scholarly journals Using Smartphone-Based Psychoeducation to Reduce Postnatal Depression Among First-Time Mothers: Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Ko Ling Chan ◽  
Wing Cheong Leung ◽  
Agnes Tiwari ◽  
Ka Lun Or ◽  
Patrick Ip
Keyword(s):  
Randomized Controlled Trial ◽  
Postnatal Depression ◽  
Controlled Trial ◽  
Mobile App ◽  
Control Group ◽  
Randomized Controlled ◽  
First Time Mothers ◽  
Expectant Mothers ◽  
First Time

BACKGROUND Smartphone-based psychoeducation interventions may be a low-cost, user-friendly alternative to resource-consuming, face-to-face antenatal classes to educate expectant mothers. OBJECTIVE This study aimed to empirically examine whether such an intervention would lead to reduced postnatal depression, anxiety, or stress and result in a better health-related quality of life. METHODS A single-blind randomized controlled trial was conducted in Hong Kong. All first-time expectant mothers with less than 24 weeks of gestation remaining and attending the antenatal clinic at a public hospital were included. Participants were assigned to the intervention group or the control group by drawing lots. The lots, presented in sealed opaque envelopes, were randomly designated as “intervention” or “control” by stratified randomization. The intervention, a psychoeducational mobile app, was provided in addition to the treatment as usual (TAU) services from the hospital. Follow up with participants took place at 4 weeks postpartum. The primary outcome was the difference in the levels of antenatal and postnatal depression, assessed by the Edinburgh Postnatal Depression Scale (EPDS). The intention-to-treat approach was employed in the analyses. RESULTS The final sample was 660 expectant mothers (nintervention=330 and ncontrol=330). The mean difference in EPDS scores between the two groups was −0.65 (95% CI −1.29 to 0.00; P=.049) after adjusting for confounding factors. Associations were found between participation in the intervention and reduced depression, and attendance in TAU classes and increased stress levels. CONCLUSIONS The smartphone-based intervention plus TAU services was effective in reducing postnatal depression at 4 weeks postpartum compared with a control condition of TAU only, making this a cost-effective alternative to TAU education for expectant mothers. Limitations of the study included the short postpartum period after which the follow-up assessment was conducted and the inclusion of first-time mothers rather than all mothers. CLINICALTRIAL HKU Clinical Trials Registry HKUCTR-2024; http://www.hkuctr.com/Study/Show/ 34f62a2f6d594273a290491827206384

scholarly journals Using Smartphone-Based Psychoeducation to Reduce Postnatal Depression Among First-Time Mothers: Randomized Controlled Trial

10.2196/12794 ◽  
2019 ◽  
Vol 7 (5) ◽  
pp. e12794 ◽  
Author(s):  
Ko Ling Chan ◽  
Wing Cheong Leung ◽  
Agnes Tiwari ◽  
Ka Lun Or ◽  
Patrick Ip
Keyword(s):  
Randomized Controlled Trial ◽  
Postnatal Depression ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
First Time Mothers ◽  
First Time

scholarly journals A randomized controlled trial of the effects of antenatal milk expression on breastfeeding among first-time mothers in China

2020 ◽  
Author(s):  
yan chen ◽  
Li-Ping Meng ◽  
Jiao-Jiao Zhang ◽  
Hong-Hua Guo ◽  
hongyu zhang
Keyword(s):  
Randomized Controlled Trial ◽  
Pregnant Women ◽  
Exclusive Breastfeeding ◽  
Self Efficacy ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
First Time Mothers ◽  
First Time

Abstract Background Limited research outside China suggest that antenatal milk expression in late pregnancy (AME) may promote breastfeeding. A few studies have evaluated the safety and efficacy of AME in women with diabetes in pregnancy, little or no evidence exists to explore its effects on breastfeeding self-efficacy and early breastfeeding, particularly in first-time mothers. The objective of this study was to explore the effect of AME on breastfeeding for the first-time mothers during the postpartum hospitalization. Methods A randomized controlled trial was conducted in a tertiary hospital in Haikou, Hainan. We recruited pregnant women who had completed 37 weeks of gestation and randomly assigned them to either the intervention group (n = 45) or the control group (n = 45). The pregnant women in the intervention group were advised to rhythmic self-massage of breasts three times daily at any time. The control group was given routine midwifery and obstetric care. The breastfeeding self-efficacy scale(BSES)was used to measure the self-efficacy of breastfeeding at 37 weeks, 38 weeks and the third day postpartum. The time to lactogenesis II and the rate of exclusive breastfeeding was measured three times every day by the researcher in the ward. Results Compared with the control group, the intervention group had higher breastfeeding self-efficacy scores measured by the scale of BSES(P < 0.05), the intervention group had higher exclusive breastfeeding rate on the first day, second day, third-day postpartum, and the difference was statistically significant༈P < 0.05). The time to lactogenesis II in the intervention group was earlier than that in the control group(P < 0.05). Conclusions Antenatal breast milk expression at term improved the confidence in the ability to breastfeed and produce milk postpartum, thus significantly improving the behavior of exclusive breastfeeding, and increasing the percentage of breastfed infants during their hospital stay, these infants were able to avoid infant formula milk in this important early period.

scholarly journals Using Personalized Anchors to Establish Routine Meditation Practice with a Mobile App: Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Chad Stecher ◽  
Mariah Sullivan ◽  
Jennifer Huberty
Keyword(s):  
Randomized Controlled Trial ◽  
Linear Trend ◽  
Controlled Trial ◽  
Health Benefits ◽  
Study Groups ◽  
Mobile App ◽  
Control Group ◽  
Daily Routine ◽  
Randomized Controlled

BACKGROUND Physical and mental health benefits can be attained from persistent, long-term performance of mindfulness meditation with a mobile meditation app, but in general, few mobile health app users persistently engage at a level necessary to attain the corresponding health benefits. Anchoring, or pairing, meditation with a mobile app to an existing daily routine can establish an unconsciously initiated meditation routine that may improve meditation persistence. OBJECTIVE The purpose of this study was to test the use of either personalized anchors or fixed anchors for establishing a persistent meditation app routine with the mobile app Calm. METHODS A randomized controlled trial was implemented that randomly assigned participants to one of three study groups: a) Personalized Anchor (PA), b) Fixed Anchor (FA), or a c) control group that did not use the anchoring strategy. All participants received app-delivered reminder messages to meditate for at least 10 minutes a day for an eight-week intervention period, and app usage data continued to be collected for an eight-week follow-up period to measure meditation persistence. Baseline, week eight, and week 16 surveys were administered to assess demographics, socioeconomic status, and changes in self-reported habit strength. RESULTS A total of 101 participants across the three study groups were included in the final analysis: a) PA (N=56), b) FA (N=49), and c) control group (N=62). Participants were predominantly White (81%), female (76%), and college educated (i.e., bachelor’s or graduate degree; 81%). The FA group had a significantly higher odds of daily meditation at the start of the intervention (1.14 OR; 95% CI 1.02 – 1.33; P = 0.04), and all participants experienced a linear decline in their odds of daily meditation during the eight-week intervention (0.96 OR; 95% CI 0.95 – 0.96; P < 0.01). Importantly, only the FA group showed a significantly smaller decline in the linear trend of their odds of daily meditation during the eight-week follow-up (their daily trend increased by 1.04 OR; 95% CI 1.01 – 1.06; P = 0.03). Additionally, those who more frequently adhered to their anchoring strategy during the intervention showed a significantly smaller decline in the linear trend of their odds of daily meditation during the eight-week follow-up period (1.13 OR; 95% CI 1.02 – 1.35; P < 0.01). CONCLUSIONS The FA group had more persistent meditation with the app, but participants in either the FA or PA groups who more frequently adhered to their anchoring strategy during the intervention had the most persistent meditation routines, and almost all of these high-anchorers used morning anchors. These findings suggest that using the anchoring strategy can create persistent meditation routines with a mobile app. However, future studies should test additional intervention tools (i.e., reminders plus incentives) to help more participants successfully adhere to their anchored meditation routine.

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

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.

scholarly journals Effectiveness of a psychological online training to promote physical activity among students: protocol of a randomized-controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Lena Violetta Krämer ◽  
Nadine Eschrig ◽  
Lena Keinhorst ◽  
Luisa Schöchlin ◽  
Lisa Stephan ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Mixed Model ◽  
Controlled Trial ◽  
Control Group ◽  
Web Based ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Link Type

Abstract Background Many students in Germany do not meet recommended amounts of physical activity. In order to promote physical activity in students, web-based interventions are increasingly implemented. Yet, data on effectiveness of web-based interventions in university students is low. Our study aims at investigating a web-based intervention for students. The intervention is based on the Health Action Process Approach (HAPA), which discriminates between processes of intention formation (motivational processes) and processes of intention implementation (volitional processes). Primary outcome is change in physical activity; secondary outcomes are motivational and volitional variables as proposed by the HAPA as well as quality of life and depressive symptoms. Methods A two-armed randomized controlled trial (RCT) of parallel design is conducted. Participants are recruited via the internet platform StudiCare (www.studicare.com). After the baseline assessment (t1), participants are randomized to either intervention group (immediate access to web-based intervention) or control group (access only after follow-up assessment). Four weeks later, post-assessment (t2) is performed in both groups followed by a follow-up assessment (t3) 3 months later. Assessments take place online. Main outcome analyses will follow an intention-to-treat principle by including all randomized participants into the analyses. Outcomes will be analysed using a linear mixed model, assuming data are missing at random. The mixed model will include group, time, and the interaction of group and time as fixed effects and participant and university as random effect. Discussion This study is a high-quality RCT with three assessment points and intention-to-treat analysis meeting the state-of-the-art of effectiveness studies. Recruitment covers almost 20 universities in three countries, leading to high external validity. The results of this study will be of great relevance for student health campaigns, as they reflect the effectiveness of self-help interventions for young adults with regard to behaviour change as well as motivational and volitional determinants. From a lifespan perspective, it is important to help students find their way into regular physical activity. Trial registration The German clinical trials register (DRKS) DRKS00016889. Registered on 28 February 2019

Challenges of Increasing Childcare Center Compliance With Nutrition Guidelines: A Randomized Controlled Trial of an Intervention Providing Training, Written Menu Feedback, and Printed Resources

2018 ◽  
Vol 33 (3) ◽  
pp. 399-411 ◽  
Author(s):  
Meghan Finch ◽  
Kirsty Seward ◽  
Taya Wedesweiler ◽  
Fiona Stacey ◽  
Alice Grady ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Group Intervention ◽  
Controlled Trial ◽  
Theoretical Domains Framework ◽  
Practice Change ◽  
Control Group ◽  
Food Groups ◽  
Randomized Controlled ◽  
Nutrition Guidelines

Purpose: To assess the effectiveness of an intervention including training, provision of written menu feedback, and printed resources on increasing childcare compliance with nutrition guidelines. Design: Parallel group randomized controlled trial. Setting: Hunter New England region, New South Wales, Australia. Participants: Forty-four childcare centers that prepare and provide food on-site to children while in care. Intervention: The intervention was designed using the Theoretical Domains Framework, targeted managers, and cooks and included implementation strategies that addressed identified barriers. Measures: Outcomes included the proportion of menus providing food servings (per child) compliant with overall nutrition guideline recommendations and each individual food group assessed via menu assessments. Cook knowledge of recommendations, intervention acceptability, adverse events, and barriers were also assessed via questionnaires with cooks and managers. Analysis: Logistic regression models, adjusted for baseline values of the outcome. Results: At baseline and follow-up, zero centers in the intervention and control groups were compliant with the overall menu guidelines or for the vegetable and meat food groups. Follow-up between-group differences in compliance for discretionary (33.3 vs 5, P = .18), dairy (41.7 vs 15, P = .16), breads and cereals (8.3 vs 10 P = 1.00), and fruit (16.7 vs 10, P = .48) were all nonsignificant. Relative to the control group, intervention centers showed a significantly greater increase in percentage of cooks with correct knowledge for vegetable servings (93.3 vs 36.4, P = .008). Conclusion: Although the application of the theoretical framework produced a broader understanding of the determinants of menu compliance, due to the complexity of guidelines, limited follow-up support, lower training uptake, and low intervention dose, the intervention was not effective in supporting the practice change required.

Citation Advantage of Promoted Articles in a Cross-Publisher Distribution Platform: 36-month Follow-up to a Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Paul Kudlow ◽  
Tashauna Brown
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Control Group ◽  
Digital Tool ◽  
Randomized Controlled ◽  
Subject Areas ◽  
The Subject ◽  
The Difference ◽  
Citation Advantage

BACKGROUND There are limited evidence-based strategies that have been shown to increase the rate at which peer-reviewed articles are cited. In a previously reported randomized controlled trial we demonstrated that promotion of article links in an online cross-publisher distribution platform (TrendMD) persistently augments citation rates after 12 months, leading to a statistically significant, 50% increase in citations relative to control. OBJECTIVE To investigate if the citation advantage of promoted articles upholds after 36-months. METHODS Three thousand two hundred articles published in 64 peer-reviewed journals across eight subject areas were block randomized at the subject level to either the TrendMD group (n=1600) or the control group (n=1600) of the study. Articles were promoted in the TrendMD Network for 6 months. We compared the citation rates in both groups after 36 months. RESULTS At 36 months, we found the citation advantage endured; articles randomized to TrendMD showed a 28% increase in mean citations relative to control. The difference in mean citations at 36 months for articles randomized to TrendMD versus control was 10.52, 95% CI [3.79, 17.25] and was statistically significant (p=0.001). CONCLUSIONS To our knowledge, this is the first randomized controlled trial to demonstrate how a post-publication article promotion intervention can be used to persistently augment citations of peer-reviewed articles. TrendMD is an efficient digital tool for knowledge translation and dissemination to targeted audiences to facilitate uptake of research.

Manganese and Lipoflavonoid Plus® to Treat Tinnitus: A Randomized Controlled Trial

2016 ◽  
Vol 27 (08) ◽  
pp. 661-668 ◽  
Author(s):  
Eveling Rojas-Roncancio ◽  
Richard Tyler ◽  
Hyung-Jin Jun ◽  
Tang-Chuan Wang ◽  
Haihong Ji ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Data Collection And Analysis ◽  
Loudness Match ◽  
Minimal Masking Level ◽  
Lost To Follow Up ◽  
To Receive

Background: Several tinnitus sufferers suggest that manganese has been helpful with their tinnitus. Purpose: We tested this in a controlled experiment where participants were committed to taking manganese and Lipoflavonoid Plus® to treat their tinnitus. Research Design: Randomized controlled trial. Study Sample: 40 participants were randomized to receive both manganese and Lipoflavonoid Plus® for 6 months, or Lipoflavonoid Plus® only (as the control). Data Collection and Analysis: Pre- and postmeasures were obtained with the Tinnitus Handicap Questionnaire, Tinnitus Primary Functions Questionnaire, and tinnitus loudness and annoyance ratings. An audiologist performed the audiogram, the tinnitus loudness match, and minimal masking level. Results: Twelve participants were dropped out of the study because of the side effects or were lost to follow-up. In the manganese group, 1 participant (out of 12) showed a decrease in the questionnaires, and another showed a decrease in the loudness and annoyance ratings. No participants from the control group (total 16) showed a decrease in the questionnaires ratings. Two participants in the control group reported a loudness decrement and one reported an annoyance decrement. Conclusions: We were not able to conclude that either manganese or Lipoflavonoid Plus® is an effective treatment for tinnitus.

scholarly journals Mindfulness-Based Program Plus Amygdala and Insula Retraining (MAIR) for the Treatment of Women with Fibromyalgia: A Pilot Randomized Controlled Trial

2020 ◽  
Vol 9 (10) ◽  
pp. 3246
Author(s):  
Juan P. Sanabria-Mazo ◽  
Jesus Montero-Marin ◽  
Albert Feliu-Soler ◽  
Virginia Gasión ◽  
Mayte Navarro-Gil ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Post Treatment ◽  
Effect Sizes ◽  
Control Group ◽  
Active Control Group ◽  
Treatment As Usual ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

The lack of highly effective treatments for fibromyalgia (FM) represents a great challenge for public health. The objective of this parallel, pilot randomized controlled trial (RCT) was two-fold: (1) to analyze the clinical effects of mindfulness plus amygdala and insula retraining (MAIR) compared to a structurally equivalent active control group of relaxation therapy (RT) in the treatment of FM; and (2) to evaluate its impact on immune-inflammatory markers and brain-derived neurotrophic factor (BDNF) in serum. A total of 41 FM patients were randomized into two study arms: MAIR (intervention group) and RT (active control group), both as add-ons of treatment as usual. MAIR demonstrated significantly greater reductions in functional impairment, anxiety, and depression, as well as higher improvements in mindfulness, and self-compassion at post-treatment and follow-up, with moderate to large effect sizes. Significant decreases in pain catastrophizing and psychological inflexibility and improvements in clinical severity and health-related quality of life were found at follow-up, but not at post-treatment, showing large effect sizes. The number needed to treat was three based on the criteria of ≥50% Fibromyalgia Impact Questionnaire (FIQ) reduction post-treatment. Compared to RT, the MAIR showed significant decreases in BDNF. No effect of MAIR was observed in immune-inflammatory biomarkers (i.e., TNF-α, IL-6, IL-10, and hs-CRP). In conclusion, these results suggest that MAIR, as an adjuvant of treatment-as-usual (TAU), appears to be effective for the management of FM symptoms and for reducing BDNF levels in serum.

scholarly journals Guided web-based treatment program for reducing cannabis use: a randomized controlled trial

2020 ◽  
Vol 15 (1) ◽  
Author(s):  
Kristina Sinadinovic ◽  
Magnus Johansson ◽  
Ann-Sofie Johansson ◽  
Thomas Lundqvist ◽  
Philip Lindner ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Treatment Program ◽  
Controlled Trial ◽  
Cannabis Use ◽  
Control Group ◽  
Web Based ◽  
Randomized Controlled ◽  
Intervention Adherence ◽  
Group Effects

Abstract Background The aim of this study was to investigate the effects of a web-based treatment program with therapist guidance for adults and adolescents with regular cannabis use from the general population. Methods A double blinded randomized controlled trial with a parallel group design was conducted (intervention group n = 151, wait-list control group n = 152). Follow-up 12 weeks from treatment commencement of a 13-module intervention. The primary outcome was frequency of cannabis use. Time by group interaction effects were modeled using generalized estimated equations and the instrumental variable approach was used to estimate the effect of intervention adherence. Results At follow-up, the intention to treat (ITT) analyses did not show any significant time by group effects. A significant association between intervention adherence and scores on the cannabis abuse screening test (CAST) was found. Secondary analysis excluding participants who had received other professional help revealed time by group effects for secondary outcomes gram cannabis consumed past week, number of dependency criteria and CAST score. Due to methodological limitations, these latter results should be interpreted with caution. Conclusions In this study we did not find a web-based treatment program with therapist guidance to be more effective than a waiting-list in reducing frequency of cannabis use. Trial registration The trial was pre-registered at ClinicalTrials.gov (NCT02408640) April 3, 2015

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