Exercise Throughout Pregnancy Does not Cause Preterm Delivery: A Randomized, Controlled Trial

Background:In spite of an extensive knowledge of the physiologic features of exercise during pregnancy, we still lack a comprehensive understanding of the effects of different types, intensities and duration of exercise throughout pregnancy on maternal and fetal well being. The aim of the current study was to examine the influence of an aerobic exercise program throughout pregnancy on gestational age at the moment of delivery.Methods:This study was a randomized controlled trial. Three hundred and twenty Caucasian (Spanish) healthy pregnant women with singleton gestation were randomly assigned to either an exercise (n = 160) or a control (n = 160) group. Gestational age (weeks) and other outcomes were measured. The exercise program included 85 sessions (general fitness class, 3 times/week, 55–60 min/session from weeks 8–10 to weeks 38–39 of pregnancy).Results:Two hundred and ninety women were analyzed (exercise group EG, n = 138, control group CG, n = 152). The mean gestational age did not differ between groups (EG= 39.7± 1.3 vs CG= 39.6 ± 1.1 weeks, P = .81). Relative to preterm deliveries in EG we found 6 (4.3%) and 11 (7.2%) in CG, (P = .73).Conclusions:A supervised program of moderate exercise performed throughout pregnancy is not a risk of preterm delivery for healthy pregnant women.

Download Full-text

Fish Oil Supplementation in Pregnancy Increases Gestational Age, Size for Gestational Age, and Birth Weight in Infants: A Randomized Controlled Trial

Journal of Nutrition ◽

10.1093/jn/nxy204 ◽

2018 ◽

Vol 149 (4) ◽

pp. 628-634 ◽

Cited By ~ 8

Author(s):

Rebecca Kofod Vinding ◽

Jakob Stokholm ◽

Astrid Sevelsted ◽

Bo L Chawes ◽

Klaus Bønnelykke ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Birth Weight ◽

Pregnant Women ◽

Gestational Age ◽

Controlled Trial ◽

Growth Curves ◽

Vitamin D Supplementation ◽

Double Blind ◽

Randomized Controlled ◽

In Pregnancy

ABSTRACT Background Randomized trials have reported that supplementation with n–3 long-chain polyunsaturated fatty acids (LCPUFAs) in pregnancy can prolong pregnancy and thereby increase birth weight. Objective We aimed to examine the relations of n–3 LCPUFA supplementation in pregnancy with duration of pregnancy, birth weight, and size for gestational age (GA). Methods This was a double-blind randomized controlled trial conducted in 736 pregnant women and their offspring, from the Copenhagen Prospective Studies on Asthma in Childhood2010cohort. They were recruited between weeks 22 and 26 in pregnancy and randomly assigned to either of 2.4 g n–3 LCPUFA or control (olive oil) daily until 1 wk after birth. Exclusion criteria were endocrine, cardiovascular, or nephrologic disorders and vitamin D supplementation intake >600 IU/d. In this study we analyzed secondary outcomes, and further excluded twin pregnancies and extrauterine death. The primary outcome for the trial was persistent wheeze or asthma. Results The random assignment ran between 2008 and 2010. Six hundred and ninety-nine mother-infant pairs were included in the analysis. n–3 LCPUFA compared with control was associated with a 2-d prolongation of pregnancy [median (IQR): 282 (275–288) d compared with 280 (273–286) d, P = 0.02], a 97-g higher birth weight (mean ± SD: 3601 ± 534 g compared with 3504 ± 528 g, P = 0.02), and an increased size for GA according to the Norwegian population-based growth curves-Skjærven (mean ± SD: 49.9 ± 28.3 percentiles compared with 44.5 ± 27.6 percentiles, P = 0.01). Conclusion Supplementing pregnant women with n–3 LCPUFAs during the third trimester is associated with prolonged gestation and increased size for GA, leading to a higher birth weight in this randomized controlled trial. This trial was registered at clinicaltrials.gov as NCT00798226.

Download Full-text

The Effect of Writing Therapy on Anxiety in Pregnant Women: A Randomized Controlled Trial

Iranian Journal of Psychiatry and Behavioral Sciences ◽

10.5812/ijpbs.98256 ◽

2020 ◽

Vol 14 (2) ◽

Author(s):

Maryam Montazeri ◽

Khalil Esmaeilpour ◽

Sakineh Mohammad-Alizadeh-Charandabi ◽

Sevda Golizadeh ◽

Mojgan Mirghafourvand

Keyword(s):

Randomized Controlled Trial ◽

Pregnant Women ◽

Controlled Trial ◽

Block Design ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled ◽

Writing Therapy ◽

Randomized Block Design ◽

Significant Difference

Background: As one of the most enjoyable life experiences, pregnancy may be accompanied by many physiological and psychological changes that make women susceptible to developing mental disorders such as anxiety. Non-pharmacological methods such as writing therapy are among the ways to deal with anxiety. Objectives: The present study aimed to determine the effect of writing therapy on anxiety in women during pregnancy. Methods: This randomized controlled trial was conducted on 70 pregnant women with a gestational age between 28 - 31 weeks. The participants were assigned to an intervention group and a control group using a randomized block design. The intervention group received three in-person writing therapy-based counseling sessions and two telephone calls between the sessions, while the control group received routine pregnancy care. The Beck anxiety inventory was completed before and six weeks after the intervention. Independent t-test and ANCOVA were used for data analysis. Results: There was no significant difference between the two groups in terms of socio-demographic variables and baseline anxiety scores. Based on ANCOVA with baseline score adjustment, the mean score of anxiety was significantly lower in the intervention group than in the control group after the intervention (adjusted mean difference = -6.8; 95%CI = -4.5 to -9.1; P < 0.001). Conclusions: According to the results, writing therapy can reduce anxiety in pregnant women; however, further studies are needed before a definitive conclusion.

Download Full-text

Harnessing Telehealth to Mitigate the Impact of the COVID-19 Pandemic on Sleep and Well-being: A Randomized Controlled Trial (Preprint)

10.2196/preprints.34409 ◽

2021 ◽

Author(s):

Kathleen P. O'Hora ◽

Raquel A. Osorno ◽

Dena Sadeghi-Bahmani ◽

Mateo Lopez ◽

Allison Morehouse ◽

...

Keyword(s):

Quality Of Life ◽

Randomized Controlled Trial ◽

Early Treatment ◽

Controlled Trial ◽

Well Being ◽

Control Group ◽

Randomized Controlled ◽

The Impact ◽

Insomnia Symptoms

BACKGROUND The COVID-19 Pandemic led to drastic increases in the prevalence and severity of insomnia symptoms. These increases in insomnia complaints have been paralleled by significant decreases in well-being, including increased symptoms of depression, anxiety, and suicidality and decreased quality of life. However, the efficacy and impact of early treatment of insomnia symptoms on future sleep and well-being remains unknown. OBJECTIVE Here, we present the framework and protocol for a novel study that aims to investigate whether a brief telehealth insomnia intervention targeting new insomnia that developed during the pandemic prevents deterioration of well-being, including symptoms of insomnia, depression, anxiety, suicidality, and quality of life. METHODS The protocol details a two-arm randomized controlled trial to investigate the efficacy of a brief, telehealth-delivered, early treatment of insomnia and evaluate its potential to prevent a deterioration of well-being. Participants with clinically significant insomnia symptoms that began during the pandemic are randomized to either a treatment group or a 28-week waitlist control group. Treatment consists of 4 telehealth sessions of Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered over 5 weeks. All participants will complete assessments of insomnia symptom severity, well-being, and daily habits checklist at baseline (week 0), and at weeks 1-6, 12, 28, and 56. RESULTS The trial began enrollment June 3, 2020 and closed enrollment June 17, 2021. As of October 2021, 49 participants have been randomized to either immediate treatment or a 28-week waitlist. 23 participants are still active in the protocol. CONCLUSIONS To our knowledge, this protocol would be represent the first study to test an early sleep intervention for improving insomnia that emerged during the COVID-19 Pandemic. The findings of this study could provide information about the utility of CBT-I for symptoms that emerge in the context of other stressors before they develop a chronic course and deepen understanding of the relationship between sleep and well-being. CLINICALTRIAL NCT04409743

Download Full-text

The Effect of a Multicomponent Dual-Task Exercise on Cortical Thickness in Older Adults with Cognitive Decline: A Randomized Controlled Trial

Journal of Clinical Medicine ◽

10.3390/jcm9051312 ◽

2020 ◽

Vol 9 (5) ◽

pp. 1312

Author(s):

Seongryu Bae ◽

Kenji Harada ◽

Sangyoon Lee ◽

Kazuhiro Harada ◽

Keitaro Makino ◽

...

Keyword(s):

Older Adults ◽

Randomized Controlled Trial ◽

Cognitive Decline ◽

Cognitive Training ◽

Cortical Thickness ◽

Exercise Intervention ◽

Controlled Trial ◽

Exercise Group ◽

Control Group ◽

Randomized Controlled

The aim of this study was to examine cortical thickness changes associated with a multicomponent exercise intervention combining physical exercise and cognitive training in older adults with cognitive decline. This study involved a secondary analysis of neuroimaging data from a randomized controlled trial with 280 older adults having cognitive decline who were randomly assigned to either a multicomponent exercise group (n = 140) that attended weekly 90-minute exercise and cognitive training sessions or a health education control group (n = 140). The cortical thickness and cognitive performance were assessed at the baseline and at trial completion (10 months). The cortical thickness in the frontal and temporal regions was determined using FreeSurfer software. Cognitive performance was evaluated using the Gerontology-Functional Assessment Tool (NCGG-FAT). The cortical thickness significantly increased in the middle temporal (p < 0.001) and temporal pole (p < 0.001) in the multicomponent exercise group compared with the control group. Cortical thickness changes were significantly associated with change in trail making test (TMT)-A, TMT-B, and story memory after a 10-month multicomponent exercise intervention. This study suggests that multicomponent exercise programs combining physical exercise and cognitive training have important implications for brain health, especially in providing protection from age-related cortical thinning.

Download Full-text

A randomized controlled trial of a specific reminiscence approach to promote the well-being of nursing home residents with dementia

International Psychogeriatrics ◽

10.1017/s1041610204000055 ◽

2004 ◽

Vol 16 (1) ◽

pp. 33-49 ◽

Cited By ~ 80

Author(s):

Claudia K. Y. Lai ◽

Iris Chi ◽

Jeanie Kayser-Jones

Keyword(s):

Randomized Controlled Trial ◽

Nursing Home ◽

Repeated Measures ◽

Comparison Group ◽

Controlled Trial ◽

Intervention Group ◽

Nursing Home Residents ◽

Well Being ◽

Control Group ◽

Randomized Controlled

Background: To date, no firm conclusions can be reached regarding the effectiveness of reminiscence for dementia. Researchers have emphasized that there is an urgent need for more systematic research in the area.Objective and Method: A single-blinded, parallel-groups (one intervention, one comparison, and one no-intervention group) randomized controlled trial (RCT) was adopted to investigate whether a specific reminiscence program leads to higher levels of psychosocial well-being in nursing home residents with dementia. The intervention adopted a life-story approach, while the comparison group provided friendly discussions to control for any changes in outcome as a result of social contacts and attention. The Social Engagement Scale (SES) and Well-being/Ill-being Scale (WIB) were the outcome measures used. The outcomes of the groups were examined with reference to the baseline (T0), immediately (T1), and six weeks (T2) after intervention. The final sample had 101 subjects (control group: n=30; comparison group: n=35; intervention group: n=36). Using multivariate analysis with repeated measures, no significant differences in outcome were found between groups at either T1 or T2. Wilcoxon signed rank tests were performed for each group comparing outcomes between T1 and T0, T2 and T1, and T2 and T0. Significant differences were observed in the intervention group when comparing T1 and T0 WIB (p=.014), but not for the other groups.Conclusion: Although the intervention did not lead to significant differences between the three groups over time, there was a significant improvement in psychosocial well-being for the intervention group.

Download Full-text

A Digital Program (Hope) for People Living With Cancer During the COVID-19 Pandemic: Protocol for a Feasibility Randomized Controlled Trial

JMIR Research Protocols ◽

10.2196/24264 ◽

2020 ◽

Vol 9 (12) ◽

pp. e24264

Author(s):

Hayley Wright ◽

Faith Martin ◽

Wendy Clyne ◽

Cain C T Clark ◽

Michael McGillion ◽

...

Keyword(s):

Mental Health ◽

Randomized Controlled Trial ◽

Data Collection ◽

Controlled Trial ◽

Well Being ◽

Control Group ◽

Wait List ◽

Care Providers ◽

Randomized Controlled ◽

Cancer Support

Background During the COVID-19 lockdown period in the United Kingdom that began on March 23, 2020, more than a quarter of a million people with cancer reported worsening mental health. Help to Overcome Problems Effectively (Hope) is a self-management program for people with cancer, designed to provide support for distress, unmet needs, and poor psychological health. In light of social distancing during the COVID-19 pandemic, digital delivery of the Hope Programme has become ever more vital for people with cancer. Previous pre-post studies of the digital Hope Programme have found reduced anxiety and depression and improved well-being for people with cancer. However, evaluation of this evidence has been limited by the lack of a control group in these previous studies. Objective We now present a protocol for a feasibility randomized controlled trial of the digital Hope Programme for people with cancer during the COVID-19 pandemic. Primary outcomes will be recruitment, dropout, and adherence rates, and estimations of sample and effect size. To detect signals of efficacy, secondary outcomes will be participant mental health and well-being. Methods Participants will be recruited by Macmillan Cancer Support (MCS) through their social media networks. The study will employ a feasibility wait-list randomized controlled trial (RCT) design, with people with cancer being randomized to join the digital Hope Programme immediately (intervention group [IG]) or join a 6-week waiting list (wait-list control group [WLCG]) with a 1:1 allocation ratio. Participants will complete digital measures of depression, anxiety, mental well-being, and confidence in managing their own health. Online questionnaires will be administered preprogram and 6 weeks postprogram. Results All people who had requested access to the Hope Programme from MCS (N=61) will be invited to participate in the trial. Baseline data collection commenced in April 2020, and the Hope Programme began for the IG in May 2020 and for the WLCG in June 2020. Postprogram data collection was completed by the end of August 2020. Conclusions This feasibility study will provide data to inform the design of a future definitive trial. Wider-scale provision of the digital Hope Programme has potential to improve the lives of thousands of people with cancer and reduce the burden on health care providers during these unprecedented times. Trial Registration ISRCTN Registry ISRCTN79623250; http://www.isrctn.com/ISRCTN79623250 International Registered Report Identifier (IRRID) DERR1-10.2196/24264

Download Full-text

Effects of Hatha Yoga on caregivers of children and adolescents with cancer: a randomized controlled trial

Escola Anna Nery ◽

10.1590/2177-9465-ean-2019-0133 ◽

2020 ◽

Vol 24 (1) ◽

Author(s):

Marina Lima Daleprane Bernardi ◽

Maria Helena Costa Amorim ◽

Luciane Bresciane Salaroli ◽

Eliana Zandonade

Keyword(s):

Randomized Controlled Trial ◽

Children And Adolescents ◽

Controlled Trial ◽

Well Being ◽

Hatha Yoga ◽

Control Group ◽

Anxiety State ◽

Clinical Group ◽

Subjective Well Being ◽

Randomized Controlled

Abstract Objective: To assess the effects of a Hatha Yoga intervention on anxiety, subjective well-being, and attention levels of caregivers of children and adolescents with cancer, admitted to a public hospital in the city of Vitória, state of Espírito Santo, Brazil. Methods: A randomized controlled trial was performed. Thirty-six volunteers were allocated to clinical (participated in 4 to 6 Hatha Yoga practices) or control groups and answered the questionnaires State-Trait Anxiety Inventory, Subjective Well-Being Scale, and Mindfulness Attention Awareness Scale before and after the intervention period. Mann-Whitney and Wilcoxon nonparametric analyses were performed to compare the groups to each other and at different moments. Results: The individuals' moderate anxiety state decreased in the clinical (p = 0.001) and control (p = 0.014) groups so that while the control group continued to present moderate anxiety, the clinical group presented low anxiety after the intervention. Positive affects increased, and adverse effects decreased in the clinical group (p <0.05). There were no relevant changes in satisfaction with life and attention levels in the two groups (p> 0.05). Conclusion and implications for practice: Hatha Yoga is a useful tool for healthcare professionals and caregivers in short-term hospital care to reduce anxiety and improve subjective well-being.

Download Full-text

Gratitude as Mood Mediates the Effects of a 6-Weeks Gratitude Intervention on Mental Well-Being: Post hoc Analysis of a Randomized Controlled Trial

Frontiers in Psychology ◽

10.3389/fpsyg.2021.799447 ◽

2022 ◽

Vol 12 ◽

Author(s):

Ernst Bohlmeijer ◽

Jannis Kraiss ◽

Marijke Schotanus-Dijkstra ◽

Peter ten Klooster

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Well Being ◽

Sensitivity Analyses ◽

Control Group ◽

Multiple Mediation ◽

Randomized Controlled ◽

Gratitude Intervention ◽

Mental Well Being ◽

Gratitude Interventions

There is a gap of knowledge about the extent to which gratitude is indeed the working mechanism of change in gratitude interventions aiming to promote mental well-being. This study explores the mediational role of gratitude as mood in the context of a recently conducted randomized controlled trial on the effects of a 6-week gratitude intervention on mental well-being in comparison with a waitlist control group. Gratitude as mood was measured at 2, 4, and 6 weeks. Both simple and multiple mediation models were conducted as well as various sensitivity analyses. Results showed a gradual increase of gratitude as mood during the intervention. The effects of the 6-week gratitude intervention on mental well-being were mediated by increases of gratitude as mood at 4 weeks but not at 2 weeks. These findings suggest a dose-response relationship for gratitude interventions, but more research is warranted.

Download Full-text

Nutrition information system (SISFORNUTRIMIL) application With Online Food Record for Indonesia Pregnant Women: Protocol for Randomized Controlled Trial

10.21203/rs.3.rs-634069/v1 ◽

2021 ◽

Author(s):

Mira Trisyani Koeryaman ◽

Saseendran Pallikadavath ◽

Isobel Ryder ◽

Ngianga Kandala

Keyword(s):

Randomized Controlled Trial ◽

Pregnant Women ◽

Dietary Diversity ◽

Controlled Trial ◽

Intervention Group ◽

Eating Behaviour ◽

Control Group ◽

Food Record ◽

Randomized Controlled ◽

The Impact

Abstract Background: The pregnant women and family may not have the necessary knowledge and skills to estimate nutrient value in food in line with dietary targets and the guidelines, i.e. they do not know whether or not they are consuming the right amount of nutrition needed during pregnancy. The aims of this randomized controlled trial (RCT) is to examine the impact of SISFORNUTRIMIL application on maternal eating behaviour and associated maternal factors such as weight gain, blood pressure, biochemical measurement, and pregnancy outcome.Methods: The study recruits 112 participants with eligible criteria during December 2019 to January 2020. The allocation of participants is 1:1 to the SISFORNUTRIMIL application user and non-user application, with criteria: singleton pregnancy (22-26 weeks), mother age between 20-35 years), have monthly income and literate. Both groups will receive 12-week standard health services from health professionals and received information about dietary diversity and food record. Particularly, intervention group could be access the SISFORNUTRIMIL on their devices, which provide necessary information about nutrition in pregnancy, food record and food choice includes total serving size calculation. In contrast, the control group only receive food information and food intake record by paper-based, and they should record and calculate the nutrition intake by traditionally. Discussion: This is the first randomized controlled trial to examine the SISFORNUTIMIL application. This mandate reflects keen interest and motivation for the proposed research study. This is in addition to the researcher’s personal efforts to reduce morbidity and mortality rate as well as a general focus on pregnancy complication prevention than nutrition treatment. Thus, an investigation of eating behaviour and associated maternal needed to address this issue. Firstly, the results could extend the scope of knowledge about nutrition intervention to include the Indonesia pregnant women context as well as the Indonesia health ministry context. Secondly, this research could help to change individual health behaviour and activity undertaken by an individual who believes her-self to be healthy.Trial registration: ISRCTN Registry: ISRCTN42690828. Date of registration: 22 October 2019.

Download Full-text

A structured exercise to relieve musculoskeletal pain caused by face-down posture after retinal surgery: a randomized controlled trial

Scientific Reports ◽

10.1038/s41598-021-01182-w ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

A-Young Kim ◽

Sungsoon Hwang ◽

Se Woong Kang ◽

So Yeon Shin ◽

Won Hyuk Chang ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Musculoskeletal Pain ◽

Controlled Trial ◽

Exercise Group ◽

Control Group ◽

Randomized Controlled ◽

Pain Scores ◽

Lower Back ◽

Physical Burden ◽

Lower Pain

AbstractFace-down posture after vitrectomy physically burdens patients. Despite being of significant concern for patients, the intraoperative pain and discomfort has not been of great interest to retinal surgeons or researchers. This randomized controlled trial evaluated the effect of a 3-day novel structured exercise on reducing musculoskeletal pain from the face-down posture in 61 participants (31 in the exercise group) who underwent vitrectomy. Among the subjects, the median age was 62 years, 42 were female, 42 had macular holes, and 19 had retinal detachments. Participants in the exercise group received initial education on the exercise and performed three daily active exercise sessions. After the sessions, the exercise group had median numeric pain scores of 2, 1, and 1 at the back neck, shoulder, and lower back, respectively, while the control group had corresponding scores of 5, 3, and 4, respectively. The exercise group reported significantly lower pain scores (P = .003, .039, and .006 for the back neck, shoulder, and lower back, respectively). Application of the structured exercise would alleviate the patients’ position-induced postoperative physical burden, by reducing pain and discomfort.

Download Full-text