Susan E Ramsey ◽

Ana M Abrantes ◽

Laura Hunt ◽

Rena R Wing ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Smoking Cessation ◽

Weight Gain ◽

Emotional Eating ◽

Distress Tolerance ◽

Controlled Trial ◽

Randomized Controlled ◽

Group Sessions ◽

Pilot Randomized Controlled Trial

Abstract Introduction The majority of women who smoke cigarettes report that concern about weight gain is a barrier to quitting. We developed an intervention incorporating distress tolerance, appetite awareness, and mindful eating skills to target concerns about post-cessation weight gain and emotional eating (DT-W). In the current study, we conducted a pilot randomized controlled trial of DT-W versus a smoking health education (HE) intervention. Methods Participants (N = 69 adult female, weight-concerned smokers) were recruited in cohorts of 4–11. Cohorts were randomized to DT-W or HE. DT-W and HE were matched on format (single individual session followed by eight group sessions), inclusion of cognitive behavioral therapy for smoking cessation (CBT) content, and pharmacotherapy (nicotine patches). Follow-up assessments occurred at 1-, 3-, and 6-months post-treatment. Results The recruitment goal was met; 61 of the 69 participants attended at least one group session. There were no significant differences between DT-W and HE in the number of group sessions attended (DT-W adjusted M = 5.09, HE adjusted M = 5.03, p = .92), ratings of treatment effectiveness or usefulness of skills, or retention at 6-month follow-up (79% in DT-W vs. 78% in HE) (ps > .05), but comprehension ratings were lower in DT-W than in HE (p = .02). Conclusions Overall, these results suggest that the study procedures and interventions were feasible and acceptable, but changes to the DT-W intervention content to improve comprehension should be considered prior to conducting a fully powered trial. Implications A distress tolerance-based treatment targeting fear of weight gain after smoking cessation and post-cessation emotional eating was feasible and acceptable relative to a smoking HE comparison condition, but changes should be considered before conducting a larger trial. Continued innovation in treatment development for weight-concerned smokers is needed.

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Effects of individualized follow-up with a smartphone-application after cardiac rehabilitation: protocol of a randomized controlled trial

BMC Sports Science Medicine and Rehabilitation ◽

10.1186/s13102-019-0148-2 ◽

2019 ◽

Vol 11 (1) ◽

Cited By ~ 2

Author(s):

Pernille Lunde ◽

Asta Bye ◽

Astrid Bergland ◽

Birgitta Blakstad Nilsson

Keyword(s):

Randomized Controlled Trial ◽

Cardiac Rehabilitation ◽

Controlled Trial ◽

Intervention Group ◽

Smartphone Application ◽

Control Group ◽

Power Calculation ◽

Large Sample Size ◽

Randomized Controlled

Abstract Background Cardiac rehabilitation (CR) programs are evidence-based and widely recommended. However, benefits from CR are likely lost among individuals who discontinue their regular exercise routines and healthy habits. One possible approach to enhance adherence to lifestyle advice after completion of CR, may be individualized follow-up enabled by a smartphone application (app). Methods A protocol of a single-blinded, pragmatic randomized controlled trial. The study will take place in the eastern part of Norway, and will include heart patients who have completed CR. Participants will be recruited from two CR centers. Based on power calculation, 113 participants will be included. The intervention group will receive individualized follow-up through an app on a weekly basis throughout a year. The app will be set up with the participant’s own goals, and the follow-up will be based on these individual goals. The control group will receive usual care, including general advice regarding physical activity, exercise and diet. The participants will be assessed at baseline (at completion of CR) and 12 months after baseline. Primary outcome of the study will be peak oxygen uptake. Secondary outcomes include exercise performance, quality of life, health status, health literacy, self-perceived goal achievement, exercise habits, body weight, blood pressure as well as lipids and triglycerides. Discussion To our knowledge, this will be the first study to examine the effects of individualized follow-up with an app for one year, in patients completing CR. Hence, it is reasonable to assume that the study may be groundbreaking. Due to the large sample size and the theoretically based intervention, the study has the potential to generate new knowledge that may improve the design of future technology-based follow-up interventions of patients that have completed rehabilitation. Trial registration ClinicalTrials.gov. NCT03174106. First registration, 19/05/2017.

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Does a tailored intervention to promote adherence in patients with chronic lung disease affect exacerbations? A randomized controlled trial

Respiratory Research ◽

10.1186/s12931-019-1219-3 ◽

2019 ◽

Vol 20 (1) ◽

Author(s):

Claudia Gregoriano ◽

Thomas Dieterle ◽

Anna-Lisa Breitenstein ◽

Selina Dürr ◽

Amanda Baum ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Ambulatory Setting ◽

Randomized Controlled ◽

Phone Calls ◽

Copd Patients ◽

The Impact ◽

Inhaled Medication

Abstract Background Poor medication-adherence is common in chronic lung patients, resulting in reduced health-outcomes and increased healthcare-costs. This study aimed to investigate the impact of an acoustic reminder and support calls on adherence to inhaled therapy in asthma and COPD patients and to determine their effect on exacerbations. Methods This single-blinded randomized controlled trial investigated asthma and COPD patients during 6 months in an ambulatory setting. The intervention consisted of daily alarm clock and support phone calls, whenever use of rescue medication doubled or inhaled medication was not taken as prescribed. Primary outcome was time to next exacerbation. Frequency of exacerbations, adherence to inhaled medication and quality of life scores were secondary outcomes. Cox and Poisson regression were used to determine intervention effect on time to exacerbation and frequency of exacerbations, respectively. Results Seventy-five participants were assigned to the intervention group and 74 to usual follow-up care. During a median follow-up of 6.2 months, 22 and 28% in the intervention and control groups respectively, experienced at least one exacerbation. Intervention had no effect on time to first exacerbation (HR 0.65, 95% CI 0.21 to 2.07, P = .24), but showed a trend toward a 39% decreased frequency of exacerbations (RR = 0.61, 95% CI 0.35 to 1.03, P = .070) for the adjusted models, respectively. The intervention group had significantly more days with 80–100% taking adherence regarding puff inhalers (82 ± 14% vs. 60 ± 30%, P < .001) and dry powder capsules (90 ± .10% vs. 80 ± 21%, P = .01). Timing adherence in participants using puff inhalers was higher in the intervention group (69 ± 25% vs. 51 ± 33%, P < .001). No significant differences in QoL were found between the two groups. Conclusion Participants assigned to the intervention group had significantly better taking and timing adherence of inhaled medication resulting in a trend towards a decreased frequency of exacerbations. However, no effect on time to next exacerbation was observed. Trial registration ClinicalTrials.gov: NCT02386722, Registered 14 February 2014.

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Long-term efficacy of indicated prevention of depression in non-professional caregivers: randomized controlled trial

Psychological Medicine ◽

10.1017/s0033291714002505 ◽

2014 ◽

Vol 45 (7) ◽

pp. 1401-1412 ◽

Cited By ~ 15

Author(s):

P. Otero ◽

F. Smit ◽

P. Cuijpers ◽

A. Torres ◽

V. Blanco ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Caregiver Burden ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Indicated Prevention ◽

Randomized Controlled ◽

Term Efficacy

BackgroundAlthough depression is a common problem among non-professional caregivers, only one trial has evaluated the efficacy of indicated prevention targeting this population and the long-term efficacy is unknown. The aim of this study was to evaluate the long-term efficacy of a brief intervention for the indicated prevention of depression in a sample of female caregivers.MethodA randomized controlled trial was conducted involving 173 participants (mean age 53.9 years) who were allocated to the intervention (n = 89) or the usual-care control group (n = 84). Blinded interviewers conducted assessments at 1, 3, 6 and 12 months of follow-up. The main outcome measure was the incidence of major depression and the secondary outcomes were compliance with treatment, depressive symptoms, emotional distress and caregiver burden.ResultsAt the 12-month follow-up, a lower incidence of depression as evaluated using the Structured Clinical Interview for Axis I Disorders of the DSM-IV was found in the intervention group compared with the control group (10.1%v.25.0%). The relative risk was 0.40 and statistically significant [χ2 = 6.68, degrees of freedom = 1,p = 0.010, 95% confidence interval (CI) 0.20–0.81], and the number needed to treat was 7 (95% CI 4–27). There was a significant delay in the onset of depression in the intervention group (p = 0.008). The good complier caregivers had a lower incidence of depression. The intervention effect on depressive symptoms, emotional distress and caregiver burden were maintained for 12 months.ConclusionsThis is the first study to demonstrate that a brief problem-solving intervention can prevent the onset of depression among non-professional caregivers over the longer term.

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Randomized Controlled Trial Evaluating Pictogram Augmentation of HIV Medication Information

Annals of Pharmacotherapy ◽

10.1345/aph.1q091 ◽

2011 ◽

Vol 45 (11) ◽

pp. 1378-1383 ◽

Cited By ~ 12

Author(s):

Kyle Wilby ◽

Carlo A Marra ◽

Jack H da Silva ◽

Maja Grubisic ◽

Stephanie Harvard ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Antiretroviral Therapy ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Fisher Exact Test ◽

Intended Meaning ◽

Randomized Controlled ◽

Medication Information

Background:: Antiretroviral therapy for the management of HIV typically requires the chronic use of 3 or more medications. As such, patients with HIV are required to manage complex dosing schedules and are at risk of multiple potential adverse effects. The use of pictograms on medication vials as a means of improving patients' understanding of medication information has been shown to positively influence understanding and adherence compared to those using text atone. Objective: To determine whether pictograms (Pharmaglyph) increase patient recall of targeted information associated with HIV medications and whether patients can interpret the intended meaning of pictograms that they had not seen previously. Methods: A randomized, controlled trial was conducted in HIV-positive patients aged 19 years or older who were receiving a new prescription for an antiretroviral medication from the ambulatory pharmacy at St. Paul's Hospital in Vancouver, British Columbia, Canada. Participants were randomized to receive either pictogram-enhanced medication information or standard counseling. At the first follow-up visit, each patient's recall of the medication information was evaluated, and differences between groups were compared. Results: Eighty-two subjects were randomized, 40 to the intervention group and 42 to the control arm. The mean (SD) number of HIV medications was nearly equal between the intervention and control groups: 3.0 (1.5) and 3.1 (1.4), respectively. After a mean of 34 days, 33 patients in the intervention arm and 39 in the control arm completed the study. The majority (88%) of the targeted pieces of information in the intervention group were correctly identified at follow-up, compared to only 2% in the control group (Fisher exact test; p < 0.0001). Conclusions: Pictograms improve the recall of targeted medication information among patients receiving antiretroviral therapy for HIV management; however, this appears to be dependent on the fact that these patients received a verbal explanation of each pictogram prior to use.

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